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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH122640-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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This is a pilot study of acceptability, feasibility, and preliminary efficacy of a brief, 10-session Behavioral Activation intervention delivered via teletherapy to increase physical activity and treat depressive symptoms.
This is a one-site, two-phase study that will use an initial group of individuals between the ages of 18 and 64 who have moderate to severe depressive symptoms and exercise less than 90 minutes a week. In both phases, participants will complete a total of 8 behavioral activation teletherapy sessions used to increase physical activity, followed by two biweekly booster sessions, for a total of 10 sessions. Participants will also complete weekly assessments remotely for both phases of the study. The screening visit and final intervention session will be in-person, and all other visits will be via telehealth. Participants will have the option to come to the clinic if they prefer.
In the initial phase (n = 15), participants who completed the intervention will have the option to participate in a focus group, and participants who partially completed the intervention will have the option to participate in a semi-structured interview. The total duration of phase one is 14 weeks. This initial phase will allow the researchers to refine and optimize the intervention to be delivered in the second phase.
In the second/pilot phase (n = 50), participants will complete a one-month and a two-month follow-up after the 10 intervention sessions. The total duration for phase two is 22 weeks.
Participants for both phases of the study will wear a Fitbit during the duration of their study participation, in order to record step count.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Activation Teletherapy | Experimental | All eligible participants will be assigned to receive the behavioral activation teletherapy intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Activation Teletherapy | Behavioral | A total of 10 teletherapy sessions to be delivered over 12-14 weeks, designed to increase physical activity among depressed individuals. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility and acceptability - Screening | Number of participants screened per week (Goal 1-2 per week) | 1 week |
| Feasibility and acceptability - Recruitment | Percentage of screened participants enrolled (Goal: 50%) | 1 week |
| Intervention Adherence | Percentage of intervention sessions attended (goal 75%) | Up to 14 weeks |
| Intervention Validity via Quality of Behavioral Activation Short Form | Fidelity on supervisor's structured feedback form with average item score ≥3. The 14-item scale has each item ranging from 0-6, with higher values indicating higher levels of fidelity. | Up to 14 weeks |
| Participant retention | Percentage of PHQ-9 assessments completed (Goal: 80%) | Up to 22 weeks |
| Participant outcome completion | Percentage of valid Fitbit wear days > 12 hours (Goal: 80%) | Up to 22 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive symptoms - 9-item Patient Health Questionnaire | Change in self-Reported Depressive Symptoms, analyzed using linear mixed effects modeling controlling for baseline depressive symptoms and additional covariates | Up to 22 weeks |
| Physical activity - self-report days per week |
| Measure | Description | Time Frame |
|---|---|---|
| Mediation of intervention through a number of pathways | Testing whether the physical activity to depression reduction pathway is mediated by changes in (a) positive and negative affect; (b) anhedonia, (c), fatigue, (d) self-esteem, (e) overall depressive symptoms and (f) emotion regulation. For each potential mediator, both a direct and indirect pathway will be tested. First, the mediational model should meet the goodness of fit criteria (e.g., a non-significant X2, fit indices greater than .90 and significant path coefficients) and second, when a direct effect path is added to the model this path is either non-significant or adds little improvement in the overall predictive value of the model (i.e., increase in R2). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chad Rethorst, PhD | University of Texas Southwestern Medical Center | Principal Investigator |
| Madhukar Trivedi, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75235 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39522018 | Derived | Rethorst CD, Trombello JM, Chen PM, Carmody TJ, Goodman LC, Lazalde A, Trivedi MH. Pilot evaluation on an adapted tele-behavioral activation to increase physical activity in persons with depression: a single-arm pilot study. BMC Psychol. 2024 Nov 9;12(1):643. doi: 10.1186/s40359-024-02053-5. |
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If other investigators are interested in accessing data, they may contact the principal investigator in writing.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form: English Informed Consent Form | Jun 29, 2023 | Dec 18, 2025 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 17, 2026 |
| ID | Term |
|---|---|
| D003863 | Depression |
| D003866 | Depressive Disorder |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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All eligible participants will receive the behavioral activation teletherapy intervention in this single-arm study.
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Change in self-reported frequency of physical activity (days per week), analyzed using linear mixed effects modeling controlling for baseline physical activity and additional covariates |
| Up to 22 weeks |
| Physical activity - self-report minutes per day | Change in self-reported frequency of physical activity (minutes per day), analyzed using linear mixed effects modeling controlling for baseline physical activity and additional covariates | Up to 22 weeks |
| Physical activity - Fitbit step counter active minutes | Change in objective data from Fitbit of "active minutes", using linear mixed effects modeling controlling for baseline physical activity and additional covariates | Up to 22 weeks |
| Physical activity - Fitbit step counter step count | Change in objective data from Fitbit of "step count", using linear mixed effects modeling controlling for baseline physical activity and additional covariates | Up to 22 weeks |
| Up to 22 weeks, using mediating timepoints post-session at Weeks 0, 3 and 7 |
| Minimum number of therapy sessions needed to achieve depression remission | The minimum number of completed therapy sessions (1-10) needed to achieve depression remission, analyzed through discrete-time survival analysis. | Up to 14 weeks |
| Depressive symptoms - IDS-SR | Change in self-reported Inventory of Depressive Symptoms (IDS-SR), analyzed using linear mixed effects modeling controlling for baseline depressive symptoms and additional covariates | Up to 22 weeks |