Depression, Anxiety Clinical Trial
Official title:
Short-term, Long-term and Cost-effectiveness of Treating Depression and Anxiety Disorders in Children and Adolescents - a Randomized Controlled Trial
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.
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.
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