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Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02190968
Recruitment Status : Completed
First Posted : July 15, 2014
Last Update Posted : January 28, 2019
Sponsor:
Collaborators:
University of Colorado, Boulder
Kaiser Permanente
Information provided by (Responsible Party):
Zindel Segal, 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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder, Recurrent, in Remission Depressive Symptoms Behavioral: Usual Depression Care Behavioral: Mindful Mood Balance Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance.
Actual Study Start Date : March 2015
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mindful Mood Balance
An 8 session internet intervention targeting residual depressive symptoms.
Behavioral: Usual Depression Care
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.

Behavioral: Mindful Mood Balance
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.

Active Comparator: Usual Depression Care
Usual Depression Care through Kaiser Permanente Colorado
Behavioral: Usual Depression Care
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.




Primary Outcome Measures :
  1. Patient Health Questionnaire-9 [ Time Frame: Change from Baseline to 12 weeks and 15 months ]
    Changes in self reported depressive symptom severity

  2. Patient Health Questionnaire-9 [ Time Frame: Between 12 weeks and 15 months ]
    Rates of depressive relapse, defined as patients who score 15 or greater on the PHQ-9

  3. Patient Health Questionnaire-9 [ Time Frame: 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 :
  1. Ruminative Responses Scale [ Time Frame: Change from Baseline to 6 weeks, 12 weeks and 15 months ]
    A self-report measure of rumination

  2. Five Facet Mindfulness Questionnaire [ Time Frame: Change from Baseline to 6 weeks, 12 weeks and 15 months ]
    Self report measure of mindful awareness

  3. Five Facet Mindfulness Scale [ Time Frame: Change from Baseline to 6 weeks, 12 weeks and 15 months ]
    Self report measure of mindful awareness

  4. Experiences Questionnaire [ Time Frame: Change from Baseline to 6 weeks, 12 weeks and 15 months ]
    Self report measure of decentering/wider awareness


Other Outcome Measures:
  1. Depression Free Days [ Time Frame: Change from Baseline to 12 weeks and 15 months ]
    Self report of days free of depression

  2. Generalized Anxiety Disorder Assessment - 7 [ Time Frame: Change from Baseline to 12 weeks and 15 months ]
    Self report measure of generalized anxiety

  3. Short Form Health Survey - 12 [ Time Frame: Change from Baseline to 12 weeks and 15 months ]
    Self report measure of physical and mental health

  4. Emotion Dot Probe Task [ Time Frame: Change from Baseline to 12 weeks and 15 months ]
    A behavioural measure of attentional bias



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190968


Locations
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United States, Colorado
Kaiser Permanente Institute for Health Research
Denver, Colorado, United States, 80237-8066
Sponsors and Collaborators
University of Toronto
University of Colorado, Boulder
Kaiser Permanente
Investigators
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Principal Investigator: Zindel V Segal, PhD University of Toronto

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Zindel Segal, Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT02190968    
Other Study ID Numbers: R01MH102229-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: January 28, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zindel Segal, University of Toronto:
Mindfulness Based Cognitive Therapy
Internet interventions
Residual depressive symptoms
Depressive relapse prevention
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms