iCBT for Children and Adolescents With Obsessive-compulsive Disorder II

U

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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