Internet-Delivered Cognitive Behavior Therapy for Anxiety and Depression Amongst French Canadians

NCT ID: NCT03043833

Last Updated: 2018-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-18
• Study Completion Date: 2018-03-30

Brief Summary

This study represents Phase II of a research program involving an international collaboration with Macquarie University (Sydney, Australia) to implement an Internet-based cognitive behavior therapy for the treatment of anxiety and depression in French-speaking Canadians from the Atlantic Provinces.

The primary objective is to establish the clinical efficacy of a French-Canadian self-guided format version of the Wellbeing Course by conducting a randomized-control trial where an experimental group will be compared to a waitlist control group. A secondary objective is to demonstrate the course's acceptability through participants' satisfaction with the course.

Conditions

Major Depression; Anxiety Disorders

Study Design

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

Study Groups

Wellbeing Course

Will receive the French-Canadian version of the Wellbeing Course consisting of five lessons based on cognitive behavior therapy delivered through the Internet over eight weeks.

Group Type: EXPERIMENTAL

The Wellbeing Course

Intervention Type: BEHAVIORAL

The Wellbeing Course (Titov et al., 2011) includes five online lessons:

• Lesson 1 presents information on the prevalence of anxiety disorders and depression as well as on how they may interfere with life goals. This lesson also discusses how cognitive, behavioral and physical symptoms can contribute to poor emotional health.
• Lesson 2 presents different strategies to generate realistic cognitions.
• Lesson 3 describes strategies for physical de-arousal and for re-engaging in reinforcing activities.
• Lesson 4 describes avoidance and safety behaviors in relation with anxiety and depression along with graded exposure.
• Lesson 5 is about problem solving, relapse prevention and staying well.

For each lesson, a "Do It Yourself" guide is included as well vignettes and additional material.

Waitlist-control

The Waitlist Control Group will receive the French-Canadian version of the Wellbeing Course once the treatment group will have completed treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

The Wellbeing Course

The Wellbeing Course (Titov et al., 2011) includes five online lessons:

• Lesson 1 presents information on the prevalence of anxiety disorders and depression as well as on how they may interfere with life goals. This lesson also discusses how cognitive, behavioral and physical symptoms can contribute to poor emotional health.
• Lesson 2 presents different strategies to generate realistic cognitions.
• Lesson 3 describes strategies for physical de-arousal and for re-engaging in reinforcing activities.
• Lesson 4 describes avoidance and safety behaviors in relation with anxiety and depression along with graded exposure.
• Lesson 5 is about problem solving, relapse prevention and staying well.

For each lesson, a "Do It Yourself" guide is included as well vignettes and additional material.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Residing in New-Brunswick, Nova-Scotia, Prince Edward Island, or Newfound land & Labrador
• Having identified French as the first official language spoken and having good reading comprehension in French.
• Reliable Internet access
• Clinically significant levels of depression or anxiety reflected by significant scores on the following measures: PHQ-9 > 9, GAD-7 >7, Penn Stage Worry Questionnaire ≥ 45, Social Phobia Inventory ≥ 19, Panic and Agoraphobia Scale ≥ 19, or by answering yes to the question "Is anxiety or low mood a problem for you"
• Not currently participating in cognitive-behavioral therapy
• No changes in medication for 4 weeks prior to the study, nor any changes in medication for the next 2 months
• Willing to disclose personal information

Exclusion Criteria

• Presence of psychotic symptoms
• Presence of severe depression as indicated by scores ≥ 23 on the PHQ-9, or a score > 2 on item 9 of the PHQ-9

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Macquarie University, Australia

OTHER

Sponsor Role: collaborator

Universite de Moncton

OTHER

Sponsor Role: lead

Responsible Party

France Talbot

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

France Talbot, Ph.D.

Role: STUDY_DIRECTOR

Université de Moncton

Locations

Université de Moncton - Adult Clinical Psychology Laboratory

Moncton, New Brunswick, Canada

Countries

Canada

Other Identifiers

File 1516-077

Identifier Type: -

Identifier Source: org_study_id