Improving Psychosocial Functioning in Older Veterans With PTSD

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder
• Interventions: Behavioral: Support group control; Behavioral: Psychosocial intervention

• Registration Number: NCT02803125
• Lead Sponsor: VA Office of Research and Development

Brief Summary

The purpose of this project is to develop an intervention to improve psychosocial functioning and quality of life for older Veterans with partial or full PTSD.

Detailed Description

This project will develop, implement, and evaluate a group protocol geared toward restoring older Veterans to better, fuller functioning. This project will determine the feasibility and acceptability of such an intervention. The intervention developed will then be compared to a support group control condition. Primary outcomes are psychosocial functioning and quality of life, with PTSD and depressive symptoms as secondary outcomes. A complementary objective is to improve attitudes toward mental health treatment and to increase readiness for change and engagement in evidence-based psychotherapies, as appropriate. Results from this study will provide feasibility data for future development and testing of the intervention protocol.

Study Timeline

• Study First Submitted: 2016-05-19
• Study First Submitted QC: 2016-06-13
• Study First Posted: 2016-06-16
• Study Start: 2017-11-14
• Primary Completion: 2022-09-09
• Study Completion: 2022-09-23
• Results First Submitted: 2023-10-19
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-30
• Last Update Submitted: 2024-04-30
• Results First Posted: 2024-08-01
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Focus groups:

• Veterans need to be at least 60 years old to be eligible to participate in the focus groups.
• Potential participants will be assessed with the Primary Care Posttraumatic Stress Disorder Screener (PC-PTSD-5) prior to being invited to participate.
• Inclusion criteria include endorsement of a military-related criterion A event and a score of 3 or higher on the PC-PTSD-5.

Pilot:

• Veterans need to be at least 60 years old to be eligible to participate in the study.
• Potential participants will be assessed for PTSD symptoms.
• Inclusion criteria include endorsement of a military-related criterion A event and several PTSD symptoms.

Comparison:

• Veterans need to be at least 60 years old to be eligible to participate in the study.
• For both intervention and support groups, participants (who will be assessed for PTSD), must endorse a military-related criterion A event and several PTSD symptoms.

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Exclusion Criteria

Focus groups:

• Veterans who are diagnosed with a psychotic disorder or have psychotic symptoms, have been hospitalized for suicidal ideation or psychosis within the past year, or have a diagnosis of dementia or other severe cognitive disorder.
• Potential participants will also be excluded if they do not agree to be audio recorded.

Pilot:

• Veterans who are in current treatment for PTSD, are diagnosed with a psychotic disorder or have psychotic symptoms, have been hospitalized for suicidal ideation or psychosis within the past year, or have a diagnosis of dementia or other severe cognitive disorder.
• Veterans will be asked not to join therapy groups or other interventions for the duration of their participation in the study.
• Potential participants will also be excluded if they do not agree to be audio recorded.

Comparison:

• Veterans who are in current treatment for PTSD, are diagnosed with a psychotic disorder or have psychotic symptoms, have been hospitalized for suicidal ideation or psychosis within the past year, or have a diagnosis of dementia or other severe cognitive disorder.
• Veterans will be asked not to join therapy groups or other interventions for the duration of their participation in the study.
• Potential participants will also be excluded if they do not agree to be audio recorded.
• In addition, Veterans who participated in the pilot phase of the study will be excluded from participating in the comparison condition phase.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Support group control	Support group control	This is the comparison group
Developed psychosocial intervention	Psychosocial intervention	The active intervention in this study that will be compared to support group control

Primary Outcome Measures

Name	Time	Method
Quality of Life Inventory (QOLI)	Reporting on baseline and post-group scores (assessed at the final group session, approximately 2.5 - 3 months after baseline)	The QOLI is a 32 item self-report measure that assesses life satisfaction across 16 life domains (e.g., health, work, recreation). For each domain, the respondent rates how important the domain is on a 0-2 scale and how satisfied he or she is in this area of life on a 7-point scale. Satisfaction scores on the measure are weighted based on the respondent's rating of the importance of the life domain in order to achieve a total score with higher scores indicating higher quality of life. The measure was validated across a number of samples, including psychiatric inpatient and outpatient VA samples. Test-retest reliability was excellent over a one-month interval (r = .91) as was the internal consistency of the measure (alphas ranged from .86-.89). The measure also demonstrated convergent and discriminant validity with other measures of life satisfaction. T scores were used with range 0 - 100, Mean (of reference population) =50, Standard deviation = 10
Inventory of Psychosocial Functioning (IPF) - Romantic, Family, Friends/Socializing Subscales	Reporting on baseline and post-group assessment (assessed at the final group session, approximately 2.5 - 3 months after baseline)	The IPF is an 80-item self-report measure designed to assess functional impairment experienced by Veterans. Respondents rate how often they have acted a certain way over the past 30 days. Items are rated on a 7-point scale ranging from 0 ("never") to 6 ("always"). The IPF yields a total score (0-66) and scores for seven subscales: romantic relationships, family, work, friendships and socializing, parenting, education, and self-care functioning (lower indicates better functioning/less impairment). Respondents have the option to skip sections that do not apply to them. The IPF has excellent internal consistency reliability (overall alpha = .93) and the scale correlates with other self-report measures of quality of life and functional impairment, such as the QOLI (r = .59). Reporting on romantic relationships (range = 0-66), family (range = 0-42), and friends/socializing (range = 0-48) functioning subscales here. Higher scores indicate more impairment.
Veterans Rand 12-item (VR-12) Health Survey	Reporting on baseline and post-group scores (assessed at the final group session, approximately 2.5 - 3 months after baseline)	The VR-12 is a 12-item scale that assesses the effects of physical and mental health on well-being, and is often used to assess quality of life. Item scores are used to compute two broad component scores: the physical component score (PCS) and the mental component score (MCS). The component scores are standardized T-Scores and the population standard for this measure was recently updated. Higher scores indicate better functioning. T scores were used with range 0 - 100, Mean (of reference population) = 50, Standard deviation = 10

Trial Locations

Locations (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA; 🇺🇸 Boston, Massachusetts, United States