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Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance

Primary Purpose

Major Depressive Disorder, Recurrent, in Remission, Depressive Symptoms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual Depression Care
Mindful Mood Balance
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder, Recurrent, in Remission focused on measuring Mindfulness Based Cognitive Therapy, Internet interventions, Residual depressive symptoms, Depressive relapse prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente Institute for Health Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindful Mood Balance

Usual Depression Care

Arm Description

An 8 session internet intervention targeting residual depressive symptoms.

Usual Depression Care through Kaiser Permanente Colorado

Outcomes

Primary Outcome Measures

Patient Health Questionnaire-9
Changes in self reported depressive symptom severity
Patient Health Questionnaire-9
Rates of depressive relapse, defined as patients who score 15 or greater on the PHQ-9
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

Secondary Outcome Measures

Ruminative Responses Scale
A self-report measure of rumination
Five Facet Mindfulness Questionnaire
Self report measure of mindful awareness
Five Facet Mindfulness Scale
Self report measure of mindful awareness
Experiences Questionnaire
Self report measure of decentering/wider awareness

Full Information

First Posted
July 10, 2014
Last Updated
January 24, 2019
Sponsor
University of Toronto
Collaborators
University of Colorado, Boulder, Kaiser Permanente
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1. Study Identification

Unique Protocol Identification Number
NCT02190968
Brief Title
Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance
Official Title
Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Toronto
Collaborators
University of Colorado, Boulder, Kaiser Permanente

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Recurrent, in Remission, Depressive Symptoms
Keywords
Mindfulness Based Cognitive Therapy, Internet interventions, Residual depressive symptoms, Depressive relapse prevention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
460 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindful Mood Balance
Arm Type
Experimental
Arm Description
An 8 session internet intervention targeting residual depressive symptoms.
Arm Title
Usual Depression Care
Arm Type
Active Comparator
Arm Description
Usual Depression Care through Kaiser Permanente Colorado
Intervention Type
Behavioral
Intervention Name(s)
Usual Depression Care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindful Mood Balance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Health Questionnaire-9
Description
Changes in self reported depressive symptom severity
Time Frame
Change from Baseline to 12 weeks and 15 months
Title
Patient Health Questionnaire-9
Description
Rates of depressive relapse, defined as patients who score 15 or greater on the PHQ-9
Time Frame
Between 12 weeks and 15 months
Title
Patient Health Questionnaire-9
Description
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
Time Frame
Between baseline to 12 weeks.
Secondary Outcome Measure Information:
Title
Ruminative Responses Scale
Description
A self-report measure of rumination
Time Frame
Change from Baseline to 6 weeks, 12 weeks and 15 months
Title
Five Facet Mindfulness Questionnaire
Description
Self report measure of mindful awareness
Time Frame
Change from Baseline to 6 weeks, 12 weeks and 15 months
Title
Five Facet Mindfulness Scale
Description
Self report measure of mindful awareness
Time Frame
Change from Baseline to 6 weeks, 12 weeks and 15 months
Title
Experiences Questionnaire
Description
Self report measure of decentering/wider awareness
Time Frame
Change from Baseline to 6 weeks, 12 weeks and 15 months
Other Pre-specified Outcome Measures:
Title
Depression Free Days
Description
Self report of days free of depression
Time Frame
Change from Baseline to 12 weeks and 15 months
Title
Generalized Anxiety Disorder Assessment - 7
Description
Self report measure of generalized anxiety
Time Frame
Change from Baseline to 12 weeks and 15 months
Title
Short Form Health Survey - 12
Description
Self report measure of physical and mental health
Time Frame
Change from Baseline to 12 weeks and 15 months
Title
Emotion Dot Probe Task
Description
A behavioural measure of attentional bias
Time Frame
Change from Baseline to 12 weeks and 15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zindel V Segal, PhD
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Institute for Health Research
City
Denver
State/Province
Colorado
ZIP/Postal Code
80237-8066
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24662625
Citation
Boggs JM, Beck A, Felder JN, Dimidjian S, Metcalf CA, Segal ZV. Web-based intervention in mindfulness meditation for reducing residual depressive symptoms and relapse prophylaxis: a qualitative study. J Med Internet Res. 2014 Mar 24;16(3):e87. doi: 10.2196/jmir.3129.
Results Reference
background
PubMed Identifier
21135325
Citation
Segal ZV, Bieling P, Young T, MacQueen G, Cooke R, Martin L, Bloch R, Levitan RD. Antidepressant monotherapy vs sequential pharmacotherapy and mindfulness-based cognitive therapy, or placebo, for relapse prophylaxis in recurrent depression. Arch Gen Psychiatry. 2010 Dec;67(12):1256-64. doi: 10.1001/archgenpsychiatry.2010.168.
Results Reference
background
PubMed Identifier
25461782
Citation
Dimidjian S, Beck A, Felder JN, Boggs JM, Gallop R, Segal ZV. Web-based Mindfulness-based Cognitive Therapy for reducing residual depressive symptoms: An open trial and quasi-experimental comparison to propensity score matched controls. Behav Res Ther. 2014 Dec;63:83-9. doi: 10.1016/j.brat.2014.09.004. Epub 2014 Sep 18.
Results Reference
background
PubMed Identifier
34320822
Citation
Boggs JM, Ritzwoller DP, Beck A, Dimidjian S, Segal ZV. Cost-Effectiveness of a Web-Based Program for Residual Depressive Symptoms: Mindful Mood Balance. Psychiatr Serv. 2022 Feb 1;73(2):158-164. doi: 10.1176/appi.ps.202000419. Epub 2021 Jul 29.
Results Reference
derived
PubMed Identifier
31995132
Citation
Segal ZV, Dimidjian S, Beck A, Boggs JM, Vanderkruik R, Metcalf CA, Gallop R, Felder JN, Levy J. Outcomes of Online Mindfulness-Based Cognitive Therapy for Patients With Residual Depressive Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Jun 1;77(6):563-573. doi: 10.1001/jamapsychiatry.2019.4693. Erratum In: JAMA Psychiatry. 2020 May 1;77(5):545.
Results Reference
derived
Links:
URL
http://mbct.com/
Description
Mindfulness Based Cognitive Therapy Website

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Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance

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