- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04825535
Non-Inferiority RCT Comparing Online and On-Site CBT in MDDi
A Non-Inferiority Randomized Controlled Trial Comparing Online and On-Site Cognitive Behaviour Therapy in Major Depressive Disorder
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Paul Ritvo, PhD
- Phone Number: 22396 4167362100
- Email: pritvo@yorku.ca
Study Contact Backup
- Name: Clarice Walters, BSc
- Phone Number: 4167682002
- Email: clarice.walters@camh.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M6J 1H4
- Centre for Addiction and Mental Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Beck Depression Inventory - 2 (0 to 63 - higher score indicates worse outcome)
Time Frame: Baseline and 4 months
|
Frequently used and validated self report measure
|
Baseline and 4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Beck Anxiety Inventory (0 to 63 - higher score indicates worse outcome)
Time Frame: Baseline and 4 months
|
Frequently used and validated self report measure
|
Baseline and 4 months
|
Change in Quick Inventory of Depressive Symptoms (0 to 48 - higher score indicates worse outcome)
Time Frame: Baseline and 4 months
|
Frequently used and validated self report measure
|
Baseline and 4 months
|
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)
Time Frame: Baseline and 4 months
|
Frequently used and validated interview-based evaluation instrument
|
Baseline and 4 months
|
Change in 5-Facet Mindfulness Questionnaire - 39-item version (39 to 195 - higher score indicates better outcome) Five-Facet Mindfulness Questionnaire
Time Frame: Baseline and 4 months
|
Frequently used and validated self report measure
|
Baseline and 4 months
|
Change in Brief Pain Inventory - 11 item (0 - 176 - high score indicates worse outcome)
Time Frame: Baseline and 4 months
|
Frequently used and validated self report measure
|
Baseline and 4 months
|
Change in EuroQol-5 Dimension (EQ-5D) Quality of Life Instrument - 5 items - 0 - 25 - high score - worse outcome)
Time Frame: Baseline and 4 months
|
Frequently used and validated self report measure
|
Baseline and 4 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: David Gratzer, MD, Centre for Addiction and Mental Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Major Depressive Disorder
-
Shalvata Mental Health CenterUnknownMAjor Depressive DisorderIsrael
-
York UniversityCentre for Addiction and Mental HealthSuspendedDisorder, Major DepressiveCanada
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDDIndia
-
Gangnam Severance HospitalCompletedMajor Depressive Disorder(MDD)Korea, Republic of
-
University College, LondonCompletedUnipolar Major Depressive DisorderUnited Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...Fondo de Investigacion SanitariaUnknown
-
Seasons Biotechnology (Taizhou) Co., Ltd.CompletedMajor Depressive Disorder (MDD)India
-
Repurposed Therapeutics, Inc.Unknown
-
GlaxoSmithKlineCompletedMajor Depressive Disorder (MDD)United States
-
AccexibleRecruitingMajor Depressive Disorder (MDD)Spain
Clinical Trials on Standard psychiatry and cognitive behavioral online intervention
-
Universidad de GranadaCompletedStress, Psychological | Vision Disorders | Self Efficacy | PsychopathySpain
-
Karolinska InstitutetKarolinska University HospitalActive, not recruiting
-
University of California, San FranciscoNational Institute of Mental Health (NIMH)Completed
-
Universidad del Valle, ColombiaUniversidad Unidad Central del Valle (UCEVA); Red de Salud de Ladera E.S.E; Hospital... and other collaboratorsUnknownDepression | Anxiety | Activities of Daily Living | Post-traumatic Stress Disorder | Intimate Partner Violence | Self Esteem
-
Hong Kong Baptist UniversityStockholm University; Research Grants Council, Hong Kong; Richmond Fellowship... and other collaboratorsRecruitingSocial Anxiety DisorderHong Kong
-
University of KentuckyPatient-Centered Outcomes Research Institute; University of California, Los...Active, not recruitingHeart Diseases | Depressive SymptomsUnited States
-
Massachusetts General HospitalUniversity of California, San FranciscoCompleted
-
University Hospital, Strasbourg, FranceCompletedStress - Prevention of Sleep Disorders, PTSD and DepressionFrance
-
University Hospital, MontpellierInstitut National de la Santé Et de la Recherche Médicale, FranceCompleted
-
Icahn School of Medicine at Mount SinaiNational Institute for Occupational Safety and Health (NIOSH/CDC)CompletedPost-Traumatic Stress DisorderUnited States