Clinical trial NCT05134103: Mindbeacon Therapist Assisted Internet Delivered CBT for Depression
Official title: A 12-week Randomized Waitlist-Controlled Trial of Mindbeacon Therapist Assisted Internet Delivered CBT for Depression
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Depression
Lead sponsor: Ontario Shores Centre for Mental Health Sciences
Sponsor class: OTHER
Collaborators: name: Mindbeacon
First posted: 2021-11-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a waitlist-controlled, randomized controlled trial.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: IAPT Definition of "Recovery" (Change between Baseline and Post-treatment)
timeFrame: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and "post-treatment" which is week 12 of treatment)
measure: IAPT Definition of "Recovery" (Change between baseline and 3 month follow-up)
timeFrame: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment)
measure: IAPT Definition of "Recovery" (Change between baseline and 12 month follow-up)
timeFrame: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment)
measure: IAPT Definition of "Reliable improvement" (Change between Baseline and Post-treatment)
timeFrame: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and "post-treatment" which is week 12 of treatment)
measure: IAPT Definition of "Reliable improvement" (Change between baseline, and 3 month follow-up)
timeFrame: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment)
measure: IAPT Definition of "Reliable improvement" (Change between baseline and 12 month follow-up)
timeFrame: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment)
measure: IAPT definition of "Reliable recovery" (Change between Baseline and Post-treatment)
timeFrame: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and post-treatment (week 12 of treatment)
measure: IAPT definition of "Reliable recovery" (Change between baseline and 3 month follow-up)
timeFrame: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment)
measure: IAPT definition of "Reliable recovery" (Change between baseline and 12 month follow-up)
timeFrame: GAD-7 and PHQ-9 which are used to compute this outcome measure are administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment)
Secondary outcomes:
measure: Work and Social Adjustment Scale (WSAS) - (Change between Baseline and Post-treatment)
timeFrame: Administered at baseline (initial screening) and post-treatment (week 12 of treatment)
measure: Work and Social Adjustment Scale (WSAS) - (Change between baseline and 3 month follow-up)
timeFrame: Administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment)
measure: Work and Social Adjustment Scale (WSAS) - (Change between baseline and 12 month follow-up)
timeFrame: Administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment)
measure: Patient Health Questionnaire 9 (PHQ-9) - (Change between baseline and post-treatment)
timeFrame: Administered at baseline (initial screening) and post-treatment (week 12 of treatment)
measure: Patient Health Questionnaire 9 (PHQ-9) - (Change between baseline and 3 month follow-up)
timeFrame: Administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment)
measure: Patient Health Questionnaire 9 (PHQ-9) - (Change between baseline and 12 month follow-up)
timeFrame: Administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment)
measure: Generalized Anxiety Disorder 7 (GAD-7) - (Change between baseline and post-treatment)
timeFrame: Administered at baseline (initial screening) and post-treatment (week 12 of treatment)
measure: Generalized Anxiety Disorder 7 (GAD-7) - (Change between baseline and 3 month follow-up)
timeFrame: Administered at baseline (initial screening) and 3 month follow-up (3 months after "post-treatment" which is week 12 of treatment)
measure: Generalized Anxiety Disorder 7 (GAD-7) - (Change between baseline and 12 month follow-up)
timeFrame: Administered at baseline (initial screening) and 12 month follow-up (12 months after "post-treatment" which is week 12 of treatment)
Other outcomes:
Locations:
Study officials:
affiliation: Ontario Shores Hospital
name: Phil Klassen, MD
role: PRINCIPAL_INVESTIGATOR
References: