Improving Psychosocial Functioning in Older Veterans With PTSD

Posttraumatic Stress Disorder Clinical Trial

Official title:

Improving Psychosocial Functioning in Older Veterans With PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803125
• Other study ID #: D1832-W
• Status: Completed
• Phase: N/A
• Start date: November 14, 2017
• Est. completion date: September 23, 2022

Study information

• Verified date: April 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 23, 2022
• Est. primary completion date: September 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 60 Years and older

Eligibility

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 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.

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• 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
• 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

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the 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. 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.	Change from baseline to follow-up at 6 months
Primary	Change in the Inventory of Psychosocial Functioning	The IPF is an 80-item self-report measure designed to assess multiple domains of 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 and scores for seven subscales: romantic relationships, family, work, friendships and socializing, parenting, education, and self-care functioning. 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).	Change from baseline to follow-up at 6 months
Primary	Change in the Veterans Rand 12-item 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 (M = 50, SD = 10) and the population standard for this measure was recently updated	Change from baseline to follow-up at 6 months