Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000628044
Ethics application status
Approved
Date submitted
29/07/2010
Date registered
2/08/2010
Date last updated
2/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Web-based Intervention for the Prevention of Depression in Medical Interns
Scientific title
Web-based Cognitive Behavioral Therapy Intervention vs. Attention Control for the Prevention of Depression in Medical Interns: A Pilot Randomized Controlled Trial (RCT)
Secondary ID [1] 252342 0
N/A
Universal Trial Number (UTN)
U1111-1116-3100
Trial acronym
N/A
Linked study record

Health condition
Health condition(s) or problem(s) studied:
depression 257840 0
Condition category
Condition code
Mental Health 258006 258006 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Web-based self help Cognitive Behavioral Therapy (CBT) program- includes 4 modules. Participants complete 1 module per week prior to intern year, then revisit the web-site at 4 time points during intern year. Modules provide education about CBT and CBT tools to employ for the prevention of depression
Intervention code [1] 256900 0
Behaviour
Intervention code [2] 256914 0
Prevention
Intervention code [3] 256915 0
Other interventions
Comparator / control treatment
Participants assigned to the attention control group will receive an email from investigators at the same 5 contact points as the intervention group. Email will contain information about depression and places to receive mental health treatment.
Control group
Active

Outcomes
Primary outcome [1] 258867 0
The self-report 9-item patient health questionnaire will be used to assess depressive symptoms pre-internship and at 3, 6, 9 and12 months of intern year.
Timepoint [1] 258867 0
3, 6, 9 and 12 months of intern year
Secondary outcome [1] 264992 0
Perceived medical errors will be assessed by 6 questions as described Fahrenkopf, 2008; West, 2006; West, 2009; Sen, 2010) at 3, 6, 9 and 12 months of intern year.
Timepoint [1] 264992 0
3, 6, 9 and 12 months of intern year

Eligibility
Key inclusion criteria
Graduating 4th year medical student, starting internship.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Non-interns

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
subjects were sent an email briefly describing the study. If interested, they clicked on a link within the study which brought them to the informed consent. If he/she consented, they were then linked to an online battery of questionnaires. All consenting subjects who completed the questionnaires were then randomly assigned by investigators to the intervention or experimental condition. Allocation was not concealed from investigators or participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 2793 0
United States of America
State/province [1] 2793 0
CT

Funding & Sponsors
Funding source category [1] 257357 0
Charities/Societies/Foundations
Name [1] 257357 0
Donaghue Foundation
Country [1] 257357 0
United States of America
Primary sponsor type
University
Name
Yale University
Address
20 York St
New Haven, CT
06520
Country
United States of America
Secondary sponsor category [1] 256597 0
University
Name [1] 256597 0
National Australian University
Address [1] 256597 0
Centre for Mental Health Research, Building 63
National Australian University
Canberra ACT 0200
Australia
Country [1] 256597 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259377 0
Yale University Human Investigations Committee
Ethics committee address [1] 259377 0
20 York St
New Haven, CT
06520
Ethics committee country [1] 259377 0
United States of America
Date submitted for ethics approval [1] 259377 0
Approval date [1] 259377 0
18/10/2008
Ethics approval number [1] 259377 0
0609001871

Summary
Brief summary
The point prevalence of depression among medical trainees increases from 4% pre-internship to 26% during the intern year and very few physicians seek mental health treatment due to barriers-to-care unique to this population (Sen, 2010; Guille, 2010). The purpose of the study is to overcome key obstacles to care with an intervention aimed at reducing the high incidence of depression among medical interns. We hypothesize that interns randomly assigned to the intervention will be less likely, compared to those not assigned to the intervention, to become depressed over the course of intern year.
Trial website
N/A
Trial related presentations / publications
Guille C, Speller H, Christensen H, Sen S. A Randomized Controlled Trial to Preliminarily Evaluate a Generic CBT-Oriented Web-based Intervention for the Prevention of Depression in Medical Interns. Oral and poster presentation at the colloquium for junior investigators at the American Psychiatric Association annual meeting (2010).
Public notes

Contacts
Principal investigator
Name 31447 0
Address 31447 0
Country 31447 0
Phone 31447 0
Fax 31447 0
Email 31447 0
Contact person for public queries
Name 14694 0
Constance Guille
Address 14694 0
Medical University of South Carolina
Dept of Psychiatry
67 President St
Charleston, SC
29425
Country 14694 0
United States of America
Phone 14694 0
1-843-792-6190
Fax 14694 0
Email 14694 0
[email protected]
Contact person for scientific queries
Name 5622 0
Constance Guille
Address 5622 0
Medical University of South Carolina
Dept of Psychiatry
67 President St
Charleston, SC
29425
Country 5622 0
United States of America
Phone 5622 0
1-843-792-6190
Fax 5622 0
Email 5622 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseWeb-based cognitive behavioral therapy intervention for the prevention of suicidal ideation in medical interns a randomized clinical trial.2015https://dx.doi.org/10.1001/jamapsychiatry.2015.1880
N.B. These documents automatically identified may not have been verified by the study sponsor.