NCT02190968

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
460

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

January 28, 2019

Status Verified

January 1, 2019

Enrollment Period

3.7 years

First QC Date

July 10, 2014

Last Update Submit

January 24, 2019

Conditions

Major Depressive Disorder, Recurrent, in RemissionDepressive Symptoms

Keywords

Mindfulness Based Cognitive TherapyInternet interventionsResidual depressive symptomsDepressive relapse prevention

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Ruminative Responses Scale

    Change from Baseline to 6 weeks, 12 weeks and 15 months

  • Five Facet Mindfulness Questionnaire

    Change from Baseline to 6 weeks, 12 weeks and 15 months

  • Five Facet Mindfulness Scale

    Change from Baseline to 6 weeks, 12 weeks and 15 months

  • Experiences Questionnaire

    Change from Baseline to 6 weeks, 12 weeks and 15 months

Other Outcomes (4)

  • Depression Free Days

    Change from Baseline to 12 weeks and 15 months

  • Generalized Anxiety Disorder Assessment - 7

    Change from Baseline to 12 weeks and 15 months

  • Short Form Health Survey - 12

    Change from Baseline to 12 weeks and 15 months

  • +1 more other outcomes

Study Arms (2)

Mindful Mood Balance

EXPERIMENTAL

An 8 session internet intervention targeting residual depressive symptoms.

Behavioral: Usual Depression CareBehavioral: Mindful Mood Balance

Usual Depression Care

ACTIVE COMPARATOR

Usual Depression Care through Kaiser Permanente Colorado

Behavioral: Usual Depression Care

Interventions

Usual Depression CareBEHAVIORAL

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.

Mindful Mood BalanceUsual Depression Care
Mindful Mood BalanceBEHAVIORAL

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.

Mindful Mood Balance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Institute for Health Research

Denver, Colorado, 80237-8066, United States

Location

Related Publications (5)

  • 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.

    PMID: 24662625BACKGROUND

  • 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.

    PMID: 21135325BACKGROUND

  • 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.

    PMID: 25461782BACKGROUND

  • 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.

    PMID: 34320822DERIVED

  • 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.

    PMID: 31995132DERIVED

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorRecurrenceDepression

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Zindel V Segal, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 10, 2014

First Posted

July 15, 2014

Study Start

March 1, 2015

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

January 28, 2019

Record last verified: 2019-01

Locations

US(1)