Mindbeacon Therapist Assisted Internet Delivered CBT for Depression

NCT ID: NCT05134103

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2021-11-18

Brief Summary

Utilization of therapist Assisted internet-delivered cognitive behavioural therapy (TAiCBT) for treating depression and anxiety disorders in stepped-care models, such as the UK's Improving Access to Psychological Therapies (IAPT) and the Ontario Structured Psychotherapy Program (SPP), is a potential solution for addressing the treatment gap in mental health. Investigators propose to investigate the effectiveness of Beacon TAiCBT for Depression to demonstrate the potential value of TAiCBT in a stepped care model. Investigators propose to conduct a 12-week pragmatic randomized controlled trial with a 1:1 (iCBT intervention: waiting-list) allocation, for participants referred to the Anxiety and Mood, Prompt Anxiety and Mood, and Trauma Programs at Ontario Shores Centre for Mental Health Sciences and on a waiting-list to receive clinical service.

The primary outcome measures will be the Improving Access to Psychological Therapies (IAPT) definitions of Recovery, Reliable Improvement, and Reliable Recovery which are derived using the PHQ-9 and GAD-7 . The PHQ-9 (Depression), GAD-7 (anxiety) and WSAS (functional impairment) will be used as secondary outcome measures for all participants.

Over the course of the study, 200 participants will be randomized (iCBT, 100; waiting-list, 100). Statistical analyses will include intention-to-treat analyses to test the interaction effects for the primary outcome measures at discharge/12-weeks and 3, and 12 months post-treatment.

It is predicted that participants in the treatment condition will show significantly reduced symptoms of depression related to the waitlist control. It is predicted that this will be maintained through follow up.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mindbeacon TAI-CBT for Depression group

Participants randomized to this condition will receive immediate Therapist-Guided Internet-CBT for Depression for 12 weeks.

Group Type: EXPERIMENTAL

Mindbeacon Therapist Guided, Internet Cognitive Behavioral Therapy for Depression

Intervention Type: BEHAVIORAL

The treatment consists of 11 depression modules delivered approximately once per week (at therapists' discretion) over a period of 12 weeks. Additionally, the therapist typically tailors treatment to client's individual needs by including supplementary modules for a variety of issues such as generalized anxiety, panic, social anxiety, post-traumatic stress, insomnia, pain, and relationships etc. Clients can complete the readings, exercises, and worksheets at any convenient time, using their web-enabled smartphone, tablet, or computer. Access to the modules and all messaging is provided through the secure platform. Messaging is "asynchronous" meaning participants can message their therapist as often as they choose and expect a response within 1-2 business days. After 12 weeks of active treatment, they will have unguided access (without therapist support) to the treatment materials that were covered for an additional 40 weeks.

Waitlist Control Group

Participants randomized to this condition will remain on the waitlist for 12 weeks before crossing over and receiving Therapist-Guided Internet-CBT for Depression for 12 weeks.

Group Type: OTHER

Waitlist Control Group

Intervention Type: OTHER

Participants assigned to this arm will wait for 12 weeks before receiving active treatment condition

Interventions

Mindbeacon Therapist Guided, Internet Cognitive Behavioral Therapy for Depression

The treatment consists of 11 depression modules delivered approximately once per week (at therapists' discretion) over a period of 12 weeks. Additionally, the therapist typically tailors treatment to client's individual needs by including supplementary modules for a variety of issues such as generalized anxiety, panic, social anxiety, post-traumatic stress, insomnia, pain, and relationships etc. Clients can complete the readings, exercises, and worksheets at any convenient time, using their web-enabled smartphone, tablet, or computer. Access to the modules and all messaging is provided through the secure platform. Messaging is "asynchronous" meaning participants can message their therapist as often as they choose and expect a response within 1-2 business days. After 12 weeks of active treatment, they will have unguided access (without therapist support) to the treatment materials that were covered for an additional 40 weeks.

Intervention Type: BEHAVIORAL

Waitlist Control Group

Participants assigned to this arm will wait for 12 weeks before receiving active treatment condition

Intervention Type: OTHER

Other Intervention Names

Internet-CBT

Eligibility Criteria

Inclusion Criteria

• Minimum age of 18 years
• Meets Diagnostic Assessment Research Tool (DART) screening criteria for a primary diagnosis of depression and reports being at least moderately depressed according to the PHQ-9
• Sufficient language proficiency to understand the treatment materials written at grade 10 reading level
• Understands what TAiCBT and is open and interested to participating in a study using this treatment modality
• Is able to reliably access the internet, and has basic computer skills to navigate the internet using a web browser
• Willing to participate in a waitlist-control study and be followed for 12 months

Exclusion Criteria

• Suicidal intent or clinically significant suicidal ideation
• Clinically significant self-harm
• Active psychotic illness
• Currently participating in psychological treatment for depression and/or receiving evidence-based treatment (other than medication) for depression
• Clinically significant alcohol and/or other substance use including prescription and over the counter medication that would likely interfere with treatment
• Current or previous diagnosis of Borderline Personality Disorder
• Does not meet DART criteria for a primary diagnosis of depression
• Change in psychotropic medication within 3 weeks of treatment baseline

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mindbeacon

UNKNOWN

Sponsor Role: collaborator

Ontario Shores Centre for Mental Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Phil Klassen, MD

Role: PRINCIPAL_INVESTIGATOR

Ontario Shores Hospital

Other Identifiers

21-004-B

Identifier Type: -

Identifier Source: org_study_id