- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02803125
Improving Psychosocial Functioning in Older Veterans With PTSD
April 13, 2023 updated by: VA Office of Research and Development
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02130
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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 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.
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Developed psychosocial intervention
The active intervention in this study that will be compared to support group control
|
This intervention is to be developed during the study.
It will likely include modules that provide anger management strategies, communication skills, and education about interpersonal relationships and social support.
In addition, psychoeducation about behavioral activation and stress management will likely be included
|
Placebo Comparator: Support group control
This is the comparison group
|
The support groups will be process-oriented in nature with core elements manualized to facilitate consistency of the intervention.
In particular, group leaders will facilitate a check-in with the group, and the agenda will be open to topics brought in by group members
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Quality of Life Inventory (QOLI)
Time Frame: Change from baseline to follow-up at 6 months
|
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.
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.
|
Change from baseline to follow-up at 6 months
|
Change in the Inventory of Psychosocial Functioning
Time Frame: Change from baseline to follow-up at 6 months
|
The IPF is an 80-item self-report measure designed to assess multiple domains of 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 and scores for seven subscales: romantic relationships, family, work, friendships and socializing, parenting, education, and self-care functioning.
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).
|
Change from baseline to follow-up at 6 months
|
Change in the Veterans Rand 12-item Health Survey
Time Frame: Change from baseline to follow-up at 6 months
|
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 (M = 50, SD = 10) and the population standard for this measure was recently updated
|
Change from baseline to follow-up at 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Anica Pless Kaiser, PhD, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 14, 2017
Primary Completion (Actual)
September 9, 2022
Study Completion (Actual)
September 23, 2022
Study Registration Dates
First Submitted
May 19, 2016
First Submitted That Met QC Criteria
June 13, 2016
First Posted (Estimate)
June 16, 2016
Study Record Updates
Last Update Posted (Actual)
April 14, 2023
Last Update Submitted That Met QC Criteria
April 13, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1832-W
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Any data to be shared will be coded data within a limited dataset, with appropriate DUA in place.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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