Behavioral Activation Teletherapy to Increase Physical Activity

Depression Clinical Trial

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Official title:

Adapted Tele-Behavioral Activation Targeted to Increase Physical Activity in Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04990401
• Other study ID #: STU-2021-0441
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2021
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: University of Texas Southwestern Medical Center
• Contact: Elizabeth Dedrick
• Phone: 214-648-5020
• Email: Elizabeth.Dedrick[@]UTSouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Episode
• Depressive Symptoms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mediation of intervention through a number of pathways	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).	Up to 22 weeks, using mediating timepoints post-session at Weeks 0, 3 and 7
Other	Minimum number of therapy sessions needed to achieve depression remission	The minimum number of completed therapy sessions (1-10) needed to achieve depression remission, analyzed through discrete-time survival analysis.	Up to 14 weeks
Other	Depressive symptoms - IDS-SR	Change in self-reported Inventory of Depressive Symptoms (IDS-SR), analyzed using linear mixed effects modeling controlling for baseline depressive symptoms and additional covariates	Up to 22 weeks
Primary	Feasibility and acceptability - Screening	Number of participants screened per week (Goal 1-2 per week)	1 week
Primary	Feasibility and acceptability - Recruitment	Percentage of screened participants enrolled (Goal: 50%)	1 week
Primary	Intervention Adherence	Percentage of intervention sessions attended (goal 75%)	Up to 14 weeks
Primary	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
Primary	Participant retention	Percentage of PHQ-9 assessments completed (Goal: 80%)	Up to 22 weeks
Primary	Participant outcome completion	Percentage of valid Fitbit wear days > 12 hours (Goal: 80%)	Up to 22 weeks
Secondary	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	Up to 22 weeks
Secondary	Physical activity - self-report days per week	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	Up to 22 weeks
Secondary	Physical activity - self-report minutes per day	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	Up to 22 weeks
Secondary	Physical activity - Fitbit step counter active minutes	Change in objective data from Fitbit of "active minutes", using linear mixed effects modeling controlling for baseline physical activity and additional covariates	Up to 22 weeks
Secondary	Physical activity - Fitbit step counter step count	Change in objective data from Fitbit of "step count", using linear mixed effects modeling controlling for baseline physical activity and additional covariates	Up to 22 weeks