Trial Outcomes & Findings for IMAGINATOR 2.0: Co-design and Early Evaluation of a Novel Blended Digital Intervention Targeting Self-harm in Young People (NCT NCT06311084)
NCT ID: NCT06311084
Last Updated: 2025-04-17
Results Overview
Percentage of eligible enrolled participants not completing outcome assessment
COMPLETED
NA
29 participants
1 year
2025-04-17
Participant Flow
The protocol initially planned for the enrolment of 20 participants, with the aim of analysing data from 15 participants who completed the study. However, we received more referrals than anticipated and 29 were eligible and analysed to account for potential attrition and ultimately, 15 participants completed the study, aligning with our target for analysis.
Participant milestones
| Measure |
Imaginator App Plus Therapy
After Baseline screening visit, participants received 3 x 1-hour Functional Imagery Training (FIT) sessions in person or via MS Teams once a week. Therapy sessions were delivered by a Child Wellbeing Practitioner (CWP), Clinical Assistant Psychology Therapists (CAPT) or therapist. After completion of the 3 therapy sessions, participants received 5 x 15-30-minute phone-call support sessions fortnightly. FIT comprised of the following key elements: Session 1 - formulation of personal drivers of SH behaviour and motivational interviewing combined with mental imagery techniques; Session 2 - mental imagery of a past achievement, formulation of goals (e.g.,a desired behaviour incompatible with or alternative to SH) and functional imagery plan to achieve them; Session 3 - practice and refinement of functional imagery, problem-solving of challenges. Follow-up phone-call sessions focused on refining functional imagery practice, problem-solving, motivational encouragement, and personalisation of the app use. Participants receiveed smartphone app-based reminders (from Imaginator app), exercises and support from the second FIT session. Upon completion of the follow-up sessions, participants were invited to an outcome assessment after 1 week, at approximately 3 months post intervention. Optional user-led feedback interviews with participants were carried out upon study completion (after final assessment).
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|---|---|
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Overall Study
STARTED
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29
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Overall Study
COMPLETED
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15
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Overall Study
NOT COMPLETED
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14
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Reasons for withdrawal
| Measure |
Imaginator App Plus Therapy
After Baseline screening visit, participants received 3 x 1-hour Functional Imagery Training (FIT) sessions in person or via MS Teams once a week. Therapy sessions were delivered by a Child Wellbeing Practitioner (CWP), Clinical Assistant Psychology Therapists (CAPT) or therapist. After completion of the 3 therapy sessions, participants received 5 x 15-30-minute phone-call support sessions fortnightly. FIT comprised of the following key elements: Session 1 - formulation of personal drivers of SH behaviour and motivational interviewing combined with mental imagery techniques; Session 2 - mental imagery of a past achievement, formulation of goals (e.g.,a desired behaviour incompatible with or alternative to SH) and functional imagery plan to achieve them; Session 3 - practice and refinement of functional imagery, problem-solving of challenges. Follow-up phone-call sessions focused on refining functional imagery practice, problem-solving, motivational encouragement, and personalisation of the app use. Participants receiveed smartphone app-based reminders (from Imaginator app), exercises and support from the second FIT session. Upon completion of the follow-up sessions, participants were invited to an outcome assessment after 1 week, at approximately 3 months post intervention. Optional user-led feedback interviews with participants were carried out upon study completion (after final assessment).
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|---|---|
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Overall Study
Lost to Follow-up
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14
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Baseline Characteristics
There was higher-than-expected attrition during the study. While we initially enrolled 29 participants (analysed in first row), only 15 completed the outcome assessment after the intervention duration. Therefore, as we were interested in changes before and after the intervention, we also report the baseline results for just the 15 participants who completed both baseline and outcome assessments (analysed in second row).
Baseline characteristics by cohort
| Measure |
Imaginator App Plus Therapy
n=29 Participants
After Baseline screening visit, participants received 3 x 1-hour Functional Imagery Training (FIT) sessions in person or via MS Teams once a week. Therapy sessions were delivered by a Child Wellbeing Practitioner (CWP), Clinical Assistant Psychology Therapists (CAPT) or therapist. After completion of the 3 therapy sessions, participants received 5 x 15-30-minute phone-call support sessions fortnightly. FIT comprised of the following key elements: Session 1 - formulation of personal drivers of SH behaviour and motivational interviewing combined with mental imagery techniques; Session 2 - mental imagery of a past achievement, formulation of goals (e.g.,a desired behaviour incompatible with or alternative to SH) and functional imagery plan to achieve them; Session 3 - practice and refinement of functional imagery, problem-solving of challenges. Follow-up phone-call sessions focused on refining functional imagery practice, problem-solving, motivational encouragement, and personalisation of the app use. Participants receiveed smartphone app-based reminders (from Imaginator app), exercises and support from the second FIT session. Upon completion of the follow-up sessions, participants were invited to an outcome assessment after 1 week, at approximately 3 months post intervention. Optional user-led feedback interviews with participants were carried out upon study completion (after final assessment).
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|---|---|
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Age, Continuous
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18.86 years
STANDARD_DEVIATION 3.74 • n=29 Participants
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Sex/Gender, Customized
Female
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28 Participants
n=29 Participants
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Sex/Gender, Customized
Transgender
|
1 Participants
n=29 Participants
|
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Race/Ethnicity, Customized
White
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17 Participants
n=29 Participants
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Race/Ethnicity, Customized
Black, African, Caribbean or Black British
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4 Participants
n=29 Participants
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|
Race/Ethnicity, Customized
Mixed or Multiple ethnic groups
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3 Participants
n=29 Participants
|
|
Race/Ethnicity, Customized
Asian of Asian British
|
2 Participants
n=29 Participants
|
|
Race/Ethnicity, Customized
Other ethnic group
|
3 Participants
n=29 Participants
|
|
Sexual Orientation
Heterosexual
|
12 Participants
n=29 Participants
|
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Sexual Orientation
Other
|
12 Participants
n=29 Participants
|
|
Sexual Orientation
Homosexual
|
3 Participants
n=29 Participants
|
|
Sexual Orientation
Not sure
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2 Participants
n=29 Participants
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|
Highest level of education completed
Postgraduate education
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1 Participants
n=29 Participants
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|
Highest level of education completed
Higher education
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7 Participants
n=29 Participants
|
|
Highest level of education completed
Secondary education
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13 Participants
n=29 Participants
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|
Highest level of education completed
Primary education
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8 Participants
n=29 Participants
|
|
Household Income
<50,000
|
18 Participants
n=29 Participants
|
|
Household Income
50,000 - 100,000
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9 Participants
n=29 Participants
|
|
Household Income
100,000 - 150,000
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1 Participants
n=29 Participants
|
|
Household Income
150,000 - 200,000
|
1 Participants
n=29 Participants
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|
Currently in education training
Yes
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14 Participants
n=29 Participants
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Currently in education training
No
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15 Participants
n=29 Participants
|
|
Employment status
Yes - Employed
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14 Participants
n=29 Participants
|
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Employment status
No - Not Employed
|
15 Participants
n=29 Participants
|
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Timeline Follow-Back Technique (TLFB)
All Baseline Participants
|
7.5 units on a scale
n=29 Participants • There was higher-than-expected attrition during the study. While we initially enrolled 29 participants (analysed in first row), only 15 completed the outcome assessment after the intervention duration. Therefore, as we were interested in changes before and after the intervention, we also report the baseline results for just the 15 participants who completed both baseline and outcome assessments (analysed in second row).
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Timeline Follow-Back Technique (TLFB)
Participants who completed the Outcome Assessment
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6.5 units on a scale
n=15 Participants • There was higher-than-expected attrition during the study. While we initially enrolled 29 participants (analysed in first row), only 15 completed the outcome assessment after the intervention duration. Therefore, as we were interested in changes before and after the intervention, we also report the baseline results for just the 15 participants who completed both baseline and outcome assessments (analysed in second row).
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Self-Harm Imagery Interview (PANAS+)
All Baseline Participants
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16 units on a scale
n=29 Participants • There was higher-than-expected attrition during the study. While we initially enrolled 29 participants (analysed in first row), only 15 completed the outcome assessment after the intervention duration. Therefore, as we were interested in changes before and after the intervention, we also report the baseline results for just the 15 participants who completed both baseline and outcome assessments (analysed in second row).
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Self-Harm Imagery Interview (PANAS+)
Participants who completed the Outcome Assessment
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14 units on a scale
n=15 Participants • There was higher-than-expected attrition during the study. While we initially enrolled 29 participants (analysed in first row), only 15 completed the outcome assessment after the intervention duration. Therefore, as we were interested in changes before and after the intervention, we also report the baseline results for just the 15 participants who completed both baseline and outcome assessments (analysed in second row).
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Self-Harm Imagery Interview (PANAS-)
All Baseline Participants
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32 units on a scale
n=29 Participants • There was higher-than-expected attrition during the study. While we initially enrolled 29 participants (analysed in first row), only 15 completed the outcome assessment after the intervention duration. Therefore, as we were interested in changes before and after the intervention, we also report the baseline results for just the 15 participants who completed both baseline and outcome assessments (analysed in second row).
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Self-Harm Imagery Interview (PANAS-)
Participants who completed the Outcome Assessment
|
33 units on a scale
n=15 Participants • There was higher-than-expected attrition during the study. While we initially enrolled 29 participants (analysed in first row), only 15 completed the outcome assessment after the intervention duration. Therefore, as we were interested in changes before and after the intervention, we also report the baseline results for just the 15 participants who completed both baseline and outcome assessments (analysed in second row).
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State Motivation for Reducing Self-harm (SM-SH) scale
All Baseline Participants
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5.67 units on a scale
n=29 Participants • There was higher-than-expected attrition during the study. While we initially enrolled 29 participants (analysed in first row), only 15 completed the outcome assessment after the intervention duration. Therefore, as we were interested in changes before and after the intervention, we also report the baseline results for just the 15 participants who completed both baseline and outcome assessments (analysed in second row).
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State Motivation for Reducing Self-harm (SM-SH) scale
Participants who completed the Outcome Assessment
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5.33 units on a scale
n=15 Participants • There was higher-than-expected attrition during the study. While we initially enrolled 29 participants (analysed in first row), only 15 completed the outcome assessment after the intervention duration. Therefore, as we were interested in changes before and after the intervention, we also report the baseline results for just the 15 participants who completed both baseline and outcome assessments (analysed in second row).
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Craving Experience Questionnaire for Self-Harm (CEQ-SH)
All Baseline Participants
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60 units on a scale
n=29 Participants • There was higher-than-expected attrition during the study. While we initially enrolled 29 participants (analysed in first row), only 15 completed the outcome assessment after the intervention duration. Therefore, as we were interested in changes before and after the intervention, we also report the baseline results for just the 15 participants who completed both baseline and outcome assessments (analysed in second row).
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Craving Experience Questionnaire for Self-Harm (CEQ-SH)
Participants who completed the Outcome Assessment
|
59 units on a scale
n=15 Participants • There was higher-than-expected attrition during the study. While we initially enrolled 29 participants (analysed in first row), only 15 completed the outcome assessment after the intervention duration. Therefore, as we were interested in changes before and after the intervention, we also report the baseline results for just the 15 participants who completed both baseline and outcome assessments (analysed in second row).
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Revised Children's Anxiety and Depression Scale (RCADS) - Anxiety subscale
All Baseline Participants
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68 units on a scale
n=11 Participants • This measure is only for 12-17 year olds, so only people in this age range are analysed. Initially, we enrolled 29 participants out of which 11 were 12-17 years old (analysed in first row). As we were interested in changes before and after the intervention, we also report the baseline results just for the participants who completed the outcome assessment. Out of the 15 participants who completed the outcome assessment, 7 were 12-17 years old (analysed in second row).
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Revised Children's Anxiety and Depression Scale (RCADS) - Anxiety subscale
Participants who completed the Outcome Assessment
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57 units on a scale
n=7 Participants • This measure is only for 12-17 year olds, so only people in this age range are analysed. Initially, we enrolled 29 participants out of which 11 were 12-17 years old (analysed in first row). As we were interested in changes before and after the intervention, we also report the baseline results just for the participants who completed the outcome assessment. Out of the 15 participants who completed the outcome assessment, 7 were 12-17 years old (analysed in second row).
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Revised Children's Anxiety and Depression Scale (RCADS) - Depression subscale
All Baseline Participants
|
20 units on a scale
n=11 Participants • This measure is only for 12-17 year olds, so only people in this age range are analysed. Initially, we enrolled 29 participants out of which 11 were 12-17 years old (analysed in first row). As we were interested in changes before and after the intervention, we also report the baseline results just for the participants who completed the outcome assessment. Out of the 15 participants who completed the outcome assessment, 7 were 12-17 years old (analysed in second row).
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Revised Children's Anxiety and Depression Scale (RCADS) - Depression subscale
Participants who completed the Outcome Assessment
|
18 units on a scale
n=7 Participants • This measure is only for 12-17 year olds, so only people in this age range are analysed. Initially, we enrolled 29 participants out of which 11 were 12-17 years old (analysed in first row). As we were interested in changes before and after the intervention, we also report the baseline results just for the participants who completed the outcome assessment. Out of the 15 participants who completed the outcome assessment, 7 were 12-17 years old (analysed in second row).
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Depression, Anxiety and Stress Scale (DASS-21) - Depression subscale
All Baseline Participants
|
35 units on a scale
n=18 Participants • This measure is only for 18-25 year olds, so only people in this age range are analysed. Initially, we enrolled 29 participants out of which 18 were 18-25 years old (analysed in first row). As we were interested in changes before and after the intervention, we also report the baseline results just for the participants who completed the outcome assessment. Out of the 15 participants who completed the outcome assessment, 8 were 18-25 years old (analysed in second row).
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Depression, Anxiety and Stress Scale (DASS-21) - Depression subscale
Participants who completed the Outcome Assessment
|
36 units on a scale
n=8 Participants • This measure is only for 18-25 year olds, so only people in this age range are analysed. Initially, we enrolled 29 participants out of which 18 were 18-25 years old (analysed in first row). As we were interested in changes before and after the intervention, we also report the baseline results just for the participants who completed the outcome assessment. Out of the 15 participants who completed the outcome assessment, 8 were 18-25 years old (analysed in second row).
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Depression, Anxiety and Stress Scale (DASS-21) - Anxiety subscale
All Baseline Participants
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29 units on a scale
n=18 Participants • This measure is only for 18-25 year olds, so only people in this age range are analysed. Initially, we enrolled 29 participants out of which 18 were 18-25 years old (analysed in first row). As we were interested in changes before and after the intervention, we also report the baseline results just for the participants who completed the outcome assessment. Out of the 15 participants who completed the outcome assessment, 8 were 18-25 years old (analysed in second row).
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Depression, Anxiety and Stress Scale (DASS-21) - Anxiety subscale
Participants who completed the Outcome Assessment
|
36 units on a scale
n=8 Participants • This measure is only for 18-25 year olds, so only people in this age range are analysed. Initially, we enrolled 29 participants out of which 18 were 18-25 years old (analysed in first row). As we were interested in changes before and after the intervention, we also report the baseline results just for the participants who completed the outcome assessment. Out of the 15 participants who completed the outcome assessment, 8 were 18-25 years old (analysed in second row).
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|
Depression, Anxiety and Stress Scale (DASS-21) - Stress subscale
All Baseline Participants
|
35 units on a scale
n=18 Participants • This measure is only for 18-25 year olds, so only people in this age range are analysed. Initially, we enrolled 29 participants out of which 18 were 18-25 years old (analysed in first row). As we were interested in changes before and after the intervention, we also report the baseline results just for the participants who completed the outcome assessment. Out of the 15 participants who completed the outcome assessment, 8 were 18-25 years old (analysed in second row).
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Depression, Anxiety and Stress Scale (DASS-21) - Stress subscale
Participants who completed the Outcome Assessment
|
37 units on a scale
n=8 Participants • This measure is only for 18-25 year olds, so only people in this age range are analysed. Initially, we enrolled 29 participants out of which 18 were 18-25 years old (analysed in first row). As we were interested in changes before and after the intervention, we also report the baseline results just for the participants who completed the outcome assessment. Out of the 15 participants who completed the outcome assessment, 8 were 18-25 years old (analysed in second row).
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Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
All Baseline Participants
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33 units on a scale
n=29 Participants • There was higher-than-expected attrition during the study. While we initially enrolled 29 participants (analysed in first row), only 15 completed the outcome assessment after the intervention duration. Therefore, as we were interested in changes before and after the intervention, we also report the baseline results for just the 15 participants who completed both baseline and outcome assessments (analysed in second row).
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Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
Participants who completed the Outcome Assessment
|
32 units on a scale
n=15 Participants • There was higher-than-expected attrition during the study. While we initially enrolled 29 participants (analysed in first row), only 15 completed the outcome assessment after the intervention duration. Therefore, as we were interested in changes before and after the intervention, we also report the baseline results for just the 15 participants who completed both baseline and outcome assessments (analysed in second row).
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Difficulties in Emotion Regulation Scale-Short Form (DERS-SF)
All Baseline Participants
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65 units on a scale
n=29 Participants • There was higher-than-expected attrition during the study. While we initially enrolled 29 participants (analysed in first row), only 15 completed the outcome assessment after the intervention duration. Therefore, as we were interested in changes before and after the intervention, we also report the baseline results for just the 15 participants who completed both baseline and outcome assessments (analysed in second row).
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Difficulties in Emotion Regulation Scale-Short Form (DERS-SF)
Participants who completed the Outcome Assessment
|
66 units on a scale
n=15 Participants • There was higher-than-expected attrition during the study. While we initially enrolled 29 participants (analysed in first row), only 15 completed the outcome assessment after the intervention duration. Therefore, as we were interested in changes before and after the intervention, we also report the baseline results for just the 15 participants who completed both baseline and outcome assessments (analysed in second row).
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11-item behaviour supplement to the Borderline Symptom List
All Baseline Participants
|
9 units on a scale
n=29 Participants • There was higher-than-expected attrition during the study. While we initially enrolled 29 participants (analysed in first row), only 15 completed the outcome assessment after the intervention duration. Therefore, as we were interested in changes before and after the intervention, we also report the baseline results for just the 15 participants who completed both baseline and outcome assessments (analysed in second row).
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11-item behaviour supplement to the Borderline Symptom List
Participants who completed the Outcome Assessment
|
10 units on a scale
n=15 Participants • There was higher-than-expected attrition during the study. While we initially enrolled 29 participants (analysed in first row), only 15 completed the outcome assessment after the intervention duration. Therefore, as we were interested in changes before and after the intervention, we also report the baseline results for just the 15 participants who completed both baseline and outcome assessments (analysed in second row).
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Alcohol Use Disorders Identification Test (AUDIT)
All Baseline Participants
|
6 units on a scale
n=29 Participants • There was higher-than-expected attrition during the study. While we initially enrolled 29 participants (analysed in first row), only 15 completed the outcome assessment after the intervention duration. Therefore, as we were interested in changes before and after the intervention, we also report the baseline results for just the 15 participants who completed both baseline and outcome assessments (analysed in second row).
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Alcohol Use Disorders Identification Test (AUDIT)
Participants who completed the Outcome Assessment
|
3 units on a scale
n=15 Participants • There was higher-than-expected attrition during the study. While we initially enrolled 29 participants (analysed in first row), only 15 completed the outcome assessment after the intervention duration. Therefore, as we were interested in changes before and after the intervention, we also report the baseline results for just the 15 participants who completed both baseline and outcome assessments (analysed in second row).
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Cannabis Use Disorder Identification Test Revised (CUDIT-R)
All Baseline Participants
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0 units on a scale
n=29 Participants • There was higher-than-expected attrition during the study. While we initially enrolled 29 participants (analysed in first row), only 15 completed the outcome assessment after the intervention duration. Therefore, as we were interested in changes before and after the intervention, we also report the baseline results for just the 15 participants who completed both baseline and outcome assessments (analysed in second row).
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Cannabis Use Disorder Identification Test Revised (CUDIT-R)
Participants who completed the Outcome Assessment
|
0 units on a scale
n=15 Participants • There was higher-than-expected attrition during the study. While we initially enrolled 29 participants (analysed in first row), only 15 completed the outcome assessment after the intervention duration. Therefore, as we were interested in changes before and after the intervention, we also report the baseline results for just the 15 participants who completed both baseline and outcome assessments (analysed in second row).
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PRIMARY outcome
Timeframe: 1 yearPopulation: 29 participants completed baseline assessment. Out of the 29, 14 did not complete the outcome assessment.
Percentage of eligible enrolled participants not completing outcome assessment
Outcome measures
| Measure |
Imaginator App Plus Therapy
n=29 Participants
After Baseline screening visit, participants received 3 x 1-hour Functional Imagery Training (FIT) sessions in person or via MS Teams once a week. Therapy sessions were delivered by a Child Wellbeing Practitioner (CWP), Clinical Assistant Psychology Therapists (CAPT) or therapist. After completion of the 3 therapy sessions, participants received 5 x 15-30-minute phone-call support sessions fortnightly. FIT comprised of the following key elements: Session 1 - formulation of personal drivers of SH behaviour and motivational interviewing combined with mental imagery techniques; Session 2 - mental imagery of a past achievement, formulation of goals (e.g.,a desired behaviour incompatible with or alternative to SH) and functional imagery plan to achieve them; Session 3 - practice and refinement of functional imagery, problem-solving of challenges. Follow-up phone-call sessions focused on refining functional imagery practice, problem-solving, motivational encouragement, and personalisation of the app use. Participants receiveed smartphone app-based reminders (from Imaginator app), exercises and support from the second FIT session. Upon completion of the follow-up sessions, participants were invited to an outcome assessment after 1 week, at approximately 3 months post intervention. Optional user-led feedback interviews with participants were carried out upon study completion (after final assessment).
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|---|---|
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Number of Patients Lost to Attrition
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14 Participants
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PRIMARY outcome
Timeframe: 3 monthsPopulation: 29 eligible participants completed the baseline assessment. Out of the 29, 27 started therapy and 16 completed therapy per protocol meaning 3 face-to-face sessions and 2 follow up phone calls.
Percentage of participants completing number of sessions as per-protocol (five sessions) out of the 27 participants who started therapy.
Outcome measures
| Measure |
Imaginator App Plus Therapy
n=27 Participants
After Baseline screening visit, participants received 3 x 1-hour Functional Imagery Training (FIT) sessions in person or via MS Teams once a week. Therapy sessions were delivered by a Child Wellbeing Practitioner (CWP), Clinical Assistant Psychology Therapists (CAPT) or therapist. After completion of the 3 therapy sessions, participants received 5 x 15-30-minute phone-call support sessions fortnightly. FIT comprised of the following key elements: Session 1 - formulation of personal drivers of SH behaviour and motivational interviewing combined with mental imagery techniques; Session 2 - mental imagery of a past achievement, formulation of goals (e.g.,a desired behaviour incompatible with or alternative to SH) and functional imagery plan to achieve them; Session 3 - practice and refinement of functional imagery, problem-solving of challenges. Follow-up phone-call sessions focused on refining functional imagery practice, problem-solving, motivational encouragement, and personalisation of the app use. Participants receiveed smartphone app-based reminders (from Imaginator app), exercises and support from the second FIT session. Upon completion of the follow-up sessions, participants were invited to an outcome assessment after 1 week, at approximately 3 months post intervention. Optional user-led feedback interviews with participants were carried out upon study completion (after final assessment).
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|---|---|
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Number of Patients Adhering to Treatment
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16 Participants
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PRIMARY outcome
Timeframe: 3 monthsThis is an acceptability measure of app use designed to assess perceptions of the app, with items rated on a 7-point Likert scale ranging from -3 to +3. A score of -3 reflects the poorest user experience, while a score of +3 represents the highest level of satisfaction. A score of 0 indicates a neutral experience. The questionnaire consists of 26 items divided across six subscales: Attractiveness (overall impression), Perspicuity (ease of understanding), Efficiency (task completion speed), Dependability (reliability), Stimulation (engagement and enjoyment), and Novelty (innovation and creativity). For each of the six dimensions, the mean score of the items that correspond to that dimension is calculated. Higher scores across these subscales reflect a better overall user experience, while lower scores highlight specific areas for improvement. For the purposes of this analysis, the average of all dimensions mean scores were calculated for each participant.
Outcome measures
| Measure |
Imaginator App Plus Therapy
n=15 Participants
After Baseline screening visit, participants received 3 x 1-hour Functional Imagery Training (FIT) sessions in person or via MS Teams once a week. Therapy sessions were delivered by a Child Wellbeing Practitioner (CWP), Clinical Assistant Psychology Therapists (CAPT) or therapist. After completion of the 3 therapy sessions, participants received 5 x 15-30-minute phone-call support sessions fortnightly. FIT comprised of the following key elements: Session 1 - formulation of personal drivers of SH behaviour and motivational interviewing combined with mental imagery techniques; Session 2 - mental imagery of a past achievement, formulation of goals (e.g.,a desired behaviour incompatible with or alternative to SH) and functional imagery plan to achieve them; Session 3 - practice and refinement of functional imagery, problem-solving of challenges. Follow-up phone-call sessions focused on refining functional imagery practice, problem-solving, motivational encouragement, and personalisation of the app use. Participants receiveed smartphone app-based reminders (from Imaginator app), exercises and support from the second FIT session. Upon completion of the follow-up sessions, participants were invited to an outcome assessment after 1 week, at approximately 3 months post intervention. Optional user-led feedback interviews with participants were carried out upon study completion (after final assessment).
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User Experience Questionnaire
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0.65 score on a scale
Interval 0.27 to 1.28
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PRIMARY outcome
Timeframe: 3 monthsThis is an 8 item version (Attkisson \& Zwick, 1982) designed to provide a sensitive and comprehensive assessment of patient satisfaction with the therapy received. This was only administered post-treatment and sum scores were calculated for each participant. Each item is rated on a 4-point Likert scale, where responses range from 1 (very dissatisfied) to 4 (very satisfied). The individual scores from each item are summed to produce a total score for each participant, with a possible range of 8 (indicating low satisfaction) to 32 (indicating high satisfaction). Higher scores on the CSQ reflect greater overall satisfaction with the therapy received.
Outcome measures
| Measure |
Imaginator App Plus Therapy
n=15 Participants
After Baseline screening visit, participants received 3 x 1-hour Functional Imagery Training (FIT) sessions in person or via MS Teams once a week. Therapy sessions were delivered by a Child Wellbeing Practitioner (CWP), Clinical Assistant Psychology Therapists (CAPT) or therapist. After completion of the 3 therapy sessions, participants received 5 x 15-30-minute phone-call support sessions fortnightly. FIT comprised of the following key elements: Session 1 - formulation of personal drivers of SH behaviour and motivational interviewing combined with mental imagery techniques; Session 2 - mental imagery of a past achievement, formulation of goals (e.g.,a desired behaviour incompatible with or alternative to SH) and functional imagery plan to achieve them; Session 3 - practice and refinement of functional imagery, problem-solving of challenges. Follow-up phone-call sessions focused on refining functional imagery practice, problem-solving, motivational encouragement, and personalisation of the app use. Participants receiveed smartphone app-based reminders (from Imaginator app), exercises and support from the second FIT session. Upon completion of the follow-up sessions, participants were invited to an outcome assessment after 1 week, at approximately 3 months post intervention. Optional user-led feedback interviews with participants were carried out upon study completion (after final assessment).
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|---|---|
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Client Satisfaction Questionnaire (CSQ)
|
25 score on a scale
Interval 22.0 to 27.5
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SECONDARY outcome
Timeframe: 3 monthsThis is an interview method conducted by the researcher who reconstructs together with the participant the number of self-harm behaviours using calendar cues. The scale records the total number of self-harm episodes within a specified timeframe of the last 3 months, with higher values indicating more frequent self-harm behaviours. The minimum number of episodes is 0 and the maximum number of episodes that can be reported for the 3 months is every day (so around 90 depending on the number of days of the month).
Outcome measures
| Measure |
Imaginator App Plus Therapy
n=15 Participants
After Baseline screening visit, participants received 3 x 1-hour Functional Imagery Training (FIT) sessions in person or via MS Teams once a week. Therapy sessions were delivered by a Child Wellbeing Practitioner (CWP), Clinical Assistant Psychology Therapists (CAPT) or therapist. After completion of the 3 therapy sessions, participants received 5 x 15-30-minute phone-call support sessions fortnightly. FIT comprised of the following key elements: Session 1 - formulation of personal drivers of SH behaviour and motivational interviewing combined with mental imagery techniques; Session 2 - mental imagery of a past achievement, formulation of goals (e.g.,a desired behaviour incompatible with or alternative to SH) and functional imagery plan to achieve them; Session 3 - practice and refinement of functional imagery, problem-solving of challenges. Follow-up phone-call sessions focused on refining functional imagery practice, problem-solving, motivational encouragement, and personalisation of the app use. Participants receiveed smartphone app-based reminders (from Imaginator app), exercises and support from the second FIT session. Upon completion of the follow-up sessions, participants were invited to an outcome assessment after 1 week, at approximately 3 months post intervention. Optional user-led feedback interviews with participants were carried out upon study completion (after final assessment).
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Timeline Follow-Back Technique (TLFB)
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0 units on a scale
Interval 0.0 to 7.0
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SECONDARY outcome
Timeframe: 3 monthsThis interview is about mental images that deal with self-harm or occur with self-harm. It asks participants to think about one of these and explores their thoughts and emotions in relation to the image. This measure specifically assesses positive emotions on a 10-item scale. Each item is rated on a 5-point Likert scale with responses ranging from 1 (not at all), very low intensity or absence of the specific emotion, to 5 (extremely), extremely high intensity of that emotion. Scores range from 10 to 50, where a score of 10 reflects low positive emotional intensity, indicating weak or minimal positive emotions associated with the imagery, while a score of 50 represents high positive emotional intensity, signifying strong and vivid positive emotions. Higher scores indicate a greater intensity of positive emotional experiences related to the imagery.
Outcome measures
| Measure |
Imaginator App Plus Therapy
n=15 Participants
After Baseline screening visit, participants received 3 x 1-hour Functional Imagery Training (FIT) sessions in person or via MS Teams once a week. Therapy sessions were delivered by a Child Wellbeing Practitioner (CWP), Clinical Assistant Psychology Therapists (CAPT) or therapist. After completion of the 3 therapy sessions, participants received 5 x 15-30-minute phone-call support sessions fortnightly. FIT comprised of the following key elements: Session 1 - formulation of personal drivers of SH behaviour and motivational interviewing combined with mental imagery techniques; Session 2 - mental imagery of a past achievement, formulation of goals (e.g.,a desired behaviour incompatible with or alternative to SH) and functional imagery plan to achieve them; Session 3 - practice and refinement of functional imagery, problem-solving of challenges. Follow-up phone-call sessions focused on refining functional imagery practice, problem-solving, motivational encouragement, and personalisation of the app use. Participants receiveed smartphone app-based reminders (from Imaginator app), exercises and support from the second FIT session. Upon completion of the follow-up sessions, participants were invited to an outcome assessment after 1 week, at approximately 3 months post intervention. Optional user-led feedback interviews with participants were carried out upon study completion (after final assessment).
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Self-Harm Imagery Interview (PANAS+)
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16 score on a scale
Interval 13.0 to 18.0
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SECONDARY outcome
Timeframe: 3 monthsThis interview is about mental images that deal with self-harm or occur with self-harm. It asks participants to think about one of these and explores their thoughts and emotions in relation to the image. This measure specifically assesses negative emotions on a 10-item scale. Each item is rated on a 5-point Likert scale with responses ranging from 1 (not at all), no negative emotional intensity, to 5 (extremely), extremely high negative emotional intensity. Scores range from 10 to 50, where a score of 10 reflects low negative emotional intensity, indicating weak or minimal negative emotions associated with the imagery, while a score of 50 represents high negative emotional intensity, signifying strong and intense negative emotions. Higher scores indicate a greater intensity of negative emotional experiences related to the imagery.
Outcome measures
| Measure |
Imaginator App Plus Therapy
n=15 Participants
After Baseline screening visit, participants received 3 x 1-hour Functional Imagery Training (FIT) sessions in person or via MS Teams once a week. Therapy sessions were delivered by a Child Wellbeing Practitioner (CWP), Clinical Assistant Psychology Therapists (CAPT) or therapist. After completion of the 3 therapy sessions, participants received 5 x 15-30-minute phone-call support sessions fortnightly. FIT comprised of the following key elements: Session 1 - formulation of personal drivers of SH behaviour and motivational interviewing combined with mental imagery techniques; Session 2 - mental imagery of a past achievement, formulation of goals (e.g.,a desired behaviour incompatible with or alternative to SH) and functional imagery plan to achieve them; Session 3 - practice and refinement of functional imagery, problem-solving of challenges. Follow-up phone-call sessions focused on refining functional imagery practice, problem-solving, motivational encouragement, and personalisation of the app use. Participants receiveed smartphone app-based reminders (from Imaginator app), exercises and support from the second FIT session. Upon completion of the follow-up sessions, participants were invited to an outcome assessment after 1 week, at approximately 3 months post intervention. Optional user-led feedback interviews with participants were carried out upon study completion (after final assessment).
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Self-Harm Imagery Interview (PANAS-)
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36 score on a scale
Interval 30.0 to 40.5
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SECONDARY outcome
Timeframe: 3 monthsThis scale measures participants' motivation to control their self-harm through 12 items that measure the strength of their motivational cognitions in the present moment. Each item is rated on a 10-point Likert scale, ranging from 0 (never), indicating that the participant has no motivation or desire to control their self-harm at that moment, to 10 (constantly), , indicating that the participant has an extremely strong and persistent motivation to control their self-harm at that moment. Average scores are calculated for each participant ranging from 0 to 10, with higher scores indicating stronger motivation to control self-harm. This scale provides a sensitive measure of participants' current motivational state regarding self-harm reduction.
Outcome measures
| Measure |
Imaginator App Plus Therapy
n=15 Participants
After Baseline screening visit, participants received 3 x 1-hour Functional Imagery Training (FIT) sessions in person or via MS Teams once a week. Therapy sessions were delivered by a Child Wellbeing Practitioner (CWP), Clinical Assistant Psychology Therapists (CAPT) or therapist. After completion of the 3 therapy sessions, participants received 5 x 15-30-minute phone-call support sessions fortnightly. FIT comprised of the following key elements: Session 1 - formulation of personal drivers of SH behaviour and motivational interviewing combined with mental imagery techniques; Session 2 - mental imagery of a past achievement, formulation of goals (e.g.,a desired behaviour incompatible with or alternative to SH) and functional imagery plan to achieve them; Session 3 - practice and refinement of functional imagery, problem-solving of challenges. Follow-up phone-call sessions focused on refining functional imagery practice, problem-solving, motivational encouragement, and personalisation of the app use. Participants receiveed smartphone app-based reminders (from Imaginator app), exercises and support from the second FIT session. Upon completion of the follow-up sessions, participants were invited to an outcome assessment after 1 week, at approximately 3 months post intervention. Optional user-led feedback interviews with participants were carried out upon study completion (after final assessment).
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State Motivation for Reducing Self-harm (SM-SH) Scale
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6.33 score on a scale
Interval 5.21 to 7.33
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SECONDARY outcome
Timeframe: 3 monthsThis questionnaire assesses the urge to self-harm and assesses frequency, intensity, salience or dismissability of intrusive thoughts surrounding self-harm. It consists of 9 items, each rated on a 10-point Likert scale, ranging from 0 (not at all), indicating that the participant has no urge to self-harm or does not experience any intrusive thoughts related to self-harm, to 10 (constantly), indicating that the participant experiences a very strong and persistent urge to self-harm or is constantly preoccupied with thoughts of self-harm. The minimum score is 0, indicating no urge to self-harm, and the maximum score is 90, indicating the highest possible urge to self-harm. Higher scores reflect a stronger and more persistent urge to engage in self-harming behaviour.
Outcome measures
| Measure |
Imaginator App Plus Therapy
n=15 Participants
After Baseline screening visit, participants received 3 x 1-hour Functional Imagery Training (FIT) sessions in person or via MS Teams once a week. Therapy sessions were delivered by a Child Wellbeing Practitioner (CWP), Clinical Assistant Psychology Therapists (CAPT) or therapist. After completion of the 3 therapy sessions, participants received 5 x 15-30-minute phone-call support sessions fortnightly. FIT comprised of the following key elements: Session 1 - formulation of personal drivers of SH behaviour and motivational interviewing combined with mental imagery techniques; Session 2 - mental imagery of a past achievement, formulation of goals (e.g.,a desired behaviour incompatible with or alternative to SH) and functional imagery plan to achieve them; Session 3 - practice and refinement of functional imagery, problem-solving of challenges. Follow-up phone-call sessions focused on refining functional imagery practice, problem-solving, motivational encouragement, and personalisation of the app use. Participants receiveed smartphone app-based reminders (from Imaginator app), exercises and support from the second FIT session. Upon completion of the follow-up sessions, participants were invited to an outcome assessment after 1 week, at approximately 3 months post intervention. Optional user-led feedback interviews with participants were carried out upon study completion (after final assessment).
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Craving Experience Questionnaire for Self-Harm (CEQ-SH)
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40 score on a scale
Interval 21.5 to 50.5
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OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: Out of the 15 participants who completed the outcome assessment after the intervention, 7 were 12-17 years old.
This is a 47 item measure for 12-17 year olds with six sub-scales (separation anxiety disorder, social phobia, generalised anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder)). This analysis focuses on the Anxiety sub-scales (37 items), which consist of Separation Anxiety Disorder, Social Phobia, Generalised Anxiety Disorder, Panic Disorder, and Obsessive-Compulsive Disorder. Each item is scored from 0 (never), indicating not experiencing the symptom described in the item during the past week, to 3 (always), consistently experiencing the symptom. Total scores range from 0 to 111. A total score is calculated by summing the individual item scores. Higher scores indicate more severe anxiety. Here raw scores are reported.
Outcome measures
| Measure |
Imaginator App Plus Therapy
n=7 Participants
After Baseline screening visit, participants received 3 x 1-hour Functional Imagery Training (FIT) sessions in person or via MS Teams once a week. Therapy sessions were delivered by a Child Wellbeing Practitioner (CWP), Clinical Assistant Psychology Therapists (CAPT) or therapist. After completion of the 3 therapy sessions, participants received 5 x 15-30-minute phone-call support sessions fortnightly. FIT comprised of the following key elements: Session 1 - formulation of personal drivers of SH behaviour and motivational interviewing combined with mental imagery techniques; Session 2 - mental imagery of a past achievement, formulation of goals (e.g.,a desired behaviour incompatible with or alternative to SH) and functional imagery plan to achieve them; Session 3 - practice and refinement of functional imagery, problem-solving of challenges. Follow-up phone-call sessions focused on refining functional imagery practice, problem-solving, motivational encouragement, and personalisation of the app use. Participants receiveed smartphone app-based reminders (from Imaginator app), exercises and support from the second FIT session. Upon completion of the follow-up sessions, participants were invited to an outcome assessment after 1 week, at approximately 3 months post intervention. Optional user-led feedback interviews with participants were carried out upon study completion (after final assessment).
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Revised Children's Anxiety and Depression Scale (RCADS) - Anxiety Subscale
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49 units on a scale
Interval 40.75 to 52.0
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OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: Out of the 15 participants who completed the outcome assessment after the intervention, 7 were 12-17 years old.
This is a 47 item measure for 12-17 year olds with six sub-scales (separation anxiety disorder, social phobia, generalised anxiety disorder, panic disorder, obsessive compulsive disorder, and low mood (major depressive disorder)). This analysis specifically focuses on the Depression subscale (10 items). Each item is scored from 0 (never), indicating not experiencing the symptom described in the item during the past week, to 3 (always), consistently experiencing the symptom. Total scores range from 0 to 30. A total score is calculated by summing the individual item scores. Higher scores indicate more severe depression. Here raw scores are reported.
Outcome measures
| Measure |
Imaginator App Plus Therapy
n=7 Participants
After Baseline screening visit, participants received 3 x 1-hour Functional Imagery Training (FIT) sessions in person or via MS Teams once a week. Therapy sessions were delivered by a Child Wellbeing Practitioner (CWP), Clinical Assistant Psychology Therapists (CAPT) or therapist. After completion of the 3 therapy sessions, participants received 5 x 15-30-minute phone-call support sessions fortnightly. FIT comprised of the following key elements: Session 1 - formulation of personal drivers of SH behaviour and motivational interviewing combined with mental imagery techniques; Session 2 - mental imagery of a past achievement, formulation of goals (e.g.,a desired behaviour incompatible with or alternative to SH) and functional imagery plan to achieve them; Session 3 - practice and refinement of functional imagery, problem-solving of challenges. Follow-up phone-call sessions focused on refining functional imagery practice, problem-solving, motivational encouragement, and personalisation of the app use. Participants receiveed smartphone app-based reminders (from Imaginator app), exercises and support from the second FIT session. Upon completion of the follow-up sessions, participants were invited to an outcome assessment after 1 week, at approximately 3 months post intervention. Optional user-led feedback interviews with participants were carried out upon study completion (after final assessment).
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Revised Children's Anxiety and Depression Scale (RCADS) - Depression Subscale
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14.5 units on a scale
Interval 12.0 to 17.75
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OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: Out of the 15 participants who completed the outcome assessment after the intervention, 8 were 18-25 years old.
This is a 21-item scale for 18-25 year olds measuring levels of depression, anxiety and stress over the past week. This analysis focuses on the Depression subscale, which assesses symptoms associated with dysphoric mood, such as feelings of worthlessness. Each item is rated on a 4-point Likert scale, ranging from 0 (did not apply to me at all), indicating that the individual did not experience depression symptoms during the past week to 3 (applied to me very much, or most of the time), indicating that the individual frequently experienced depression symptoms. The Depression subscale consists of 7 items, with scores ranging from 0 to 21. Since the DASS-21 is a short version of the full scale, the total score for the Depression subscale is calculated by summing the individual item scores and then multiplying the final score by 2. Higher scores on this subscale indicate more severe depression, reflecting a higher intensity of depressive symptoms in the past week.
Outcome measures
| Measure |
Imaginator App Plus Therapy
n=8 Participants
After Baseline screening visit, participants received 3 x 1-hour Functional Imagery Training (FIT) sessions in person or via MS Teams once a week. Therapy sessions were delivered by a Child Wellbeing Practitioner (CWP), Clinical Assistant Psychology Therapists (CAPT) or therapist. After completion of the 3 therapy sessions, participants received 5 x 15-30-minute phone-call support sessions fortnightly. FIT comprised of the following key elements: Session 1 - formulation of personal drivers of SH behaviour and motivational interviewing combined with mental imagery techniques; Session 2 - mental imagery of a past achievement, formulation of goals (e.g.,a desired behaviour incompatible with or alternative to SH) and functional imagery plan to achieve them; Session 3 - practice and refinement of functional imagery, problem-solving of challenges. Follow-up phone-call sessions focused on refining functional imagery practice, problem-solving, motivational encouragement, and personalisation of the app use. Participants receiveed smartphone app-based reminders (from Imaginator app), exercises and support from the second FIT session. Upon completion of the follow-up sessions, participants were invited to an outcome assessment after 1 week, at approximately 3 months post intervention. Optional user-led feedback interviews with participants were carried out upon study completion (after final assessment).
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Depression, Anxiety and Stress Scale (DASS-21) - Depression Subscale
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34 score on a scale
Interval 20.0 to 36.5
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OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: Out of the 15 participants who completed the outcome assessment after the intervention, 8 were 18-25 years old.
This is a 21-item scale for 18-25 year olds measuring levels of depression, anxiety and stress over the past week. This analysis focuses on the Anxiety subscale, which measures symptoms associated with physiological arousal (e.g., trembling). Each item is rated on a 4-point Likert scale, ranging from 0 (did not apply to me at all), indicating that the individual did not experience anxiety symptoms during the past week to 3 (applied to me very much, or most of the time), indicating that the individual frequently experienced anxiety symptoms. The Anxiety subscale includes 7 items, with scores ranging from 0 to 21. Since the DASS-21 is a short version of the full scale, the total score for the Anxiety subscale is calculated by summing the individual item scores and multiplying the final score by 2. Higher scores on this subscale indicate more severe anxiety, reflecting greater physiological arousal and anxiety symptoms experienced over the past week.
Outcome measures
| Measure |
Imaginator App Plus Therapy
n=8 Participants
After Baseline screening visit, participants received 3 x 1-hour Functional Imagery Training (FIT) sessions in person or via MS Teams once a week. Therapy sessions were delivered by a Child Wellbeing Practitioner (CWP), Clinical Assistant Psychology Therapists (CAPT) or therapist. After completion of the 3 therapy sessions, participants received 5 x 15-30-minute phone-call support sessions fortnightly. FIT comprised of the following key elements: Session 1 - formulation of personal drivers of SH behaviour and motivational interviewing combined with mental imagery techniques; Session 2 - mental imagery of a past achievement, formulation of goals (e.g.,a desired behaviour incompatible with or alternative to SH) and functional imagery plan to achieve them; Session 3 - practice and refinement of functional imagery, problem-solving of challenges. Follow-up phone-call sessions focused on refining functional imagery practice, problem-solving, motivational encouragement, and personalisation of the app use. Participants receiveed smartphone app-based reminders (from Imaginator app), exercises and support from the second FIT session. Upon completion of the follow-up sessions, participants were invited to an outcome assessment after 1 week, at approximately 3 months post intervention. Optional user-led feedback interviews with participants were carried out upon study completion (after final assessment).
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Depression, Anxiety and Stress Scale (DASS-21) - Anxiety Subscale
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22 score on a scale
Interval 18.0 to 26.0
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OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: Out of the 15 participants who completed the outcome assessment after the intervention, 8 were 18-25 years old.
This is a 21-item scale for 18-25 year olds measuring levels of depression, anxiety and stress over the past week. This analysis focuses on the Stress subscale, which measures symptoms of tension and reactivity to stressful events. Each item is rated on a 4-point Likert scale, ranging from 0 (did not apply to me at all), indicating that the individual did not experience stress symptoms during the past week to 3 (applied to me very much, or most of the time), indicating that the individual frequently experienced stress symptoms. The Stress subscale includes 7 items, with scores for this subscale ranging from 0 to 21. Since the DASS-21 is a short version of the full scale, the total score for the Stress subscale is calculated by summing the individual item scores and multiplying the final score by 2 to adjust for the reduced number of items. Higher scores on this subscale indicate more severe stress, reflecting greater tension and reactivity to stressors over the past week.
Outcome measures
| Measure |
Imaginator App Plus Therapy
n=8 Participants
After Baseline screening visit, participants received 3 x 1-hour Functional Imagery Training (FIT) sessions in person or via MS Teams once a week. Therapy sessions were delivered by a Child Wellbeing Practitioner (CWP), Clinical Assistant Psychology Therapists (CAPT) or therapist. After completion of the 3 therapy sessions, participants received 5 x 15-30-minute phone-call support sessions fortnightly. FIT comprised of the following key elements: Session 1 - formulation of personal drivers of SH behaviour and motivational interviewing combined with mental imagery techniques; Session 2 - mental imagery of a past achievement, formulation of goals (e.g.,a desired behaviour incompatible with or alternative to SH) and functional imagery plan to achieve them; Session 3 - practice and refinement of functional imagery, problem-solving of challenges. Follow-up phone-call sessions focused on refining functional imagery practice, problem-solving, motivational encouragement, and personalisation of the app use. Participants receiveed smartphone app-based reminders (from Imaginator app), exercises and support from the second FIT session. Upon completion of the follow-up sessions, participants were invited to an outcome assessment after 1 week, at approximately 3 months post intervention. Optional user-led feedback interviews with participants were carried out upon study completion (after final assessment).
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Depression, Anxiety and Stress Scale (DASS-21) - Stress Subscale
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28 score on a scale
Interval 25.5 to 32.5
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OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsThis is a 14-item measure with positively worded items rated on a 5-point Likert scale, ranging from 1 to 5. A score of 1 ("none of the time") represents the lowest level of mental well-being, indicating that the individual rarely or never experiences the feelings or behaviors described in the item (e.g., feeling happy, confident, or connected). Conversely, a score of 5 ("all of the time") indicates the highest level of mental well-being, suggesting that the individual frequently or always experiences these positive mental health states. The total score is calculated by summing the individual item scores, with possible scores ranging from 14 to 70, where higher scores indicate better mental well-being and a greater level of positive mental health.
Outcome measures
| Measure |
Imaginator App Plus Therapy
n=15 Participants
After Baseline screening visit, participants received 3 x 1-hour Functional Imagery Training (FIT) sessions in person or via MS Teams once a week. Therapy sessions were delivered by a Child Wellbeing Practitioner (CWP), Clinical Assistant Psychology Therapists (CAPT) or therapist. After completion of the 3 therapy sessions, participants received 5 x 15-30-minute phone-call support sessions fortnightly. FIT comprised of the following key elements: Session 1 - formulation of personal drivers of SH behaviour and motivational interviewing combined with mental imagery techniques; Session 2 - mental imagery of a past achievement, formulation of goals (e.g.,a desired behaviour incompatible with or alternative to SH) and functional imagery plan to achieve them; Session 3 - practice and refinement of functional imagery, problem-solving of challenges. Follow-up phone-call sessions focused on refining functional imagery practice, problem-solving, motivational encouragement, and personalisation of the app use. Participants receiveed smartphone app-based reminders (from Imaginator app), exercises and support from the second FIT session. Upon completion of the follow-up sessions, participants were invited to an outcome assessment after 1 week, at approximately 3 months post intervention. Optional user-led feedback interviews with participants were carried out upon study completion (after final assessment).
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Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
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41 score on a scale
Interval 35.75 to 45.0
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OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsThis is an 18-item scale adapted from the original long version that measures general emotion regulation ability as well as various aspects of emotion regulation (in six subscales), e.g. difficulties engaging in goal directed behaviour when upset, and limited access to emotion regulation strategies. Each item is rated on a 5-point Likert scale, with 1 representing "Almost Never" (0-10% of the time), indicating minimal difficulty with emotion regulation, and 5 representing "Almost Always" (91-100% of the time), indicating frequent or almost constant difficulty. The total score is calculated by summing the item scores. The scale has a minimum value of 18 and a maximum value of 90. Higher scores indicate greater emotion regulation difficulties, reflecting more significant challenges in managing and regulating emotions. Conversely, lower scores suggest better emotion regulation skills and fewer difficulties in handling emotional responses.
Outcome measures
| Measure |
Imaginator App Plus Therapy
n=15 Participants
After Baseline screening visit, participants received 3 x 1-hour Functional Imagery Training (FIT) sessions in person or via MS Teams once a week. Therapy sessions were delivered by a Child Wellbeing Practitioner (CWP), Clinical Assistant Psychology Therapists (CAPT) or therapist. After completion of the 3 therapy sessions, participants received 5 x 15-30-minute phone-call support sessions fortnightly. FIT comprised of the following key elements: Session 1 - formulation of personal drivers of SH behaviour and motivational interviewing combined with mental imagery techniques; Session 2 - mental imagery of a past achievement, formulation of goals (e.g.,a desired behaviour incompatible with or alternative to SH) and functional imagery plan to achieve them; Session 3 - practice and refinement of functional imagery, problem-solving of challenges. Follow-up phone-call sessions focused on refining functional imagery practice, problem-solving, motivational encouragement, and personalisation of the app use. Participants receiveed smartphone app-based reminders (from Imaginator app), exercises and support from the second FIT session. Upon completion of the follow-up sessions, participants were invited to an outcome assessment after 1 week, at approximately 3 months post intervention. Optional user-led feedback interviews with participants were carried out upon study completion (after final assessment).
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Difficulties in Emotion Regulation Scale-Short Form (DERS-SF)
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55.5 score on a scale
Interval 51.25 to 63.5
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OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsThis is an 11-item scale measuring engagement in other risky, self-destructive behaviours (e.g., binge eating, substance misuse). The items are designed to assess the frequency and severity of these behaviors, which are commonly associated with borderline personality disorder. Each item is rated on a Likert scale from 0 to 4, with 0 representing "Not at all", indicating no engagement in the behavior during the assessed period, and 4 representing "Daily or more often", indicating the participant engaged in the behavior on a daily basis or more frequently. The total score is calculated by summing the responses. The scale has a minimum value of 0 and a maximum value of 44, with higher scores indicating more frequent or severe engagement in these behaviors.
Outcome measures
| Measure |
Imaginator App Plus Therapy
n=15 Participants
After Baseline screening visit, participants received 3 x 1-hour Functional Imagery Training (FIT) sessions in person or via MS Teams once a week. Therapy sessions were delivered by a Child Wellbeing Practitioner (CWP), Clinical Assistant Psychology Therapists (CAPT) or therapist. After completion of the 3 therapy sessions, participants received 5 x 15-30-minute phone-call support sessions fortnightly. FIT comprised of the following key elements: Session 1 - formulation of personal drivers of SH behaviour and motivational interviewing combined with mental imagery techniques; Session 2 - mental imagery of a past achievement, formulation of goals (e.g.,a desired behaviour incompatible with or alternative to SH) and functional imagery plan to achieve them; Session 3 - practice and refinement of functional imagery, problem-solving of challenges. Follow-up phone-call sessions focused on refining functional imagery practice, problem-solving, motivational encouragement, and personalisation of the app use. Participants receiveed smartphone app-based reminders (from Imaginator app), exercises and support from the second FIT session. Upon completion of the follow-up sessions, participants were invited to an outcome assessment after 1 week, at approximately 3 months post intervention. Optional user-led feedback interviews with participants were carried out upon study completion (after final assessment).
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11-item Behaviour Supplement to the Borderline Symptom List
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10 score on a scale
Interval 4.25 to 11.0
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OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsThis is a 10-item measure of alcohol misuse and possible dependence, in which participants are asked to rate items related to their drinking (e.g. 'How often do you have a drink containing alcohol') on a 5-point scale ranging from 0 to 4. A score of 0 indicates "Never" engaging in the behavior (e.g., never drinking alcohol or never experiencing a specific consequence), while a score of 4 represents "Daily or almost daily", reflecting the highest level of engagement. The AUDIT is an effective means of identifying hazardous or harmful drinking behaviour. The total score is obtained by summing the individual item scores, with the scale ranging from 0 to 40. Higher scores indicate a greater risk of alcohol misuse, with scores of 8 or higher commonly used to identify individuals at risk for hazardous or harmful drinking. Conversely, lower scores suggest minimal or no alcohol-related problems.
Outcome measures
| Measure |
Imaginator App Plus Therapy
n=15 Participants
After Baseline screening visit, participants received 3 x 1-hour Functional Imagery Training (FIT) sessions in person or via MS Teams once a week. Therapy sessions were delivered by a Child Wellbeing Practitioner (CWP), Clinical Assistant Psychology Therapists (CAPT) or therapist. After completion of the 3 therapy sessions, participants received 5 x 15-30-minute phone-call support sessions fortnightly. FIT comprised of the following key elements: Session 1 - formulation of personal drivers of SH behaviour and motivational interviewing combined with mental imagery techniques; Session 2 - mental imagery of a past achievement, formulation of goals (e.g.,a desired behaviour incompatible with or alternative to SH) and functional imagery plan to achieve them; Session 3 - practice and refinement of functional imagery, problem-solving of challenges. Follow-up phone-call sessions focused on refining functional imagery practice, problem-solving, motivational encouragement, and personalisation of the app use. Participants receiveed smartphone app-based reminders (from Imaginator app), exercises and support from the second FIT session. Upon completion of the follow-up sessions, participants were invited to an outcome assessment after 1 week, at approximately 3 months post intervention. Optional user-led feedback interviews with participants were carried out upon study completion (after final assessment).
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|---|---|
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Alcohol Use Disorders Identification Test (AUDIT)
|
1 score on a scale
Interval 0.0 to 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsThisis an 8-item measure used to screen for problem cannabis use. Participants are asked to rate a series of items related to their cannabis use (e.g., "How often do you use cannabis") on a 5-point Likert scale, where 0 represents "Never" or no engagement in the behavior, and 4 represents "Daily or almost daily", indicating the highest level of cannabis use. The total score is calculated by summing the responses, with the scale ranging from 0 to 40. A higher score indicates greater severity of cannabis misuse, and individuals with higher scores may be at risk for problematic cannabis use. Conversely, a lower score suggests minimal or no problematic cannabis use.
Outcome measures
| Measure |
Imaginator App Plus Therapy
n=15 Participants
After Baseline screening visit, participants received 3 x 1-hour Functional Imagery Training (FIT) sessions in person or via MS Teams once a week. Therapy sessions were delivered by a Child Wellbeing Practitioner (CWP), Clinical Assistant Psychology Therapists (CAPT) or therapist. After completion of the 3 therapy sessions, participants received 5 x 15-30-minute phone-call support sessions fortnightly. FIT comprised of the following key elements: Session 1 - formulation of personal drivers of SH behaviour and motivational interviewing combined with mental imagery techniques; Session 2 - mental imagery of a past achievement, formulation of goals (e.g.,a desired behaviour incompatible with or alternative to SH) and functional imagery plan to achieve them; Session 3 - practice and refinement of functional imagery, problem-solving of challenges. Follow-up phone-call sessions focused on refining functional imagery practice, problem-solving, motivational encouragement, and personalisation of the app use. Participants receiveed smartphone app-based reminders (from Imaginator app), exercises and support from the second FIT session. Upon completion of the follow-up sessions, participants were invited to an outcome assessment after 1 week, at approximately 3 months post intervention. Optional user-led feedback interviews with participants were carried out upon study completion (after final assessment).
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|---|---|
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Cannabis Use Disorder Identification Test Revised (CUDIT-R)
|
0 score on a scale
Interval 0.0 to 0.0
|
Adverse Events
Imaginator App Plus Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place