Improving Access to the Treatment of Anxiety and Depression Among Young Adults

NCT03156556 | Completed

• 1 other identifier: 1617070
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder; Major Depressive Disorder; Social Anxiety Disorder; Panic Disorder; Agoraphobia

Outcome Measures

Primary Outcomes (2)

• Changes in depression as assessed with the Patient Health Questionnaire-9 items

  French version: 9 items assessing symptoms of major depressive disorder on a scale from 0 (Not at all) to 3 (Nearly every day).

  Pre-test (Week 1), Post-test (Week 8) and 3-month follow-up

• Changes in anxiety as assessed with the Generalized Anxiety Disorder Scale 7-Item Scale

  French version: 7 items assessing symptoms of generalized anxiety disorder on a scale from 0 (Not at all) to 3 (Nearly every day).

  Pre-test (Week 1), Post-test (Week 8) and 3 month follow-up

Secondary Outcomes (5)

• Changes in anxiety as assessed with the Panic and Agoraphobia Scale (PAS)

  Pre-test (Week 1), Post-test (Week 8) and 3 month follow-up

• Changes in anxiety as assessed with the Social Phobia Inventory (SPIN)

  Pre-test (Week 1), Post-test (Week 8) and 3 month follow-up

• Changes in resilience as assessed with the Connor-Davidson Resilience Scale

  Pre-test (Week 1), Post-test (Week 8) and 3 month follow-up

• Changes in life satisfaction as assessed with the Life Satisfaction Questionnaire

  Pre-test (Week 1), Post-test (Week 8) and 3 month follow-up

• Treatment acceptability

  Post-test (Week 8)

Study Arms (1)

Mood Mechanic

EXPERIMENTAL

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

Interventions

Mood Mechanic Course BEHAVIORAL

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.

Also known as: Cours Mécanique de l'Humeur (French-Canadian translation)

Mood Mechanic

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Resident of New Brunswick;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universite de Moncton: lead
• Royal Bank of Canada: collaborator
• MindCare Inc.: collaborator
• Macquarie University, Australia: collaborator
• University of Regina: collaborator
• Horizon Health Network: collaborator

Study Sites (1)

Université de Moncton

Moncton, New Brunswick, E1A 3E9, Canada

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder; Depressive Disorder, Major; Phobia, Social; Panic Disorder; Agoraphobia

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Depressive Disorder; Mood Disorders; Phobic Disorders

Study Officials

• Josée LeBlanc, B.A.

  Université de Moncton

  PRINCIPAL INVESTIGATOR

• France Talbot, Ph.D.

  Université de Moncton

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 8-week pretest/post-test open trial including a 3-month follow-up.

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 17, 2017
• Study Start: May 15, 2017
• Primary Completion: January 31, 2018
• Study Completion: January 31, 2018
• Last Updated: June 2, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)