Dataset Information

Outcomes of Online Mindfulness-Based Cognitive Therapy for Patients With Residual Depressive Symptoms: A Randomized Clinical Trial.

ABSTRACT:

Importance

Patients with residual depressive symptoms face a gap in care because few resources, to date, are available to manage the lingering effects of their illness.

Objective

To evaluate the effectiveness for treating residual depressive symptoms with Mindful Mood Balance (MMB), a web-based application that delivers mindfulness-based cognitive therapy, plus usual depression care compared with usual depression care only.

Design, setting, and participants

This randomized clinical trial was conducted in primary care and behavioral health clinics at Kaiser Permanente Colorado, Denver. Adults identified with residual depressive symptoms were recruited between March 2, 2015, and November 30, 2018. Outcomes were assessed for a 15-month period, comprising a 3-month intervention interval and a 12-month follow-up period.

Interventions

Patients were randomized to receive usual depression care (UDC; n?=?230) or MMB plus UDC (n?=?230), which included 8 sessions delivered online for a 3-month interval plus minimal phone or email coaching support.

Main outcomes and measures

Primary outcomes were reduction in residual depressive symptom severity, assessed using the Patient Health Questionaire-9 (PHQ-9); rates of depressive relapse (PHQ-9 scores ?15); and rates of remission (PHQ-9 scores <5). Secondary outcomes included depression-free days, anxiety symptoms (General Anxiety Disorder-7 Item Scale), and functional status (12-Item Short Form Survey).

Results

Among 460 randomized participants (mean [SD] age, 48.30 [14.89] years; 346 women [75.6%]), data were analyzed for the intent-to-treat sample, which included 362 participants (78.7%) at 3 months and 330 (71.7%) at 15 months. Participants who received MMB plus UDC had significantly greater reductions in residual depressive symptoms than did those receiving UDC only (mean [SE] PHQ-9 score, 0.95 [0.39], P?Conclusions and relevanceUse of MMB plus UDC resulted in significant improvement in depression and functional outcomes compared with UDC only. The MMB web-based treatment may offer a scalable approach for the management of residual depressive symptoms.

Trial registration

ClinicalTrials.gov identifier: NCT02190968.

SUBMITTER: Segal ZV

PROVIDER: S-EPMC6990961 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Publications

Outcomes of Online Mindfulness-Based Cognitive Therapy for Patients With Residual Depressive Symptoms: A Randomized Clinical Trial.

Segal Zindel V ZV Dimidjian Sona S Beck Arne A Boggs Jennifer M JM Vanderkruik Rachel R Metcalf Christina A CA Gallop Robert R Felder Jennifer N JN Levy Joseph J

JAMA psychiatry 20200601 6

<h4>Importance</h4>Patients with residual depressive symptoms face a gap in care because few resources, to date, are available to manage the lingering effects of their illness.<h4>Objective</h4>To evaluate the effectiveness for treating residual depressive symptoms with Mindful Mood Balance (MMB), a web-based application that delivers mindfulness-based cognitive therapy, plus usual depression care compared with usual depression care only.<h4>Design, setting, and participants</h4>This randomized ...[more]

PMID: 31995132

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Project description:BACKGROUND:Depressive symptoms are a common problem in patients with diabetes, laying an additional burden on both the patients and the health care system. Patients suffering from these symptoms rarely receive adequate evidence-based psychological help as part of routine clinical care. Offering brief evidence-based treatments aimed at alleviating depressive symptoms could improve patients' medical and psychological outcomes. However, well-designed trials focusing on the effectiveness of psychological treatments for depressive symptoms in patients with diabetes are scarce. The Mood Enhancement Therapy Intervention Study (METIS) tests the effectiveness of two treatment protocols in patients with diabetes. Individually administered Cognitive Behavioral Therapy (CBT) and Mindfulness-Based Cognitive Therapy (MBCT) are compared with a waiting list control condition in terms of their effectiveness in reducing the severity of depressive symptoms. Furthermore, we explore several potential moderators and mediators of change underlying treatment effectiveness, as well as the role of common factors and treatment integrity. METHODS/DESIGN:The METIS trial has a randomized controlled design with three arms, comparing CBT and MBCT with a waiting list control condition. Intervention groups receive treatment immediately; the waiting list control group receives treatment three months later. Both treatments are individually delivered in 8 sessions of 45 to 60 minutes by trained therapists. Primary outcome is severity of depressive symptoms. Anxiety, well-being, diabetes-related distress, HbA1c levels, and intersession changes in mood are assessed as secondary outcomes. Assessments are held at pre-treatment, several time points during treatment, at post-treatment, and at 3-months and 9-months follow-up. The study has been approved by a medical ethical committee. DISCUSSION:Both CBT and MBCT are expected to help improve depressive symptoms in patients with diabetes. If MBCT is at least equally effective as CBT, MBCT can be established as an alternative approach to CBT for treating depressive symptoms in patients with diabetes. By analyzing moderators and mediators of change, more information can be gathered for whom and why CBT and MBCT are effective. TRIAL REGISTRATION:Clinical Trials NCT01630512.

Project description:BackgroundThe incidence of mental health disorders in Canada is increasing with costs of CAD $51 billion (US $40 billion) per year. Depression is the most prevalent cause of disability while cognitive behavioral therapy (CBT) is the best validated behavioral depression treatment. CBT, when combined with mindfulness meditation (CBT-M), has strong evidence for increased efficacy. While randomized controlled trials (RCTs) have demonstrated online CBT-M efficacy, comparisons with in-office delivery are lacking.ObjectiveThe aim of this research is to assess whether online group CBT-M (with standard psychiatric care) is non-inferior in efficacy and more cost-effective than office-based, on-site group CBT-M at post-intervention and 6-months follow-up in major depressive disorder. The study will also assess whether digitally recorded data (ie, online workbooks completed, Fitbit step count, and online text messages) predict depression symptom reduction in online participants.MethodsThis single-center, two-arm, noninferiority RCT employs assessor-blinded and self-report outcomes and economic evaluation. The research site is the Centre for Addiction and Mental Health (Toronto), a research-based psychiatry institution where participants will be identified from service wait lists and through contacts with other Toronto clinics. Inclusion criteria are as follows: (1) aged 18-60 years, any ethnicity; (2) Beck Depression Inventory-II (BDI-II) of mild severity (score ≥14) with no upper severity limit; (3) Mini-International Neuropsychiatric Interview-confirmed, psychiatric major depressive disorder diagnosis; (4) fluent in English. All patients are diagnosed by staff psychiatrists. Exclusion criteria are as follows: (1) receipt of weekly structured psychotherapy; (2) observation of Diagnostic and Statistical Manual of Mental Disorders (5th Edition) criteria for severe alcohol or substance use disorder (in past 3 months), borderline personality disorder, schizophrenia (or other primary psychotic disorder), bipolar disorder, or obsessive-compulsive disorder; (3) clinically significant suicidal ideation (imminent intent or attempted suicide in the past 6 months); and (4) treatment-resistant depression. All participants receive standard psychiatric care, experimental participants receive online group CBT-M, and controls receive standard care in-office group CBT-M. The online group program (in collaboration with NexJ Health, Inc) combines smartphone and computer-accessed workbooks with mental health phone counselling (16 hours in 16 weeks) that coordinates software interactions (eg, secure text messaging and Fitbit-tracked walking). The primary outcome is BDI-II, and secondary outcomes are anxiety (Beck Anxiety Inventory), depression (ie, Quick Inventory of Depressive Symptomatology and 17-item Hamilton Depression Rating Scale), mindfulness (Five-Facet Mindfulness Questionnaire), quality of life (European Quality of Life Five Dimension), and pain (Brief Pain Inventory).ResultsBased on prior studies with the BDI-II and 80% power to reject an inferiority hypothesis with a 1-sided type I error rate of 5%, a sample of 78 per group is adequate to detect small-to-medium-effect sizes.ConclusionsThis study assesses online CBT-M efficacy and noninferiority in relation to in-person CBT, and the cost-effectiveness of both interventions.Trial registrationClinicalTrials.gov NCT04825535; https://www.clinicaltrials.gov/ct2/show/NCT04825535.International registered report identifier (irrid)DERR1-10.2196/29726.

Dataset Information

Outcomes of Online Mindfulness-Based Cognitive Therapy for Patients With Residual Depressive Symptoms: A Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Trial registration

Publications

Outcomes of Online Mindfulness-Based Cognitive Therapy for Patients With Residual Depressive Symptoms: A Randomized Clinical Trial.

Similar Datasets

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