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

Major Depressive Disorder Clinical Trial

Official title: A Non-Inferiority Randomized Controlled Trial Comparing Online and On-Site Cognitive Behaviour Therapy in Major Depressive Disorder

Status Suspended

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

• NCT number: NCT04825535
• Study type: Interventional
• Source: Centre for Addiction and Mental Health
• Status: Suspended
• Phase: N/A
• Start date: April 2024
• Completion date: April 2025