Behavioral Activation Teletherapy to Increase Physical Activity (BAT)

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.

All eligible participants will receive the behavioral activation teletherapy intervention in this single-arm study.

All eligible participants will be assigned to receive the behavioral activation teletherapy intervention.

A total of 10 teletherapy sessions to be delivered over 12-14 weeks, designed to increase physical activity among depressed individuals.

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.

Change in self-Reported Depressive Symptoms, analyzed using linear mixed effects modeling controlling for baseline depressive symptoms and additional covariates

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

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

Change in objective data from Fitbit of "active minutes", using linear mixed effects modeling controlling for baseline physical activity and additional covariates

Change in objective data from Fitbit of "step count", using linear mixed effects modeling controlling for baseline physical activity and additional covariates

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).

The minimum number of completed therapy sessions (1-10) needed to achieve depression remission, analyzed through discrete-time survival analysis.

Change in self-reported Inventory of Depressive Symptoms (IDS-SR), analyzed using linear mixed effects modeling controlling for baseline depressive symptoms and additional covariates

Inclusion Criteria: 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. Exclusion Criteria: 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

If other investigators are interested in accessing data, they may contact the principal investigator in writing.