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Cognitive Behavioral Therapy

Online vs In-Person Cognitive Behavioral Therapy for Depression

N/A

Waitlist Available

Led By David Gratzer, MD

Research Sponsored by Centre for Addiction and Mental Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Psychiatrist diagnosis of Major Depression Disorder;

Psychiatrist diagnosis of Major Depression Disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 4 months

Awards & highlights

Study Summary

This trial will assess whether an online form of CBT-M is non-inferior in efficacy and more cost-effective than in-person CBT-M for adults with MDD.

Who is the study for?

Adults with Major Depressive Disorder (MDD) who score at least mild severity on the Beck Depression Inventory-II and have been confirmed by a psychiatrist. Participants must be fluent in English and not currently receiving weekly structured psychotherapy or have certain other mental health conditions, severe substance abuse issues, recent suicidal behavior, or treatment-resistant depression.Check my eligibility

What is being tested?

The trial is testing if online Cognitive Behavioral Therapy combined with mindfulness (CBT-M), alongside standard psychiatric care, is as effective as the same therapy given in person. The study will compare outcomes immediately after treatment and six months later to see if one method is more cost-effective without losing efficacy.See study design

What are the potential side effects?

Since this trial involves psychological therapy rather than medication, side effects are not typical but may include temporary increases in emotional distress due to discussing personal topics during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Major Depression Disorder by a psychiatrist.

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I have been diagnosed with Major Depression Disorder by a psychiatrist.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Change in 5-Facet Mindfulness Questionnaire - 39-item version (39 to 195 - higher score indicates better outcome) Five-Facet Mindfulness Questionnaire

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

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

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Standard psychiatry and cognitive behavioural online interventionExperimental Treatment1 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 II: Standard psychiatry and cognitive behavioural in-person interventionActive Control1 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.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

Centre for Addiction and Mental HealthLead Sponsor

354 Previous Clinical Trials

80,964 Total Patients Enrolled

84 Trials studying Depression

18,971 Patients Enrolled for Depression

York UniversityLead Sponsor

58 Previous Clinical Trials

17,320 Total Patients Enrolled

7 Trials studying Depression

2,625 Patients Enrolled for Depression

David Gratzer, MDPrincipal InvestigatorCentre for Addiction and Mental Health

Media Library

CBT-M (Cognitive Behavioral Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04825535 — N/A

Depression Research Study Groups: Standard psychiatry and cognitive behavioural in-person intervention, Standard psychiatry and cognitive behavioural online intervention

Depression Clinical Trial 2023: CBT-M Highlights & Side Effects. Trial Name: NCT04825535 — N/A

CBT-M (Cognitive Behavioral Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04825535 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still space available in this exploration for participants?

"Clinicaltrials.gov data indicates that this trial is currently not seeking participants, as the most recent update was made on March 30th 2021 since its initial posting on April 1st 2021. In contrast, 1296 other trials are actively recruiting for patients to join their studies now."

Answered by AI

Does the protocol of this trial encompass those over sixty years of age?

"This clinical trial has a maximum age of 60 and requires that all participants are at least 18 years old."

Answered by AI

Who meets the eligibility criteria for this clinical trial?

"This trial is seeking 156 participants with psychosis and involutional depression between the ages of 18-60. The qualifications for entry include a BDI-II score no lower than 14, diagnosis of Major Depression Disorder via MINI International Neuropsychiatric Interview, plus being fluent in English."

Answered by AI