Mindfulness and Relaxation Interventions in Individual Psychotherapies for Children and Adolescents

NCT ID: NCT04034576

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-08
• Study Completion Date: 2024-05-24

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.

Conditions

Hyperkinetic Disorder; Depressive Disorder; Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive behavior therapy of trainee therapists

Intervention Type: 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 + 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.

Group Type: ACTIVE_COMPARATOR

Cognitive behavior therapy of trainee therapists

Intervention Type: 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.

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.

Group Type: OTHER

Cognitive behavior therapy of trainee therapists

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 11 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Esslingen University of Applied Sciences

OTHER

Sponsor Role: collaborator

Leibniz Institute for Research and Information in Education

UNKNOWN

Sponsor Role: collaborator

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Julia Kalmar

Dr. Julia Kalmar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julia Kalmar, Dr.

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Johannes Mander, PD Dr.

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Hinrich Bents, Dr.

Role: STUDY_DIRECTOR

Heidelberg University

Eva Vonderlin, Dr.

Role: STUDY_DIRECTOR

Heidelberg University

Thomas Heidenreich, Prof. Dr.

Role: STUDY_CHAIR

University of Applied Sciences Esslingen

Sabina Pauen, Prof. Dr.

Role: STUDY_CHAIR

Heidelberg University

Andreas Neubauer, Dr.

Role: STUDY_CHAIR

Leibniz Institute for Research and Information in Education Frankfurt (Main)

Locations

Heidelberg University

Heidelberg, , Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 30295914 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35410284 (View on PubMed)

Other Identifiers

MARSCA

Identifier Type: -

Identifier Source: org_study_id