An interventional study of The Wellbeing Course in Major Depression and Anxiety Disorders, sponsored by Universite de Moncton. Completed at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-05-01.
Sponsored by Universite de Moncton · Not applicable, Interventional, and Treatment
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.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's enrollment of 64 is below the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →Universite de Moncton is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
The Waitlist Control Group will receive the French-Canadian version of the Wellbeing Course once the treatment group will have completed treatment.
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.
Changes in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Symptoms of depression
Time frame: Pretest, posttest (week 8), 3-month follow-up
Changes in anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7)
Symptoms of anxiety
Time frame: Pretest, posttest (week 8), 3-month follow-up
Changes in life satisfaction as assessed by the Satisfaction with Life Scale (SWLS)
Life satisfaction as assessed by the SWLS (Diener et al.,1995)
Time frame: Pretest, posttest (week 8), 3-month follow-up
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)
Time frame: 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
Pathological personality traits as assessed by the Self-administered Standardised Assessment of Personality - Abbreviated Scale (SAPAS)
Time frame: Pretest (week 1), posttest (week 8), 3-month follow-up
Changes in anxiety as assessed by the Penn State Worry Questionnaire (PSWQ)
Symptoms of worry
Time frame: Pretest (week 1), posttest (week 8), 3-month follow-up
Changes in social anxiety as assessed by the Social Phobia Inventory (SPIN)
Symptoms of social anxiety symptoms
Time frame: Pretest (week 1), posttest (week 8), 3-month follow-up
Changes in panic and agoraphobia as assessed by the Panic and Agoraphobia Scale (PAS)
frequency and intensity of panic symptoms
Time frame: Pretest (week 1), posttest (week 8), 3-month follow-up
Plan to share: Undecided — There is currently in place a memorandum of understanding with Macquarie University, our collaborators. This agreement allows for the sharing of data once personally identifiable information has been removed.
No publications or documents are linked to this record.
Ran from Jan 2017 to primary completion in Jan 2018, 12 months.
Of 647 non-industry interventional studies with no phase under Depressive Disorder, Major, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 55. This study's 12 months is below that.
Counting every sponsor, half of 687 studies reached it within 33 months; a quarter within 17 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Universite de Moncton