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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05196464
Other study ID # 1576467
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date June 30, 2023

Study information

Verified date April 2024
Source Syracuse VA Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date June 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States Syracuse Veterans Affairs Medical Center Syracuse New York

Sponsors (3)

Lead Sponsor Collaborator
Syracuse VA Medical Center Michael E. DeBakey VA Medical Center, VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Access to mental health care Access to care is measured by hours of active treatment Veterans receive within and outside of VA. 1 month
Primary Psychological Distress 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
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