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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03821259
Other study ID # CAHSS1802/04
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 6, 2018
Est. completion date May 17, 2019

Study information

Verified date June 2020
Source University of Edinburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Older adults are becoming a growing proportion of people utilising mental health services. However, the needs of this population are poorly understood despite the evidence that mental health conditions are manifested differently in old age. One of those conditions is Post Traumatic Stress Disorder (PTSD) which has been associated with an increased risk of adverse outcomes in old age, including health problems, difficulties in daily functioning, less satisfaction with life and multiple psychiatric co-morbidities, such as depression and anxiety. Despite the serious consequences, PTSD symptoms in old age tend to be underreported or misperceived as a physical illness or part of an ageing process.

Traumatic life experiences do not necessarily lead to PTSD. Psychological resources, including emotional stability and social support, allow individuals to find appropriate coping strategies and maintain well-being in old age. Group identification, defined as a sense of belonging to a specific group, influences the response to social support and may be important in predicting distress in old age. On the other hand, socioeconomic deprivation is likely to increase this distress as exposure to traumatic events is more prevalent in disadvantaged populations.

The present study will investigate the impact of those factors on PTSD symptoms in later life. The researcher will recruit 85 older adults from the Older People Psychological Therapies Service, who are in receipt of psychological treatment for PTSD, anxiety or depression. Participants will be asked to provide basic demographic information, which will be used to describe the participant characteristics and to estimate the degree of socioeconomic deprivation. Participants will also complete five measures to screen for cognitive impairment and measure PTSD symptoms, lifetime trauma exposure, emotion regulation and group identification.

The findings will help improve the diagnostic process and development of psychological treatments for PTSD in older adults by expanding our knowledge of this condition in later life.


Description:

Aim of the study:

To investigate the importance and relative contribution of interpersonal and intra-individual factors, including lifetime trauma exposure, emotion regulation, social group belonging and socioeconomic deprivation in predicting PTSD symptoms in older adults.

Primary research questions:

1. Will greater lifetime trauma exposure predict higher levels of PTSD symptoms in older adults?

2. Will greater difficulties in emotion regulation predict higher levels of PTSD symptoms in older adults?

3. Will a lower number of group identifications predict higher levels of PTSD symptoms in older adults?

4. Will higher levels of socioeconomic deprivation predict higher levels of PTSD symptoms in older adults?

Secondary research questions:

1. What is the relative contribution of lifetime trauma exposure in predicting levels of PTSD symptoms in older adults?

2. What is the relative contribution of difficulties in emotion regulation in predicting levels of PTSD symptoms in older adults?

3. What is the relative contribution of group identifications in predicting levels of PTSD symptoms in older adults?

4. What is the relative contribution of socioeconomic deprivation in predicting levels of PTSD symptoms in older adults?

Design:

The study will employ a cross-sectional, within-groups design. An opportunistic clinical sample of older adults, aged 65 and over, in receipt of psychological treatment for PTSD, anxiety or depression in the Older People Psychological Therapies Service in NHS Tayside will be recruited. Participants will be asked to provide basic demographic information and to complete five measures, screening for cognitive impermanent and measuring PTSD symptoms, lifetime trauma exposure, emotion regulation and group identification. Correlation and multiple regression analyses will be used to answer the research hypotheses.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date May 17, 2019
Est. primary completion date May 17, 2019
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- Aged 65 years and over

- In receipt of psychological treatment for PTSD, anxiety or depression

- Fluent English speaker

- Ability to give consent

Exclusion Criteria:

- Cognitive impairment (MoCA =20)

- Under investigation for or a confirmed diagnosis of dementia

- Currently experiencing an episode of a serious mental illness, e.g. psychosis

- Ongoing substance misuse

- Ongoing serious risk issues (i.e. risk of harm to self and others, suicidality)

Study Design


Intervention

Other:
Psychological measures
Participants will be asked to provide basic demographic information and to complete five measures, screening for cognitive impermanent and measuring PTSD symptoms, lifetime trauma exposure, emotion regulation and group identification.

Locations

Country Name City State
United Kingdom Tayside Older People Psychological Therapies service Dundee

Sponsors (2)

Lead Sponsor Collaborator
University of Edinburgh NHS Tayside

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Trauma History Questionnaire (THQ; Green, 1996) 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. through study completion, an average of 6 months
Primary The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004) 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 (a=.80-.89) and acceptable validity. through study completion, an average of 6 months
Primary The Civilian Version of the PTSD Checklist (PCL-C; Weathers, Litz, Huska & Keane, 1994) 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 (a=.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. through study completion, an average of 6 months
Primary The Group Identification Scale (GIS; Sani et al., 2012) 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 (a=.85-.92) and construct validity. through study completion, an average of 6 months
Primary The Scottish Index of Multiple Deprivation (SIMD; Scottish Executive, 2016) 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). through study completion, an average of 6 months
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