Clinical trial NCT02190968: 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
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder, Recurrent, in Remission
Depressive Symptoms
Keywords: Mindfulness Based Cognitive Therapy
Internet interventions
Residual depressive symptoms
Depressive relapse prevention
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: University of Colorado, Boulder
name: Kaiser Permanente
First posted: 2014-07-15
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: Change from Baseline to 12 weeks and 15 months
measure: Patient Health Questionnaire-9
timeFrame: Between 12 weeks and 15 months
measure: Patient Health Questionnaire-9
timeFrame: Between baseline to 12 weeks.
Secondary outcomes:
measure: Ruminative Responses Scale
timeFrame: Change from Baseline to 6 weeks, 12 weeks and 15 months
measure: Five Facet Mindfulness Questionnaire
timeFrame: Change from Baseline to 6 weeks, 12 weeks and 15 months
measure: Five Facet Mindfulness Scale
timeFrame: Change from Baseline to 6 weeks, 12 weeks and 15 months
measure: Experiences Questionnaire
timeFrame: Change from Baseline to 6 weeks, 12 weeks and 15 months
Other outcomes:
measure: Depression Free Days
timeFrame: Change from Baseline to 12 weeks and 15 months
measure: Generalized Anxiety Disorder Assessment - 7
timeFrame: Change from Baseline to 12 weeks and 15 months
measure: Short Form Health Survey - 12
timeFrame: Change from Baseline to 12 weeks and 15 months
measure: Emotion Dot Probe Task
timeFrame: Change from Baseline to 12 weeks and 15 months
Locations:
city: Denver
country: United States
facility: Kaiser Permanente Institute for Health Research
state: Colorado
Study officials:
affiliation: University of Toronto
name: Zindel V Segal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.