Depression, Depressive Disorder, Depressive Episode, Depressive Symptoms
Conditions
Keywords
Therapy, Teletherapy, Physical Activity, Exercise
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.
Interventions
BEHAVIORALBehavioral Activation Teletherapy
A total of 10 teletherapy sessions to be delivered over 12-14 weeks, designed to increase physical activity among depressed individuals.
Sponsors
National Institute of Mental Health (NIMH)
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All eligible participants will receive the behavioral activation teletherapy intervention in this single-arm study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant retention | Up to 22 weeks | Percentage of PHQ-9 assessments completed (Goal: 80%) |
| Intervention Validity via Quality of Behavioral Activation Short Form | 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. |
| Feasibility and acceptability - Screening | 1 week | Number of participants screened per week (Goal 1-2 per week) |
| Feasibility and acceptability - Recruitment | 1 week | Percentage of screened participants enrolled (Goal: 50%) |
| Intervention Adherence | Up to 14 weeks | Percentage of intervention sessions attended (goal 75%) |
| Participant outcome completion | Up to 22 weeks | Percentage of valid Fitbit wear days \> 12 hours (Goal: 80%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical activity - Fitbit step counter step count | 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 |
| Depressive symptoms - 9-item Patient Health Questionnaire | 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 | 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 | 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 | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mediation of intervention through a number of pathways | Up to 22 weeks, using mediating timepoints post-session at Weeks 0, 3 and 7 | 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). |
| Depressive symptoms - IDS-SR | Up to 22 weeks | Change in self-reported Inventory of Depressive Symptoms (IDS-SR), analyzed using linear mixed effects modeling controlling for baseline depressive symptoms and additional covariates |
| Minimum number of therapy sessions needed to achieve depression remission | Up to 14 weeks | The minimum number of completed therapy sessions (1-10) needed to achieve depression remission, analyzed through discrete-time survival analysis. |
Countries
United States
Outcome results
None listed