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

Anxiety Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03043833
• Other study ID #: File 1516-077
• Status: Completed
• Phase: N/A
• Start date: January 18, 2017
• Est. completion date: March 30, 2018

Study information

• Verified date: April 2018
• Source: Universite de Moncton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 30, 2018
• Est. primary completion date: January 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

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.

Locations

Country	Name	City	State
Canada	Université de Moncton - Adult Clinical Psychology Laboratory	Moncton	New Brunswick

Sponsors (2)

Lead Sponsor	Collaborator
Universite de Moncton	Macquarie University, Australia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)	Symptoms of depression	Pretest, posttest (week 8), 3-month follow-up
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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