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

NCT03043833 | Completed

• 1 other identifier: File 1516-077
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (2)

Wellbeing Course

EXPERIMENTAL

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

Waitlist-control

NO INTERVENTION

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

Interventions

The Wellbeing Course 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.

Wellbeing Course

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universite de Moncton: lead
• Macquarie University, Australia: collaborator

Study Sites (1)

Université de Moncton - Adult Clinical Psychology Laboratory

Moncton, New Brunswick, E1A 3E9, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Anxiety Disorders

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• France Talbot, Ph.D.

  Université de Moncton

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 6, 2017
• Study Start: January 18, 2017
• Primary Completion: January 30, 2018
• Study Completion: March 30, 2018
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

CA (1)