Trial document




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  DRKS00009323

Trial Description

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Title

Efficacy of an internet-based self-management intervention for adult primary care patients with mild and moderate depression or dysthymia

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Trial Acronym

Get.Started!

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URL of the Trial

http://www.deutsche-depressionshilfe.de/stiftung/11098.php

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Brief Summary in Lay Language

The goal of the present study „Get.Started!“ is to evaluate the efficiency and acceptance of a six week, internet-based self-management tool for patients with mild or moderate depression or dysthymia. The program consists of 6 workshops which are based on cognitive behavioral therapy. In each workshop participants will be provided information materials and worksheets. The topics of the modules are for example: “Thinking, feeling and doing”, “Planning and doing things that you enjoy”, “Getting things done”.
The effect on depressive symptoms of the online tool will be compared to a progressive muscle relaxation training (PMR, Ericson). This will also be self-administered. Aim of this relaxation technique is the gradual learning of tension and relaxation of certain muscle groups. The process of the PMR is characterized by easy learning and easily imparting plausibility for the patients. For six weeks the participants will receive a weekly instruction and an audio file to practice at home.
During the study, mood and other symptoms will be monitored with online ratings and in telephone interviews. To detect long-term effects there will be questionnaires again after three, six and twelve months.

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Brief Summary in Scientific Language

The project GET.STARTED focusses on evaluating the efficiency of a guided online self-management tool “IfightDepression” (IFD) in comparison to a self-administered training of progressive muscle relaxation in treating patients with mild to moderate depression. It is a 2-arm, randomized, controlled clinical trial using changes in the IDS score as primary outcome.
After they completed a screening process the participant will be randomly assigned to one of the two interventions: the IFD tool or a self-administered training in progressive muscle relaxation.
The guided IFD self-management tool, developed, evidence-based, and internationally consented within the EU-funded project Predi-Nu, is based on elements of CBT and includes six core modules (e.g., “Thinking, feeling and doing”, “Planning and doing things that you enjoy”, “Getting things done”). Each module consists of information, worksheets, exercises and mood ratings. Patients will be asked to use the tool for six weeks and necessary guidance and instruction will be provided by mental health professionals (e.g. psychiatrists, psychologists) from the study center.
In the present study progressive muscle relaxation (PMR) is used as the control condition. Participants in this group will receive a download link for one lesson per week. For six weeks they will be encouraged to practice PMR and learn how to deliberately induce physical relaxation to reduce stress and psychological tension.
IDS-SR scores as well as PHQ, ZUF-8, SF-12 and an adapted version of the INEP scale are assessed at several time points during the intervention and three, six and twelve month afterwards.

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Organizational Data

  •   DRKS00009323
  •   2016/02/25
  •   [---]*
  •   yes
  •   Approved
  •   080-15-09032015, Ethikkommission an der Medizinischen Fakultät der Universität Leipzig
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Secondary IDs

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Health Condition or Problem studied

  •   F32.0 -  Mild depressive episode
  •   F32.1 -  Moderate depressive episode
  •   F33.0 -  Recurrent depressive disorder, current episode mild
  •   F33.1 -  Recurrent depressive disorder, current episode moderate
  •   F34.1 -  Dysthymia
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Interventions/Observational Groups

  •   6 weeks of CBT based self-management training with the online Tool "IfightDepression". Each week the participant will work on one of the following topics: "thinking, feeling and doing", "sleep and depression", "planning and doing enjoyable things", "getting things done", "identifying negative thoughts" and "changing negative thoughts". Each workshop consists of information material and a worksheet to transfer the exercise into everyday life. Guidance will be provided via telephone through the study assistant.
  •   6 weeks of self-administered muscle relaxation training, information and audio-file will be provided weekly, guidance is provided via telefone through the study assistant
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary outcome of the study is the reduction of depressive symptoms in the treatment group compared to the control condition as measured by the IDS-SR-score after the 6 week Intervention.

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Secondary Outcome

Secondary outcomes are changes in depressive sympotms over the course of the intervention (PHQ-9, IDS, CGI), the acceptance and feasibility (ZUF-8) of the "ifightDepressoin" tool and other training effects such as changes in perceived quality of life (SF-12). We also plan to look at possible adverse effects (INEP) and moderating variables e.g. gender.
Measurement:
before the beginning of the intervention (T0: IDS, PHQ-9, CGI, SF-12)

weekly during the intervention (PHQ-9, rating of the workshops)

3 weeks after the beginning of the intervention (T1: IDS, CGI, documentation AE/SAE),

at the end of intervention (T2: IDS, PHQ-9, CGI, ZUF-8, SF-12, documentation of AE/SAE),

follow up 3, 6 and 12 Month after the end of the intervention (T3,4 and5: IDS, CGI, ZUF-8, SF-12, documentation of AE/SAE, PHQ-9)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/05/01
  •   250
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

Mild or moderate depression, dysthymia or recurrent depression according to MINI (ICD-10: F32.0; F32.1; F33.0; F33.1; F34.1), 18-75 years of age, outpatient status, sufficient language skills (regarding both speaking and writing) and able to meet the requirements of the study, Internet-access (privately at home or sufficient opportunity to access the internet regularly), written informed consent

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Exclusion Criteria

ICD-10 diagnoses: dementia, alcohol/ drug addiction; schizophrenia; manic episode or bipolar disorder; obsessive-compulsive disorder according to MINI (F0, F1, F2, F30, F31, F42), acute suicidal tendencies, known personality disorder (F60.2, F60.31), Severe somatic disorders requiring immediate treatment, Participation in another clinical trial within the last 4 weeks, known alcohol/ drug abuse within the last 6 months, pregnancy

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Addresses

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Sources of Monetary or Material Support

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    • Stiftung Deutsche Depressionshilfe am Universitätsklinikum Leipzig
    • Semmelweisstr. 10
    • 04103  Leipzig
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/09/02
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Trial Publications, Results and other Documents

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