Mindfulness and Relaxation Interventions in Individual Psychotherapies for Children and Adolescents

Depressive Disorder Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04034576
• Other study ID #: MARSCA
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2019
• Est. completion date: February 2024

Study information

• Verified date: October 2021
• Source: Heidelberg University
• Contact: Julia Kalmar, Dr.
• Phone: +49 6221 547901
• Email: julia.kalmar[@]zpp.uni-hd.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: February 2024
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Attention Deficit Disorder with Hyperactivity
• Depression
• Depressive Disorder
• Disease
• Hyperkinetic Disorder

Intervention

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.

Locations

Country	Name	City	State
Germany	Heidelberg University	Heidelberg

Sponsors (3)

Lead Sponsor	Collaborator
Heidelberg University	Esslingen University of Applied Sciences, Leibniz Institute for Research and Information in Education

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Mander J, Blanck P, Neubauer AB, Kröger P, Flückiger 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Practice Quality-Mindfulness to patients (PQ-M)	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
Other	Credibility/Expectancy Questionnaire (CEQ)	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
Other	Heidelberg Inventory of Cognitive-Behavioral Interventions (HICBI)	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
Other	Therapist Presence Inventory (TPI)	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
Other	Adherence scale (Ad-S)	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
Primary	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	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.	measured for 24 weeks on weekly basis at the end of each session (session duration is 50 minutes), starting on first treatment day
Secondary	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.	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	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.	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	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.	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	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.	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	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.	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	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	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