Depressive DisorderPhase 1/2NCT01399502
Promotion of Self-help Strategies for Depression
A Phase 1/2 study testing Mood Memo emails in people with Depressive Disorder and Depression, run by Orygen at 1 site in Australia.
Trial summary
The purpose of this study is to investigate the effectiveness of health promotion emails for depression. It is hypothesised that emails containing self-help advice will improve depression symptoms more than emails containing information about depression. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depressive Disorder, Depression
- What is being tested?
- Mood Memo emails
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,736 participants
- Where
- 1 siteAustralia
- Study dates
- Nov 2011to Dec 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Access to the internet at least once per week
- Resident of Australia, New Zealand, Canada, Ireland, United Kingdom, USA
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Orygen Youth Health Research Centre
Parkville, Victoria, 3052
About this study
The purpose of this study is to investigate the effectiveness of health promotion emails for depression. It is hypothesised that emails containing self-help advice will improve depression symptoms more than emails containing information about depression.
Read the detailed description
Depression symptoms are commonly experienced and disrupt day-to-day life. Increasing depression literacy and the use of effective self-help methods could improve depression across the community. The internet is an ideal promotional medium for health messages, because it is often used to search for information about mental health issues, and health messages can be widely disseminated at little cost. An email campaign could be a low-cost approach to improving self-help behavior and knowledge about depression in adults with depression symptoms.
- Conditions
- Depressive Disorder, Depression
- Being tested
- Mood Memo emails
- Keywords
- Depression, Self Care
- Medical subject headings
- Depressive Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mood Memo emailsBehavioural
Participants will receive 12 emails over 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Self-help advice | Active comparator | 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. Receives: Behavioral: Mood Memo emails |
| Depression information | Placebo comparator | Each email will contain different information about depression, such as symptoms, risk factors, prevalence. Receives: Behavioral: Mood Memo emails |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptom score on PHQ-9 at post-intervention
Measured: 6-weeks post baseline
Depression symptom score on PHQ-9 at 6-month follow-up
Measured: 6-months post end-of-intervention
Secondary outcomes (4)
Psychological distress on K10 at post-intervention
Measured: 6-weeks post baseline
Psychological functioning on Work and Social Adjustment Scale at post-intervention
Measured: 6-weeks post baseline
Psychological functioning on Work and Social Adjustment Scale at 6-month follow-up
Measured: 6-months post end-of-intervention
Psychological distress on K10 at 6-month follow-up
Measured: 6-months post end-of-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,736 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orygen
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, University of Melbourne, Sidney Myer Fund
- Responsible party
- Principal investigator, Amy Morgan, Orygen
- Investigators
- Anthony F Jorm, PhD, DSc, Principal investigator, Orygen Youth Health Research Centre, The University of MelbourneAndrew J Mackinnon, PhD, Principal investigator, Orygen Youth Health Research Centre, The University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399502
- Sponsor's protocol ID
- 0931313
- Status last verified
- Dec 2013
- First submitted
- 19 Jul 2011
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Morgan AJ, Jorm AF, Mackinnon AJ. Self-Help for Depression via E-mail: A Randomised Controlled Trial of Effects on Depression and Self-Help Behaviour. PLoS One. 2013 Jun 21;8(6):e66537. doi: 10.1371/journal.pone.0066537. Print 2013.
PubMed 23805231
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promotion of Self-help Strategies for Depression
- ClinicalTrials.gov ID
- NCT01399502
- Acronym / sponsor ID
- 0931313
- Conditions
- Depressive Disorder, Depression
- Keywords
- Depression, Self Care
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,736 participants (actual)
- Lead sponsor
- OrygenUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia, University of Melbourne, Sidney Myer Fund
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effectiveness of health promotion emails for depression. It is hypothesised that emails containing self-help advice will improve depression symptoms more than emails containing information about depression.
Detailed description
Depression symptoms are commonly experienced and disrupt day-to-day life. Increasing depression literacy and the use of effective self-help methods could improve depression across the community. The internet is an ideal promotional medium for health messages, because it is often used to search for information about mental health issues, and health messages can be widely disseminated at little cost. An email campaign could be a low-cost approach to improving self-help behavior and knowledge about depression in adults with depression symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-help advice | Active comparator | Behavioral: Mood Memo emailsEach 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. |
| Depression information | Placebo comparator | Behavioral: Mood Memo emailsEach email will contain different information about depression, such as symptoms, risk factors, prevalence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Access to the internet at least once per week
- Resident of Australia, New Zealand, Canada, Ireland, United Kingdom, USA
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mood Memo emailsParticipants will receive 12 emails over 6 weeks. | Behavioural | Depression information, Self-help advice |
Primary outcome
Depression symptom score on PHQ-9 at post-intervention
Time frame: 6-weeks post baseline
Depression symptom score on PHQ-9 at 6-month follow-up
Time frame: 6-months post end-of-intervention
4 secondary outcomes
Psychological distress on K10 at post-intervention
Time frame: 6-weeks post baseline
Psychological functioning on Work and Social Adjustment Scale at post-intervention
Time frame: 6-weeks post baseline
Psychological functioning on Work and Social Adjustment Scale at 6-month follow-up
Time frame: 6-months post end-of-intervention
Psychological distress on K10 at 6-month follow-up
Time frame: 6-months post end-of-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
- Derived from this study: PubMed 23805231Morgan AJ, Jorm AF, Mackinnon AJ. Self-Help for Depression via E-mail: A Randomised Controlled Trial of Effects on Depression and Self-Help Behaviour. PLoS One. 2013 Jun 21;8(6):e66537. doi: 10.1371/journal.pone.0066537. Print 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony F Jorm, PhD, DSc principal investigator
Orygen Youth Health Research Centre, The University of Melbourne
Andrew J Mackinnon, PhD principal investigator
Orygen Youth Health Research Centre, The University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mood Memo emails in people with Depressive Disorder and Depression, run by Orygen at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression symptom score on PHQ-9 at post-intervention (time frame: 6-weeks post baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01399502, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013.