iCBT for Children and Adolescents With Obsessive-compulsive Disorder II

University Hospital Tuebingen

Status: Completed

Conditions: Psychotherapy Intervention Evaluation

Treatments: Behavioral: Cognitive-behavioral psychotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05037344

AZ 53-5400.1-004/44

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 60 patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children and adolescents (ages 6-18) with a primary DSM-5 obsessive-compulsive disorder and at least 1 primary caretaker
• German-speaking (child & caretakers)
• Family home equipped with broadband connection and appropriate computer, monitor, HD webcam, and speaker and smart phone
• written informed content of the child and his caretaker
• OCD as highest treatment priority

Exclusion criteria

• IQ below 70
• not speaking and understanding German
• A psychiatric comorbidity that makes participation clinically inappropriate (for example, primary anorexia nervosa), depression with suicidality, psychosis or any other psychiatric disorder that requires acute treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Internet-based psychotherapy

Experimental group

Description:

16 weeks of internet-based cognitive behavioral therapy

Treatment:

Behavioral: Cognitive-behavioral psychotherapy

Internet-based psychotherapy waiting group

Active Comparator group

Description:

16 weeks of internet-based cognitive bahavioral therapy after waiting of 16 weeks

Treatment:

Behavioral: Cognitive-behavioral psychotherapy