Trial Outcomes & Findings for Post-traumatic Stress Disorder (PTSD) Symptoms in Later Life (NCT NCT03821259)
NCT ID: NCT03821259
Last Updated: 2020-07-13
Results Overview
This questionnaire measures lifetime exposure to a range of potentially traumatic experiences in three broad areas of (1) crime-related events, (2) general trauma and disasters, as well as (3) unwanted sexual experiences and physical violence, and (4) other unspecified extraordinarily stressful event . Participants will be required to answer 24 items in a yes/no. Total scores range from 0 to 24. Scores for subscales are as following: (1) crime-related events: 0 - 4; (2) general trauma and disasters: 0 - 13; (3) unwanted sexual experiences and physical violence: 0 - 6; (4) other: 0 -1. Higher scores indicate more traumatic events. The THQ was developed to be applicable to various populations and has been widely used in research. In a recent review of studies employing this measure, the THQ demonstrated sound psychometric properties, including a good interrater reliability and construct validity.
COMPLETED
88 participants
through study completion, an average of 6 months
2020-07-13
Participant Flow
The study recruited an opportunistic sample of suitable participants who were identified and initially approached about the study by a psychologist involved in their care. Consequently no participants were excluded following their enrolment in the study.
Participant milestones
| Measure |
Older Adults With Mental Health History
Eligible participants, aged 65 and over in receipt of psychological treatment for PTSD, anxiety or depression, were recruited within the Older Adult Psychological Therapies service.
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|---|---|
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Overall Study
STARTED
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88
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Overall Study
COMPLETED
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88
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Older Adults With Mental Health History
n=88 Participants
Eligible participants, aged 65 and over in receipt of psychological treatment for PTSD, anxiety or depression, were recruited within the Older Adult Psychological Therapies service.
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|---|---|
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Age, Continuous
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72.17 years
STANDARD_DEVIATION 4.67 • n=88 Participants
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Sex: Female, Male
Female
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61 Participants
n=88 Participants
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Sex: Female, Male
Male
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27 Participants
n=88 Participants
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Region of Enrollment
United Kingdom
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88 Participants
n=88 Participants
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The Civilian Version of the PTSD Checklist (PCL-C)
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42.14 units on a scale
STANDARD_DEVIATION 14.47 • n=88 Participants
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PRIMARY outcome
Timeframe: through study completion, an average of 6 monthsThis questionnaire measures lifetime exposure to a range of potentially traumatic experiences in three broad areas of (1) crime-related events, (2) general trauma and disasters, as well as (3) unwanted sexual experiences and physical violence, and (4) other unspecified extraordinarily stressful event . Participants will be required to answer 24 items in a yes/no. Total scores range from 0 to 24. Scores for subscales are as following: (1) crime-related events: 0 - 4; (2) general trauma and disasters: 0 - 13; (3) unwanted sexual experiences and physical violence: 0 - 6; (4) other: 0 -1. Higher scores indicate more traumatic events. The THQ was developed to be applicable to various populations and has been widely used in research. In a recent review of studies employing this measure, the THQ demonstrated sound psychometric properties, including a good interrater reliability and construct validity.
Outcome measures
| Measure |
Older Adults With Mental Health History
n=88 Participants
Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.
|
|---|---|
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The Trauma History Questionnaire (THQ; Green, 1996)
Total number of traumatic events
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5.93 score on a scale
Standard Deviation 3.42
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The Trauma History Questionnaire (THQ; Green, 1996)
Crime-related events
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0.76 score on a scale
Standard Deviation 0.88
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The Trauma History Questionnaire (THQ; Green, 1996)
General trauma and disasters
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3.81 score on a scale
Standard Deviation 2.09
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The Trauma History Questionnaire (THQ; Green, 1996)
Unwanted sexual experiences and physical violence
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0.97 score on a scale
Standard Deviation 1.37
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PRIMARY outcome
Timeframe: through study completion, an average of 6 monthsThis questionnaire measures six aspects of emotion regulation, including (1) acceptance of emotional responses, (2) engagement in goal-directed behaviours, (3) impulse control, (4) emotional awareness, (5) access to emotion regulation strategies and (6) emotional clarity. Participants will be required to answer 36 items by indicating the frequency of each item on a 5-point scale ranging from 1='almost never' to 5='almost always'. The total score ranges from 36 to 180. Subscales will be explored for the purpose of this study. The score ranges for each subscale are as following: (1) acceptance of emotional responses: 6 - 30, (2) engagement in goal-directed behaviours: 5 - 25, (3) impulse control: 6 - 30, (4) emotional awareness: 6 - 30, (5) access to emotion regulation strategies: 8 - 40 and (6) emotional clarity: 5 - 25. Higher scores indicate greater difficulties in emotion regulation. The DERS demonstrated a good internal consistency (α=.80-.89) and acceptable validity.
Outcome measures
| Measure |
Older Adults With Mental Health History
n=87 Participants
Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.
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|---|---|
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The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
DERS total score
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93.63 score on a scale
Standard Deviation 24.33
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The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
Acceptance of emotional responses
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17.20 score on a scale
Standard Deviation 6.99
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The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
Engagement in goal-directed behaviours
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16.59 score on a scale
Standard Deviation 4.76
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The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
Impulse control
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12.26 score on a scale
Standard Deviation 5.37
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The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
Emotional awareness
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14.56 score on a scale
Standard Deviation 4.37
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The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
Access to emotion regulation strategies
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21.51 score on a scale
Standard Deviation 7.13
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The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
Emotional clarity
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11.51 score on a scale
Standard Deviation 4.18
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PRIMARY outcome
Timeframe: through study completion, an average of 6 monthsThis questionnaire measures PTSD symptoms in the civilian population. Participants will be required to answer 17 items by rating the intensity of their symptoms on a 5-point scale ranging from 1='not at all' to 5='extremely'. Total scores range from 17 to 85. Higher scores indicate greater symptom severity. The PCL-C demonstrated a high internal consistency (α=.87-.94), good test-retest reliability and positive correlations with other widely used PTSD scales. It has been reported that this measure is suitable for use with older adults with a recommended cut-off score of 37 to reliably diagnose PTSD in this population.
Outcome measures
| Measure |
Older Adults With Mental Health History
n=88 Participants
Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.
|
|---|---|
|
The Civilian Version of the PTSD Checklist (PCL-C; Weathers, Litz, Huska & Keane, 1994)
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42.14 score on a scale
Standard Deviation 14.47
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PRIMARY outcome
Timeframe: through study completion, an average of 6 monthsThis questionnaire measures identification with three groups (i.e. family, community and a social group chosen by the participant from the list provided, e.g. a group of friends, a voluntary group or a sports group). Identification with each group is measured with 4 items which encompass a general sense of belonging and commonality with in-group members, e.g. "I have a sense of belonging to \[my group\]". Participants rate their answers on a 7-point scale from 1='strongly disagree' to 7='strongly agree'. Total scores for 4 items measuring identification with each group range from 4 to 28. The cut-off score for group identification is 20, hence individuals whose total score is ≥20 across 4 items will be considered as identifying with the given group. The total number of groups the participant can identify with ranges between 0 and 3 groups. This number will be used in the final analysis. The GIS demonstrated a good internal reliability (α=.85-.92) and construct validity.
Outcome measures
| Measure |
Older Adults With Mental Health History
n=88 Participants
Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.
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|---|---|
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The Group Identification Scale (GIS; Sani et al., 2012)
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1.73 Number of groups participants identified
Standard Deviation 1.04
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PRIMARY outcome
Timeframe: through study completion, an average of 6 monthsThe SIMD measures socioeconomic deprivation according to postcode information and is the only readily available measure of socioeconomic deprivation which covers the whole population of Scotland. For the purpose of this study, we will report the postcode information based on their assigned quintile, which ranges from 1 (most deprived) to 5 (least deprived).
Outcome measures
| Measure |
Older Adults With Mental Health History
n=88 Participants
Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.
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|---|---|
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The Scottish Index of Multiple Deprivation (SIMD; Scottish Executive, 2016)
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3.31 units on a scale
Standard Deviation 1.27
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Adverse Events
Older Adults With Mental Health History
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Klaudia Suchorab
University of Edinburgh/NHS Tayside
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place