Behavioral Activation Teletherapy for Melancholia

Phase-Based Progress Estimates

Effectiveness

Safety

Melancholia+3 More

Behavioral Activation Teletherapy - Behavioral

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Eligibility

18 - 65

All Sexes

What conditions do you have?

Select

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

Effectiveness Progress

1 of 3

Other trials for Melancholia

Behavioral activation and medication optimization

Behavioral Intervention Group (MOTIVATE)

Fall Prevention

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

Safety Progress

1 of 3

Other trials for Melancholia

Behavioral activation and medication optimization

Behavioral Intervention Group (MOTIVATE)

Fall Prevention

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 - 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.