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Improving Access to the Treatment of Anxiety and Depression Among Youth Linguistic Minorities

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03156556
Recruitment Status : Unknown
Verified October 2018 by France Talbot, Universite de Moncton.
Recruitment status was:  Active, not recruiting
First Posted : May 17, 2017
Last Update Posted : October 15, 2018
Sponsor:
Collaborators:
Royal Bank of Canada
MindCare Inc.
Macquarie University, Australia
University of Regina
Information provided by (Responsible Party):
France Talbot, Universite de Moncton

Brief Summary:

Anxiety and depression represent the most common mental health problems. Unfortunately, only a minority of people in need will seek or access traditional mental health services. Access to traditional psychological care is even more challenging for linguistic minorities as well as for people living in rural areas and for young adults - a group that has the highest rate of anxiety and depression but the lowest rate of consulting traditional services.Telepsychotherapy can facilitate access to effective psychological care as done in Australia where the government has been offering an evidence-based 8-week online therapy program called the Wellbeing Course. This online course helps people manage worry, stress, anxiety and depression. It has been evaluated in several clinical trials and successfully implemented as an Australian national treatment service. Its transdiagnostic nature, and the fact that the guidance of a clinician is not required for an efficient and safe administration and maintenance of therapeutic gains make it not only a viable option, but also an easily accessible fist line intervention. More recently, findings from a feasibility study conducted by our research laboratory have supported the efficacy of a French-Canadian translation among French-speaking minorities in New-Brunswick. A version of the Wellbeing Course for young adults has been developed called the Mood Mechanic Course. Empirical support has been obtained.

This study is a feasibility open trial, the first phase of a 3-phase research program designed to implement a French-Canadian translation of the Mood Mechanic Course in New Brunswick targeting groups for which access to traditional services has been most problematic: youth (18 to 25 years old), people living in rural areas and linguistic minorities. The course is an 8-week week program based on principles of cognitive behaviour therapy. It includes five online lessons, do-it-yourself exercises, case stories, and additional resources on different topic such as sleep hygiene. Twenty young adults will be recruited across New Brunswick among French-Canadian minority communities. Self-report measures assessing anxiety and depression will be administered pre/post treatment and at a 3-month follow-up. It is expected that the course will help overcome barriers in help seeking to improve the mental health of our communities.


Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Major Depressive Disorder Social Anxiety Disorder Panic Disorder Agoraphobia Behavioral: Mood Mechanic Course Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: 8-week pretest/post-test open trial including a 3-month follow-up.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Access to the Treatment of Anxiety and Depression Among Linguistic Minorities: A Feasibility Open Trial of Internet-Delivered Transdiagnostic Cognitive Behaviour Therapy Amongst French Canadians Young Adults
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : October 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Mood Mechanic

The Mood Mechanic Course is comprised of five online lessons completed over an 8-week period.

  • Lesson 1 presents information on anxiety and depression as well as on the cycle of symptoms.
  • Lesson 2 presents different strategies to generate helpful cognitions.
  • Lesson 3 describes strategies for physical de-arousal and for re-engaging in reinforcing activities.
  • Lesson 4 describes avoidance and safety behaviors and graded exposure.
  • Lesson 5 is about problem solving and relapse prevention.

For each lesson, a "Do It Yourself" guide is included containing homework as well as case stories. Additional material on different topics is also included such as structured problem solving.

Behavioral: Mood Mechanic Course
French-Canadian version of the Mood Mechanic Course. Performed by a professional translator (Bourret Translation Inc.) and reviewed by the research supervisor, Professor France Talbot, clinical psychologist as well with expertise in CBT.
Other Name: Cours Mécanique de l'Humeur (French-Canadian translation)




Primary Outcome Measures :
  1. Changes in depression as assessed with the Patient Health Questionnaire-9 items [ Time Frame: Pre-test (Week 1), Post-test (Week 8) and 3-month follow-up ]
    French version: 9 items assessing symptoms of major depressive disorder on a scale from 0 (Not at all) to 3 (Nearly every day).

  2. Changes in anxiety as assessed with the Generalized Anxiety Disorder Scale 7-Item Scale [ Time Frame: Pre-test (Week 1), Post-test (Week 8) and 3 month follow-up ]
    French version: 7 items assessing symptoms of generalized anxiety disorder on a scale from 0 (Not at all) to 3 (Nearly every day).


Secondary Outcome Measures :
  1. Changes in anxiety as assessed with the Panic and Agoraphobia Scale (PAS) [ Time Frame: Pre-test (Week 1), Post-test (Week 8) and 3 month follow-up ]
    French version: 14 items assessing symptoms of panic attacks, panic disorder and agoraphobia.

  2. Changes in anxiety as assessed with the Social Phobia Inventory (SPIN) [ Time Frame: Pre-test (Week 1), Post-test (Week 8) and 3 month follow-up ]
    French version: 17 items assessing symptoms of social anxiety disorder on a scale from 0 (Not at all) to 4 (Extremely).

  3. Changes in resilience as assessed with the Connor-Davidson Resilience Scale [ Time Frame: Pre-test (Week 1), Post-test (Week 8) and 3 month follow-up ]
    French version: 25 items assessing psychological resilience on a scale from 0 (Not at all true) to 4 (True nearly all the time).

  4. Changes in life satisfaction as assessed with the Life Satisfaction Questionnaire [ Time Frame: Pre-test (Week 1), Post-test (Week 8) and 3 month follow-up ]
    French version: 5 items assessing life satisfaction using a scale from 1 (Strongly disagree) to 7 (Strongly agree).

  5. Treatment acceptability [ Time Frame: Post-test (Week 8) ]
    Four questions: (1) 'Overall, how satisfied were you with the Course?', (2) 'How satisfied were you with the Lessons and Lesson Summaries?', (3) 'Would you feel confident in recommending this treatment to a friend?', and (4) 'Was it worth your time doing the Course?' These questions have been used in previous research examining the acceptability of iCBT (e.g., Titov et al., 2013). For the purposes of revising and improving the program for future studies among Francophone minority communities, participants will also be asked to provide feedback about the program over the phone at post-treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Resident of New Brunswick;
  • 18 to 25 years of age;
  • French as their native language;
  • Good comprehension of written French;
  • Reliable access to the Internet;
  • Clinical levels of depression, generalized anxiety disorder, panic disorder or social anxiety disorder, as indicated by the total score of at least one of the following measures: QSP-9 ≥ 5; GAD-7 ≥ 5, PAS ≥ 19, SPIN ≥ 19;
  • Not currently following another cognitive-behavioral therapy (CBT);
  • No change of medication at least one month prior to the study and no change expected over the next two months;
  • In agreement to share relevant personal information.

Exclusion Criteria:

  • Severe depression or suicide intent or plan (score ≥ 23 or a score > 2 on item 9 (suicidal ideation) of PHQ-9;
  • Currently experiencing psychotic symptoms.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03156556


Locations
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Canada, New Brunswick
Université de Moncton
Moncton, New Brunswick, Canada, E1A 3E9
Sponsors and Collaborators
Universite de Moncton
Royal Bank of Canada
MindCare Inc.
Macquarie University, Australia
University of Regina
Investigators
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Principal Investigator: Josée LeBlanc, B.A. Université de Moncton
Study Director: France Talbot, Ph.D. Université de Moncton
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Responsible Party: France Talbot, Associate professor, Universite de Moncton
ClinicalTrials.gov Identifier: NCT03156556    
Other Study ID Numbers: 1617070
First Posted: May 17, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease
Anxiety Disorders
Depressive Disorder
Depressive Disorder, Major
Panic Disorder
Phobia, Social
Agoraphobia
Pathologic Processes
Mental Disorders
Mood Disorders
Phobic Disorders