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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

Tracking Information
First Submitted Date December 19, 2018
First Posted Date January 29, 2019
Results First Submitted Date October 7, 2019
Results First Posted Date June 23, 2020
Last Update Posted Date July 13, 2020
Actual Study Start Date November 6, 2018
Actual Primary Completion Date May 17, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 10, 2020)
  • The Trauma History Questionnaire (THQ; Green, 1996) [ Time Frame: through study completion, an average of 6 months ]
    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.
  • The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004) [ Time Frame: through study completion, an average of 6 months ]
    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.
  • The Civilian Version of the PTSD Checklist (PCL-C; Weathers, Litz, Huska & Keane, 1994) [ Time Frame: through study completion, an average of 6 months ]
    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.
  • The Group Identification Scale (GIS; Sani et al., 2012) [ Time Frame: through study completion, an average of 6 months ]
    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.
  • The Scottish Index of Multiple Deprivation (SIMD; Scottish Executive, 2016) [ Time Frame: through study completion, an average of 6 months ]
    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).
Original Primary Outcome Measures
 (submitted: January 28, 2019)
  • Demographic form [ Time Frame: through study completion, an average of 6 months ]
    The form collects basic demographic information, including the participant's age, gender, marital status, academic achievement, employment status, previous outpatient or inpatient psychological or psychiatric treatment, duration of the current episode of depression, anxiety or PTSD, use of medication, and postcode.
  • The Montreal Cognitive Assessment (MoCA; Nasreddine, Phillips, Bedirian, Charbonneau, Whitehead, et al., 2005) [ Time Frame: through study completion, an average of 6 months ]
    This measure briefly screens for mild cognitive impairment (MCI) by assessing several cognitive domains, including (1) attention, (2) executive function, (3) memory and (4) orientation, with a maximum score of 30. The MoCa has been translated to multiple languages and has been widely used in clinical practice. It has demonstrated sound psychometric properties, with a good internal consistency (α=.83), and better sensitivity and specificity for detecting MCI than other commonly used screening measures. Compared to other screening tools, the MoCA has also been shown to better predict dementia in the longer term. A cut-off score of ≤20 has been recommended to optimise its sensitivity and specificity for detection of MCI in older adults.
  • The Trauma History Questionnaire (THQ; Green, 1996) [ Time Frame: through study completion, an average of 6 months ]
    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. Participants will be required to answer 24 items in a yes/no format and indicate the frequency and age of onset for each experienced event. 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.
  • The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004) [ Time Frame: through study completion, an average of 6 months ]
    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'. Higher scores indicate greater difficulties in emotion regulation. The DERS demonstrated a good internal consistency (α=.80-.89) and acceptable validity. It has been reported that this measure is suitable for use with older adults.
  • The Civilian Version of the PTSD Checklist (PCL-C; Weathers, Litz, Huska & Keane, 1994) [ Time Frame: through study completion, an average of 6 months ]
    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'. 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.
  • The Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983) [ Time Frame: through study completion, an average of 6 months ]
    This questionnaire measures symptoms of depression and anxiety on two 7-item subscales. Participants will be required to answer the total of 14 items by rating their symptom severity on a 4-point scale ranging from 0='not at all' to 3='most of the time'. Higher scores indicate greater symptom severity. The HADS has been widely used in research with older adults and demonstrated a good internal consistency (α=.75-.84) and test-retest reliability. This scale is suitable for the assessment of symptom severity, however, appropriate cut-off scores have yet to be determined in the older adult population.
  • The Group Identification Scale (GIS; Sani et al., 2012) [ Time Frame: through study completion, an average of 6 months ]
    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 four items, encompassing a general sense of belonging and commonality with in-group members. The items are rated on a 7-point scale ranging from 1='strongly disagree' to 7='strongly agree'. The cut-off score for group identification is 20, hence individuals scoring ≥20 will be considered as identifying with the given group. The GIS demonstrated a good internal reliability (α=.85-.92) and construct validity.
  • The Scottish Index of Multiple Deprivation (SIMD; Scottish Executive, 2016) [ Time Frame: through study completion, an average of 6 months ]
    The SIMD measures socioeconomic deprivation according to postcode information. Each postcode has a designated value between 1 and 10, where 1 indicates the least deprived and 10 indicates the most deprived households.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post-traumatic Stress Disorder (PTSD) Symptoms in Later Life
Official Title Post-traumatic Stress Disorder (PTSD) Symptoms in Later Life: the Contribution of Cumulative Trauma Exposure, Emotion Regulation, Group Identifications, and Socioeconomic Deprivation
Brief 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.

Detailed 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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population 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.
Condition Post Traumatic Stress Disorder
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.
Study Groups/Cohorts Older adults with mental health history
Eligible participants, aged 65 and over, will be established in treatment for PTSD, anxiety or depression in the Older Adult Psychological Therapies service.
Intervention: Other: Psychological measures
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 10, 2020)
88
Original Estimated Enrollment
 (submitted: January 28, 2019)
85
Actual Study Completion Date May 17, 2019
Actual Primary Completion Date May 17, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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)
Sex/Gender
Sexes Eligible for Study: All
Ages 65 Years and older   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03821259
Other Study ID Numbers CAHSS1802/04
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Edinburgh
Study Sponsor University of Edinburgh
Collaborators NHS Tayside
Investigators
Principal Investigator: Klaudia Suchorab, MSc NHS Tayside/University of Edinburgh
PRS Account University of Edinburgh
Verification Date June 2020