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Improving Psychosocial Functioning in Older Veterans With PTSD

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VA Office of Research and Development

Status

Completed

Conditions

Posttraumatic Stress Disorder

Treatments

Behavioral: Support group control
Behavioral: Psychosocial intervention

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT02803125
D1832-W

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

34 participants in 2 patient groups, including a placebo group

Developed psychosocial intervention
Active Comparator group
Description:
The active intervention in this study that will be compared to support group control
Treatment:
Behavioral: Psychosocial intervention
Support group control
Placebo Comparator group
Description:
This is the comparison group
Treatment:
Behavioral: Support group control

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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