Access to CareNCT05196464
ACT Workshops: A Novel Delivery Modality to Increase Access to Care for Rural Veterans
A study testing Acceptance and Commitment Therapy (ACT) Workshop and Treatment as usual (TAU) in people with Access to Care and Psychological Distress, run by Syracuse VA Medical Center at 1 site in United States.
Trial summary
This study investigates access, effectiveness, and acceptability of 1-day ACT workshops on problematic mental health symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Access to Care, Psychological Distress
- What is being tested?
- Acceptance and Commitment Therapy (ACT) Workshop and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) current mental health symptoms as measured by one of the following indicators: PHQ-9 ≥ 10, PCL-5 ≥ 30, or GAD-7 ≥ 10.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Syracuse Veterans Affairs Medical Center
Syracuse, New York, 13210
About this study
This study investigates access, effectiveness, and acceptability of 1-day ACT workshops on problematic mental health symptoms.
Read the 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.
- Conditions
- Access to Care, Psychological Distress
- Being tested
- Acceptance and Commitment Therapy (ACT) Workshop, Treatment as usual (TAU)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy (ACT) WorkshopBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| VA primary care patients | Other | VA primary care patients with psychological distress are being enrolled Receives: Behavioral: Acceptance and Commitment Therapy (ACT) Workshop; Behavioral: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Access to mental health care
Access to care is measured by hours of active treatment Veterans receive within and outside of VA.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Apr 2021
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Access to CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two intervention randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syracuse VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- VA Office of Research and Development, Michael E. DeBakey VA Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05196464
- Sponsor's protocol ID
- 1576467
- Status last verified
- Apr 2024
- First submitted
- 14 Dec 2021
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACT Workshops: A Novel Delivery Modality to Increase Access to Care for Rural Veterans
- ClinicalTrials.gov ID
- NCT05196464
- Acronym / sponsor ID
- 1576467
- Conditions
- Access to Care, Psychological Distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Syracuse VA Medical CenterUS federal agency
- Collaborators
- VA Office of Research and Development, Michael E. DeBakey VA Medical Center
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates access, effectiveness, and acceptability of 1-day ACT workshops on problematic mental health symptoms.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- two intervention randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| VA primary care patients | Other | Behavioral: Acceptance and Commitment Therapy (ACT) Workshop, Behavioral: Treatment as usual (TAU)VA primary care patients with psychological distress are being enrolled |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) current mental health symptoms as measured by one of the following indicators: PHQ-9 ≥ 10, PCL-5 ≥ 30, or GAD-7 ≥ 10.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment Therapy (ACT) WorkshopACT 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. | Behavioural | VA primary care patients |
| 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. | Behavioural | VA primary care patients |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy (ACT) Workshop and Treatment as usual (TAU) in people with Access to Care and Psychological Distress, run by Syracuse VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Access to mental health care (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.