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Mindfulness and Relaxation Interventions in Individual Psychotherapies for Children and Adolescents

Not Applicable
Completed
Conditions
Depressive Disorder
Anxiety Disorder
Hyperkinetic Disorder
Interventions
Behavioral: Cognitive behavior therapy of trainee therapists
Registration Number
NCT04034576
Lead Sponsor
Heidelberg University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
90
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Treatment as usualCognitive behavior therapy of trainee therapistsStandard 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.
TAU + mindfulness interventionCognitive behavior therapy of trainee therapistsThe 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.
TAU + relaxation interventionCognitive behavior therapy of trainee therapistsThe 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.
Primary Outcome Measures
NameTimeMethod
Changes in Youth Self-Report 11-18 R (YSR 11-18 R)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.

Secondary Outcome Measures
NameTimeMethod
Kentucky Inventory of Mindfulness Skills (KIMS-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

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

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

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.

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

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.

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

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.

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

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.

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 symptomson 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.

Diagnostic System for Mental Disorders in Childhood and Adolescence (DISYPS-III), problem scales of the anxiety self-rating scale (SBB-ANG)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.

Trial Locations

Locations (1)

Heidelberg University

🇩🇪

Heidelberg, Germany

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