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Trial Outcomes & Findings for Investigating Compassion-Based Guided Self-Help for Depression in People With Skin Conditions (NCT NCT04132973)

NCT ID: NCT04132973

Last Updated: 2021-10-26

Results Overview

Percentage of participants that log in to the online intervention during their sixth week (i.e. participant retention).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

34 participants

Primary outcome timeframe

Week 6 for each participant (rolling recruitment).

Results posted on

2021-10-26

Participant Flow

Participant milestones

Participant milestones
Measure
Compassion Guided Self-help
Participants will engage in a six-week online compassion-based self-help programme with email guidance from the researcher. Compassion for Skin Conditions: Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010).
Overall Study
STARTED
34
Overall Study
Completed Intervention
11
Overall Study
COMPLETED
8
Overall Study
NOT COMPLETED
26

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Investigating Compassion-Based Guided Self-Help for Depression in People With Skin Conditions

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Compassion Guided Self-help
n=34 Participants
Participants will engage in a six-week online compassion-based self-help programme with email guidance from the researcher. Compassion for Skin Conditions: Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010).
Age, Continuous
38.2 years
STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male
Female
31 Participants
n=5 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants
Race/Ethnicity, Customized
White
28 participants
n=5 Participants
Race/Ethnicity, Customized
British Pakistani
1 participants
n=5 Participants
Race/Ethnicity, Customized
British African
1 participants
n=5 Participants
Race/Ethnicity, Customized
Mixed heritage
2 participants
n=5 Participants
Race/Ethnicity, Customized
Japanese
1 participants
n=5 Participants
Race/Ethnicity, Customized
Not specified
1 participants
n=5 Participants
Region of Enrollment
United Kingdom
31 participants
n=5 Participants
Region of Enrollment
Italy
1 participants
n=5 Participants
Region of Enrollment
Malaysia
1 participants
n=5 Participants
Region of Enrollment
Spain
1 participants
n=5 Participants
Skin condition (self-reported)
Eczema
16 participants
n=5 Participants
Skin condition (self-reported)
Psoriasis
13 participants
n=5 Participants
Skin condition (self-reported)
Other
11 participants
n=5 Participants

PRIMARY outcome

Timeframe: Week 6 for each participant (rolling recruitment).

Percentage of participants that log in to the online intervention during their sixth week (i.e. participant retention).

Outcome measures

Outcome measures
Measure
Compassion Guided Self-help
n=34 Participants
Participants will engage in a six-week online compassion-based self-help programme with email guidance from the researcher. Compassion for Skin Conditions: Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010).
Acceptability of Intervention Overall
11 Participants

PRIMARY outcome

Timeframe: Day 1

Likert scale ratings for acceptability components (ease of use, helpfulness of information, ease of understanding, adequacy of information, and visual appeal) for each weekly session. These items have been adapted from the Website Evaluation Questionnaire as no suitable validated measure could be found. Scale mean scores range from 0 to 4, with higher scores indicating higher perceived acceptability.

Outcome measures

Outcome measures
Measure
Compassion Guided Self-help
n=16 Participants
Participants will engage in a six-week online compassion-based self-help programme with email guidance from the researcher. Compassion for Skin Conditions: Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010).
Acceptability of Session 1
2.35 score on a scale
Standard Deviation 1.28

PRIMARY outcome

Timeframe: Day 8

Likert scale ratings for acceptability components (ease of use, helpfulness of information, ease of understanding, adequacy of information, and visual appeal) for each weekly session. These items have been adapted from the Website Evaluation Questionnaire as no suitable validated measure could be found. Scale mean scores range from 0 to 4, with higher scores indicating higher perceived acceptability.

Outcome measures

Outcome measures
Measure
Compassion Guided Self-help
n=13 Participants
Participants will engage in a six-week online compassion-based self-help programme with email guidance from the researcher. Compassion for Skin Conditions: Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010).
Acceptability of Session 2
2.35 score on a scale
Standard Deviation 1.30

PRIMARY outcome

Timeframe: Day 15

Likert scale ratings for acceptability components (ease of use, helpfulness of information, ease of understanding, adequacy of information, and visual appeal) for each weekly session. These items have been adapted from the Website Evaluation Questionnaire as no suitable validated measure could be found. Scale mean scores range from 0 to 4, with higher scores indicating higher perceived acceptability.

Outcome measures

Outcome measures
Measure
Compassion Guided Self-help
n=9 Participants
Participants will engage in a six-week online compassion-based self-help programme with email guidance from the researcher. Compassion for Skin Conditions: Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010).
Acceptability of Session 3
2.56 score on a scale
Standard Deviation 1.13

PRIMARY outcome

Timeframe: Day 22

Likert scale ratings for acceptability components (ease of use, helpfulness of information, ease of understanding, adequacy of information, and visual appeal) for each weekly session. These items have been adapted from the Website Evaluation Questionnaire as no suitable validated measure could be found. Scale mean scores range from 0 to 4, with higher scores indicating higher perceived acceptability.

Outcome measures

Outcome measures
Measure
Compassion Guided Self-help
n=5 Participants
Participants will engage in a six-week online compassion-based self-help programme with email guidance from the researcher. Compassion for Skin Conditions: Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010).
Acceptability of Session 4
2.7 score on a scale
Standard Deviation 1.29

PRIMARY outcome

Timeframe: Day 29

Likert scale ratings for acceptability components (ease of use, helpfulness of information, ease of understanding, adequacy of information, and visual appeal) for each weekly session. These items have been adapted from the Website Evaluation Questionnaire as no suitable validated measure could be found. Scale mean scores range from 0 to 4, with higher scores indicating higher perceived acceptability.

Outcome measures

Outcome measures
Measure
Compassion Guided Self-help
n=7 Participants
Participants will engage in a six-week online compassion-based self-help programme with email guidance from the researcher. Compassion for Skin Conditions: Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010).
Acceptability of Session 5
2.43 score on a scale
Standard Deviation 1.36

PRIMARY outcome

Timeframe: Day 36

Likert scale ratings for acceptability components (ease of use, helpfulness of information, ease of understanding, adequacy of information, and visual appeal) for each weekly session. These items have been adapted from the Website Evaluation Questionnaire as no suitable validated measure could be found. Scale mean scores range from 0 to 4, with higher scores indicating higher perceived acceptability.

Outcome measures

Outcome measures
Measure
Compassion Guided Self-help
n=5 Participants
Participants will engage in a six-week online compassion-based self-help programme with email guidance from the researcher. Compassion for Skin Conditions: Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010).
Acceptability of Session 6
2.97 score on a scale
Standard Deviation 1.25

SECONDARY outcome

Timeframe: Days 1 and 43.

Self-report measure of depression. Measure ranges from 0 to 42, with higher scores indicating higher levels of depressive symptomatology.

Outcome measures

Outcome measures
Measure
Compassion Guided Self-help
n=8 Participants
Participants will engage in a six-week online compassion-based self-help programme with email guidance from the researcher. Compassion for Skin Conditions: Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010).
Change From Baseline Depression Subscale of the Depression Anxiety Stress Scales (DASS-DEP) Score After Six Weeks.
-7.75 score on a scale
Standard Deviation 7.03

SECONDARY outcome

Timeframe: Days 1 and 43.

Self-report measure of self-compassion. Measure ranges from 26 to 130, with higher scores indicating higher levels of self-compassion.

Outcome measures

Outcome measures
Measure
Compassion Guided Self-help
n=8 Participants
Participants will engage in a six-week online compassion-based self-help programme with email guidance from the researcher. Compassion for Skin Conditions: Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010).
Change From Baseline Self-Compassion Scale (SCS) Score After Six Weeks.
17.88 score on a scale
Standard Deviation 27.82

SECONDARY outcome

Timeframe: Days 1 and 43.

Self-report measure of impact of skin condition on quality of life. Measure ranges from 0 to 30, with higher scores indicating higher effect of the skin condition on the person's life.

Outcome measures

Outcome measures
Measure
Compassion Guided Self-help
n=8 Participants
Participants will engage in a six-week online compassion-based self-help programme with email guidance from the researcher. Compassion for Skin Conditions: Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010).
Change From Baseline Dermatology Life Quality Index (DLQI) Score After Six Weeks.
-6.38 score on a scale
Standard Deviation 6.61

Adverse Events

Compassion Guided Self-help

Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Compassion Guided Self-help
n=34 participants at risk
Participants will engage in a six-week online compassion-based self-help programme with email guidance from the researcher. Compassion for Skin Conditions: Online guided self-help intervention derived from Compassion Focused Therapy (Gilbert, 2010).
Psychiatric disorders
Psychological distress
8.8%
3/34 • Number of events 3 • Rolling recruitment: from baseline for each participant until data collection ended on Day 42. Participants also were able to contact the lead researcher by email after this point (no fixed end point for this).

Additional Information

Elaine Clarke

The University of Sheffield

Phone: 01142226533

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place