Non-Inferiority RCT Comparing Online and On-Site CBT in MDDi

Not Applicable

Suspended

• Conditions: Major Depressive Disorder

• Registration Number: NCT04825535
• Lead Sponsor: Centre for Addiction and Mental Health

Brief Summary

In recent years, Cognitive Behavioral Therapy has been integrated with mindfulness meditation (CBT-M) following evidence for increased efficacy when modalities are combined. We will assess whether online group CBT-M plus standard psychiatric care is non-inferior in efficacy and more cost-effective than office-based, on-site group CBT-M (plus standard psychiatric care) per outcomes at post-intervention and at 6-month follow up in adults with major depressive disorder (MDD). This non-inferiority randomized controlled trial will employ both assessor-blinded and self-report outcome measures and will include a full economic evaluation.

Detailed Description

Depression is a commonly diagnosed mental health disorder that represents the most prevalent cause of disability worldwide. Cognitive Behavioural Therapy (CBT) is the best-evidenced treatment for depression, but despite demonstrated efficacy, many individuals cannot access adequate psychotherapeutic treatment due to the limitations of face-to-face delivery. In recent years, CBT has been integrated with mindfulness meditation (CBT-M) following strong evidence for increased efficacy when the two modalities are combined. Previous RCTs have demonstrated that online CBT-M is effective in depressive symptom reduction, but direct comparisons to in-office CBT delivery assessing cost and treatment outcomes are required to facilitate innovation and clinical policy change.

Objectives: To assess whether online group CBT-M plus standard psychiatric care is non-inferior in efficacy and more cost-effective than office-based, on-site group CBT-M (plus standard psychiatric care) per outcomes at post-intervention and at 6-month follow up in adults diagnosed with major depressive disorder (MDD). The study will assess whether digitally recorded adherence data (i.e. online workbooks completed, Fitbit tracked step count, online text-messages exchanged, phone sessions completed) predict outcome benefits in the online-group participants as measured by changes in depressive symptoms.

Methods: This single-centre, 2-arm non-inferiority randomized controlled trial will employ both assessor-blinded and self-report outcome measures and will include a full economic evaluation.

The research site is the Centre for Addiction and Mental Health (CAMH), a large research-based psychiatry institution located in Toronto, Canada. Participants will be identified from wait-lists for CAMH services and through contacts with other Toronto outpatient clinics.

Interventions: All participants will receive standard psychiatric care (1 pharmacotherapy focused visit/month with a psychiatrist of 15-30 minute duration). Experimental participants additionally receive online CBT-M while control participants receive standard care in-office group CBT-M. The online group CBT-M program (in collaboration with NexJ Health, Inc.) combines exposure to smartphone and computer accessed workbooks with phone-based mental health counselling (16 hours in 16 weeks) that coordinates with ongoing software interactions (e.g. secure text messaging, Fitbit tracked walking). Each participant is loaned a Fitbit-HR Charge 3 to assess physical activity as measured by daily step count.

Study Timeline

• Study First Submitted: 2021-03-21
• Study First Submitted QC: 2021-03-30
• Study First Posted: 2021-04-01
• Status Verified: 2024-04
• Study Start: 2024-04
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-08
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• Beck Depression Inventory-II of at least mild severity (BDI-II score ≥ 14) with no upper severity limit;
• Psychiatrist diagnosis of Major Depression Disorder;
• Mini-International Neuropsychiatric Interview (MINI)-confirmed diagnosis of Major Depression Disorder;
• fluent in English.

Exclusion Criteria

• individuals currently receiving weekly structured psychotherapy;
• individuals who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for severe alcohol/substance use disorder (in the past 3 months), borderline personality disorder, schizophrenia or any other primary psychotic disorder, bipolar disorder or obsessive-compulsive disorder;
• individuals who manifest clinically significant suicidal ideation defined as imminent intent or attempted suicide (in the past 6 months);
• individuals who are judged to have treatment resistant depression (TRD), as defined by failure in at least two trials of antidepressant medications and/or a course of psychotherapy during the current depressive episode

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Beck Depression Inventory - 2 (0 to 63 - higher score indicates worse outcome)	Baseline and 4 months	Frequently used and validated self report measure

Secondary Outcome Measures

Name	Time	Method
Change in 5-Facet Mindfulness Questionnaire - 39-item version (39 to 195 - higher score indicates better outcome) Five-Facet Mindfulness Questionnaire	Baseline and 4 months	Frequently used and validated self report measure
Change in EuroQol-5 Dimension (EQ-5D) Quality of Life Instrument - 5 items - 0 - 25 - high score - worse outcome)	Baseline and 4 months	Frequently used and validated self report measure
Change in Brief Pain Inventory - 11 item (0 - 176 - high score indicates worse outcome)	Baseline and 4 months	Frequently used and validated self report measure
Change in Hamilton Depression Rating Scale - 24-item version (0 to 72) Hamilton Depression Rating Scale - 24 item (0 - 96 - higher score indicates worse outcome)	Baseline and 4 months	Frequently used and validated interview-based evaluation instrument
Change in Beck Anxiety Inventory (0 to 63 - higher score indicates worse outcome)	Baseline and 4 months	Frequently used and validated self report measure
Change in Quick Inventory of Depressive Symptoms (0 to 48 - higher score indicates worse outcome)	Baseline and 4 months	Frequently used and validated self report measure

Trial Locations

Locations (1)

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada