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Mindfulness and Relaxation Interventions in Individual Psychotherapies for Children and Adolescents (MARS-CA)

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ClinicalTrials.gov Identifier: NCT04034576
Recruitment Status : Recruiting
First Posted : July 26, 2019
Last Update Posted : August 9, 2019
Sponsor:
Collaborators:
Esslingen University of Applied Sciences
Leibniz Institute for Research and Information in Education
Information provided by (Responsible Party):
Julia Kalmar, Heidelberg University

Brief Summary:
The study 'Mindfulness and Relaxation interventions in Individual Training Psychotherapies for Children and Adolescents' (MARS-CA) aims to examine the effects of short session-introducing interventions with mindfulness elements (SIIME) on juvenile patients' psychopathological symptomatology and therapeutic alliance at the beginning of the first 24 therapy sessions.

Condition or disease Intervention/treatment Phase
Hyperkinetic Disorder Depressive Disorder Anxiety Disorder Behavioral: Cognitive behavior therapy of trainee therapists Not Applicable

Detailed Description:
Short session-introducing interventions with mindfulness elements (SIIME) shall be compared with session-introducing relaxation interventions (SIRI) and no session-introducing interventions (treatment as usual, (TAU)). Patients between 11 and 19 years and a primary diagnosis of hyperkinetic disorder, depressive disorder or anxiety disorder are invited to participate. Psychotherapy will be conducted by trainee therapists at a trainee outpatient clinic for children and adolescents. It is hypothesized that psychopathological symptomatology and therapeutic alliance improve more in the mindfulness condition than in the relaxation condition and TAU, and that mindfulness moderates the relationship between therapeutic alliance and psychopathological symptomatology stronger than the relaxation condition and TAU.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Session-introducing Mindfulness and Relaxation Interventions in Individual Training Psychotherapies for Children and Adolescents: A Randomized Controlled Trial.
Actual Study Start Date : April 30, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: TAU + mindfulness intervention
The mindfulness-based intervention consists of three five to ten minutes session-introducing interventions (mindful walking, body scan, breathing space). At the beginning of each of the 24 therapy sessions patients receive one of the three mindfulness interventions. Each intervention is instructed for four sessions consecutively and eight sessions in total. After completion of the mindfulness intervention, the regular therapy session begins.
Behavioral: Cognitive behavior therapy of trainee therapists
In all three treatment arms, trainee therapists perform a cognitive behavior therapy (CBT) under conditions of the German health care system. This treatment is not a manualized intervention, but rather based on individualized treatment plans that have been developed together with expert supervisors during a five session diagnostic stage. Treatment duration is 24 sessions, while on average every fourth is supervized by an CBT expert therapist.

Active Comparator: TAU + relaxation intervention
The relaxation interventions (progressive muscle relaxation (PMR), imagery journey, walking relaxation) are parallelized to the three mindfulness-based interventions. At the beginning of each of the 24 therapy sessions, patients receive one of the three relaxation interventions. Each intervention is instructed for four sessions consecutively and eight sessions in total. After completion of the relaxation intervention, the regular therapy session begins.
Behavioral: Cognitive behavior therapy of trainee therapists
In all three treatment arms, trainee therapists perform a cognitive behavior therapy (CBT) under conditions of the German health care system. This treatment is not a manualized intervention, but rather based on individualized treatment plans that have been developed together with expert supervisors during a five session diagnostic stage. Treatment duration is 24 sessions, while on average every fourth is supervized by an CBT expert therapist.

Treatment as usual
Standard cognitive behavior therapy treatment, based on the individualized case conception of the trainee therapist, is conducted during the whole treatment sessions. No particular session-introductions are applied.
Behavioral: Cognitive behavior therapy of trainee therapists
In all three treatment arms, trainee therapists perform a cognitive behavior therapy (CBT) under conditions of the German health care system. This treatment is not a manualized intervention, but rather based on individualized treatment plans that have been developed together with expert supervisors during a five session diagnostic stage. Treatment duration is 24 sessions, while on average every fourth is supervized by an CBT expert therapist.




Primary Outcome Measures :
  1. Changes in Youth Self-Report 11-18 R (YSR 11-18 R) [ Time Frame: on first treatment day, after 3 weeks, 10 weeks, 17 weeks, 24 weeks (in each case after a 50 minutes therapy session) and at a 6-month follow-up ]
    The YSR 11-18 R measures general symptom severity in patients. Eight different subscales are differentiated across 112 items: anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, delinquent behavior, and aggressive behaviors. The three subscales anxious/depressed, withdrawn/depressed and somatic complaints are regarded as internalizing problems while the two subscales delinquent behavior and aggressive behavior are regarded as externalizing behavior. To calculate subscales as well as the total score corresponding items are summed. Items are rated on a 3-point Likert-scale (0 = not true, 1 = somewhat or sometimes true, 2 = very true or often true). Higher scores reflect higher symptom severity. T-scores are used to interpret and compare the results to the corresponding age and gender group.


Secondary Outcome Measures :
  1. Therapeutic Alliance Scale for Children (FTB-KJ) [ Time Frame: measured for 24 weeks on weekly basis at the end of each session (session duration is 50 minutes), starting on first treatment day ]
    The FTB-KJ is a self-report instrument to measure therapeutic alliance. It contains a patient and therapist perspective with 12 items rated on a four-step scale. In addition to the items of the FTB-KJ, a two-item short version of the Therapeutic Presence Inventory will be applied. Furthermore, two items will assess if patients and therapists perceive the session-introducing intervention positively or negatively.

  2. Child and Adolescent Mindfulness Measure (CAMM) [ Time Frame: on first treatment day, after 3 weeks, 10 weeks, 17 weeks, 24 weeks (in each case after a 50 minutes therapy session) and at a 6-month follow-up ]
    The CAMM is based on the Kentucky Inventory of Mindfulness Skilss (KIMS) and assesses the general development of mindfulness in patients.The measure includes ten items, rated on a five-step scale.

  3. Self-compassion scale (SCS-D) [ Time Frame: on first treatment day, after 3 weeks, 10 weeks, 17 weeks, 24 weeks (in each case after a 50 minutes therapy session) and at a 6-month follow-up ]
    To assess patients' and therapists' general development of self-compassion across the course of the study, we will apply the SCS and an adapted version of the SCS for children translated into German. It consists of 26 items and is rated on a five-step scale.

  4. Diagnostic System for Mental Disorders in Childhood and Adolescence (DISYPS-III), problem scales of the ADHD self-rating scale (SBB-ADHS) Title: Patients' hyperkinetic disorder symptoms [ Time Frame: on first treatment day, after 3 weeks, 10 weeks, 17 weeks, 24 weeks (in each case after a 50 minutes therapy session) and at a 6-month follow-up ]
    To assess the patients' hyperkinetic disorder symptoms, we will apply the DISYPS-III SBB-ADHS, consisting of 20 items rated on a four-step scale.

  5. Diagnostic System for Mental Disorders in Childhood and Adolescence (DISYPS-III), problem scales of the depression self-rating scale (SBB-DES) [ Time Frame: on first treatment day, after 3 weeks, 10 weeks, 17 weeks, 24 weeks (in each case after a 50 minutes therapy session) and at a 6-month follow-up ]
    To assess depressive symptoms of the patients, we will apply the DISYPS-III SBB-DES. The problem scales of the SBB-DES consist of 29 items, rated on a four-step scale.

  6. Diagnostic System for Mental Disorders in Childhood and Adolescence (DISYPS-III), problem scales of the anxiety self-rating scale (SBB-ANG) [ Time Frame: on first treatment day, after 3 weeks, 10 weeks, 17 weeks, 24 weeks (in each case after a 50 minutes therapy session) and at a 6-month follow-up ]
    To assess anxiety symptoms of the patients, we will apply the DISYPS-III SBB-ANG. The problem scales of the SBB-ANG consist of 44 items, rated on a four-step scale.

  7. Kentucky Inventory of Mindfulness Skills (KIMS-D) [ Time Frame: on first treatment day, after 3 weeks, 10 weeks, 17 weeks, 24 weeks (in each case after a 50 minutes therapy session) and at a 6-month follow-up ]
    General development of mindfulness amongst therapists across the course of the study will be assessed by the German version of the KIMS. Ot consists of 39 items that are rated on a five-step scale


Other Outcome Measures:
  1. Practice Quality-Mindfulness to patients (PQ-M) [ Time Frame: on first treatment day, after 3 weeks, 10 weeks, 17 weeks, 24 weeks (in each case after a 50 minutes therapy session) and at a 6-month follow-up ]
    The six items of the PQ-M assess the perceived quality of mindfulness implementation operationalised as perseverance in (a) receptive (b) present-moment attention.

  2. Credibility/Expectancy Questionnaire (CEQ) [ Time Frame: on first treatment day, after 3 weeks, 10 weeks, 17 weeks, 24 weeks (in each case after a 50 minutes therapy session) and at a 6-month follow-up ]
    The questionnaire assesses treatment expectancy and rationale credibility in clinical outcome studies.

  3. Heidelberg Inventory of Cognitive-Behavioral Interventions (HICBI) [ Time Frame: on first treatment day, after 3 weeks, 10 weeks, 17 weeks, 24 weeks (in each case after a 50 minutes therapy session) and at a 6-month follow-up ]
    Assesses the application of specific therapeutic techniques

  4. Therapist Presence Inventory (TPI) [ Time Frame: on first treatment day, after 3 weeks, 10 weeks, 17 weeks, 24 weeks (in each case after a 50 minutes therapy session) and at a 6-month follow-up ]
    Assesses patients' and therapists' in-session therapeutic presence

  5. Adherence scale (Ad-S) [ Time Frame: on first treatment day, after 3 weeks, 10 weeks, 17 weeks, 24 weeks (in each case after a 50 minutes therapy session) and at a 6-month follow-up ]
    Was specifically designed to assess potential adherence effects in therapists and patients. It consists of 8 items in the patient version and 13 items in the therapist version. Patients rate five statements about how they perceived the session-introducing interventions (0 = not correct at all, 4 = true) and are asked whether and how often they practiced at home. The therapist version contains a list of 10 possible components for the session introduction (e.g. mindfulness intervention, review over the last session) that can be rated from 0 (not correct at all) to 4 (true). Also, therapists are asked to rate 3 statements about how they perceived the session introduction (0=not correct at all to 4= true).



Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A primary hyperkinetic disorder, depressive disorder or anxiety disorder diagnosis
  • treatment at the Center for Psychological Psychotherapy, University of Heidelberg

Exclusion Criteria:

  • age below 11 or above 19
  • insufficient German language skills
  • psychotic disorder
  • acute suicidality

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04034576


Contacts
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Contact: Julia Kalmar, Dr. +49 6221 547901 ext 7901 julia.kalmar@zpp.uni-hd.de
Contact: Johannes Mander, PD Dr. +49 6221 547902 ext 7902 johannes.mander@zpp.uni-hd.de

Locations
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Germany
Heidelberg University Recruiting
Heidelberg, Germany
Contact: Julia Kalmar, Dr.    +49 6221 547901 ext 7901    julia.kalmar@zpp.uni-hd.de   
Sponsors and Collaborators
Heidelberg University
Esslingen University of Applied Sciences
Leibniz Institute for Research and Information in Education
Investigators
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Principal Investigator: Julia Kalmar, Dr. Heidelberg University
Principal Investigator: Johannes Mander, PD Dr. Heidelberg University
Study Director: Hinrich Bents, Dr. Heidelberg University
Study Director: Eva Vonderlin, Dr. Heidelberg University
Study Chair: Thomas Heidenreich, Prof. Dr. University of Applied Sciences Esslingen
Study Chair: Sabina Pauen, Prof. Dr. Heidelberg University
Study Chair: Andreas Neubauer, Dr. Leibniz Institute for Research and Information in Education Frankfurt (Main)

Publications:
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Responsible Party: Julia Kalmar, Dr. Julia Kalmar, Heidelberg University
ClinicalTrials.gov Identifier: NCT04034576     History of Changes
Other Study ID Numbers: MARSCA
First Posted: July 26, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julia Kalmar, Heidelberg University:
Mindfulness-based intervention
Session-introducing interventions
Child and adolescent psychotherapy
Cognitive-behavioral therapy
Therapeutic alliance
Depressive disorder
Hyperkinetic disorder
Anxiety disorder
Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Anxiety Disorders
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders