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

NCT04825535 | Suspended

• 1 other identifier: 08-2020
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

internet-based intervention; major depressive disorder; health coaching

Outcome Measures

Primary Outcomes (1)

• Change in Beck Depression Inventory - 2 (0 to 63 - higher score indicates worse outcome)

  Frequently used and validated self report measure

  Baseline and 4 months

Secondary Outcomes (6)

• Change in Beck Anxiety Inventory (0 to 63 - higher score indicates worse outcome)

  Baseline and 4 months

• Change in Quick Inventory of Depressive Symptoms (0 to 48 - higher score indicates worse outcome)

  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)

  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

  Baseline and 4 months

• Change in Brief Pain Inventory - 11 item (0 - 176 - high score indicates worse outcome)

  Baseline and 4 months

Study Arms (2)

Standard psychiatry and cognitive behavioural online intervention

EXPERIMENTAL

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.

Behavioral: Standard psychiatry and cognitive behavioral online intervention

Standard psychiatry and cognitive behavioural in-person intervention

ACTIVE COMPARATOR

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.

Behavioral: Standard psychiatry and cognitive behavioural in-person intervention

Interventions

Standard psychiatry and cognitive behavioral online intervention 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 online intervention

Standard psychiatry and cognitive behavioural in-person intervention 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.

Standard psychiatry and cognitive behavioural in-person intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Related Publications (1)

• 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.

  PMID: 35393942 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• David Gratzer, MD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: One assessor will be blinded to the (2) comparison groups of all participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Online CBT intervention

Study Record Dates

• First Submitted: March 21, 2021
• First Posted: April 1, 2021
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 8, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)