Posttraumatic Stress DisorderNCT02803125
Improving Psychosocial Functioning in Older Veterans With PTSD
A study testing Psychosocial intervention in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Psychosocial intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2017to 23 Sep 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
About this study
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Psychosocial intervention, Support group control
- Keywords
- PTSD, Aging, Veteran, Intervention
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychosocial interventionBehavioural
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 controlBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Developed psychosocial intervention | Active comparator | The active intervention in this study that will be compared to support group control Receives: Behavioral: Psychosocial intervention |
| Support group control | Placebo comparator | This is the comparison group Receives: Behavioral: Support group control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: Reporting on baseline and post-group scores (assessed at the final group session, approximately 2.5 - 3 months after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study start14 Nov 2017
- Primary completion9 Sep 2022
- Study completion23 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Anica Pless Kaiser, PhD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803125
- Sponsor's protocol ID
- D1832-W
- Status last verified
- Apr 2024
- First submitted
- 19 May 2016
- Last updated
- 1 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Any data to be shared will be coded data within a limited dataset, with appropriate Data Use Agreement (DUA) in place.
Publications
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. 2026 May;23(2):293-306. doi: 10.1037/ser0000962. Epub 2025 Jun 26.
PubMed 40569724Pless 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.
PubMed 38432471
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Psychosocial Functioning in Older Veterans With PTSD
- ClinicalTrials.gov ID
- NCT02803125
- Acronym / sponsor ID
- D1832-W
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD, Aging, Veteran, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 9 Sep 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Posted 1 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Developed psychosocial intervention | Active comparator | Behavioral: Psychosocial interventionThe active intervention in this study that will be compared to support group control |
| Support group control | Placebo comparator | Behavioral: Support group controlThis is the comparison group |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
- 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.
Key exclusion criteria (12 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychosocial interventionThis 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 | Behavioural | Developed psychosocial intervention |
| Support group controlThe 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 | Behavioural | Support group control |
Primary outcome
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.
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40569724Pless 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. 2026 May;23(2):293-306. doi: 10.1037/ser0000962. Epub 2025 Jun 26.
- Derived from this study: PubMed 38432471Pless 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.
- Individual participant dataSharing planned: No. Any data to be shared will be coded data within a limited dataset, with appropriate Data Use Agreement (DUA) in place.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anica Pless Kaiser, PhD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychosocial intervention in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02803125, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024; AzTrials last refreshed its copy on 30 Oct 2026.