Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02943876 |
| Other study ID # |
10015082 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2017 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
May 2021 |
| Source |
University of Calgary |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Major depressive episode (MDE) is one of the most prevalent and disabling form of mental
illness in the general population. Despite increased mental health services and
antidepressants use in the past 10 years, there has been no measurable change in the
prevalence of MDE in the Canadian general population, which motivates the search for
additional strategies for reducing the burden of MDE. One strategy that has been successful
in the fields of oncology, cardiology and diabetes is early identification and prevention -
identifying people who are at high risk and taking preventive actions to lower the risk so as
to prevent symptoms from progressing into a MDE. As multivariable risk prediction algorithms
are used to estimate an individual's risk (probability) of future disease, they can play an
important role in the process of early identification. The proposed study stems from a
project funded by an operating grant from the Canadian Institutes of Health Research (CIHR).
With the CIHR support, the team developed and validated sex-specific prediction algorithms
for MDE. As risk prediction is at very early stage in psychiatry and MDE is still highly
stigmatized, to facilitate the future implementation of the developed risk prediction
algorithms, the proposed study seeks to answer the following research questions: (1) Does
disclosure of personalized depression risk information promote high-risk individuals to take
preventive actions? (2) Will disclosure of personalized depression risk information
negatively affect high-risk people's mental health status in terms of increased psychological
distress? To answer the questions, the investigators planned to conduct a randomized
controlled trial (RCT) with an embedded qualitative component. The proposed study will
develop an evidence base for guiding the disclosure of personalized risk information and
understanding the process of risk communication and consumer empowerment, contributing to the
advancement of early prevention of MDE in Canada.
Description:
Rationale: The proposed study stems from a CIHR project and is driven by the results of
knowledge translation (KT) activities. The investigators developed the first sex-specific
risk prediction models for major depressive episode (MDE) using data from over 10,000
Canadians. The models include age, personal and family history of MDE, childhood trauma, and
predictors that may change over time. Using the models, individuals can answer the question:
what is my risk of having a MDE in the next 4 years? Knowing this personalized risk
information may assist health professionals in communicating with patients and planning
preventive actions; disclosing the information may also empower consumers to actively engage
in self-help. In the past 5 years, the KT activities with over 500 stakeholders informed that
the investigators need to clearly delineate the benefits (enhanced risk perceptions and
self-help) and potential risk (increased psychological distress and impaired function) of
disclosing the information before implementing the tools.
The goal of this study is to produce evidence about the benefits and potential risks
associated with risk disclosure (i.e., the expected outputs). The primary objectives are to
compare those who do and do not receive personalized depression risk information in (1)
accuracy of risk perceptions, the use of self-help strategies, and (2) changes in
psychological distress and functional measures over one year among those who are at high risk
of MDE. The secondary objective is to examine the differential impacts of the disclosure on
the outcomes by demographics and levels of baseline risk. To achieve these objectives, the
investigators propose a 3-year randomized controlled trial (RCT) with an embedded qualitative
component.
The proposed study will be a RCT with an embedded qualitative component. The RCT will have
one interventional arm (receiving personalized depression risk information) and one control
arm. The personalized depression risk will be generated using the sex-specific prediction
algorithms for MDE that we developed in Canadians aged 18+ years old. Because the prediction
algorithms are sex-specific, the investigators propose to recruit 350 men and 350 women at
baseline. After baseline assessment for eligibility, participants will be randomized into
intervention and control groups, in men and women separately. To obtain in-depth information
about how the personalized depression risk information is processed by participants and how
the information affects them emotionally, the research team will conduct qualitative
interviews 1 month after the personalized risk information is disclosed. To understand how
the personalized risk information affect participants' health behaviors, the investigators
will conduct another round of qualitative interviews at 12-month.
Recruitment: The target population of future preventive studies are high risk individuals in
the general population, who reside in different regions across the country. For the proposed
study, a feasible approach for recruiting eligible participants is the random digit dialing
method (RDD). In the past 10 years, we have used the RDD for recruitment in CIHR-funded
longitudinal studies and an ongoing national RCT funded by the Movember Foundation.
Recruitment, screening and baseline assessment will be done by a telephone interview firm
identified through a competitive bidding process.
A random sample of land line and cell phone numbers will be selected. When a household is
reached, the person who is 18+ years will be assessed for eligibility. If a household has 2+
persons aged 18+ years, one will be randomly selected. The interviewers will explain the
study objectives and procedures and answer questions. Potential participants will be ensured
about confidentiality, that participation is voluntary and that they may withdraw at any
time. Oral consent will be obtained before assessment of eligibility. Outcome measures will
be assessed at baseline, 6 and 12-month.
Baseline Assessment and Randomization Screening: Once a potentially eligible participant is
identified, the interviewer will confirm the participant's age and administer the World
Health Organization's Composite International Diagnostic Interview - Short Form for Major
Depression (CIDI-SFMD) and the sex-specific prediction algorithms. Interviewees who are in a
MDE or are below the risk thresholds based on the risk calculators, will be excluded.
Individuals with MDE will be encouraged to contact family doctors and information about local
mental health resources will be provided. For those who are at low risk, the web site of the
sex-specific risk prediction algorithms (www.predictingdepression.com) will be provided so
they may monitor their risk in the future.
Baseline assessment: In eligible participants, the interviewer will administer the
Non-specific Psychological Distress Scale (K10), Self-help Strategy Use Scale (SSUS), and ask
questions about absenteeism and perceived risk of MDE. Our pilot study showed that the
screening and baseline assessment take 20 to 25 minutes.
Randomization will be carried out in men and in women separately. Eligible participants who
complete the baseline telephone interview will be randomized into intervention and control
groups. The randomization will be conducted and managed by the project coordinator affiliated
with the project. 350 random numbers (between 0 and 1) will first be generated for men and
women separately using Excel ("RAND()") for 350 study identification numbers (ID), ranging
from 1 to 350. The 350 random numbers will then be sorted at the descending order and
categorized into 2 equal groups:
- the ID numbers in the first group (n = 175) will be allocated to the control group
- the ID numbers in the second group (n = 175) will be allocated to the intervention group
Intervention and Control: For the participants in the intervention group, the personalized
risk will be disclosed and the interviewer will inform them that they will be contacted again
at 6 months and 12 months. The interest in receiving such personalized depression information
has been confirmed by our recent pilot study using the same sampling method. The team's pilot
data (n = 200) showed that 100% of high-risk individuals were interested in knowing their
risks. Participants in the intervention group will also be informed that some may be
contacted in one month for a 30-minute qualitative interview. A package including the
following materials will be mailed to intervention participants: (1) thank-you letter, (2) a
website containing general information about MDE, and self-help strategies. (3) $20 incentive
as appreciation of their participation. For participants in the control group, the project
coordinator will inform them that they will be contacted again at 6 and 12 months. Their
personal risks will be provided at the 12-month interview. The control group participants
will receive the same package as those in the intervention group.
Blinding and follow-up assessments: The telephone interviewers will securely transfer
encrypted baseline data to the PI on a bi-weekly basis. The group assignment data will be
transferred in a separate file. The follow-up assessments will be conducted at the telephone
interview laboratory at the Mathison Mental Health Research & Education Center. One month
before the scheduled follow-up interviews, letters will be sent to participants to remind
them of the upcoming interview. After the 12-month interview, participants' group status will
be linked with interview data by study ID numbers.
Over the study period, investigators will be blinded to participants' group status. The
interviewers who conduct randomization, will not be involved in follow-up interviews. The
interviewers who conduct the follow-up interviews in Calgary will not have access to
participants' group status. Given the description of study objectives, participants may know
their group status. Therefore, it is possible that some participants in the control group may
try to find more information about personalized depression risk. At the follow-up
assessments, the research staff will ask if they have used any risk prediction tools over the
study period. At the follow-up assessments, if participants develop a MDE, they will be
encouraged to contact family doctors and information about local mental health resources will
be provided.
Qualitative Interviews: To obtain in-depth information about how disclosing personalized
depression risk affects participants' decision processes, mental health and health behaviors,
the investigators will conduct two rounds of qualitative interviews via telephone, 1 month
after these participants receive the personalized depression risk and at 12 months. Each will
include a initial random sub-sample of 20 men and 20 women from the intervention group. The
qualitative interviews strengthen this study as the researchers will use the findings to
"triangulate" our quantitative results and to guide interpretation of the quantitative
results. The interviews will be audio recorded. Qualitative interviews will be transcribed
verbatim then analyzed inductively for themes. As per Berg themes will be chosen to "reflect
all relevant aspects of the messages." The analysis will follow the interpretive practices of
constant comparison and attempt to uncover patterns both within and between interviews. Nvivo
10 software will be used to support thematic analysis. It is expected to achieve theoretical
saturation with the initial sample. However, if new themes continue to emerge in final
interviews, more interviews will be conducted until no new themes emerge.
Risk and mitigation: The investigators acknowledge concerns about the changes in response
rates in telephone surveys due to cell phone use and telemarketing. Including eligible
participants across the country will enhance the generalizability of the study. Given the
vast geographic area of Canada, RDD is the only feasible method. The goal of this study is to
recruit participants for a RCT, rather than selecting a representative sample. In a RCT,
selection bias is not a serious concern as long as the bias is the same across the
intervention and control groups. To mitigate the risk, the interviewers will also access the
validated cellphone database. However the use of cellphone numbers is associated with
increased costs. Another potential risk of the proposed study is attrition which may incur
selection bias. The population-based cohort studies on mental disorders in the workplace,
conducted in our lab, showed that we could achieve 77% response rate at one year follow-up
without any financial incentives. The strategies for reducing attrition will include
appropriately designed introductory scripts, a minimum of nine call back attempts spaced over
weekdays and times of day and provision of $20 incentive for each completed interview.
Finally, those deemed low risk but who go on to develop MDE will be excluded from the RCT at
the screening stage, which is a limitation. the investigators have planned to provide the
risk prediction algorithms so that they can monitor their risks in the future.
