Behavioral Activation Teletherapy to Increase Physical Activity

University of Texas Southwestern Medical Center65 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Depression Depressive Disorder Depressive Symptoms Depressive Episode

Interventions

Behavioral Activation TeletherapyBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

Feasibility and acceptability - Screening

Number of participants screened per week (Goal 1-2 per week)

Time frame: 1 week

Feasibility and acceptability - Recruitment

Percentage of screened participants enrolled (Goal: 50%)

Time frame: 1 week

Intervention Adherence

Percentage of intervention sessions attended (goal 75%)

Time frame: 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.

Time frame: Up to 14 weeks

Participant retention

Percentage of PHQ-9 assessments completed (Goal: 80%)

Time frame: Up to 22 weeks

Participant outcome completion

Percentage of valid Fitbit wear days \> 12 hours (Goal: 80%)

Time frame: Up to 22 weeks

Secondary Outcomes

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

Time frame: Up to 22 weeks

Physical activity - self-report days per week

Data from ClinicalTrials.gov

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