Psychotherapy in paediatric patients with quiescent inflammatory bowel disease
| ISRCTN | ISRCTN24678005 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24678005 |
| Secondary identifying numbers | 2857 |
- Submission date
- 07/04/2023
- Registration date
- 14/04/2023
- Last edited
- 04/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Inflammatory bowel diseases (IBD) are chronic and pervasive conditions of the gastrointestinal tract with a rising incidence in paediatric and young adult populations. Evidence suggests that psychological disorders might be associated with relapse of disease activity. This study aims to evaluate the effectiveness of Brief Psychodynamic Psychotherapy in addition to standard medical therapy (SMT) in maintaining clinical remission in adolescents and young adults with quiescent (inactive) IBD, compared to SMT alone.
Who can participate?
Patients aged 11 to 21 years with quiescent IBD
What does the study involve?
Participants are randomly allocated into two groups: the first group completes eight sessions of psychotherapy in addition to their current medical treatment, and the second group continues their current medical therapy. The rate of youths who have quiescent disease is measured 1 year later.
What are the possible benefits and risks of participating?
Possible benefits include prolonged times of remission of the disease and fewer hospitalizations. There are no risks to the participants.
Where is the study run from?
Bambino Gesù Children's Hospital (Italy)
When is the study starting and how long is it expected to run for?
September 2019 to December 2022
Who is funding the study?
Bambino Gesù Children's Hospital (Italy)
Who is the main contact?
Dr Francesco Milo, francesco.milo@opbg.net (Italy)
Contact information
Public
Bambino Gesù Children's Hospital
Piazza S. Onofrio 4
Rome
00165
Italy
 ORCID ID |
0000-0003-2746-4086 |
|---|---|
| Phone | +39 (0)668592228 |
| francesco.milo@opbg.net |
Principal Investigator
Bambino Gesù Children's Hospital
Piazza S. Onofrio 4
Rome
00165
Italy
| ORCID ID |
0000-0002-2146-4176 |
|---|---|
| Phone | +39 (0)668592228 |
| paola.tabarini@opbg.net |
Study information
| Study design | Single-centre two-arm interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital, Medical and other records |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Psychodynamic psychotherapy in adolescents and young adults with quiescent inflammatory bowel disease: a randomised clinical trial |
| Study objectives | It is hypothesized that psychodynamic psychotherapy + Standard Medical Therapy would be superior to Standard Medical Therapy alone |
| Ethics approval(s) | Approved 06/07/2022, Ethics Committee Bambino Gesù Children's Hospital (Piazza S. Onofrio 4, 00165, Rome, Italy; +39 (0)6 6859 2572 – 3580; comitato.etico@opbg.net), ref: 2857_OPBG_2022 |
| Health condition(s) or problem(s) studied | Adolescents and young adults (AYA) with quiescent inflammatory bowel disease (IBD), Crohn's disease (CD) and ulcerative colitis (UC) |
| Intervention | 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 “standard medical therapy”, consisting of the continuation of the current medical therapy and regular medical consultations of 15–30 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) between the two treatment groups. Disease activity is measured according to the PCDAI score for patients with CD and the PUCAI score for those with UC. Active disease is defined as a score ≥ 10 on PCDAI / PUCAI scores and the presence of levels of elevated inflammatory markers (e.g. C-reactive protein levels ≥ 8 mg/L and faecal calprotectin level ≥75 µg/g) combined with endoscopic inflammatory findings. A paediatric gastroenterologist, who is blinded about participants' allocation, performed disease activity assessment by reviewing patients' electronic health records. The study's secondary outcomes comprise the assessment of healthcare utilization between the two groups, using the frequency of hospitalizations over the next 52 weeks after baseline and adherence to medication. Participants are labelled "adherent" if they follow all prescribed medication in the period of 52 weeks after baseline; otherwise, they are labelled "non-adherent". The difference in adherence is evaluated by comparing the proportion of "adherent" and "non-adherent" patients between the two groups. |
| Intervention type | Behavioural |
| Primary outcome measure | Remission maintenance: the proportion of participants with steroid-free remission defined by disease activity and measured using the Pediatric Crohn's Disease Activity Index (PCDAI) score for patients with CD and the Pediatric Ulcerative Colitis Activity Index (PUCAI) score for those with UC from baseline to week 52 |
| Secondary outcome measures | 1. Healthcare utilization measured using the frequency of hospitalizations recorded in patient medical records from baseline to week 52 2. Adherence to medication measured by quantifying adherent and non-adherent participants recorded in patient medical records from baseline to week 52 |
| Overall study start date | 01/09/2019 |
| Completion date | 15/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 11 Years |
| Upper age limit | 21 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | 1. IBD patients aged between 11 and 21 years old 2. Able to read, write, and speak Italian language 3. Without expectation of surgery in the upcoming 3 months |
| Key exclusion criteria | 1. Severe cognitive, neurological and psychiatric co-occurring conditions that could interfere with patients' participation 2. Inability to provide informed consent and receiving psychological treatment or psychotropic medication at the time of recruitment (or other psychotropic medication <2 years before recruitment) |
| Date of first enrolment | 09/09/2021 |
| Date of final enrolment | 09/12/2021 |
Locations
Countries of recruitment
- Italy
Study participating centre
Roma
00165
Italy
Sponsor information
Hospital/treatment centre
Piazza S. Onofrio 4
Rome (Vatican City State)
00165
Italy
| Phone | +39 (0)6 6859 2572 – 3580 |
|---|---|
| comitato.etico@opbg.net | |
| Website | https://www.ospedalebambinogesu.it/ |
"ROR" |
https://ror.org/02sy42d13 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Other non-profit organizations
- Alternative name(s)
- Bambino Gesù Children's Hospital, Baby Jesus Paediatric Hospital, Bambino Gesù Pediatric Hospital, Bambino Gesù Children's Hospital of Rome, Pediatric Hospital Bambino Gesù, Bambino Gesù Hospital, OPBG
- Location
- Italy
Results and Publications
| Intention to publish date | 15/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon reasonable request from Francesco Milo (francesco.milo@opbg.net) The type of data that will be shared: anonymized raw data in the Excel file Timing for availability: 4 weeks Whether consent from participants was required and obtained: prior to recruitment during outpatients’ visits Comments on data anonymization: data were anonymized and the file was encrypted before all data analysis |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 24/08/2023 | 03/01/2024 | Yes | No | |
| Basic results | 04/01/2024 | 04/01/2024 | No | No |
Additional files
Editorial Notes
04/01/2024: Basic results uploaded.
03/01/2024: Publication reference added.
14/04/2023: Trial's existence confirmed by the Ethics Committee Bambino Gesù Children's Hospital.
