- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07618312
Improving Patient Engagement in Mental Health Services
Improving Patient Engagement in Mental Health Services: Adaptation and Implementation of a Behavioral Activation Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The goal of this hybrid type II implementation trial is to test a telehealth behavioral activation intervention delivered in Spanish by community health workers in Spanish speakers living in rural and frontier areas of Montana and New Mexico. The main questions it aims to answer are:
Does an adapted behavioral activation intervention reduce depressive symptoms? Is engagement in the intervention the primary mechanism by which depressive scores are reduced?
Researchers will compare depressive symptoms in the intervention group as compared to a waitlisted group.
Participants will receive a weekly behavioral activation session via telehealth and will be asked to complete weekly surveys and homework. They will complete the Beck Depression Inventory (21 items) at baseline, after 12 weeks, and after 32 weeks.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sally Moyce, PhD RN
- Phone Number: 14069942787
- Email: sally.moyce@montana.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age 18 years or older
- Spanish-speaking adult who prefers to receive services in Spanish
Resident of a rural or frontier community in Montana or New Mexico
Positive screen for depressive symptoms at or above study eligibility threshold on Spanish-language screening measure
Able and willing to participate in telehealth sessions
Able to provide informed consent
Exclusion Criteria:
- Active suicidal intent requiring immediate emergency intervention
Current psychosis or mania
Severe cognitive impairment that would prevent participation
Currently receiving intensive psychiatric treatment that would conflict with the intervention
Unable to participate in telehealth sessions
Unable to provide informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment
Administration of Behavioral Activation via Telehealth
|
Adapted version of BA intervention delivered via telehealth
|
|
No Intervention: Waitlist
waiting for BA intervention or post intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Beck Depression Inventory (21 items)
Time Frame: Baseline, After 12 weeks, After 32 weeks
|
Baseline, After 12 weeks, After 32 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavioral Activation for Depression Scale Short Form, Session Attendance, Activation Homework
Time Frame: weekly for 12 weeks
|
Engagement Measures
|
weekly for 12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Moyce022026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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