Clinical trial NCT04034576: Mindfulness and Relaxation Interventions in Individual Psychotherapies for Children and Adolescents
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
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Esslingen University of Applied Sciences
name: Leibniz Institute for Research and Information in Education
First posted: 2019-07-26
Enrollment: 90
Sex: ALL
Minimum age (years): 11
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Changes in Youth Self-Report 11-18 R (YSR 11-18 R)
timeFrame: 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:
measure: Therapeutic Alliance Scale for Children (FTB-KJ)
timeFrame: measured for 24 weeks on weekly basis at the end of each session (session duration is 50 minutes), starting on first treatment day
measure: Child and Adolescent Mindfulness Measure (CAMM)
timeFrame: 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
measure: Self-compassion scale (SCS-D)
timeFrame: 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
measure: 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
timeFrame: 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
measure: Diagnostic System for Mental Disorders in Childhood and Adolescence (DISYPS-III), problem scales of the depression self-rating scale (SBB-DES)
timeFrame: 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
measure: Diagnostic System for Mental Disorders in Childhood and Adolescence (DISYPS-III), problem scales of the anxiety self-rating scale (SBB-ANG)
timeFrame: 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
measure: Kentucky Inventory of Mindfulness Skills (KIMS-D)
timeFrame: 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:
measure: Practice Quality-Mindfulness to patients (PQ-M)
timeFrame: 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
measure: Credibility/Expectancy Questionnaire (CEQ)
timeFrame: 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
measure: Heidelberg Inventory of Cognitive-Behavioral Interventions (HICBI)
timeFrame: 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
measure: Therapist Presence Inventory (TPI)
timeFrame: 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
measure: Adherence scale (Ad-S)
timeFrame: 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
Locations:
city: Heidelberg
country: Germany
facility: Heidelberg University
Study officials:
affiliation: Heidelberg University
name: Julia Kalmar, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Heidelberg University
name: Johannes Mander, PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Heidelberg University
name: Hinrich Bents, Dr.
role: STUDY_DIRECTOR
affiliation: Heidelberg University
name: Eva Vonderlin, Dr.
role: STUDY_DIRECTOR
affiliation: University of Applied Sciences Esslingen
name: Thomas Heidenreich, Prof. Dr.
role: STUDY_CHAIR
affiliation: Heidelberg University
name: Sabina Pauen, Prof. Dr.
role: STUDY_CHAIR
affiliation: Leibniz Institute for Research and Information in Education Frankfurt (Main)
name: Andreas Neubauer, Dr.
role: STUDY_CHAIR
References:
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.
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.