Reducing Residual Depressive Symptoms With Web-based Mindful Mood Balance

Depressive Symptoms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02190968
• Other study ID #: R01MH102229-01A1
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: November 2018

Study information

• Verified date: January 2019
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Symptoms
• Major Depressive Disorder, Recurrent, in Remission
• Recurrence

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Institute for Health Research	Denver	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Toronto	Kaiser Permanente, University of Colorado, Boulder

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Depression Free Days	Self report of days free of depression	Change from Baseline to 12 weeks and 15 months
Other	Generalized Anxiety Disorder Assessment - 7	Self report measure of generalized anxiety	Change from Baseline to 12 weeks and 15 months
Other	Short Form Health Survey - 12	Self report measure of physical and mental health	Change from Baseline to 12 weeks and 15 months
Other	Emotion Dot Probe Task	A behavioural measure of attentional bias	Change from Baseline to 12 weeks and 15 months
Primary	Patient Health Questionnaire-9	Changes in self reported depressive symptom severity	Change from Baseline to 12 weeks and 15 months
Primary	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
Primary	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	Ruminative Responses Scale	A self-report measure of rumination	Change from Baseline to 6 weeks, 12 weeks and 15 months
Secondary	Five Facet Mindfulness Questionnaire	Self report measure of mindful awareness	Change from Baseline to 6 weeks, 12 weeks and 15 months
Secondary	Five Facet Mindfulness Scale	Self report measure of mindful awareness	Change from Baseline to 6 weeks, 12 weeks and 15 months
Secondary	Experiences Questionnaire	Self report measure of decentering/wider awareness	Change from Baseline to 6 weeks, 12 weeks and 15 months

External Links

•   Mindfulness Based Cognitive Therapy Website