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Completed

NCT Number: NCT02803125

Improving Psychosocial Functioning in Older Veterans With PTSD

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Boston, Massachusetts, 02130, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

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

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

    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.

  2. Quality of Life Inventory (QOLI)

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

    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

  3. Veterans Rand 12-item (VR-12) Health Survey

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

    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

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Jun 16, 2016
Registry last updated
Aug 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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