Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-02-25 @ 9:00 PM
Study NCT ID:
NCT01399502
Status:
COMPLETED
Last Update Posted:
2013-12-11
First Post:
2011-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Promotion of Self-help Strategies for Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1736}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-09', 'studyFirstSubmitDate': '2011-07-19', 'studyFirstSubmitQcDate': '2011-07-20', 'lastUpdatePostDateStruct': {'date': '2013-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression symptom score on PHQ-9 at post-intervention', 'timeFrame': '6-weeks post baseline'}, {'measure': 'Depression symptom score on PHQ-9 at 6-month follow-up', 'timeFrame': '6-months post end-of-intervention'}], 'secondaryOutcomes': [{'measure': 'Psychological distress on K10 at post-intervention', 'timeFrame': '6-weeks post baseline'}, {'measure': 'Psychological functioning on Work and Social Adjustment Scale at post-intervention', 'timeFrame': '6-weeks post baseline'}, {'measure': 'Psychological functioning on Work and Social Adjustment Scale at 6-month follow-up', 'timeFrame': '6-months post end-of-intervention'}, {'measure': 'Psychological distress on K10 at 6-month follow-up', 'timeFrame': '6-months post end-of-intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Depression', 'Self Care'], 'conditions': ['Depressive Disorder', 'Depression']}, 'referencesModule': {'references': [{'pmid': '23805231', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Access to the internet at least once per week\n* Resident of Australia, New Zealand, Canada, Ireland, United Kingdom, USA\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT01399502', 'briefTitle': 'Promotion of Self-help Strategies for Depression', 'organization': {'class': 'OTHER', 'fullName': 'Orygen'}, 'orgStudyIdInfo': {'id': '0931313'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Self-help advice', 'description': '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.', 'interventionNames': ['Behavioral: Mood Memo emails']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Depression information', 'description': 'Each email will contain different information about depression, such as symptoms, risk factors, prevalence.', 'interventionNames': ['Behavioral: Mood Memo emails']}], 'interventions': [{'name': 'Mood Memo emails', 'type': 'BEHAVIORAL', 'description': 'Participants will receive 12 emails over 6 weeks.', 'armGroupLabels': ['Depression information', 'Self-help advice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3052', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Orygen Youth Health Research Centre', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}], 'overallOfficials': [{'name': 'Anthony F Jorm, PhD, DSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orygen Youth Health Research Centre, The University of Melbourne'}, {'name': 'Andrew J Mackinnon, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orygen Youth Health Research Centre, The University of Melbourne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orygen', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Health and Medical Research Council, Australia', 'class': 'OTHER'}, {'name': 'University of Melbourne', 'class': 'OTHER'}, {'name': 'Sidney Myer Fund', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD candidate', 'investigatorFullName': 'Amy Morgan', 'investigatorAffiliation': 'Orygen'}}}}