Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01399502




Registration number
NCT01399502
Ethics application status
Date submitted
19/07/2011
Date registered
21/07/2011
Date last updated
11/12/2013

Titles & IDs
Public title
Promotion of Self-help Strategies for Depression
Scientific title
Secondary ID [1] 0 0
0931313
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressive Disorder 0 0
Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Mood Memo emails

Active comparator: Self-help advice - Each email will contain a self-help strategy for coping with depressive symptoms. The email will contain information about why the strategy will be effective, tips for implementing the strategy and overcoming barriers, and how to set a goal to implement the strategy. Strategies are based on previous research published by the trial co-ordinators.

Placebo comparator: Depression information - Each email will contain different information about depression, such as symptoms, risk factors, prevalence.


BEHAVIORAL: Mood Memo emails
Participants will receive 12 emails over 6 weeks.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Depression symptom score on PHQ-9 at post-intervention
Timepoint [1] 0 0
6-weeks post baseline
Primary outcome [2] 0 0
Depression symptom score on PHQ-9 at 6-month follow-up
Timepoint [2] 0 0
6-months post end-of-intervention
Secondary outcome [1] 0 0
Psychological distress on K10 at post-intervention
Timepoint [1] 0 0
6-weeks post baseline
Secondary outcome [2] 0 0
Psychological functioning on Work and Social Adjustment Scale at post-intervention
Timepoint [2] 0 0
6-weeks post baseline
Secondary outcome [3] 0 0
Psychological functioning on Work and Social Adjustment Scale at 6-month follow-up
Timepoint [3] 0 0
6-months post end-of-intervention
Secondary outcome [4] 0 0
Psychological distress on K10 at 6-month follow-up
Timepoint [4] 0 0
6-months post end-of-intervention

Eligibility
Key inclusion criteria
* Access to the internet at least once per week
* Resident of Australia, New Zealand, Canada, Ireland, United Kingdom, USA
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2012
Sample size
Target
Accrual to date
Final
1736
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Orygen Youth Health Research Centre - Parkville
Recruitment postcode(s) [1] 0 0
3052 - Parkville

Funding & Sponsors
Primary sponsor type
Other
Name
Orygen
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Melbourne
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Sidney Myer Fund
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anthony F Jorm, PhD, DSc
Address 0 0
Orygen Youth Health Research Centre, The University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

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

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01399502