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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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24 July 2017 |
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Main ID: |
ISRCTN02446836 |
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Date of registration:
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05/02/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of a supportive German online program for people with depression or adjustment
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Scientific title:
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Effects of a supportive German online program for people with depression or adjustment: a randomized controlled trial |
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Date of first enrolment:
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14/01/2013 |
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Target sample size:
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608 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN02446836 |
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Study type:
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Interventional |
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Study design:
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Prospective randomized controlled longitudinal study (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Germany
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Wulf
Roessler |
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Address:
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Rotenbleicher Weg 67
21335
Lueneburg
Germany |
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Telephone:
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+49 (0)4131 677 7666 |
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Email:
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roessler@dgsp.uzh.ch |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. The target group consists of insurants of the commercial insurance KKH with a principal diagnosis of mood disorders (F32.0, F32.1, F33.0, F33.1 and F34.1) or adjustment disorder (F43.2) at an age between 18 to 65 years, either sex.
2. Current incapacity to work certificate and an Internet access/e-mail account
Exclusion criteria: 1. Presence of severe depression
2. Risk of suicide (dedicated collection of active and passive suicidal tendencies)
3. Missing declaration of consent ("informed consent")
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Mild depressive episode, Moderate depressive episode, Recurrent depressive disorder, current episode mild, Recurrent depressive disorder, current episode moderate, Dysthymia, Adjustment disorders
Mental and Behavioural Disorders
Mild depressive episode
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Intervention(s)
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Intervention: online intervention with 12 weekly training sessions based on the individual needs of the user including video, audio and written information as well as specific assistance to deal with depressive symptoms.
Control: 12-week online-based written information on depression and health. The written information contains texts, instructions and suggestions for a healthy lifestyle.
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Primary Outcome(s)
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Improvement of depressive symptoms or symptoms of adjustment disorder (weekly screening by the PHQ-9; pre-post measurement with two follow-ups by the BDI-II)
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Secondary Outcome(s)
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1. Reduction of sick days (routine data analysis)
2. Positive effects on patient reported outcomes (PROs; including quality of life, self-efficacy, physical and mental stress symptoms measured by EQ-5D, MANSA, ASF, SCL-14)
3. The use of disease-related services covered by the German statutory health insurance (SHI) (e.g. prescriptions, doctor consultations and hospitalization from routine data analysis)
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Secondary ID(s)
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DRKS00004616
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Source(s) of Monetary Support
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Federal state of Lower Saxony (Germany) - The European Regional Development Fund, within the framework of the Innovation-Incubator at Leuphana University Lueneburg
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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