Improving Psychosocial Functioning in Older Veterans With PTSD
NCT ID: NCT02803125
Last Updated: 2024-08-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
34 participants
INTERVENTIONAL
2017-11-14
2022-09-23
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Intensive Treatment for Chronic Pain and Posttraumatic Stress Disorder (PTSD)
NCT01120067
An RCT of a Primary Care-Based PTSD Intervention: Clinician-Supported PTSD Coach
NCT02685358
Peer-Delivered Whole Health Coaching for Veterans With PTSD
NCT03364192
Assessing and Enhancing Social Support
NCT05187156
Group Treatment for PTSD: A Randomized Clinical Trial With Veterans
NCT01544088
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Developed psychosocial intervention
The active intervention in this study that will be compared to support group control
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
This is the comparison group
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
VA Office of Research and Development
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Anica Pless Kaiser, PhD
Role: PRINCIPAL_INVESTIGATOR
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D1832-W
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.