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The Process-Outcome Mindfulness Effects in Trainees (PrOMET) study: protocol of a pragmatic randomized controlled trial

Identifieur interne : 000804 ( Ncbi/Merge ); précédent : 000803; suivant : 000805

The Process-Outcome Mindfulness Effects in Trainees (PrOMET) study: protocol of a pragmatic randomized controlled trial

Auteurs : Johannes Mander [Allemagne] ; Paula Kröger [Allemagne] ; Thomas Heidenreich [Allemagne] ; Christoph Flückiger [Suisse] ; Wolfgang Lutz [Allemagne] ; Hinrich Bents [Allemagne] ; Sven Barnow [Allemagne]

Source :

RBID : PMC:4504414

Abstract

Background

Mindfulness has its origins in an Eastern Buddhist tradition that is over 2500 years old and can be defined as a specific form of attention that is non-judgmental, purposeful, and focused on the present moment. It has been well established in cognitive-behavior therapy in the last decades, while it has been investigated in manualized group settings such as mindfulness-based stress reduction and mindfulness-based cognitive therapy. However, there is scarce research evidence on the effects of mindfulness as a treatment element in individual therapy. Consequently, the demand to investigate mindfulness under effectiveness conditions in trainee therapists has been highlighted.

Methods/Design

To fill in this research gap, we designed the PrOMET Study. In our study, we will investigate the effects of brief, audiotape-presented, session-introducing interventions with mindfulness elements conducted by trainee therapists and their patients at the beginning of individual therapy sessions in a prospective, randomized, controlled design under naturalistic conditions with a total of 30 trainee therapists and 150 patients with depression and anxiety disorders in a large outpatient training center. We hypothesize that the primary outcomes of the session-introducing intervention with mindfulness elements will be positive effects on therapeutic alliance (Working Alliance Inventory) and general clinical symptomatology (Brief Symptom Checklist) in contrast to the session-introducing progressive muscle relaxation and treatment-as-usual control conditions. Treatment duration is 25 therapy sessions. Therapeutic alliance will be assessed on a session-to-session basis. Clinical symptomatology will be assessed at baseline, session 5, 15 and 25. We will conduct multilevel modeling to address the nested data structure. The secondary outcome measures include depression, anxiety, interpersonal functioning, mindful awareness, and mindfulness during the sessions.

Discussion

The study results could provide important practical implications because they could inform ideas on how to improve the clinical training of psychotherapists that could be implemented very easily; this is because there is no need for complex infrastructures or additional time concerning these brief session-introducing interventions with mindfulness elements that are directly implemented in the treatment sessions.

Trial registration

From ClinicalTrials.gov, Identifier: NCT02270073 (registered October 6, 2014)


Url:
DOI: 10.1186/s40359-015-0082-3
PubMed: 26185680
PubMed Central: 4504414

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PMC:4504414

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<p>Mindfulness has its origins in an Eastern Buddhist tradition that is over 2500 years old and can be defined as a specific form of attention that is non-judgmental, purposeful, and focused on the present moment. It has been well established in cognitive-behavior therapy in the last decades, while it has been investigated in manualized group settings such as mindfulness-based stress reduction and mindfulness-based cognitive therapy. However, there is scarce research evidence on the effects of mindfulness as a treatment element in individual therapy. Consequently, the demand to investigate mindfulness under effectiveness conditions in trainee therapists has been highlighted.</p>
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<p>To fill in this research gap, we designed the PrOMET Study. In our study, we will investigate the effects of brief, audiotape-presented, session-introducing interventions with mindfulness elements conducted by trainee therapists and their patients at the beginning of individual therapy sessions in a prospective, randomized, controlled design under naturalistic conditions with a total of 30 trainee therapists and 150 patients with depression and anxiety disorders in a large outpatient training center. We hypothesize that the primary outcomes of the session-introducing intervention with mindfulness elements will be positive effects on therapeutic alliance (Working Alliance Inventory) and general clinical symptomatology (Brief Symptom Checklist) in contrast to the session-introducing progressive muscle relaxation and treatment-as-usual control conditions. Treatment duration is 25 therapy sessions. Therapeutic alliance will be assessed on a session-to-session basis. Clinical symptomatology will be assessed at baseline, session 5, 15 and 25. We will conduct multilevel modeling to address the nested data structure. The secondary outcome measures include depression, anxiety, interpersonal functioning, mindful awareness, and mindfulness during the sessions.</p>
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<p>The study results could provide important practical implications because they could inform ideas on how to improve the clinical training of psychotherapists that could be implemented very easily; this is because there is no need for complex infrastructures or additional time concerning these brief session-introducing interventions with mindfulness elements that are directly implemented in the treatment sessions.</p>
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<p>From ClinicalTrials.gov, Identifier:
<ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/study/NCT02270073?view=results">NCT02270073</ext-link>
(registered October 6, 2014)</p>
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<region type="district" nuts="2">District de Karlsruhe</region>
<settlement type="city">Heidelberg</settlement>
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</author>
<author>
<name sortKey="Kroger, Paula" sort="Kroger, Paula" uniqKey="Kroger P" first="Paula" last="Kröger">Paula Kröger</name>
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<nlm:aff id="Aff1">University of Heidelberg, Center for Psychological Psychotherapy, Bergheimer Str. 58a, 69115 Heidelberg, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>University of Heidelberg, Center for Psychological Psychotherapy, Bergheimer Str. 58a, 69115 Heidelberg</wicri:regionArea>
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<region type="district" nuts="2">District de Karlsruhe</region>
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<author>
<name sortKey="Heidenreich, Thomas" sort="Heidenreich, Thomas" uniqKey="Heidenreich T" first="Thomas" last="Heidenreich">Thomas Heidenreich</name>
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<nlm:aff id="Aff2">Department of Social Work, Health and Nursing, University of Applied Sciences Esslingen, Esslingen, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Social Work, Health and Nursing, University of Applied Sciences Esslingen, Esslingen</wicri:regionArea>
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<wicri:noRegion>Esslingen</wicri:noRegion>
<wicri:noRegion>Esslingen</wicri:noRegion>
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<name sortKey="Fluckiger, Christoph" sort="Fluckiger, Christoph" uniqKey="Fluckiger C" first="Christoph" last="Flückiger">Christoph Flückiger</name>
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<nlm:aff id="Aff3">Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland</nlm:aff>
<country xml:lang="fr">Suisse</country>
<wicri:regionArea>Department of Clinical Psychology and Psychotherapy, University of Bern, Bern</wicri:regionArea>
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<settlement type="city">Berne</settlement>
<region type="région" nuts="3">Canton de Berne</region>
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<orgName type="university">Université de Berne</orgName>
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<author>
<name sortKey="Lutz, Wolfgang" sort="Lutz, Wolfgang" uniqKey="Lutz W" first="Wolfgang" last="Lutz">Wolfgang Lutz</name>
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<nlm:aff id="Aff4">Department of Clinical Psychology and Psychotherapy, University of Trier, Trier, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Clinical Psychology and Psychotherapy, University of Trier, Trier</wicri:regionArea>
<wicri:noRegion>Trier</wicri:noRegion>
<orgName type="university">Université de Trèves</orgName>
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<region type="land" nuts="1">Rhénanie-Palatinat</region>
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<author>
<name sortKey="Bents, Hinrich" sort="Bents, Hinrich" uniqKey="Bents H" first="Hinrich" last="Bents">Hinrich Bents</name>
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<nlm:aff id="Aff1">University of Heidelberg, Center for Psychological Psychotherapy, Bergheimer Str. 58a, 69115 Heidelberg, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>University of Heidelberg, Center for Psychological Psychotherapy, Bergheimer Str. 58a, 69115 Heidelberg</wicri:regionArea>
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<region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Karlsruhe</region>
<settlement type="city">Heidelberg</settlement>
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</author>
<author>
<name sortKey="Barnow, Sven" sort="Barnow, Sven" uniqKey="Barnow S" first="Sven" last="Barnow">Sven Barnow</name>
<affiliation wicri:level="3">
<nlm:aff id="Aff5">Department of Clinical Psychology and Psychotherapy, University of Heidelberg, Heidelberg, Germany</nlm:aff>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Clinical Psychology and Psychotherapy, University of Heidelberg, Heidelberg</wicri:regionArea>
<placeName>
<region type="land" nuts="1">Bade-Wurtemberg</region>
<region type="district" nuts="2">District de Karlsruhe</region>
<settlement type="city">Heidelberg</settlement>
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</analytic>
<series>
<title level="j">BMC Psychology</title>
<idno type="eISSN">2050-7283</idno>
<imprint>
<date when="2015">2015</date>
</imprint>
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<front>
<div type="abstract" xml:lang="en">
<sec>
<title>Background</title>
<p>Mindfulness has its origins in an Eastern Buddhist tradition that is over 2500 years old and can be defined as a specific form of attention that is non-judgmental, purposeful, and focused on the present moment. It has been well established in cognitive-behavior therapy in the last decades, while it has been investigated in manualized group settings such as mindfulness-based stress reduction and mindfulness-based cognitive therapy. However, there is scarce research evidence on the effects of mindfulness as a treatment element in individual therapy. Consequently, the demand to investigate mindfulness under effectiveness conditions in trainee therapists has been highlighted.</p>
</sec>
<sec>
<title>Methods/Design</title>
<p>To fill in this research gap, we designed the PrOMET Study. In our study, we will investigate the effects of brief, audiotape-presented, session-introducing interventions with mindfulness elements conducted by trainee therapists and their patients at the beginning of individual therapy sessions in a prospective, randomized, controlled design under naturalistic conditions with a total of 30 trainee therapists and 150 patients with depression and anxiety disorders in a large outpatient training center. We hypothesize that the primary outcomes of the session-introducing intervention with mindfulness elements will be positive effects on therapeutic alliance (Working Alliance Inventory) and general clinical symptomatology (Brief Symptom Checklist) in contrast to the session-introducing progressive muscle relaxation and treatment-as-usual control conditions. Treatment duration is 25 therapy sessions. Therapeutic alliance will be assessed on a session-to-session basis. Clinical symptomatology will be assessed at baseline, session 5, 15 and 25. We will conduct multilevel modeling to address the nested data structure. The secondary outcome measures include depression, anxiety, interpersonal functioning, mindful awareness, and mindfulness during the sessions.</p>
</sec>
<sec>
<title>Discussion</title>
<p>The study results could provide important practical implications because they could inform ideas on how to improve the clinical training of psychotherapists that could be implemented very easily; this is because there is no need for complex infrastructures or additional time concerning these brief session-introducing interventions with mindfulness elements that are directly implemented in the treatment sessions.</p>
</sec>
<sec>
<title>Trial registration</title>
<p>From ClinicalTrials.gov, Identifier:
<ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/study/NCT02270073?view=results">NCT02270073</ext-link>
(registered October 6, 2014)</p>
</sec>
</div>
</front>
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<div type="abstract" xml:lang="en">Mindfulness has its origins in an Eastern Buddhist tradition that is over 2500 years old and can be defined as a specific form of attention that is non-judgmental, purposeful, and focused on the present moment. It has been well established in cognitive-behavior therapy in the last decades, while it has been investigated in manualized group settings such as mindfulness-based stress reduction and mindfulness-based cognitive therapy. However, there is scarce research evidence on the effects of mindfulness as a treatment element in individual therapy. Consequently, the demand to investigate mindfulness under effectiveness conditions in trainee therapists has been highlighted.</div>
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