NCT02498132

Development and Testing of a Behavioral Activation Mobile Therapy for Elevated Depressive Systems

Completed NA Results posted Last updated 29 November 2023

What this trial tests

NA trial testing Behavioral Activation in Depression in 52 participants. Completed in 31 December 2016.

Timeline

1 June 2016

Primary endpoint
1 September 2016

31 December 2016

Quick facts

Lead sponsor	University of Maryland, College Park
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	52
Start date	1 June 2016
Primary completion	1 September 2016
Estimated completion	31 December 2016

Drugs / interventions tested

• Behavioral Activation
• Cognitvie Based Therapy
• Treatment as Usual

Conditions studied

• Depression — all drugs for Depression →

Sponsor

University of Maryland, College Park

Who can join

Adults 18 to 65, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Average Decrease of Beck Depression Inventory-II Score Primary · Baseline and Week 8

The BDI-II is a well-validated tool for the assessment of depressive symptoms and is our key outcome measure. For assessing weekly changes in mood, we will use the Profile of Mood States, a brief self-report scale that has demonstrated satisfactory psychometric properties. For MDD diagnosis, during the phone screening, participants will complete a shortened version of the MDD module of the Structured Clinical Interview for the DSM-IV. The scale for the Beck's Depression Inventory is 0-63 where higher scores indicate more severe depressive symptoms. Scores were analyzed as a 10 point decrease f

Group	Value	95% CI
Behavioral Activation	-12.21	± 13.15
Cognitive Behavioral Therapy	-13.36	± 11.51
Treatment as Usual	-7.75	± 14.99

Client Treatment Adherence Secondary · Once a week for 8 weeks

Client treatment adherence will be measured based on the activity selection and scheduling component of Moodivate.

Group	Value	95% CI
Behavioral Activation	46.76	± 30.10

Sponsor's own description

Elevated depressive symptomatology is a widespread public health concern and individuals with elevated depressive symptoms most frequently report such symptoms to primary care physicians (PCPs). PCPs have few evidence-based resources beyond antidepressant medication for treating elevated depressive symptoms, which results in negative outcomes for their depressed patients. Mobile technologies offer an ideal strategy to meet widespread treatment needs. The purpose of the proposed project is to\\ customize Behavioral Activation (BA), a straightforward, empirically supported treatment for elevated depressive symptoms, for a mobile format (Moodivate) in order to address the currently unmet needs of PCPs and their patients with elevated depressive symptoms.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.