Clinical trial NCT03333239: Short-term, Long-term and Cost-effectiveness of Treating Depression and Anxiety Disorders in Children and Adolescents
Official title: Short-term, Long-term and Cost-effectiveness of Treating Depression and Anxiety Disorders in Children and Adolescents - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression, Anxiety
Keywords: childhood and adolescence
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
Collaborators: name: University of Bremen
First posted: 2017-11-06
Enrollment: 420
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline children´s psychiatric symptomatology at 12 months
timeFrame: baseline and 12 months
measure: Change from baseline children´s psychiatric symptomatology at 24 months
timeFrame: baseline and 24 months
measure: Change from baseline children´s psychiatric symptomatology at 36 months
timeFrame: baseline and 36 months
measure: Change from baseline children´s psychiatric symptomatology at 48 months
timeFrame: baseline and 48 months
measure: Change from baseline children´s psychiatric symptomatology at 60 months
timeFrame: baseline and 60 months
Secondary outcomes:
measure: Change from baseline children´s depressive symptomatology at 12 months
timeFrame: baseline and 12 months
measure: Change from baseline children´s depressive symptomatology at 24 months
timeFrame: baseline and 24 months
measure: Change from baseline children´s depressive symptomatology at 36 months
timeFrame: baseline and 36 months
measure: Change from baseline children´s depressive symptomatology at 48 months
timeFrame: baseline and 48 months
measure: Change from baseline children´s depressive symptomatology at 60 months
timeFrame: baseline and 60 months
measure: Change from baseline children´s anxiety at 12 months
timeFrame: baseline and 12 months
measure: Change from baseline children´s anxiety at 24 months
timeFrame: baseline and 24 months
measure: Change from baseline children´s anxiety at 36 months
timeFrame: baseline and 36 months
measure: Change from baseline children´s anxiety at 48 months
timeFrame: baseline and 48 months
measure: Change from baseline children´s anxiety at 60 months
timeFrame: baseline and 60 months
measure: Change from baseline parent reported children´s psychiatric symptoms at 12 months
timeFrame: baseline and 12 months
measure: Change from baseline parent reported children´s psychiatric symptoms at 24 months
timeFrame: baseline and 24 months
measure: Change from baseline parent reported children´s psychiatric symptoms at 36 months
timeFrame: baseline and 36 months
measure: Change from baseline parent reported children´s psychiatric symptoms at 48 months
timeFrame: baseline and 48 months
measure: Change from baseline parent reported children´s psychiatric symptoms at 60 months
timeFrame: baseline and 60 months
measure: Change from baseline children´s self reported psychiatric symptoms at 12 months
timeFrame: baseline and 12 months
measure: Change from baseline children´s self reported psychiatric symptoms at 24 months
timeFrame: baseline and 24 months
measure: Change from baseline children´s self reported psychiatric symptoms at 36 months
timeFrame: baseline and 36 months
measure: Change from baseline children´s self reported psychiatric symptoms at 48 months
timeFrame: baseline and 48 months
measure: Change from baseline children´s self reported psychiatric symptoms at 60 months
timeFrame: baseline and 60 months
measure: Change from baseline children´s structural functioning at 12 months
timeFrame: baseline and 12 months
measure: Change from baseline children´s structural functioning at 24 months
timeFrame: baseline and 24 months
measure: Change from baseline children´s structural functioning at 36 months
timeFrame: baseline and 36 months
measure: Change from baseline children´s structural functioning at 48 months
timeFrame: baseline and 48 months
measure: Change from baseline children´s structural functioning at 60 months
timeFrame: baseline and 60 months
measure: Change from baseline children´s health related quality of life at 12 months
timeFrame: baseline and 12 months
measure: Change from baseline children´s health related quality of life at 24 months
timeFrame: baseline and 24 months
measure: Change from baseline children´s health related quality of life at 36 months
timeFrame: baseline and 36 months
measure: Change from baseline children´s health related quality of life at 48 months
timeFrame: baseline and 48 months
measure: Change from baseline children´s health related quality of life at 60 months
timeFrame: baseline and 60 months
measure: Change from baseline children´s global impairment at 12 months
timeFrame: baseline and 12 months
measure: Change from baseline children´s global impairment at 24 months
timeFrame: baseline and 24 months
measure: Change from baseline children´s global impairment at 36 months
timeFrame: baseline and 36 months
measure: Change from baseline children´s global impairment at 48 months
timeFrame: baseline and 48 months
measure: Change from baseline children´s global impairment at 60 months
timeFrame: baseline and 60 months
measure: Change from baseline relational functioning at 12 months
timeFrame: baseline and 12 months
measure: Change from baseline relational functioning at 24 months
timeFrame: baseline and 24 months
measure: Change from baseline relational functioning at 36 months
timeFrame: baseline and 36 months
measure: Change from baseline relational functioning at 48 months
timeFrame: baseline and 48 months
measure: Change from baseline relational functioning at 60 months
timeFrame: baseline and 60 months
measure: Change from baseline children´s global functioning at 12 months
timeFrame: baseline and 12 months
measure: Change from baseline children´s global functioning at 24 months
timeFrame: baseline and 24 months
measure: Change from baseline children´s global functioning at 36 months
timeFrame: baseline and 36 months
measure: Change from baseline children´s global functioning at 48 months
timeFrame: baseline and 48 months
measure: Change from baseline children´s global functioning at 60 months
timeFrame: baseline and 60 months
measure: Change from baseline health economic data at 12 months
timeFrame: baseline and 12 months
measure: Change from baseline health economic data at 24 months
timeFrame: baseline and 24 months
measure: Change from baseline health economic data at 36 months
timeFrame: baseline and 36 months
measure: Change from baseline health economic data at 48 months
timeFrame: baseline and 48 months
measure: Change from baseline health economic data at 60 months
timeFrame: baseline and 60 months
Other outcomes:
Locations:
Study officials:
affiliation: UKE Universitätsklinikum Hamburg-Eppendorf
name: Silke Wiegand-Grefe, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: