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Short-term, Long-term and Cost-effectiveness of Treating Depression and Anxiety Disorders in Children and Adolescents

NCT ID: NCT03333239

Last Updated: 2017-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-22

Study Completion Date

2023-08-31

Brief Summary

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The current study will evaluate and compare the effectiveness of cognitive-behavioral and psychodynamic therapy. Therefore 420 children and adolescents (ages 8-16 years) with depression and/or anxiety disorder will be randomly assigned to a treatment or a control condition. The intervention´s short-term effectiveness and sustainability as well as cost-effectiveness will be examined over a 5 year period for each participant.

Detailed Description

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This study aims to optimize patient-centered care and to ensure scientific and legal approval of cognitive-behavioral and psychodynamic therapy for children and adolescents in the German health-care system. This prospective, randomized and controlled trial will therefore compare psychodynamic and cognitive behavioral therapy with a low-frequency family intervention (control intervention) for children and adolescents with depression and anxiety disorder. Number of diagnoses or fulfilled diagnostic criteria - diagnosed by a trained psychologist who is blind for treatment condition - will be the primary outcome. Secondary outcomes are patients´ and parents´ strain caused by symptoms, patients´ quality of life, global and family functioning and treatments´ cost effectiveness are secondary outcomes.

Patients will be recruited at the end of an inpatient hospital stay in northern Germany (Hamburg and Bremen) in two clinics for child and adolescent psychiatry and in surgery. After gathering informed consent from parents and patients, the latter will be randomly assigned to one type of outpatient treatment (psychodynamic, cognitive behavioral therapy or family intervention). Psychodynamic and cognitive-behavioral therapy as well as the control intervention will be provided manual-based. Treatment sessions will be audio recorded to control adherence.

Data will be collected annually over a period of five years starting at the beginning of treatment. This allows examination of varying treatment intervals as well as the sustainability and health economics of therapy effects.

To analyze data, comparisons of means will be performed. Groupwise analyses of interaction will be performed for inferential testing of differences in subgroups. Differences in therapy effects will be inferentially analyzed by multifactor analysis of covariance, analysis of variance or logistic regression. Interaction effects and predicting variables are of special interest.

In a Subsample of 32 depressive adolescents (ages 13-16) patients expectations before and experiences whilst therapy will be analyzed by a mixed-methods-approach.

Conditions

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Depression, Anxiety

Keywords

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childhood and adolescence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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psychodynamic psychotherapy

Group Type EXPERIMENTAL

psychodynamic psychotherapy

Intervention Type BEHAVIORAL

the intervention follows the published in german manual: Psychoanalytische Behandlung von Kindern und Jugendlichen mit Angststörungen und Depressionen: Behandlungsmanual (Baumeister-Duru, Hofmann, Timmermann \& Wulf, 2013)

cognitive behavioral psychotherapy

Group Type EXPERIMENTAL

cognitive behavioral psychotherapy

Intervention Type BEHAVIORAL

the interventions follow the published in german manuals: Depression (Ihle, Groen, Walter, Esser, \& Petermann, 2012) and Soziale Ängste und Leistungsängste (Büch, Döpfner, \& Petermann, 2015)

psychodynamic family intervention

Group Type ACTIVE_COMPARATOR

psychodynamic family intervention

Intervention Type BEHAVIORAL

the intervention follows an adapted version of the manual: Chimp´s - Children of mentally ill parents (Wiegand-Gefe, Halverscheid, \& Plass, 2011)

Interventions

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psychodynamic psychotherapy

the intervention follows the published in german manual: Psychoanalytische Behandlung von Kindern und Jugendlichen mit Angststörungen und Depressionen: Behandlungsmanual (Baumeister-Duru, Hofmann, Timmermann \& Wulf, 2013)

Intervention Type BEHAVIORAL

cognitive behavioral psychotherapy

the interventions follow the published in german manuals: Depression (Ihle, Groen, Walter, Esser, \& Petermann, 2012) and Soziale Ängste und Leistungsängste (Büch, Döpfner, \& Petermann, 2015)

Intervention Type BEHAVIORAL

psychodynamic family intervention

the intervention follows an adapted version of the manual: Chimp´s - Children of mentally ill parents (Wiegand-Gefe, Halverscheid, \& Plass, 2011)

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* diagnosis of a depressive disorder (ICD-10; F30-F39) or an anxiety disorder (ICD-10; F40-F42)
* informed consent
* ages 8 to 16 years

Exclusion Criteria

* psychotic disorders, eating disorders, substance use related disorders (except caffeine and nicotine), autism spectrum disorders, mutism, personality disorders
* neurologic disorders
* severe mental retardation (filling out questionnaires and interview are not feasible)
* low command of the german language
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bremen

OTHER

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Silke Wiegand-Grefe, Prof. Dr.

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Silke Wiegand-Grefe, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

UKE Universitätsklinikum Hamburg-Eppendorf

Central Contacts

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Silke Wiegand-Grefe, Prof. Dr.

Role: CONTACT

Phone: +49-40-741053603

Email: [email protected]

Antje Masemann, M. Sc.

Role: CONTACT

Phone: +49-40-741052633

Email: [email protected]

Other Identifiers

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vakjp_2

Identifier Type: -

Identifier Source: org_study_id