Depression DisorderNCT07618312
Improving Patient Engagement in Mental Health Services
A study testing Behavioral Activation in people with Depression Disorder and Engagement, run by Montana State University.
Trial summary
Hybrid Type II Implementation Trial Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression Disorder, Engagement
- What is being tested?
- Behavioral Activation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2027to Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Improving Patient Engagement in Mental Health Services: Adaptation and Implementation of a Behavioral Activation Intervention
Hybrid Type II Implementation Trial
Read the 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.
- Conditions
- Depression Disorder, Engagement
- Being tested
- Behavioral Activation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ActivationBehavioural
Adapted version of BA intervention delivered via telehealth
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Administration of Behavioral Activation via Telehealth Receives: Behavioral: Behavioral Activation |
| Waitlist | No intervention | waiting for BA intervention or post intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Depression Inventory (21 items)
Measured: Baseline, After 12 weeks, After 32 weeks
Secondary outcomes (1)
Behavioral Activation for Depression Scale Short Form, Session Attendance, Activation Homework
Engagement Measures
Measured: weekly for 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study startMar 2027 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionFeb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression DisorderStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montana State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618312
- Sponsor's protocol ID
- Moyce022026
- Status last verified
- May 2026
- First submitted
- 10 Feb 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Patient Engagement in Mental Health Services: Adaptation and Implementation of a Behavioral Activation Intervention
- ClinicalTrials.gov ID
- NCT07618312
- Acronym / sponsor ID
- Moyce022026
- Conditions
- Depression Disorder, Engagement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Montana State UniversityUniversity, hospital or other
- Study start
- Mar 2027 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Feb 2030 (estimated)
- First posted
- 1 Jun 2026 (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.
Hybrid Type II Implementation Trial
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Behavioral ActivationAdministration of Behavioral Activation via Telehealth |
| Waitlist | No intervention | –waiting for BA intervention or post intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Behavioral ActivationAdapted version of BA intervention delivered via telehealth | Behavioural | Treatment |
Primary outcome
Beck Depression Inventory (21 items)
Time frame: Baseline, After 12 weeks, After 32 weeks
1 secondary outcome
Behavioral Activation for Depression Scale Short Form, Session Attendance, Activation Homework
Time frame: weekly for 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation in people with Depression Disorder and Engagement, run by Montana State University.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sally Moyce, PhD RN (14069942787, sally.moyce@montana.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory (21 items) (time frame: Baseline, After 12 weeks, After 32 weeks). 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 1 Jun 2026.