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

Primary Purpose

Major Depression, Anxiety Disorders

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

The Wellbeing Course

About this trial

This is an interventional treatment trial for Major Depression

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Université de Moncton - Adult Clinical Psychology Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Wellbeing Course

Waitlist-control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Changes in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)

Symptoms of depression

Changes in anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7)

Symptoms of anxiety

Secondary Outcome Measures

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

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

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)

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)

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

Symptoms of worry

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

Symptoms of social anxiety symptoms

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

frequency and intensity of panic symptoms

Full Information

NCT ID

NCT03043833

First Posted

January 30, 2017

Last Updated

April 30, 2018

Sponsor

Universite de Moncton

Collaborators

Macquarie University, Australia

1. Study Identification

Unique Protocol Identification Number

NCT03043833

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

January 18, 2017 (Actual)

Primary Completion Date

January 30, 2018 (Actual)

Study Completion Date

March 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universite de Moncton

Collaborators

Macquarie University, Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depression, Anxiety Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Wellbeing Course

Arm Type

Experimental

Arm Description

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.

Arm Title

Waitlist-control

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

The Wellbeing Course

Intervention Description

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 Outcome Measure Information:

Title

Changes in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)

Description

Symptoms of depression

Time Frame

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

Title

Changes in anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7)

Description

Symptoms of anxiety

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

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

Title

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

Description

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

Time Frame