Post Traumatic Stress Disorder Clinical Trial
Official title:
Post-traumatic Stress Disorder (PTSD) Symptoms in Later Life: the Contribution of Cumulative Trauma Exposure, Emotion Regulation, Group Identifications, and Socioeconomic Deprivation
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 |
Verified date | June 2020 |
Source | University of Edinburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Tayside Older People Psychological Therapies service | Dundee |
Lead Sponsor | Collaborator |
---|---|
University of Edinburgh | NHS Tayside |
United Kingdom,
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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