Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03156556 |
| Other study ID # |
1617070 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 15, 2017 |
| Est. completion date |
January 31, 2018 |
Study information
| Verified date |
May 2022 |
| Source |
Universite de Moncton |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
BACKGROUND. Anxiety and depression are highly prevalent mental health problems and chronic
conditions accounting for the highest proportion of mental disorders in Canada. Young adults
aged 15 to 24 are particularly vulnerable, this age group having the highest prevalence rates
reported during a 12-month period of anxiety (11.6%) and depression (7%) in Canada. Access to
evidence-based psychological treatments for anxiety and depression has been limited and
particularly problematic for linguistic minorities.
RATIONALE FOR PERFORMING THE STUDY. Self-administered internet-based cognitive-behavioural
therapy (iCBT) is a first-line therapy that could better meet the needs of young adults. Not
only could its delivery format provide increased access to French services in both urban and
rural areas, but it could also help young adults to overcome many of the barriers reported by
Canadians with unmet or partially met needs for counselling.
An established iCBT shown to be effective for the treatment of anxiety and depression is the
Wellbeing program developed by Titov and colleagues. The Wellbeing Course presents a number
of advantages. It is a transdiagnostic program that allows the treatment of both anxiety and
depression, which makes it a cost-efficient treatment. More recent evidence suggests that no
direct clinical contact is required for gains to be significant and maintained over a
12-month follow-up. A version of the Wellbeing Course for young adults has been developed
called the Mood Mechanic Course. Data gathered so far support its efficacy.
The majority of iCBT programs are only available in English, despite the fact that their
translation can be a highly cost-effective strategy. More recently, findings from a
feasibility study have supported the efficacy of a French-Canadian translation of the
Wellbeing Course among French-speaking minorities in New-Brunswick.
PRIMARY OBJECTIVES. To examine the feasibility and acceptability of a French-Canadian and
self-guided version of the Mood Mechanic Course on anxiety and depression among young adults.
SECONDARY OBJECTIVES. To assess the impact of the course on more specific symptoms of
anxiety, resilience and life satisfaction.
HYPOTHESES. It is expected that:
- Participants will demonstrate a significant improvement from pre- to post-treatment on
primary outcome measures of anxiety and depression and secondary outcome measures of
life satisfaction.
- These improvements will be maintained during a three-month follow-up.
- Participants will report a high level of satisfaction with the course. No specific
hypothesis is formulated regarding the impact of the Mood Mechanic Course on resilience
as this component of the study is exploratory.
SAMPLE: A sample of 20 young adults will be recruited in among the general population New
Brunswick using advertisements in various media as well as through a secure study website
administered by Accra Solutions Inc (www.etherapies.ca). A sample of 20 to 25 participants
has been recommended for feasibility or pilot studies when the aim is to demonstrate the
efficacy in a single group and when the effect sizes will probably be moderate or large.
INTERVENTION. The Mood Mechanic Course is comprised of 5 online lessons completed over an
8-week period. For each lesson, a "Do It Yourself" guide is included containing homework as
well as case stories and additional material on different topics.
INVESTIGATION PLAN. Young adults interested in the project will apply online through the
website after reading a description of the project and filling out online questionnaires
evaluating the study inclusion and exclusion criteria. A consent form will be sent
electronically to applicants meeting the eligibility criteria. Entering their email address
and clicking "I accept" will be considered as informed consent. A copy of the consent form
will be sent to the participants through an encrypted email account created for the purpose
of the study. Additional measures will be completed online as part of the pretest.
Applicants not meeting the study criteria will be sent an email to thank them for their
interest in the study and will be provided a list of mental health resources. Applicants
showing severe depression or suicidal thoughts will be encouraged to contact their family
physician and will be sent a list of mental health resources as well.
Within one statutory day, candidates meeting the study criteria will receive an email
informing them of their eligibility. Within five statutory days, participants will be
contacted by phone to review the study procedures and to answer any questions that they may
have. They will then be asked to provide contact information (i.e., name and phone number)
and an emergency contact (either their family physician or a family member or friend) to be
used only in the event that their state would significantly deteriorate. The outcome measures
will be administered online through the secure study website using the software Ninja
Forms.The lessons will be accessible through the secure study website using the Moodle
software.
STANDARDIZED EMAILS. No contact with a clinician will be provided, but weekly contact will be
maintained with the participants through standardized emails offering instructions, reminders
and support.
SAFETY STUDY PROCEDURES. We are committed to the participants' safety. Safety measures will
be included at all stages of this study based on Titov's procedures.
Screening and Selection: Just before applying to the study, it will be mentioned on the study
website that this research project does not offer crisis or emergency services. Emergency
contacts will be provided on the website.
During the study: All applicants will be informed (verbally and in writing) about the steps
to take if they were to feel more distressed during the study, including contact details of
the researchers, the importance of contacting their family physician, and contact details of
emergency services. Applicants must also provide an emergency contact, be it their family
physician or a family or friend who we will contact if we are concerned about the immediate
state and safety of the participant (this is explained to the participants verbally, and in
the Consent Form).
All participants' mood and symptoms will be monitored at the beginning of each new lesson
using the Generalized Anxiety Disorder 7 item-scale (GAD-7) and Patient Health
Questionnaire-9 items (PHQ-9). If participants' scores increase by more than 5 points from
the pre-test and if the total score is ≥ 15 on the PHQ-9, they will receive an email
including resources that can be used in case of an emergency. If participants' scores at the
PHQ-9 is ≥ 23 or if they answer "3" on question 9 (suicidal ideation), the research director
will contact them on the same day that the score is received to assess their situation and
provide management. All adverse events will be promptly reported to the ethics committee of
the Université de Moncton.
A list of mental health resources will be offered to all participants who will chose to end
their participation during the study as well as at the end of the study. If participants
withdrawing from the study present, based on their questionnaires, a deterioration of their
state as described above, the same procedure will be followed.
At the 3-month follow-up, participants whose scores on the questionnaires indicate a clinical
level of depression (>15 on the PHQ-9) or anxiety (> 10 on the GAD-7), will receive an email
mentioning that if they wish to discuss their symptoms or other treatment options, we invite
them to communicate with the research coordinator, or to indicate when it would be a good
time for her to contact them. Otherwise we will encourage participants to communicate with
their family physician or the closest mental health center to receive the necessary help, if
it has not already been done. A mental health resource list will also be provided. If the
scores indicate a severe level of depression (≥ 23 on the PHQ-9 or if they answer "3" on
question 9), the same procedure as the one described above if such a situation were to happen
during treatment, will be followed.
STATISTICAL ANALYSIS AND CLINICAL SIGNIFICANCE OF THE RESULTS. Changes in outcomes and
maintenance of therapy gains will be evaluated using one-way repeated measures ANOVAs.
Missing data will be handled using the last observation carried forward (LOCF). Two indices
of clinical improvement will be estimated: remission and recovery rates.
DATA SAFETY. All data collected as part of this research will remain confidential except in
the case of a breach of confidentiality if a participant presented, for example, an immediate
risk of harm. Participants must create a username and password that will be used to complete
the online questionnaires. Standardized emails will be sent to participants from a encrypted
email account created by Accra Solutions Inc. for the purposes of the study. Only the name of
the participants will be included in these emails, to which they will have consented. To
maintain participants' privacy and confidentiality, they will not be able to use a username
that contains identifiable information (e.g., real name, address, city you live in). They
will be asked to create a username of four letter (four first letters of their mother or
father's name) and four numbers (day and month of their birthday). The participants will
generate a password. It will be specified to use a secure one made of 8 characters including
letters, numbers and a special character.Only researchers of the study, the system
administrator and Macquarie University will have access to the data as specified in the
consent form and as specified in the memorandum of understanding with Macquarie University.
STORAGE AND ARCHIVING OF STUDY DOCUMENTS. The consent form and the identification form
including the contact information and password will be printed and kept in a locked filing
cabinet in the office of Professor France Talbot, research director. All electronic data will
be stored in a secure database within https://www.etherapies.ca. A data file will be created
in SPSS for all data and will be stored on a computer in the research director's research
laboratory, the Telepsychotherapy Unit. The names of the participants will not appear in this
file, only their password. As well, a password is required to access the files on this
computer. The data file will be saved on a USB key kept in a locked filing cabinet in the
Telepsychotherapy Unit. The information gathered during the study will be destroyed after 5
years. The data file will be kept seven years following the publication of the results, and
then destroyed.
