Improving Psychosocial Functioning in Older Veterans With PTSD

NCT ID: NCT02803125

Last Updated: 2024-08-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-14

Study Completion Date

2022-09-23

Brief Summary

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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

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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.

Conditions

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Posttraumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Developed psychosocial intervention

The active intervention in this study that will be compared to support group control

Group Type ACTIVE_COMPARATOR

Psychosocial intervention

Intervention Type BEHAVIORAL

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

Support group control

This is the comparison group

Group Type PLACEBO_COMPARATOR

Support group control

Intervention Type BEHAVIORAL

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

Interventions

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Psychosocial intervention

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

Intervention Type BEHAVIORAL

Support group control

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

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.

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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anica Pless Kaiser, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Locations

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VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Pless Kaiser A, Ream M, Spiro A, Sloan DM, Cook JM, Vogt D, Moye JA. Feasibility, acceptability, and outcomes: A pilot trial of the enhancing social function in older veterans with PTSD (ESVP) group intervention. Psychol Serv. 2025 Jun 26:10.1037/ser0000962. doi: 10.1037/ser0000962. Online ahead of print.

Reference Type DERIVED
PMID: 40569724 (View on PubMed)

Pless Kaiser A, Daks JS, Korsun L, Heintz H, Moye J, Sloan DM, Cook JM, Vogt D, Spiro A 3rd. Enhancing social functioning in older veterans with PTSD: Rationale and design of an intervention and initial RCT. Contemp Clin Trials. 2024 Apr;139:107485. doi: 10.1016/j.cct.2024.107485. Epub 2024 Mar 2.

Reference Type DERIVED
PMID: 38432471 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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D1832-W

Identifier Type: -

Identifier Source: org_study_id

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