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

March 3, 2025 updated by: Julia Kalmar, Heidelberg University

The Impact of Session-introducing Mindfulness and Relaxation Interventions in Individual Training Psychotherapies for Children and Adolescents: a Randomized Controlled Trial.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Heidelberg, Germany
        • Heidelberg University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
measured for 24 weeks on weekly basis at the end of each session (session duration is 50 minutes), starting on first treatment day
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.
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
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.
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
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.
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
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.
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
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.
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
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
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 Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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
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
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
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
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).
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Heidelberg University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Esslingen University of Applied Sciences
Leibniz Institute for Research and Information in Education

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 8, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 24, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 24, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MARSCA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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