Behavioral Activation Teletherapy to Increase Physical Activity

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.

Full Title of Study: “Adapted Tele-Behavioral Activation Targeted to Increase Physical Activity in Depression”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2024

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Behavioral Activation Teletherapy
    • All eligible participants will be assigned to receive the behavioral activation teletherapy intervention.

Clinical Trial Outcome Measures

Primary Measures

  • Feasibility and acceptability – Screening
    • Time Frame: 1 week
    • Number of participants screened per week (Goal 1-2 per week)
  • Feasibility and acceptability – Recruitment
    • Time Frame: 1 week
    • Percentage of screened participants enrolled (Goal: 50%)
  • Intervention Adherence
    • Time Frame: Up to 14 weeks
    • Percentage of intervention sessions attended (goal 75%)
  • Intervention Validity via Quality of Behavioral Activation Short Form
    • Time Frame: 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.
  • Participant retention
    • Time Frame: Up to 22 weeks
    • Percentage of PHQ-9 assessments completed (Goal: 80%)
  • Participant outcome completion
    • Time Frame: Up to 22 weeks
    • Percentage of valid Fitbit wear days > 12 hours (Goal: 80%)

Secondary Measures

  • Depressive symptoms – 9-item Patient Health Questionnaire
    • Time Frame: Up to 22 weeks
    • Change in self-Reported Depressive Symptoms, analyzed using linear mixed effects modeling controlling for baseline depressive symptoms and additional covariates
  • Physical activity – self-report days per week
    • Time Frame: 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 – self-report minutes per day
    • Time Frame: 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 active minutes
    • Time Frame: 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 – Fitbit step counter step count
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Texas Southwestern Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Madhukar H. Trivedi, MD, Professor of Medicine – University of Texas Southwestern Medical Center
  • Overall Official(s)
    • Joseph M Trombello, PhD, ABPP, Principal Investigator, University of Texas Southwestern Medical Center
    • Madhukar Trivedi, MD, Principal Investigator, University of Texas Southwestern Medical Center
  • Overall Contact(s)
    • Elizabeth Dedrick, 214-648-5020, Elizabeth.Dedrick@UTSouthwestern.edu

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