Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance.

Conditions
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Major Depressive Disorder, Recurrent, in Remission, Depressive Symptoms

Intervention / Treatment
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* Behavioral: Usual Depression Care
* Behavioral: Mindful Mood Balance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a PHQ-9 score between 5 and 9 At least one prior episode of MDD Exclusion Criteria: presence of schizophrenia or current psychosis, organic mental disorder or pervasive developmental delay

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindful Mood Balance<br>An 8 session internet intervention targeting residual depressive symptoms. | Behavioral: Usual Depression Care<br>* Usual Depression Care will be based on the Kaiser Permanente Adult Depression National Guidelines - an adaptation of STAR*D (Rush et al., 2006) for antidepressant management and the IMPACT (Unitzer et al., 2002; 2008) model for therapy.<br>Behavioral: Mindful Mood Balance<br>* Mindful Mood Balance is an individually tailored, web-based version of Mindfulness-Based Cognitive Therapy, a manualized, group skills training program (Segal et al., 2002) that is based on an integration of aspects of cognitive therapy for depression (Beck, 1979) with components of the mindfulness-based stress reduction program (Kabat-Zinn, 1990). Patients participated in 8 internet sessions, each of which incorporates didactic and experiential learning, along with home practice of skills taught in the program.<br>|
| Active Comparator: Usual Depression Care<br>Usual Depression Care through Kaiser Permanente Colorado | Behavioral: Usual Depression Care<br>* Usual Depression Care will be based on the Kaiser Permanente Adult Depression National Guidelines - an adaptation of STAR*D (Rush et al., 2006) for antidepressant management and the IMPACT (Unitzer et al., 2002; 2008) model for therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire-9 | Changes in self reported depressive symptom severity | Change from Baseline to 12 weeks and 15 months | 
| Patient Health Questionnaire-9 | Rates of depressive relapse, defined as patients who score 15 or greater on the PHQ-9 | Between 12 weeks and 15 months | 
| Patient Health Questionnaire-9 | 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 | Between baseline to 12 weeks. | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness Based Cognitive Therapy, Internet interventions, Residual depressive symptoms, Depressive relapse prevention