Mindfulness and Relaxation Interventions in Individual Psychotherapies for Children and Adolescents

NCT04034576 | Completed

• 1 other identifier: MARSCA
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Eight different subscales are differentiated across 112 items: anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, delinquent behavior, and aggressive behaviors. The three subscales anxious/depressed, withdrawn/depressed and somatic complaints are regarded as internalizing problems while the two subscales delinquent behavior and aggressive behavior are regarded as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.

  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 Outcomes (7)

• Therapeutic Alliance Scale for Children (FTB-KJ)

  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)

  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)

  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

  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)

  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 Outcomes (5)

• Practice Quality-Mindfulness to patients (PQ-M)

  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)

  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)

  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

Study Arms (3)

TAU + mindfulness intervention

EXPERIMENTAL

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

TAU + relaxation intervention

ACTIVE COMPARATOR

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

Treatment as usual

OTHER

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

Interventions

Cognitive behavior therapy of trainee therapists BEHAVIORAL

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.

TAU + mindfulness intervention; TAU + relaxation intervention; Treatment as usual

Eligibility Criteria

• Age: 11 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Heidelberg University: lead
• Esslingen University of Applied Sciences: collaborator
• Leibniz Institute for Research and Information in Education: collaborator

Study Sites (1)

Heidelberg University

Heidelberg, Germany

Location

Related Publications (2)

• 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.

  PMID: 30295914 BACKGROUND

• 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.

  PMID: 35410284 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Depressive Disorder; Anxiety Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Mood Disorders

Study Officials

• Julia Kalmar, Dr.

  Heidelberg University

  PRINCIPAL INVESTIGATOR

• Johannes Mander, PD Dr.

  Heidelberg University

  PRINCIPAL INVESTIGATOR

• Hinrich Bents, Dr.

  Heidelberg University

  STUDY DIRECTOR

• Eva Vonderlin, Dr.

  Heidelberg University

  STUDY DIRECTOR

• 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)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Julia Kalmar

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 26, 2019
• Study Start: February 8, 2019
• Primary Completion: May 24, 2024
• Study Completion: May 24, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)