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

Universitätsklinikum Hamburg-Eppendorf

Status: Unknown

Conditions: Depression, Anxiety

Treatments: Behavioral: psychodynamic psychotherapy; Behavioral: psychodynamic family intervention; Behavioral: cognitive behavioral psychotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03333239

vakjp_2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 420 estimated patients

Sex: All

Ages: 8 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

---

420 participants in 3 patient groups

psychodynamic psychotherapy

Experimental group

Treatment:

Behavioral: psychodynamic psychotherapy

cognitive behavioral psychotherapy

Experimental group

Treatment:

Behavioral: cognitive behavioral psychotherapy

psychodynamic family intervention

Active Comparator group

Treatment:

Behavioral: psychodynamic family intervention