Improving Access to Treatment for Anxiety and Depression Among French Canadians Using an Internet-Delivered Cognitive Behavior Therapy: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universite de Moncton
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Changes in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: The Wellbeing Course (Behavioral)
Waitlist-control
The Waitlist Control Group will receive the French-Canadian version of the Wellbeing Course once the treatment group will have completed treatment.
Outcomes
Primary Outcomes
Changes in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Pretest, posttest (week 8), 3-month follow-up
Symptoms of depression
Changes in anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: Pretest, posttest (week 8), 3-month follow-up
Symptoms of anxiety
Secondary Outcomes
- Changes in life satisfaction as assessed by the Satisfaction with Life Scale (SWLS)(Pretest, posttest (week 8), 3-month follow-up)
- Changes in health as assessed by the Short-Form Health Survey(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(Pretest (week 1), posttest (week 8), 3-month follow-up)
- Changes in anxiety as assessed by the Penn State Worry Questionnaire (PSWQ)(Pretest (week 1), posttest (week 8), 3-month follow-up)
- Changes in social anxiety as assessed by the Social Phobia Inventory (SPIN)(Pretest (week 1), posttest (week 8), 3-month follow-up)
- Changes in panic and agoraphobia as assessed by the Panic and Agoraphobia Scale (PAS)(Pretest (week 1), posttest (week 8), 3-month follow-up)
Investigators
France Talbot
Associate Professor
Universite de Moncton