ACT Workshops: A Novel Delivery Modality to Increase Access to Care for Rural Veterans

• Sponsor: Syracuse VA Medical Center (U.S. Fed)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05196464
• Collaborator: VA Office of Research and Development (U.S. Fed), Michael E. DeBakey VA Medical Center (U.S. Fed)
• Enrollment: 32
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 21
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

This study investigates access, effectiveness, and acceptability of 1-day ACT workshops on problematic mental health symptoms.

Condition or Disease	Intervention/Treatment	Phase
Access to Care; Psychological Distress	Behavioral: Acceptance and Commitment Therapy (ACT) Workshop; Behavioral: Treatment as usual (TAU)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: two intervention randomized clinical trialtwo intervention randomized clinical trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ACT Workshops: A Novel Delivery Modality to Increase Access to Care for Rural Veterans
• Actual Study Start Date: Apr 1, 2021
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm

Intervention/Treatment

Other: VA primary care patients VA primary care patients with psychological distress are being enrolled

Behavioral: Acceptance and Commitment Therapy (ACT) Workshop; 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.; Behavioral: Treatment as usual (TAU); 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.

Outcome Measures

Primary Outcome Measures

1. Access to mental health care [1 month]

   Access to care is measured by hours of active treatment Veterans receive within and outside of VA.

2. Psychological Distress [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

1. cognitive impairment measured by BOMC,

2. current psychosis or mania as evidenced in the medical record,

3. current suicidal intent as measured by the P4,

4. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Syracuse Veterans Affairs Medical Center	Syracuse	New York	United States	13210

Sponsors and Collaborators

• Syracuse VA Medical Center
• VA Office of Research and Development
• Michael E. DeBakey VA Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Syracuse VA Medical Center
• ClinicalTrials.gov Identifier: NCT05196464
• Other Study ID Numbers: 1576467
• First Posted: Jan 19, 2022
• Last Update Posted: Jan 19, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jan 19, 2022