Clinical trial NCT03043833: 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
Overall status: COMPLETED
Phase: NA
Conditions: Major Depression
Anxiety Disorders
Lead sponsor: Universite de Moncton
Sponsor class: OTHER
Collaborators: name: Macquarie University, Australia
First posted: 2017-02-06
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Pretest, posttest (week 8), 3-month follow-up
measure: Changes in anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Pretest, posttest (week 8), 3-month follow-up
Secondary outcomes:
measure: Changes in life satisfaction as assessed by the Satisfaction with Life Scale (SWLS)
timeFrame: Pretest, posttest (week 8), 3-month follow-up
measure: Changes in health as assessed by the Short-Form Health Survey
timeFrame: Pretest (week 1), posttest (week 8), 3-month follow-up
measure: Changes in personality as assessed by the Self-administered Standardised Assessment of Personality - Abbreviated Scale
timeFrame: Pretest (week 1), posttest (week 8), 3-month follow-up
measure: Changes in anxiety as assessed by the Penn State Worry Questionnaire (PSWQ)
timeFrame: Pretest (week 1), posttest (week 8), 3-month follow-up
measure: Changes in social anxiety as assessed by the Social Phobia Inventory (SPIN)
timeFrame: Pretest (week 1), posttest (week 8), 3-month follow-up
measure: Changes in panic and agoraphobia as assessed by the Panic and Agoraphobia Scale (PAS)
timeFrame: Pretest (week 1), posttest (week 8), 3-month follow-up
Other outcomes:
Locations:
city: Moncton
country: Canada
facility: Université de Moncton - Adult Clinical Psychology Laboratory
state: New Brunswick
Study officials:
affiliation: Université de Moncton
name: France Talbot, Ph.D.
role: STUDY_DIRECTOR
References: