Behavioral Activation Teletherapy for Melancholia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Melancholia+3 More
Behavioral Activation Teletherapy - Behavioral
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial looks at whether a ten-session behavior intervention delivered over teletherapy can help people with depression become more active and improve their symptoms.

Eligible Conditions
  • Melancholia
  • Mental Depression
  • Depression

Treatment Effectiveness

Study Objectives

6 Primary · 5 Secondary · Reporting Duration: Up to 22 weeks, using mediating timepoints post-session at Weeks 0, 3 and 7

1 week
Feasibility and acceptability - Recruitment
Feasibility and acceptability - Screening
Up to 14 weeks
Intervention Adherence
Intervention Validity via Quality of Behavioral Activation Short Form
Minimum number of therapy sessions needed to achieve depression remission
Up to 22 weeks
Depressive symptoms - 9-item Patient Health Questionnaire
Depressive symptoms - IDS-SR
Participant outcome completion
Participant retention
Physical activity - Fitbit step counter active minutes
Physical activity - Fitbit step counter step count
Physical activity - self-report days per week
Physical activity - self-report minutes per day
Week 22
Mediation of intervention through a number of pathways

Trial Safety

Trial Design

1 Treatment Group

Behavioral Activation Teletherapy
1 of 1
Experimental Treatment

65 Total Participants · 1 Treatment Group

Primary Treatment: Behavioral Activation Teletherapy · No Placebo Group · N/A

Behavioral Activation Teletherapy
Behavioral
Experimental Group · 1 Intervention: Behavioral Activation Teletherapy · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 22 weeks, using mediating timepoints post-session at weeks 0, 3 and 7

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
943 Previous Clinical Trials
606,117 Total Patients Enrolled
Joseph M Trombello, PhD, ABPPPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
Madhukar Trivedi, MDPrincipal InvestigatorUniversity of Texas Southwestern Medical Center
14 Previous Clinical Trials
110,595 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have moderate-to-severe depressive symptoms, with a PHQ-9 score ≥ 10.
You do not meet the minimum amount of physical activity for your age and gender.
You have a smartphone.\n

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 16th, 2021

Last Reviewed: October 24th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%