Clinical trial NCT04825535: Non-Inferiority RCT Comparing Online and On-Site CBT in MDDi
Official title: A Non-Inferiority Randomized Controlled Trial Comparing Online and On-Site Cognitive Behaviour Therapy in Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: internet-based intervention
major depressive disorder
health coaching
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Online CBT intervention
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Beck Depression Inventory - 2 (0 to 63 - higher score indicates worse outcome)
timeFrame: Baseline and 4 months
Secondary outcomes:
measure: Change in Beck Anxiety Inventory (0 to 63 - higher score indicates worse outcome)
timeFrame: Baseline and 4 months
measure: Change in Quick Inventory of Depressive Symptoms (0 to 48 - higher score indicates worse outcome)
timeFrame: Baseline and 4 months
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)
timeFrame: Baseline and 4 months
measure: Change in 5-Facet Mindfulness Questionnaire - 39-item version (39 to 195 - higher score indicates better outcome) Five-Facet Mindfulness Questionnaire
timeFrame: Baseline and 4 months
measure: Change in Brief Pain Inventory - 11 item (0 - 176 - high score indicates worse outcome)
timeFrame: Baseline and 4 months
measure: Change in EuroQol-5 Dimension (EQ-5D) Quality of Life Instrument - 5 items - 0 - 25 - high score - worse outcome)
timeFrame: Baseline and 4 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: David Gratzer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ritvo P, Gratzer D, Knyahnytska Y, Ortiz A, Walters C, Katz J, Laposa J, Baldissera C, Wayne N, Pfefer-Litman D, Tomlinson G, Daskalakis Z. Comparing Online and On-Site Cognitive Behavior Therapy in Major Depressive Disorder: Protocol for a Noninferiority Randomized Controlled Trial. JMIR Res Protoc. 2022 Apr 8;11(4):e29726. doi: 10.2196/29726.