Clinical trial NCT02803125: Improving Psychosocial Functioning in Older Veterans With PTSD
Official title: Improving Psychosocial Functioning in Older Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD
Aging
Veteran
Intervention
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-06-16
Enrollment: 34
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Inventory of Psychosocial Functioning (IPF) - Romantic, Family, Friends/Socializing Subscales
timeFrame: Reporting on baseline and post-group assessment (assessed at the final group session, approximately 2.5 - 3 months after baseline)
measure: Quality of Life Inventory (QOLI)
timeFrame: Reporting on baseline and post-group scores (assessed at the final group session, approximately 2.5 - 3 months after baseline)
measure: Veterans Rand 12-item (VR-12) Health Survey
timeFrame: Reporting on baseline and post-group scores (assessed at the final group session, approximately 2.5 - 3 months after baseline)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: Anica Pless Kaiser, PhD
role: PRINCIPAL_INVESTIGATOR
References: