Behavioral Activation Teletherapy to Increase Physical Activity

NCT04990401 | Completed DMC

• 2 other identifiers: STU-2021-04411R34MH122640-01A1
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression; Depressive Disorder; Depressive Symptoms; Depressive Episode

Keywords

Therapy; Teletherapy; Physical Activity; Exercise

Outcome Measures

Primary Outcomes (6)

• 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

Secondary Outcomes (5)

• Depressive symptoms - 9-item Patient Health Questionnaire

  Up to 22 weeks

• Physical activity - self-report days per week

  Up to 22 weeks

• Physical activity - self-report minutes per day

  Up to 22 weeks

• Physical activity - Fitbit step counter active minutes

  Up to 22 weeks

• Physical activity - Fitbit step counter step count

  Up to 22 weeks

Other Outcomes (3)

• Mediation of intervention through a number of pathways

  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

  Up to 14 weeks

• Depressive symptoms - IDS-SR

  Up to 22 weeks

Study Arms (1)

Behavioral Activation Teletherapy

EXPERIMENTAL

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

Behavioral: Behavioral Activation Teletherapy

Interventions

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.

Behavioral Activation Teletherapy

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

Related Publications (1)

• 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.

  PMID: 39522018 DERIVED

MeSH Terms

Conditions

Depression; Depressive Disorder; Motor Activity

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mood Disorders; Mental Disorders

Study Officials

• Chad Rethorst, PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

• Madhukar Trivedi, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

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

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: August 4, 2021
• Study Start: August 31, 2021
• Primary Completion: May 30, 2025
• Study Completion: May 31, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)