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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2025-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Individual MBCT vs. CBT in Major Depression: A Pilot Study.

NCT05108701

Major Depressive Disorder

COMPLETED NA

Mindbeacon Therapist Assisted Internet Delivered CBT for Depression

NCT05134103

Major Depressive Disorder

WITHDRAWN NA

The Internet Therapy for Depression Trial

NCT04009135

Chronic Pain Major Depressive Disorder

COMPLETED NA

Mindfulness-based Behavioural Therapy (MIBT) Versus Psychodynamic Therapy for Patients With Major Depressive Disorder in Psychotherapeutic Day Treatment. A Randomised Clinical Pilot Trial

NCT01070134

Major Depressive Disorder Personality Disorder

UNKNOWN NA

Smartphone-enabled Health Coaching Intervention for Youth Diagnosed With Major Depressive Disorders

NCT03406052

Disorder, Major Depressive

SUSPENDED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Major Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Online CBT intervention

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

One assessor will be blinded to the (2) comparison groups of all participants.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard psychiatry and cognitive behavioural online intervention

The online group CBT-M program combines software-based workbooks with phone-based Navigator-Coaching that coordinates software interactions (e.g., secure text messaging, Fitbit tracked walking, food monitoring via photography). Navigation coaching is supplied by students who were pursuing graduate degrees (MSc, MA, PhD) in kinesiology and health science, education, and psychology.

Group Type EXPERIMENTAL

Standard psychiatry and cognitive behavioral online intervention

Intervention Type BEHAVIORAL

The cognitive behavioral online intervention has been assessed in a prior trial. Ritvo, P, Knyahnytska, Y, Pirboglou, M, Wang, W, Tomlinson, G, Zhao, H, Linklater, R, Kirk, M., Katz, J., Harber, L., Daskalakis, ZJ An online mindfulness-based cognitive behavioural therapy intervention for youth diagnosed with major depressive disorders: J Med Internet Res 2021, Mar 17; 23 (3), e24380

Standard psychiatry and cognitive behavioural in-person intervention

The on-site, usual-care CBT group follows the structure of the Mind Over Mood workbook in reviewing CBT concepts and procedures. A series of work sheets assist participants in differentiating moods, and in differentiating moods from thoughts and situational influences, leading to modifications of thinking, behaviour, emotion and mood. Group leaders are standard leaders in the CAMH group-CBT program who have Masters-level degrees in psychology, social work and occupational therapists.

Group Type ACTIVE_COMPARATOR

Standard psychiatry and cognitive behavioural in-person intervention

Intervention Type BEHAVIORAL

The effectiveness of standard care office-based group CBT-MM at CAMH is indicated in a past study (n = 119) where depression symptoms reduced (after 16 weeks treatment) by 27% \[3,18 \]. The office-based groups follow a carefully conceived structure that centers on the workbook Mind Over Mood (MOM) (Guilford Press) \[41\]. Key CBT concepts and procedures are conveyed via work sheets that structure personal and group exploration.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Standard psychiatry and cognitive behavioral online intervention

The cognitive behavioral online intervention has been assessed in a prior trial. Ritvo, P, Knyahnytska, Y, Pirboglou, M, Wang, W, Tomlinson, G, Zhao, H, Linklater, R, Kirk, M., Katz, J., Harber, L., Daskalakis, ZJ An online mindfulness-based cognitive behavioural therapy intervention for youth diagnosed with major depressive disorders: J Med Internet Res 2021, Mar 17; 23 (3), e24380

Intervention Type BEHAVIORAL

Standard psychiatry and cognitive behavioural in-person intervention

The effectiveness of standard care office-based group CBT-MM at CAMH is indicated in a past study (n = 119) where depression symptoms reduced (after 16 weeks treatment) by 27% \[3,18 \]. The office-based groups follow a carefully conceived structure that centers on the workbook Mind Over Mood (MOM) (Guilford Press) \[41\]. Key CBT concepts and procedures are conveyed via work sheets that structure personal and group exploration.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No