Behavioral Activation Teletherapy to Increase Physical Activity
- Conditions
- Depressive DisorderDepressive EpisodeDepressionDepressive Symptoms
- Interventions
- Behavioral: Behavioral Activation Teletherapy
- Registration Number
- NCT04990401
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 65
- Be18-64 years old;
- Able and willing to provide informed consent;
- Have moderate-to-severe depressive symptoms, with a PHQ-9 score ≥ 10;
- Insufficient moderate-to-vigorous physical activity (< 90 minutes a week);
- Demonstrated interest in increasing physical activity;
- Have a smartphone.
- Have any current, past, or lifetime manic or hypomanic episode, psychosis, schizophrenia or schizophreniform disorder;
- Be currently experiencing active suicidal ideation (i.e. with suicidal thoughts, plan, and intent) or at a high risk for suicide during the course of the study, as designated by the PI;
- Have a medical condition that prohibits physical activity; be medically prohibited to exercise by primary care physician (PCP), OB-GYN (obstetrician-gynecologist) or study MD.
- Be in current, active psychotherapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Behavioral Activation Teletherapy Behavioral Activation Teletherapy All eligible participants will be assigned to receive the behavioral activation teletherapy intervention.
- Primary Outcome Measures
Name Time Method Feasibility and acceptability - Screening 1 week Number of participants screened per week (Goal 1-2 per week)
Intervention Adherence Up to 14 weeks Percentage of intervention sessions attended (goal 75%)
Participant retention Up to 22 weeks Percentage of PHQ-9 assessments completed (Goal: 80%)
Participant outcome completion Up to 22 weeks Percentage of valid Fitbit wear days \> 12 hours (Goal: 80%)
Feasibility and acceptability - Recruitment 1 week Percentage of screened participants enrolled (Goal: 50%)
Intervention Validity via Quality of Behavioral Activation Short Form Up to 14 weeks 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.
- Secondary Outcome Measures
Name Time Method Physical activity - self-report days per week Up to 22 weeks 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
Physical activity - Fitbit step counter active minutes Up to 22 weeks Change in objective data from Fitbit of "active minutes", using linear mixed effects modeling controlling for baseline physical activity and additional covariates
Physical activity - self-report minutes per day Up to 22 weeks 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
Physical activity - Fitbit step counter step count Up to 22 weeks Change in objective data from Fitbit of "step count", using linear mixed effects modeling controlling for baseline physical activity and additional covariates
Depressive symptoms - 9-item Patient Health Questionnaire Up to 22 weeks Change in self-Reported Depressive Symptoms, analyzed using linear mixed effects modeling controlling for baseline depressive symptoms and additional covariates
Trial Locations
- Locations (1)
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States