Trial Details

Not Recruiting
Basic Information
Clinical ID c2190
Identifier ISRCTN24678005
Trial Title Psychodynamic psychotherapy in adolescents and young adults with quiescent inflammatory bowel disease: a randomised clinical trial
Trial URL Visit Original Page
Study Information
Study Results

Yes

Conditions Adolescents and young adults (AYA) with quiescent inflammatory bowel disease (IBD), Crohn's disease (CD) and ulcerative colitis (UC) Digestive System
Interventions On completion of the baseline Information Report Form (IRF), each recruited participant will be randomly allocated to either the treatment or control arm . A data analyst not actively involved in the recruitment process performed the randomization. Randomization will use a 1:1 allocation ratio and will follow a computer-generated randomization sequence that will be generated using Stata version 17 or later. Participants randomized to the STPP intervention group will receive structured individual therapy delivered by a psychodynamic psychotherapist with advanced post-graduate training based in the outpatient clinic, with weekly briefing sessions to disclose difficulties perceived by the patients/therapists or define additional treatment adaptations. Eight 50-60-minute weekly sessions over a period of 8 weeks will be offered. The sessions will be delivered face-to-face and based in the outpatient clinic. The intervention was developed specifically for this project and was based on psychodynamic principles and adapted for the psychosocial needs of individuals with IBD. To ensure the trustworthiness of the intervention, two psychodynamic psychotherapists with advanced post-graduate training performed all interventions. Participants in the control group will receive a tandard medical therapy consisting of the continuation of the current medical therapy and regular medical consultations of 150 min with the (paediatric) gastroenterologist every 3 months, in which overall well-being, disease activity, and future diagnostic/treatment plans were discussed. The study's primary outcome is remission maintenance: the proportion of participants with steroid-free remission at week 52 (1 year) be
Participant Information
Sponsor Bambino Ges鈭毾€ Children's Hospital
City -
Country/Region Italy
Enrollment Criteria
Sex Requirement ALL
Age Requirement -
Study Design
Study Type Interventional
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date 2022-12-15