Major DepressionNCT03043833
Internet-Delivered Cognitive Behavior Therapy for Anxiety and Depression Amongst French Canadians
A study testing The Wellbeing Course in people with Major Depression and Anxiety Disorders, run by Universite de Moncton at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Major Depression, Anxiety Disorders
- What is being tested?
- The Wellbeing Course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 18 Jan 2017to 30 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Université de Moncton - Adult Clinical Psychology Laboratory
Moncton, New Brunswick, E1A 3E9
About this study
Official title: Improving Access to Treatment for Anxiety and Depression Among French Canadians Using an Internet-Delivered Cognitive Behavior Therapy: A Randomized Controlled Trial
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.
- Conditions
- Major Depression, Anxiety Disorders
- Being tested
- The Wellbeing Course
- Medical subject headings
- Depressive Disorder, Major, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Wellbeing CourseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Wellbeing Course | Experimental | 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. Receives: Behavioral: The Wellbeing Course |
| Waitlist-control | No intervention | The Waitlist Control Group will receive the French-Canadian version of the Wellbeing Course once the treatment group will have completed treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Symptoms of depression
Measured: Pretest, posttest (week 8), 3-month follow-up
Changes in anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7)
Symptoms of anxiety
Measured: Pretest, posttest (week 8), 3-month follow-up
Secondary outcomes (6)
Changes in life satisfaction as assessed by the Satisfaction with Life Scale (SWLS)
Life satisfaction as assessed by the SWLS (Diener et al.,1995)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Pretest (week 1), posttest (week 8), 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start18 Jan 2017
- Primary completion30 Jan 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universite de Moncton
- Sponsor type
- University, hospital or other
- Collaborators
- Macquarie University, Australia
- Responsible party
- Principal investigator, France Talbot, Universite de Moncton
- Investigators
- France Talbot, Ph.D., Study director, Université de Moncton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043833
- Sponsor's protocol ID
- File 1516-077
- Status last verified
- Apr 2018
- First submitted
- 30 Jan 2017
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Access to Treatment for Anxiety and Depression Among French Canadians Using an Internet-Delivered Cognitive Behavior Therapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03043833
- Acronym / sponsor ID
- File 1516-077
- Conditions
- Major Depression, Anxiety Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Universite de MonctonUniversity, hospital or other
- Collaborators
- Macquarie University, Australia
- Study start
- 18 Jan 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 6 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wellbeing Course | Experimental | Behavioral: The Wellbeing CourseWill 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. |
| Waitlist-control | No intervention | –The Waitlist Control Group will receive the French-Canadian version of the Wellbeing Course once the treatment group will have completed treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Wellbeing CourseThe 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. | Behavioural | Wellbeing Course |
Primary outcome
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
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
6 secondary outcomes
Changes in life satisfaction as assessed by the Satisfaction with Life Scale (SWLS)
Time frame: Pretest, posttest (week 8), 3-month follow-up
Changes in health as assessed by the Short-Form Health Survey
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
Time frame: Pretest (week 1), posttest (week 8), 3-month follow-up
Changes in anxiety as assessed by the Penn State Worry Questionnaire (PSWQ)
Time frame: Pretest (week 1), posttest (week 8), 3-month follow-up
Changes in social anxiety as assessed by the Social Phobia Inventory (SPIN)
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)
Time frame: Pretest (week 1), posttest (week 8), 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
France Talbot, Ph.D. study director
Université de Moncton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Wellbeing Course in people with Major Depression and Anxiety Disorders, run by Universite de Moncton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) (time frame: Pretest, posttest (week 8), 3-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.