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

Primary Purpose

Hyperkinetic Disorder, Depressive Disorder, Anxiety Disorder

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cognitive behavior therapy of trainee therapists
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperkinetic Disorder focused on measuring Mindfulness-based intervention, Session-introducing interventions, Child and adolescent psychotherapy, Cognitive-behavioral therapy, Therapeutic alliance, Depressive disorder, Hyperkinetic disorder, Anxiety disorder

Eligibility Criteria

11 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Heidelberg UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

TAU + mindfulness intervention

TAU + relaxation intervention

Treatment as usual

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Changes in Youth Self-Report 11-18 R (YSR 11-18 R)
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

Therapeutic Alliance Scale for Children (FTB-KJ)
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.
Child and Adolescent Mindfulness Measure (CAMM)
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.
Self-compassion scale (SCS-D)
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.
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
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.
Diagnostic System for Mental Disorders in Childhood and Adolescence (DISYPS-III), problem scales of the depression self-rating scale (SBB-DES)
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.
Diagnostic System for Mental Disorders in Childhood and Adolescence (DISYPS-III), problem scales of the anxiety self-rating scale (SBB-ANG)
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.
Kentucky Inventory of Mindfulness Skills (KIMS-D)
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

Full Information

First Posted
July 17, 2019
Last Updated
October 20, 2021
Sponsor
Heidelberg University
Collaborators
Esslingen University of Applied Sciences, Leibniz Institute for Research and Information in Education
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1. Study Identification

Unique Protocol Identification Number
NCT04034576
Brief Title
Mindfulness and Relaxation Interventions in Individual Psychotherapies for Children and Adolescents
Acronym
MARS-CA
Official Title
The Impact of Session-introducing Mindfulness and Relaxation Interventions in Individual Training Psychotherapies for Children and Adolescents: A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2019 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heidelberg University
Collaborators
Esslingen University of Applied Sciences, Leibniz Institute for Research and Information in Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperkinetic Disorder, Depressive Disorder, Anxiety Disorder
Keywords
Mindfulness-based intervention, Session-introducing interventions, Child and adolescent psychotherapy, Cognitive-behavioral therapy, Therapeutic alliance, Depressive disorder, Hyperkinetic disorder, Anxiety disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAU + mindfulness intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
TAU + relaxation intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Treatment as usual
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavior therapy of trainee therapists
Intervention Description
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 Measure Information:
Title
Changes in Youth Self-Report 11-18 R (YSR 11-18 R)
Description
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.
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
Secondary Outcome Measure Information:
Title
Therapeutic Alliance Scale for Children (FTB-KJ)
Description
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.
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
Title
Child and Adolescent Mindfulness Measure (CAMM)
Description
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.
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
Title
Self-compassion scale (SCS-D)
Description
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.
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
Title
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
Description
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.
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
Title
Diagnostic System for Mental Disorders in Childhood and Adolescence (DISYPS-III), problem scales of the depression self-rating scale (SBB-DES)
Description
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.
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
Title
Diagnostic System for Mental Disorders in Childhood and Adolescence (DISYPS-III), problem scales of the anxiety self-rating scale (SBB-ANG)
Description
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.
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
Title
Kentucky Inventory of Mindfulness Skills (KIMS-D)
Description
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
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
Other Pre-specified Outcome Measures:
Title
Practice Quality-Mindfulness to patients (PQ-M)
Description
The six items of the PQ-M assess the perceived quality of mindfulness implementation operationalised as perseverance in (a) receptive (b) present-moment attention.
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
Title
Credibility/Expectancy Questionnaire (CEQ)
Description
The questionnaire assesses treatment expectancy and rationale credibility in clinical outcome studies.
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
Title
Heidelberg Inventory of Cognitive-Behavioral Interventions (HICBI)
Description
Assesses the application of specific therapeutic techniques
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
Title
Therapist Presence Inventory (TPI)
Description
Assesses patients' and therapists' in-session therapeutic presence
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
Title
Adherence scale (Ad-S)
Description
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).
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Kalmar, Dr.
Phone
+49 6221 547901
Ext
7901
Email
julia.kalmar@zpp.uni-hd.de
First Name & Middle Initial & Last Name or Official Title & Degree
Johannes Mander, PD Dr.
Phone
+49 6221 547902
Ext
7902
Email
johannes.mander@zpp.uni-hd.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Kalmar, Dr.
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Johannes Mander, PD Dr.
Organizational Affiliation
Heidelberg University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hinrich Bents, Dr.
Organizational Affiliation
Heidelberg University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Eva Vonderlin, Dr.
Organizational Affiliation
Heidelberg University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thomas Heidenreich, Prof. Dr.
Organizational Affiliation
University of Applied Sciences Esslingen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sabina Pauen, Prof. Dr.
Organizational Affiliation
Heidelberg University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Andreas Neubauer, Dr.
Organizational Affiliation
Leibniz Institute for Research and Information in Education Frankfurt (Main)
Official's Role
Study Chair
Facility Information:
Facility Name
Heidelberg University
City
Heidelberg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Kalmar, Dr.
Phone
+49 6221 547901
Ext
7901
Email
julia.kalmar@zpp.uni-hd.de

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30295914
Citation
Mander J, Blanck P, Neubauer AB, Kroger P, Fluckiger C, Lutz W, Barnow S, Bents H, Heidenreich T. Mindfulness and progressive muscle relaxation as standardized session-introduction in individual therapy: A randomized controlled trial. J Clin Psychol. 2019 Jan;75(1):21-45. doi: 10.1002/jclp.22695. Epub 2018 Oct 8.
Results Reference
background
PubMed Identifier
35410284
Citation
Kalmar J, Baumann I, Gruber E, Vonderlin E, Bents H, Neubauer AB, Heidenreich T, Mander J. The impact of session-introducing mindfulness and relaxation interventions in individual psychotherapy for children and adolescents: a randomized controlled trial (MARS-CA). Trials. 2022 Apr 11;23(1):291. doi: 10.1186/s13063-022-06212-0.
Results Reference
derived

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Mindfulness and Relaxation Interventions in Individual Psychotherapies for Children and Adolescents

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