Trial document





This trial has been registered retrospectively.
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  DRKS00011700

Trial Description

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Title

Effectiveness of Acceptance and Commitment Therapy compared to Cognitive Behavioral Therapy in an inpatient setting

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

In this study the effectiveness of a relatively new psychotherapeutic approach compared to established psychotherapeutic treatments is investigated under natural conditions. Therefore inpatients of a psychiatric ward for depressive disorders and other mental diseases are investigated at admission, discharge and 6 months after discharge with the help of a structured interview as well as questionnaires. Patients coming from the emergency ward, waiting list or from another ward will be admitted on our ward, informed by the head of department and after consent distributed into each of the groups by chance, i.e. by capacity. During their stay patients will attend to either therapeutic approach (Acceptance and Commitment therapy, Cognitive Behavior Therapy, respectively) as well as other treatments such as occupational therapy twice a week. All group therapy sessions will be audiotaped to investigate the sessions at the end of the study. All patients will be informed due to the consent form. The study aims the following goals: 1. Investigate the effectiveness of Acceptance and Commitment Therapy (ACT) compared to Cognitive Behavioral Therapy (CBT). 2. Find out, for which group of patients ACT and for which group of patients CBT lead to higher outcomes. 3. Empirical investigation of the theoretical therapeutic model and possible correlations with primary outcome measures. 4. Development of a rating form for treatment integrity of ACT and CBT.
We expect ACT and CBT to lead to an improvement for all diseases to the same extent. We assume patients with more than one mental disease to benefit more from ACT than from CBT; also we believe that patients with a lower life satisfaction and lower values in ACT-specific variables (e.g. mindfulness) to benefit more from ACT. We expect ACT-specific variables to be associated with an improvement in disorder specific variables (e.g. depression) and that all ACT patients will improve in ACT-specific variables (e.g. mindfulness).

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Brief Summary in Scientific Language

Acceptance and Commitment Therapy (ACT) is a relatively new psychotherapeutic approach, which has been proved to be an effective treatment. This study aims 3 main goals:
1. Investigate the effectiveness of ACTcompared to Cognitive Behavioral Therapy (CBT).
2. Find out, for which group of patients ACT and for which group of patients CBT lead to higher outcomes.
3. Empirical investigation of the theoretical therapeutic model and possible correlations with primary outcome measures.
4. Development of a rating form for treatment integrity of ACT and CBT.
Therefore psychiatric inpatients of a ward for mood disorders and comorbid diseases are investigated pre, post and 6 months follow-up with the help of SCID-I Interview and a few disorderspecific and ACT-specific (e.g. Mindfulness) measurements.

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Organizational Data

  •   DRKS00011700
  •   2017/07/10
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  •   yes
  •   Approved
  •   2015-16, Ethikkommission der Humboldt-Universität zu Berlin Lebenswissenschaftliche Fakultät Leitung: Prof. Rasha Abdel Rahman
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Secondary IDs

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Health Condition or Problem studied

  •   F30-F39 -  Mood [affective] disorders
  •   F10-F19 -  Mental and behavioural disorders due to psychoactive substance use
  •   F40-F48 -  Neurotic, stress-related and somatoform disorders
  •   F50-F59 -  Behavioural syndromes associated with physiological disturbances and physical factors
  •   F60-F69 -  Disorders of adult personality and behaviour
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Interventions/Observational Groups

  •   Acceptance and Commitment Therapy group sessions. Twice a week. At pre, post and 6 months follow-up batterie of self rating measures. In addition at pre time of measurement a structured interview (SCID-I) for diagnosis.
  •   Cognitive Behavioral Therapy group sessions. Twice a week. At pre, post and 6 months follow-up batterie of self rating measures. In addition at pre time of measurement a structured interview (SCID-I) for diagnosis.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
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Primary Outcome

Depression (ADS, MADRS), general symptom severity (ISR), Satisfaction with Life (SWLS, Impairment in life functioning areas) at admission, discharge and 6 months after completion of therapy in electronic form via tablet.

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Secondary Outcome

Personality disorders (SCID-II), satisfaction with treatment, mindfulness (MAAS), psychological flexibility (PsyFlex), cognitive defusion (CFQ), valued living (VQ), verbal IQ (WST), sociodemografic (age, sex, migrational background) and clinical data (pretreatments, duration of current symptoms) at admission, discharge and 6 months after completion of therapy in electronic form via tablet.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2015/09/07
  •   170
  •   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

at least one mental disease.

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Exclusion Criteria

No inform consent, crisis intervention/will soon be shifted to another ward, acutely psychotic, mental disability, acutely intoxicated/primarily substance addiction/less than 3 months abstinent, overloaded by demands (e.g. language barrier), has already been included.

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Addresses

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    • Ev. Krankenhaus Königin Elisabeth Herzberge
    • Ms. 
    • Herzbergstraße 79
    • 10365  Berlin
    • Germany
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    • Ev. Krankenhaus KEH
    • Ms.  Mareike  Pleger 
    • Herzberstraße 79
    • 10365  Berlin
    • Germany
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    • Ev. Krankenhaus KEH
    • Ms.  Mareike  Pleger 
    • Herzbergstraße 79
    • 10365  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Ev. Krankenhaus Königin Elisabeth Herzberge
    • 10365  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2018/10/30
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Trial Publications, Results and other Documents

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