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e-CBT vs Mental Health Coaching for Anxiety

N/A

Waitlist Available

Led By Nazanin Alavi, MD, FRCPC

Research Sponsored by Dr. Nazanin Alavi

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0, week 6, week 12, 6-month follow-up

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the efficacy of an electronically-delivered cognitive behavioural therapy (e-CBT) program to a mental health coaching program to treat generalized anxiety disorder (GAD).

Who is the study for?

This trial is for adults aged 18-65 with Generalized Anxiety Disorder (GAD) as per DSM-5, who can understand English and have reliable internet access. It's not suitable for those with active psychosis, severe substance abuse, suicidal thoughts, ongoing psychotherapy or acute mania.

What is being tested?

The study compares an online cognitive behavioural therapy program (e-CBT) to a mental health coaching program in treating GAD. Over 12 weeks, participants will either engage in e-CBT modules with therapist feedback or weekly themed chats through the platform.

What are the potential side effects?

While there are no direct side effects from participating in e-CBT or mental health coaching programs themselves, discussing anxiety might temporarily increase distress or emotional discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0, week 6, week 12, 6-month follow-up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0, week 6, week 12, 6-month follow-up

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, week 6, week 12, 6-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in symptoms (Depression Anxiety Scale - 42 Item)

Change in symptoms (Generalized Anxiety Disorder - 7 Item)

Change in symptoms (Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: e-CBTExperimental Treatment1 Intervention

12 weekly sessions of approximately 30 slides and interactive content, delivered through OPTT. The e-CBT module content mirrors in-person standard CBT content, including different weekly topics, general information, skill overviews, and homework. Participants are instructed to go through the content and complete homework at the end of the session which helps them practice skills they learned through that session. Homework is submitted through OPTT and reviewed by the therapist assigned to the participant, who will provide personalized feedback within three days of submission. Therapists have access to pre-designed session-specific feedback templates to use as a basic structure to write their feedback. By doing so, the time needed to respond to each patient is reduced and therefore the number of patients each therapist can handle increases.

Group II: Mental Health CoachingExperimental Treatment1 Intervention

Weekly interactions with the therapist using general questions on the following topics: Week 1 (Mood) Week 2 (Sleep) Week 3 (Activity) Week 4 (Hobbies) Week 5 (Friendship) Week 6 (New Events) Week 7 (Job/Study) Week 8 (Diet/Food) Week 9 (Books/Movies/Shows) Week 10 (Phone/Apps/Games) Week 11 (Habits) Week 12 (Accomplishments)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

e-CBT

2021

N/A

~300

Mental Health Coaching

2021

N/A

~100