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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04990401




Registration number
NCT04990401
Ethics application status
Date submitted
21/07/2021
Date registered
4/08/2021

Titles & IDs
Public title
Behavioral Activation Teletherapy to Increase Physical Activity
Scientific title
Adapted Tele-Behavioral Activation Targeted to Increase Physical Activity in Depression
Secondary ID [1] 0 0
STU-2021-0441
Universal Trial Number (UTN)
Trial acronym
BAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 0 0
Depressive Disorder 0 0
Depressive Symptoms 0 0
Depressive Episode 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Behavioral Activation Teletherapy

Experimental: Behavioral Activation Teletherapy - All eligible participants will be assigned to receive the behavioral activation teletherapy 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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility and acceptability - Screening
Timepoint [1] 0 0
1 week
Primary outcome [2] 0 0
Feasibility and acceptability - Recruitment
Timepoint [2] 0 0
1 week
Primary outcome [3] 0 0
Intervention Adherence
Timepoint [3] 0 0
Up to 14 weeks
Primary outcome [4] 0 0
Intervention Validity via Quality of Behavioral Activation Short Form
Timepoint [4] 0 0
Up to 14 weeks
Primary outcome [5] 0 0
Participant retention
Timepoint [5] 0 0
Up to 22 weeks
Primary outcome [6] 0 0
Participant outcome completion
Timepoint [6] 0 0
Up to 22 weeks
Secondary outcome [1] 0 0
Depressive symptoms - 9-item Patient Health Questionnaire
Timepoint [1] 0 0
Up to 22 weeks
Secondary outcome [2] 0 0
Physical activity - self-report days per week
Timepoint [2] 0 0
Up to 22 weeks
Secondary outcome [3] 0 0
Physical activity - self-report minutes per day
Timepoint [3] 0 0
Up to 22 weeks
Secondary outcome [4] 0 0
Physical activity - Fitbit step counter active minutes
Timepoint [4] 0 0
Up to 22 weeks
Secondary outcome [5] 0 0
Physical activity - Fitbit step counter step count
Timepoint [5] 0 0
Up to 22 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
65
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Other
Name
University of Texas Southwestern Medical Center
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Chad Rethorst, PhD
Address 0 0
University of Texas Southwestern Medical Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Shahera Ranjha
Address 0 0
Country 0 0
Phone 0 0
469-602-2719
Fax 0 0
Email 0 0
shahera.ranjha@utsouthwestern.edu
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
If other investigators are interested in accessing data, they may contact the principal investigator in writing.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04990401