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

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

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 Overview

• Status: Completed
• Conditions: Anxiety Disorders; Major Depression
• Intervention / Treatment: Behavioral: The Wellbeing Course

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1A 3E9
      • Université de Moncton - Adult Clinical Psychology Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No Intervention: Waitlist-control; 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?

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

Collaborators and Investigators

• Sponsor: Universite de Moncton
• Collaborators: Macquarie University, Australia

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2017
• Primary Completion (Actual): January 30, 2018
• Study Completion (Actual): March 30, 2018

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: February 2, 2017
• First Posted (Estimate): February 6, 2017

Study Record Updates

• Last Update Posted (Actual): May 1, 2018
• Last Update Submitted That Met QC Criteria: April 30, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Anxiety Disorders
• Other Study ID Numbers: File 1516-077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: There is currently in place a memorandum of understanding with Macquarie University, our collaborators. This agreement allows for the sharing of data once personally identifiable information has been removed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No