Back to resultsImproving Psychosocial Functioning in Older Veterans With PTSD
Primary Purpose
Posttraumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychosocial intervention
Support group control
Sponsored by
About this trial
This is an interventional other trial for Posttraumatic Stress Disorder focused on measuring PTSD, Aging, Veteran, Intervention
Eligibility Criteria
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.
Sites / Locations
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Developed psychosocial intervention
Support group control
Arm Description
The active intervention in this study that will be compared to support group control
This is the comparison group
Outcomes
Primary Outcome Measures
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 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 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
Secondary Outcome Measures
Full Information
NCT ID
NCT02803125
First Posted
May 19, 2016
Last Updated
April 13, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT02803125
Brief Title
Improving Psychosocial Functioning in Older Veterans With PTSD
Official Title
Improving Psychosocial Functioning in Older Veterans With PTSD
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 14, 2017 (Actual)
Primary Completion Date
September 9, 2022 (Actual)
Study Completion Date
September 23, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
PTSD, Aging, Veteran, Intervention
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Developed psychosocial intervention
Arm Type
Active Comparator
Arm Description
The active intervention in this study that will be compared to support group control
Arm Title
Support group control
Arm Type
Placebo Comparator
Arm Description
This is the comparison group
Intervention Type
Behavioral
Intervention Name(s)
Psychosocial intervention
Intervention Description
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
Intervention Name(s)
Support group control
Intervention Description
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 Outcome Measure Information:
Title
Change in the Quality of Life Inventory (QOLI)
Description
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.
Time Frame
Change from baseline to follow-up at 6 months
Title
Change in the Inventory of Psychosocial Functioning
Description
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).
Time Frame
Change from baseline to follow-up at 6 months
Title
Change in the Veterans Rand 12-item Health Survey
Description
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
Time Frame
Change from baseline to follow-up at 6 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
All participants included in the current study will be male Veterans.
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anica Pless Kaiser, PhD
Organizational Affiliation
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Any data to be shared will be coded data within a limited dataset, with appropriate DUA in place.
Learn more about this trial
Improving Psychosocial Functioning in Older Veterans With PTSD
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