Clinical trial NCT04990401: Behavioral Activation Teletherapy to Increase Physical Activity
Official title: Adapted Tele-Behavioral Activation Targeted to Increase Physical Activity in Depression
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Depressive Disorder
Depressive Symptoms
Depressive Episode
Keywords: Therapy
Teletherapy
Physical Activity
Exercise
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All eligible participants will receive the behavioral activation teletherapy intervention in this single-arm study.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility and acceptability - Screening
timeFrame: 1 week
measure: Feasibility and acceptability - Recruitment
timeFrame: 1 week
measure: Intervention Adherence
timeFrame: Up to 14 weeks
measure: Intervention Validity via Quality of Behavioral Activation Short Form
timeFrame: Up to 14 weeks
measure: Participant retention
timeFrame: Up to 22 weeks
measure: Participant outcome completion
timeFrame: Up to 22 weeks
Secondary outcomes:
measure: Depressive symptoms - 9-item Patient Health Questionnaire
timeFrame: Up to 22 weeks
measure: Physical activity - self-report days per week
timeFrame: Up to 22 weeks
measure: Physical activity - self-report minutes per day
timeFrame: Up to 22 weeks
measure: Physical activity - Fitbit step counter active minutes
timeFrame: Up to 22 weeks
measure: Physical activity - Fitbit step counter step count
timeFrame: Up to 22 weeks
Other outcomes:
measure: Mediation of intervention through a number of pathways
timeFrame: Up to 22 weeks, using mediating timepoints post-session at Weeks 0, 3 and 7
measure: Minimum number of therapy sessions needed to achieve depression remission
timeFrame: Up to 14 weeks
measure: Depressive symptoms - IDS-SR
timeFrame: Up to 22 weeks
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: Chad Rethorst, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Southwestern Medical Center
name: Madhukar Trivedi, MD
role: PRINCIPAL_INVESTIGATOR
References: