Internet-based psychotherapy for children and adolescents with obsessive-compulsive symptoms and an age of 6 to 18 years. Sessions are verified with teleconferencing with an psychotherapist, children and their parents. The psychotherapy is supported by an App and a wristband to obtain psychophysiological data. The investigators have already successfully performed a feasibility study.The goal of the current proposal is to develop an internet and smart phone delivered CBT (iCBT) for the treatment of pediatric OCD on the bases of the feasibility study. Internal testing on iCBT therapy package and developmental workchanges has been done. The investigators are now evaluating effectiveness in an RCT.
In this study the investigators test effectiveness of an internet-based therapy approach for children with obsessive-compulsive disorders in an RCT design with a waiting control group. The investigators are planninng the investigation of 20 patients in each group.Therapy is verified by experts via teleconferences and a therapy app. Outcomes for the treatment group are evaluated before randomization (baseline, t0), 16 weeks (end of treatment, t1), 32 weeks (follow-up 1, t2), and 48 weeks after randomization (follow-up 2, t3). For the waiting list-group, outcomes are measured before the first randomization (baseline), at 16 weeks (waiting list period), 32 weeks (end of treatment), 48 weeks after the first randomization (follow-up I) and 64 weeks after the first randomization (follow-up II).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
The goal is to develop an internet and smart phone delivered CBT (iCBT) for the treatment of pediatric OCD on the bases of our feasibility study. This group will start directly with therapy of 16 weeks. The waiting group gets the same intervention after 16 weeks of waiting.
University Hospital Tuebingen
Tübingen, Germany
Change in Schedule for Affective Disorders and Schizophrenia for School-Age Children Present and Lifetime Version (K-SADS-PL)
Clinical interview for psychiatric disorders for children and parents.
Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Interview/questionnaire for obsessive-compusive disorders.
Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Children's Global Assessment Scale (CGAS)
The CGAS is a measure of level of functioning in children and adolescents.
Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Child Behavior Checklist (CBCL/6-18R)
A 113-item 3-point questionnaire for parents that assesses a wide range of child behavioral and emotional problems.
Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents (KINDL)
A 24 item 5 point scale self-report questionnaire for children and parents to quality of life.
Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Child Obsessive Compulsive Disorder Impact Scale (COIS-RC)
A 33-item self-report questionnaire to the impact of OCD symptoms on the psychosocial functioning of the children.
Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Youth Self-Report (YSR/11-18R)
A 112 item 3-point scale completed by the children themselves and addresses a variety of behavioral and emotional problems.
Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Depression Inventory for Children and Adolescents (DIKJ)
The questionnaire measures depressive symptoms in the children. It has 26 items and a 4 point scale.
Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Junior temperament and character inventory (JTCI)
The questionnaire assesses temperament characteristics with 103/86 items and a 5-point scale.
Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Screen for Child Anxiety Related Emotional Disorders (SCARED)
The SCARED assesses DSM-IV anxiety symptoms.
Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Clinical Global Impressions-Severity (CGI-S)
A clinical 7-point rating scale of symptom severity.
Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Clinical Global Impressions-Improvement (CGI-I)
A clinical 7-point rating scale of symptom severity.
Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Impairment by OCD symptoms
Children and parents indicate impairment by OCD via app.
Time frame: Every day throughout the therapy process
Change in Extend of avoidance behavior
Children and parents indicate extend of avoidance behavior via app.
Time frame: Every day throughout the therapy process
Change in Daily mood
Children indicate their mood via app.
Time frame: Every day throughout the therapy process
Change in How the day has been
Children indicate how good the day has been via app.
Time frame: Every day throughout the therapy process
Change in How strong OCD is
Children and parants indicate how strong OCD is via app.
Time frame: Every day throughout the therapy process
Change in How the week has been
Children and parants indicate how the week has been via app.
Time frame: weekly throughout the therapy process
Change in Anxiety ratings during exposures
Children indicate how high anxiety was during exposures via app.
Time frame: Every exposure throughout the therapy process
Change in Heart rate variability
Heart rate variability as an indicator of stress levels is assessed with wristbands.
Time frame: Every day throughout the therapy process
Change in time the OCD takes
Children and parants indicate how much time OCD takes via app.
Time frame: Every day throughout the therapy process
Change in HEXACO- Personality Inventory-Revised (HEXACO-PI-R)
This questionnaire assesses the core personality traits of children.
Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in Engagement- Fragebogen
Questionnaire for emotional, cognitive and behavioral engagement at school with 5 items each.
Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
Change in How convinced the patient of his/her OCD thoughts is
assessed by App
Time frame: every exposure
Change in Ulmer Life Quality Inventory for parents of chronically ill children(ULQIE)
Questionnaire to life quality of parents related to the impairment through the illness of the child.
Time frame: baseline,16 weeks, 32 weeks, 48 weeks, 64 weeks
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