Comparing the Efficacy of E-CBT to Mental Health Coaching for GAD

NCT04754438 | Completed

• 1 other identifier: 6032033
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the efficacy of an electronically-delivered cognitive behavioural therapy (e-CBT) program versus a mental health coaching program to treat generalized anxiety disorder (GAD). This randomized trial intervention will provide the e-CBT and mental health coaching for GAD through a secure, online platform. Participants will be between the ages of 18 and 65 years with a confirmed diagnosis of GAD according to the Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5). Participants will either be offered an e-CBT program tailored to GAD or an online mental health coaching program over 12 weeks to address their anxiety symptoms. e-CBT participants will complete pre-designed modules and homework assignments while receiving personalized feedback and asynchronous interaction with a therapist through the platform. Participants in the coaching group will be contacted weekly through the online platform's chat feature. Therapists will ask the participants a series of pre-designed questions that revolve around a different theme each week to prompt conversation. Using clinically validated symptomology questionnaires, the efficacy of the e-CBT program will be compared to the coaching group. These questionnaires will be completed at baseline, week 6, week 12, and at a 6-month follow-up. Questionnaires include the State-Trait Anxiety Inventory (STAI), the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF), the Generalized Anxiety Disorder - 7 Item (GAD-7), and the Depression Anxiety Stress Scale - 42 Item (DASS-42).

Conditions

Anxiety; Generalized Anxiety Disorder

Keywords

Mental Health; Psychotherapy; Electronic; Internet; Anxiety

Outcome Measures

Primary Outcomes (4)

• Change in symptoms (State-Trait Anxiety Inventory)

  Clinically validated symptom questionnaire. Scale of 0-4, 4 being the worst.

  Week 0, week 6, week 12, 6-month follow-up

• Change in symptoms (Generalized Anxiety Disorder - 7 Item)

  Clinically validated symptom questionnaire. Scale of 0-3, 3 being the worst.

  Week 0, week 6, week 12, 6-month follow-up

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

  Clinically validated symptom questionnaire. Scale of 0-5, 5 being the best.

  Week 0, week 6, week 12, 6-month follow-up

• Change in symptoms (Depression Anxiety Scale - 42 Item)

  Clinically validated symptom questionnaire. Scale of 0-3, 3 being the worst.

  Week 0, week 6, week 12, 6-month follow-up

Study Arms (2)

e-CBT

EXPERIMENTAL

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.

Behavioral: e-CBT

Mental Health Coaching

EXPERIMENTAL

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)

Behavioral: Mental Health Coaching

Interventions

e-CBT BEHAVIORAL

Electronically delivered cognitive behavioural therapy

e-CBT

Mental Health Coaching BEHAVIORAL

Electronically delivered mental health coaching

Mental Health Coaching

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18-65 years of age at the start of the study
• Diagnosis of GAD according to DSM-5 by attending psychiatrist on research team
• Competence to consent to participate
• Ability to speak and read English
• Consistent and reliable access to the internet

You may not qualify if:

• Active psychosis
• Acute mania
• Severe alcohol or substance use disorder
• Active suicidal or homicidal ideation
• Receiving another form of psychotherapy

Sponsors & Collaborators

• Dr. Nazanin Alavi: lead

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G3, Canada

Location

Related Publications (1)

• Stephenson C, Kumar A, Malakouti N, Nikjoo N, Jagayat J, Gizzarelli T, Patel C, Gutierrez G, Shirazi A, Yang M, Omrani M, Alavi N. Comparing the Efficacy of an Electronically Delivered Cognitive Behavioral Therapy Program to a Mental Health Check-In Program for Generalized Anxiety Disorder: Protocol for a Randomized Trial. JMIR Res Protoc. 2023 Sep 20;12:e48899. doi: 10.2196/48899.

  PMID: 37587552 DERIVED

Related Links

• Publication

MeSH Terms

Conditions

Anxiety Disorders; Generalized Anxiety Disorder; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental Disorders; Personal Satisfaction; Behavior

Study Officials

• Nazanin Alavi, MD, FRCPC

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Model Details: The randomized trial intervention will provide e-CBT for GAD through the Online Psychotherapy Tool (OPTT), a secure, cloud-based, digital mental health platform. Participants will be randomly assigned to either an e-CBT program tailored to GAD or a mental health coaching program over 12 weeks to address their anxiety symptoms. In the e-CBT group, participants will complete pre-designed modules and homework assignments while receiving personalized feedback and asynchronous interaction with a therapist through the platform. There will be 12 weekly sessions that include approximately 30 slides each along with interactive content, delivered through OPTT. In the mental health coaching group, participants will have weekly interaction with a therapist through the chat function in OPTT where the coach will check in on the participant and touch on a specific subject each week.

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 15, 2021
• Study Start: April 1, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)