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

Study Overview
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Brief Summary
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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.

Official Title
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Improving Access to Treatment for Anxiety and Depression Among French Canadians Using an Internet-Delivered Cognitive Behavior Therapy: A Randomized Controlled Trial

Conditions
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Major Depression, Anxiety Disorders

Intervention / Treatment
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* Behavioral: The Wellbeing Course


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wellbeing Course<br>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. | Behavioral: The Wellbeing Course<br>* 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.<br>|
| No Intervention: Waitlist-control<br>The Waitlist Control Group will receive the French-Canadian version of the Wellbeing Course once the treatment group will have completed treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) | Symptoms of depression | Pretest, posttest (week 8), 3-month follow-up | 
| Changes in anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7) | Symptoms of anxiety | Pretest, posttest (week 8), 3-month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in life satisfaction as assessed by the Satisfaction with Life Scale (SWLS) | Life satisfaction as assessed by the SWLS (Diener et al.,1995) | Pretest, posttest (week 8), 3-month follow-up | 
| Changes in health as assessed by the Short-Form Health Survey | Physical and mental health as assessed by the Short-Form Health Survey (SF-12; Ware et al., 1998) | Pretest (week 1), posttest (week 8), 3-month follow-up | 
| Changes in personality as assessed by the Self-administered Standardised Assessment of Personality - Abbreviated Scale | Pathological personality traits as assessed by the Self-administered Standardised Assessment of Personality - Abbreviated Scale (SAPAS) | Pretest (week 1), posttest (week 8), 3-month follow-up | 
| Changes in anxiety as assessed by the Penn State Worry Questionnaire (PSWQ) | Symptoms of worry | Pretest (week 1), posttest (week 8), 3-month follow-up | 
| Changes in social anxiety as assessed by the Social Phobia Inventory (SPIN) | Symptoms of social anxiety symptoms | Pretest (week 1), posttest (week 8), 3-month follow-up | 
| Changes in panic and agoraphobia as assessed by the Panic and Agoraphobia Scale (PAS) | frequency and intensity of panic symptoms | Pretest (week 1), posttest (week 8), 3-month follow-up |