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Completed

NCT Number: NCT03043833

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

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.

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Key information

Conditions

Major Depression Anxiety Disorders Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université de Moncton - Adult Clinical Psychology Laboratory

Moncton, New Brunswick, E1A 3E9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

  1. Changes in life satisfaction as assessed by the Satisfaction with Life Scale (SWLS)

    Time frame: Pretest, posttest (week 8), 3-month follow-up

    Life satisfaction as assessed by the SWLS (Diener et al.,1995)

  2. Changes in health as assessed by the Short-Form Health Survey

    Time frame: Pretest (week 1), posttest (week 8), 3-month follow-up

    Physical and mental health as assessed by the Short-Form Health Survey (SF-12; Ware et al., 1998)

  3. Changes in personality as assessed by the Self-administered Standardised Assessment of Personality - Abbreviated Scale

    Time frame: Pretest (week 1), posttest (week 8), 3-month follow-up

    Pathological personality traits as assessed by the Self-administered Standardised Assessment of Personality - Abbreviated Scale (SAPAS)

  4. Changes in anxiety as assessed by the Penn State Worry Questionnaire (PSWQ)

    Time frame: Pretest (week 1), posttest (week 8), 3-month follow-up

    Symptoms of worry

  5. Changes in social anxiety as assessed by the Social Phobia Inventory (SPIN)

    Time frame: Pretest (week 1), posttest (week 8), 3-month follow-up

    Symptoms of social anxiety symptoms

  6. Changes in panic and agoraphobia as assessed by the Panic and Agoraphobia Scale (PAS)

    Time frame: Pretest (week 1), posttest (week 8), 3-month follow-up

    frequency and intensity of panic symptoms

Sponsors and collaborators

Lead sponsor

Universite de Moncton

Other

Collaborators

  • Macquarie University, Australia

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 6, 2017
Registry last updated
May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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