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Post-traumatic Stress Disorder (PTSD) Symptoms in Later Life

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ClinicalTrials.gov Identifier: NCT03821259
Recruitment Status : Completed
First Posted : January 29, 2019
Results First Posted : June 23, 2020
Last Update Posted : July 13, 2020
Sponsor:
Collaborator:
NHS Tayside
Information provided by (Responsible Party):
University of Edinburgh

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Cross-Sectional
Condition Post Traumatic Stress Disorder
Intervention Other: Psychological measures
Enrollment 88
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Older Adults With Mental Health History
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 88
Completed 88
Not Completed 0
Arm/Group Title Older Adults With Mental Health History
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 88
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 88 participants
72.17  (4.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 88 participants
Female
61
  69.3%
Male
27
  30.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United Kingdom Number Analyzed 88 participants
88
 100.0%
The Civilian Version of the PTSD Checklist (PCL-C)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 88 participants
42.14  (14.47)
[1]
Measure Description: The Civilian Version of the PTSD Checklist (PCL-C; Blanchard, Jones-Alexander, Buckley, & Forneris, 1996; Weathers, Litz, Herman, Huska, & Keane, 1993) measures PTSD symptoms in the civilian population. Participants answered 17 items by rating levels of distress caused by each symptom in the past month on a 5-point scale (1 = not at all to 5 = extremely). Total scores range from 17 to 85. Higher scores indicate greater symptom severity.
1.Primary Outcome
Title The Trauma History Questionnaire (THQ; Green, 1996)
Hide Description 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.
Time Frame through study completion, an average of 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Older Adults With Mental Health History
Hide Arm/Group Description:
Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.
Overall Number of Participants Analyzed 88
Mean (Standard Deviation)
Unit of Measure: score on a scale
Total number of traumatic events 5.93  (3.42)
Crime-related events 0.76  (0.88)
General trauma and disasters 3.81  (2.09)
Unwanted sexual experiences and physical violence 0.97  (1.37)
2.Primary Outcome
Title The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
Hide Description This 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.
Time Frame through study completion, an average of 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Older Adults With Mental Health History
Hide Arm/Group Description:
Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.
Overall Number of Participants Analyzed 87
Mean (Standard Deviation)
Unit of Measure: score on a scale
DERS total score 93.63  (24.33)
Acceptance of emotional responses 17.20  (6.99)
Engagement in goal-directed behaviours 16.59  (4.76)
Impulse control 12.26  (5.37)
Emotional awareness 14.56  (4.37)
Access to emotion regulation strategies 21.51  (7.13)
Emotional clarity 11.51  (4.18)
3.Primary Outcome
Title The Civilian Version of the PTSD Checklist (PCL-C; Weathers, Litz, Huska & Keane, 1994)
Hide Description This 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.
Time Frame through study completion, an average of 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Older Adults With Mental Health History
Hide Arm/Group Description:
Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.
Overall Number of Participants Analyzed 88
Mean (Standard Deviation)
Unit of Measure: score on a scale
42.14  (14.47)
4.Primary Outcome
Title The Group Identification Scale (GIS; Sani et al., 2012)
Hide Description This 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.
Time Frame through study completion, an average of 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Older Adults With Mental Health History
Hide Arm/Group Description:
Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.
Overall Number of Participants Analyzed 88
Mean (Standard Deviation)
Unit of Measure: Number of groups participants identified
1.73  (1.04)
5.Primary Outcome
Title The Scottish Index of Multiple Deprivation (SIMD; Scottish Executive, 2016)
Hide Description The 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).
Time Frame through study completion, an average of 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Older Adults With Mental Health History
Hide Arm/Group Description:
Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.
Overall Number of Participants Analyzed 88
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.31  (1.27)
Time Frame 7 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Older Adults With Mental Health History
Hide Arm/Group Description Eligible participants, aged 65 and over in receipt of psychological treatment for anxiety or depression, were recruited within the Older Adult Psychological Therapies service.
All-Cause Mortality
Older Adults With Mental Health History
Affected / at Risk (%)
Total   0/88 (0.00%) 
Hide Serious Adverse Events
Older Adults With Mental Health History
Affected / at Risk (%)
Total   0/88 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Older Adults With Mental Health History
Affected / at Risk (%)
Total   0/88 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Klaudia Suchorab
Organization: University of Edinburgh/NHS Tayside
Phone: +44 1738 621151
EMail: klaudia.suchorab@nhs.net
Layout table for additonal information
Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03821259    
Other Study ID Numbers: CAHSS1802/04
First Submitted: December 19, 2018
First Posted: January 29, 2019
Results First Submitted: October 7, 2019
Results First Posted: June 23, 2020
Last Update Posted: July 13, 2020