NCT05196464

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 19, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

2.2 years

First QC Date

December 14, 2021

Last Update Submit

April 19, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Access to mental health care

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

    1 month

  • 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

Study Arms (1)

VA primary care patients

OTHER

VA primary care patients with psychological distress are being enrolled

Behavioral: Acceptance and Commitment Therapy (ACT) WorkshopBehavioral: Treatment as usual (TAU)

Interventions

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.

VA primary care patients

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.

VA primary care patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \) current mental health symptoms as measured by one of the following indicators: PHQ-9 ≥ 10, PCL-5 ≥ 30, or GAD-7 ≥ 10.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Syracuse Veterans Affairs Medical Center

Syracuse, New York, 13210, United States

Location

MeSH Terms

Interventions

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: two intervention randomized clinical trial
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2021

First Posted

January 19, 2022

Study Start

April 1, 2021

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

April 22, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations