Trial document





This trial has been registered retrospectively.
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  DRKS00011536

Trial Description

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Title

PRO*MDD: Effectiveness of outpatient treatment PROgrams for Major Depressive Disorder: Metacognitive Therapy vs. Behavioral Activation

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Major depressive disorder (MDD) is a highly prevalent, often recurrent or chronic, disabling psychiatric disease, which is associated with low quality of live, high treatment costs and impaired psychosocial functioning and participation. Psychotherapy plays a key role in the treatment of MDD. Treatment has been significantly improved by intensive research of psychotherapeutic methods, however there is still room for optimization.
Metacognitive therapy (MCT) is an innovative therapeutic method that has shown high effect in several smaller studies. Behavioral Activation (BA) is an treatment with high scientific evidence. MCT and BA target different psychological mechanism that maintain depression and hardly overlap in the employed treatment techniques. Thus, they appear especially suitable for a comparison in regard to effectiveness and development of treatment methods.
In the planned study these two treatments will be compared for the first time within the routine clinical setting of an outpatient clinic. 128 depressed patients will be included (64 per treatment condition). In both conditions, patients receive one group therapy session and one individual therapy session per week for a maximum of six months. Treatment may stop earlier if patients recover. The primary outcome is the severity of depressive symptoms. Further outcome measures address general psychiatric symptoms, quality of life, comorbidity with other psychiatric disorders as well as psychosocial functioning and participation.
Primary and secondary outcomes will be assessed before the start of treatment, three, six, 12, 18 and 30 months after the start of treatment.

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Brief Summary in Scientific Language

Major depressive disorder (MDD) is a highly prevalent, often recurrent or chronic, disabling psychiatric disease, which is associated with low quality of live, high treatment costs and impaired psychosocial functioning and participation. Psychotherapy plays a key role in the treatment of MDD. Treatment has been significantly improved by intensive research of psychotherapeutic methods, however there is still room for optimization.
Metacognitive therapy (MCT) is an innovative therapeutic method that targets metacognitive processes underlying depression like rumination and threat monitoring. MCT has shown high effect sizes within less than ten treatment sessions in case studies and smaller randomized controlled trials. Behavioral Activation (BA) is an evidence based therapeutic method grounded in the reward deficit theory. MCT and BA target different psychological mechanism that maintain depression and hardly overlap in the employed treatment techniques. Thus, they appear especially suitable for a comparison in regard to effectiveness, development of treatment methods, specific indication (“what works for whom”) and research of treatment process.
The PROMDD trial will be the first randomized controlled trial to examine the effectiveness of MCT and BA within the routine clinical setting of an outpatient clinic. 128 consecutive patients with a severe or moderate depressive episode will be randomly assigned to either MCT or BA (64 per treatment condition). In both conditions, patients receive one group therapy session and one individual therapy session per week for a maximum of six months. Treatment may stop earlier if patients recover. The primary outcome is the severity of depressive symptoms assessed by the Hamilton Rating Scale for Depression (HRSD). Further outcome measures address general, MDD-specific and method-specific process parameters, quality of life, comorbidity with other psychiatric disorders as well as psychosocial functioning and participation.
Primary and secondary outcomes will be assessed before the start of treatment, three, six, 12, 18 (one year follow-up) and 30 months (two year follow-up) after the start of treatment. In addition, selected method-specific process parameters and severity of depression will be collected weekly during treatment.
By means of an explorative data analysis, possible moderator and mediator variables (e.g. psychological change specific for the method used, sex, age, severity of symptoms, course of depression, comorbidity, traumatic experiences during childhood) will be addressed.

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Organizational Data

  •   DRKS00011536
  •   2017/02/13
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  •   yes
  •   Approved
  •   16-176, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
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Secondary IDs

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Health Condition or Problem studied

  •   F33 -  Recurrent depressive disorder
  •   F32 -  Depressive episode
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Interventions/Observational Groups

  •   outpatient Metacognitive therapy -programm (MCT) with one individual and one group session per week for 6 months
  •   outpatient Behavioral Activation-programm (BA) with one individual and one group session per week for 6 months
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

primary outcome: severity of depressive symptoms assessed by the Hamilton Rating Scale for Depression (HRSD) at the end of treatment (6 months assessment)

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Secondary Outcome

Secondary outcomes address general psychopathology (BSI), quality of life (SF-12), psychosocial functioning and participation (WHODAS), course of other psychiatric disorders (SKID I und II), metacognitions, rumination and worying (MDD-S, MCQ-30, RSQ-D) as well as behavioral activation (BADS).Secondary Outcomes will be assessed at baseline as well as 3, 6, 12, 18 and 30months after start of treatment

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/09/27
  •   128
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Primary Diagnosis of MDD according to DSM-IV (SCID-I-Interview)
severity of depression > 16 Punkte in HRSD-Interview.
willingness to participate in the study (informed consent)
willingness to participate over a maximum of 6 months in the study and take part in the therapy session regularly (no plans to move or to have inpatient treatment)

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Exclusion Criteria

lifetime diagnosis of psychotic disorder
lifetime diagnosis of bipolar disorder
IQ below 85
acute sucidality
acute serious substance abuse disorder, that calls for detoxication
Inadequate german language skills

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Addresses

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    • Klinik für Psychiatrie und Psychotherapie, Universität zu Lübeck
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie, Universität zu Lübeck
    • Ms.  Dr. med.  Eva  Faßbinder 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie, Universität zu Lübeck
    • Ms.  Dr. med.  Eva  Faßbinder 
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Psychiatrie und Psychotherapie, Universität zu Lübeck
    • Ratzeburger Allee 160
    • 23538  Lübeck
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.