Dramatherapy for Psychological and Social Well-Being in Obesity and Bariatric Care
Recruiting · NCT07685483 · Interventional (participants receive a specific treatment) · Lead sponsor: Universite du Littoral Cote d'Opale
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Obesity is currently a major public health challenge in France, particularly in the Hauts-de-France region, where prevalence exceeds 20% of the adult population. Bariatric surgery has considerably increased over the last two decades and is now recognized as an effective therapeutic option within a multidisciplinary care pathway. However, many patients continue to experience difficulties related to body image, emotional regulation, problematic eating behaviors, and long-term adherence to adapted physical activity (APA), which may limit the sustainability of treatment benefits. International literature highlights the importance of integrating psychological and psychosocial support alongside medical, nutritional, and physical interventions. This monocentric randomized controlled trial aims to evaluate the effects of adding dramatherapy (DT) to a standardized APA program in adult patients with obesity enrolled in medical or bariatric care pathways at the Institut de l'Obésité of Clinique ELSAN Saint-Omer (France). Participants will be randomized to receive either standard APA alone or APA combined with DT. The intervention is designed to improve emotional expression, body perception, self-confidence, psychosocial well-being, and long-term adherence to care. Dramatherapy sessions will include theatrical expression, role play, improvisation, relaxation, and body-oriented creative exercises adapted to patients with obesity. The primary objective is to evaluate the effect of DT on quality of life at the end of care, compared with APA alone, using the French version of the EQVOD questionnaire. Secondary objectives include the evaluation of eating behaviors and problematic eating regulation (TFEQ-R18, SCOFF), body image and body-related quality of life (BIQLI), self-efficacy (GSES), anxiety and depressive symptoms (BDI-II), adherence to APA programs, and anthropometric parameters such as body mass index, abdominal circumference, and body composition. Assessments will be conducted at baseline, at the end of the intervention, and at 6- and 12-month follow-up. The study also includes a complementary qualitative component based on semi-structured interviews, ethnographic observation, body mapping, and identity boxes in order to explore patients' subjective experiences, psychosocial trajectories, and perceived impact of the intervention. Quantitative and qualitative data will be analyzed using a mixed-methods approach. A total of 250 participants are expected to be included. This study seeks to provide evidence regarding the potential added value of integrating dramatherapy into obesity and bariatric care pathways.
Who can take part
Inclusion criteria
- Age 18 years or older.
- Body mass index (BMI) ≥ 40 kg/m², or BMI ≥ 35 kg/m² with obesity-related comorbidities, or BMI ≥ 30 kg/m² with associated eating disorders or problematic eating behaviors.
- Enrollment in a medical or bariatric care pathway at the Institut de l'Obésité, Clinique ELSAN Saint-Omer, including a therapeutic education program with adapted physical activity.
- Availability and willingness to complete the planned study procedures and follow-up assessments.
- Written informed consent provided after complete information about the study.
- Affiliation to a social security system.
Exclusion criteria
- Major medical contraindications to adapted physical activity or group sessions, including unstable cardiovascular disease or severe non-compensable locomotor limitations.
- Severe psychiatric disorders or severe unstable eating disorders contraindicating bariatric surgery or preventing adequate participation in group sessions.
- Major cognitive impairment or neuropsychological disorders preventing understanding of instructions or completion of assessments.
- Unstable medical treatment or recent therapeutic modification likely to significantly affect body weight, fatigability, or mental health.
- Inability to complete the full study protocol, including prolonged unavailability or planned relocation outside the region.
- Refusal or inability to provide informed consent.
- Major logistical barriers preventing access to the intervention site without feasible alternative arrangements.
- Participation in a structured adapted physical activity program within the 3 months preceding inclusion.
Where it is running
1 location listed.
- Clinique Elsan de Saint Omer - Blendecques, Hauts-de-France, France