Improving Psychosocial Functioning in Older Veterans With PTSD

NCT02803125 | Completed Results

• 1 other identifier: D1832-W
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD; Aging; Veteran; Intervention

Outcome Measures

Primary Outcomes (3)

• Inventory of Psychosocial Functioning (IPF) - Romantic, Family, Friends/Socializing Subscales

  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.

  Reporting on baseline and post-group assessment (assessed at the final group session, approximately 2.5 - 3 months after baseline)

• Quality of Life Inventory (QOLI)

  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

  Reporting on baseline and post-group scores (assessed at the final group session, approximately 2.5 - 3 months after baseline)

• Veterans Rand 12-item (VR-12) Health Survey

  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

  Reporting on baseline and post-group scores (assessed at the final group session, approximately 2.5 - 3 months after baseline)

Study Arms (2)

Developed psychosocial intervention

ACTIVE COMPARATOR

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

Behavioral: Psychosocial intervention

Support group control

PLACEBO COMPARATOR

This is the comparison group

Behavioral: Support group control

Interventions

Psychosocial intervention 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

Developed psychosocial intervention

Support group control 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

Support group control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Boston, Massachusetts, 02130, United States

Location

Related Publications (2)

• 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.

  PMID: 40569724 DERIVED

• 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.

  PMID: 38432471 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Anica Pless Kaiser, PhD
• Organization: VA Boston Healthcare System

Anica.PlessKaiser@va.gov

857-364-5309

Study Officials

• Anica Pless Kaiser, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: June 16, 2016
• Study Start: November 14, 2017
• Primary Completion: September 9, 2022
• Study Completion: September 23, 2022
• Last Updated: August 1, 2024
• Results First Posted: August 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)