Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance

Not Applicable

Completed

• Conditions: Depressive Symptoms; Major Depressive Disorder, Recurrent, in Remission
• Interventions: Behavioral: Usual Depression Care; Behavioral: Mindful Mood Balance

• Registration Number: NCT02190968
• Lead Sponsor: University of Toronto

Brief Summary

Many patients report residual depressive symptoms despite seemingly successful treatment. With the investigators' previous funding, we developed - Mindful Mood Balance - an online treatment that targets RDS by teaching specific emotion regulation and depression self-management skills that are entirely compatible with antidepressant treatment. The investigators now propose a controlled study to determine whether MMB is more effective than usual care at reducing RDS and other key outcomes. If successful, MMB's online delivery format would provide high fidelity and low-cost empirically supported management of residual symptoms, leading to more robust remission, improved functioning and sustained recovery from MDD over time.

Detailed Description

Residual depressive symptoms (RDS) following remission of major depressive disorder (MDD) are reported by 80-90% of adults receiving first-line antidepressant pharmacotherapy and carry an elevated risk for a chronic course of illness, rapid relapse and functional impairment. Strategies for managing residual symptoms, however, have met with mixed success. Mindful Mood Balance (MMB; R34 MH0877223) is an individually tailored, web-based treatment designed to train remitted depressed patients to disengage from dysphoria-activated depressogenic thinking that perpetuates RDS and increases risk for relapse/recurrence. MMB was developed to increase access to Mindfulness-Based Cognitive Therapy (MBCT; R01 MH066992), an empirically supported prophylactic group treatment that can be easily sequenced with acute phase antidepressant pharmacotherapy. Results from our open trial of MMB (N=100) showed an effect size of d=1.09 for pre to post treatment reductions in depression scores among patients with RDS and d=1.54 in a quasi-experimental comparison to patients receiving usual care, with an on average reduction of 1.98 points on the PHQ-9 for MMB patients. The investigators now propose a pragmatic randomized clinical trial of MMB to evaluate its effectiveness in reducing RDS in recurrently depressed patients. Patients will be members of Kaiser-Permanente Colorado (N = 460), aged 18 to 75, who score \>5 and \<9 on the PHQ-9, in remission from MDD and will be randomized 1:1 to either the usual depression care pathway (DepCare) or Mindful Mood Balance (MMB)+DepCare.

The investigators plan to test whether patients receiving MMB+DepCare will show greater reductions in RDS at both 8 week and 12 months follow up, than those receiving DepCare alone. The investigators are also interested in examining whether fewer patients in MMB+DepCare will relapse over the follow up and will have higher end state functioning and quality of life. In order to examine the costs associated with adding this online treatment to the Depression Care Pathways at KPCO, the investigators will calculate the marginal costs per additional number of depression free days (DFDs) for patients. Resolution of RDS can reduce the enormous personal and social costs experienced by Americans with this persistent symptom burden.

Study Timeline

• Study First Submitted: 2014-07-10
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-15
• Study Start: 2015-03
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-24
• Last Update Posted: 2019-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

• Patients with a PHQ-9 score between 5 and 9
• At least one prior episode of MDD

Read More

Exclusion Criteria

• presence of schizophrenia or current psychosis, organic mental disorder or pervasive developmental delay

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindful Mood Balance	Usual Depression Care	An 8 session internet intervention targeting residual depressive symptoms.
Usual Depression Care	Usual Depression Care	Usual Depression Care through Kaiser Permanente Colorado
Mindful Mood Balance	Mindful Mood Balance	An 8 session internet intervention targeting residual depressive symptoms.

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9	Between baseline to 12 weeks.	Conversion from moderate/high risk to low risk symptom categories, defined as a patient whose PHQ-9 score drops from a baseline PHQ-9 score between 5 and 9 to a mean score of 4 or less

Secondary Outcome Measures

Name	Time	Method
Ruminative Responses Scale	Change from Baseline to 6 weeks, 12 weeks and 15 months	A self-report measure of rumination
Five Facet Mindfulness Scale	Change from Baseline to 6 weeks, 12 weeks and 15 months	Self report measure of mindful awareness
Experiences Questionnaire	Change from Baseline to 6 weeks, 12 weeks and 15 months	Self report measure of decentering/wider awareness
Five Facet Mindfulness Questionnaire	Change from Baseline to 6 weeks, 12 weeks and 15 months	Self report measure of mindful awareness

Trial Locations

Locations (1)

Kaiser Permanente Institute for Health Research; 🇺🇸 Denver, Colorado, United States