Trial document





This trial has been registered retrospectively.
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  DRKS00014069

Trial Description

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Title

Mediators of change within a cognitive and a mindfulness-based intervention for depression

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Persons suffering from a major depressive episode are randomised allocated to either a cognitive intervention or a mindfulness-based cognitive intervention. Within a group session, the participants are introduced to the fundations of the particular interventions and one key technique of this intervention. They practice this technique for one week on their own and then a seccond group session take place. Experience with the intervention technique are discussed and questions are answered. Afterwards, there is a seccond week of practice followed by a final session. Depressive symptoms, thoughts and attitudes, momentary affect and mindfulness skills are assed before, during, and after the intervention period. This allows to investigate if and how this variables change due to the regular practices of the interventiion techniques. This would forster a better understanding of how psychotherapy for depression works and how psychotherapy could be improved.

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Brief Summary in Scientific Language

The study aims to investigate mechanisms of change of two psychotherapy interventions. The design follows the criteria for mediator/mechanism of change research proposed by Kazdin (2007) to overcome methodological problems of former studies (e.g., the temporal order of mediator and dependent variable). The goal is to examine whether there exist treatment-specific or common mediators of change within both interventions.
Participants with a major depressive episode are randomised allocated to either a cognitive or a mindfulness-based cognitive intervention. During a short-term intervention, cognitive change variables (automatic thought and dysfunctional attitudes) as well as changes in mindfulness skills, momentary affect, and pleasantness of activity ratings are measured regulary. Both cognitive change variables are proposed mediatiors of change according to cognitive theory while all other mediator variables are discussed within mindfulness intervention theories. Furthermore, depressive symptoms are assed regulary. All potential mediator variables are measured before the corresponding depressive symptoms, thus, allowing to investigate whether changes in mediators have causal impact on depressive symptoms.

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Organizational Data

  •   DRKS00014069
  •   2018/02/26
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  •   yes
  •   Approved
  •   [---]*, Ethikkommission des Fachbereichs Erziehungs -und Sozialwissenschaften der Universität Hildesheim
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Secondary IDs

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Health Condition or Problem studied

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

  •   Cognitive intervention:
    Participants were familiarized with the cognitive model and it was emphasized that the connection between an activating event and its (emotional) consequences depends on the specific beliefs a person holds about the situation. Then, a situation from a participant was used as an example for determining dysfunctional automatic thoughts and evidence for and against these thoughts as well as for developing a new interpretation of this situation and achieving new emotional consequences. The results were noted on a flipchart using a column protocol for recording dysfunctional thoughts. At the end of the first session, participants received an audio instruction for the daily recording and challenging of their dysfunctional thoughts. All participants in the CI group were asked to complete this daily record of dysfunctional thoughts for one or two situations per day during the next week. At the end of the first session, participants received an audio instructions for the daily recording of dysfunctional thoughts. In the second session, participants’ problems with this protocol were reviewed, questions were answered and one or two new examples of identifying dysfunctional thoughts as well as challenging and reconstructing them were conducted together. The second week followed the routine of week one and participants had to complete the daily record of dysfunctional thoughts again. Afterwards a final session was carried out.
  •   Mindfulness-based cognitive intervention:
    The MI was based on the first two sessions of the MBCT program (Segal, Williams, & Teasdale, 2002) In the first session, the raisin exercise (an exercise in which participants practice to pay attention to the appearance, texture, smell, and flavor of a raisin) and the body scan were practiced and participant’s experiences during these practices were discussed. Comparable with the procedure in the CI group, participants received a CD with a record of the body scan meditation and were told to practice this meditation once a day. The second session started with practicing the body scan together and then talking about the experience and challenges during this practice as well as during the daily practice at home. Based on participants’ feedback, the therapists emphasized key aspects of mindfulness (e.g. nonjudgmental awareness of the present moment) and possibilities to deal with common problems during mindfulness practice (e.g. mind-wandering, unpleasant experiences). Again, participants had to practice the body scan once a day during the second week of study. Afterwards a final session was carried out.
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Characteristics

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

Changes in automatic thoughts (Automatic Thoughts Questionnaire-Revised (ATQ-R); German version: Pössel, Seemann, & Hautzinger, 2005), dysfunctional attitudes (Dysfunctional Attitude Scale (DAS); German short version: Joormann, 2004), mindfulness skills (Kentucky Inventory of Mindfulness Skills (KIMS); German version: Ströhle, Nachtigall, Michalak & Heidenreich, 2010), positive and negative affect (Positive and Negative Affect Schedule (PANAS); German version: Krohne, Egloff, Kohlmann & Tausch, 1996), pleasentness of activity (4 Items, based on a study by Geschwind, Peeters, Drukker, van Os & Wichers, 2011)

Th ATQ-R and DAS were assessed pre-treatment as well as every second day (= 7 measurements). The KIMS was measured pre- and post-treatment as well as after one week. Affect and pleasentness of activity were assessed evey day (=14 measurements).

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Secondary Outcome

changes in depressive symptoms (German version of BDI-II: Hautzinger, Keller, & Kuehner, 2006). Depressive Symptoms were measured pre- and post-treatment as well as every second day (=8 measurements).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2014/02/24
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

To be included, participants had to meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV; American Psychiatric Association, 1994) criteria for a current episode of MDD.

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Exclusion Criteria

Participants were excluded if they met one of the following criteria: a bipolar disorder, a lifetime psychotic disorder, a current alcohol or substance abuse or addiction, active suicidal ideations, a change in anti-depressive medication within the last six weeks preceding the study or a current psychotherapy. Diagnostic criteria were derived from the German version of the Structured Clinical Interview for DSM-IV (SCID I; Wittchen, Wunderlich, Gruschwitz, & Zaudig, 1997).

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Addresses

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    • Universität Hildesheim,Institut für Psychologie,Arbeitsgruppe Klinische Psychologie
    • Universitätsplatz 1
    • 31141  Hildesheim
    • Germany
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    • Universität Hildesheim, Institut für Psychologie
    • Ms.  M.Sc.  Christine  Hofheinz 
    • Universitätsplatz 1
    • 31141  Hildesheim
    • Germany
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    • Universität Hildesheim,Institut für Psychologie
    • Ms.  M.Sc.  Christine  Hofheinz 
    • Universitätsplatz 1
    • 31141  Hildesheim
    • Germany
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Sources of Monetary or Material Support

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    • Universität Hildesheim,Institut für Psychologie,Arbeitsgruppe Klinische Psychologie
    • Universitätsplatz 1
    • 31141  Hildesheim
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/02/27
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Trial Publications, Results and other Documents

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