- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05196464
ACT Workshops: A Novel Delivery Modality to Increase Access to Care for Rural Veterans
April 19, 2024 updated by: Syracuse VA Medical Center
This study investigates access, effectiveness, and acceptability of 1-day ACT workshops on problematic mental health symptoms.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study proposes to investigate access, effectiveness, and acceptability of 1-day ACT workshops delivered in 2 rural VA primary clinics with 32 Veterans with problematic mental health symptoms (i.e., depression, PTSD, or anxiety) that are risk factors for suicide.
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Syracuse, New York, United States, 13210
- Syracuse Veterans Affairs Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 1) current mental health symptoms as measured by one of the following indicators: PHQ-9 ≥ 10, PCL-5 ≥ 30, or GAD-7 ≥ 10.
Exclusion Criteria:
- cognitive impairment measured by BOMC,
- current psychosis or mania as evidenced in the medical record,
- current suicidal intent as measured by the P4,
- use of mental health services within or outside of VA in the last 6 months as measured by CPRS and the non-VA services questionnaire.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: VA primary care patients
VA primary care patients with psychological distress are being enrolled
|
ACT workshops are single-day workshops that last 5-6 hours.
The workshops will 1) Acceptance and Mindfulness Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations (e.g., learning how to recognize, and develop cognitive distance from unhelpful thoughts) and strategies to willingly face experiences that cannot be changed; and 2) Committed Action Training to help Veterans clarify what matters most to them (e.g., valued domains including family, friends, spirituality, career) and what they want to stand for in life, how they want to behave, and what strengths and qualities they want to develop.
Within this context, the workshop will encourage engagement in, rather than avoidance of, actions consistent with valued directions, including engagement in healthcare.
Workshop participants will be given homework related to implementing a key coping skill.
TAU will consist of a consult to a mental health provider at their rural clinic.
The patient will then be scheduled for an intake and offered traditional mental health treatment options.
Treatment options are likely to include outpatient individual psychotherapy, psychotherapy groups, or medication management.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Access to mental health care
Time Frame: 1 month
|
Access to care is measured by hours of active treatment Veterans receive within and outside of VA.
|
1 month
|
|
Psychological Distress
Time Frame: 1 month
|
Psychological distress as measured by the Depression, Anxiety, and Stress Scale (DASS-21).
Score range on 0-42.
Higher scores indicate greater psychological distress.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2021
Primary Completion (Actual)
June 30, 2023
Study Completion (Actual)
June 30, 2023
Study Registration Dates
First Submitted
December 14, 2021
First Submitted That Met QC Criteria
January 18, 2022
First Posted (Actual)
January 19, 2022
Study Record Updates
Last Update Posted (Actual)
April 22, 2024
Last Update Submitted That Met QC Criteria
April 19, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 1576467
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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