Clinical trial

Dramatherapy for Psychological and Social Well-Being in Obesity and Bariatric Care

Recruiting now · Not applicable · 1 countries · Registry ID NCT07685483

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity (Disorder), Obesity & Overweight, Eating Disorders, Bariatric Surgery

Full registry criteria

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.

Treatments and study arms

Adapted Physical Activity

Behavioral

Standardized supervised adapted physical activity program including cardiovascular exercises, muscle strengthening, and progressive movement activities adapted to patients with obesity. The program consists of 12 sessions delivered over 6 weeks by qualified APA professionals.

Dramatherapy

Behavioral

Group dramatherapy intervention including theatrical expression, role play, improvisation, breathing and relaxation exercises, body-oriented creative activities, and collective interaction aimed at improving emotional expression, body image, self-confidence, and psychosocial well-being.

Primary outcomes

Change in Quality of Life Assessed by the Échelle Qualité de Vie, Obésité et Diététique / Quality of Life, Obesity and Dietetics Global ScoreBaseline and end of care 6 weeks, 6 months, 12 months

Quality of life will be assessed using the global score of the French version of the Échelle Qualité de Vie, Obésité et Diététique (EQVOD), also known as the Quality of Life, Obesity and Dietetics (QOLOD) rating scale. The EQVOD/QOLOD is an obesity-specific quality-of-life questionnaire. Scores are transformed to a 0-100 scale, with higher scores indicating better health-related quality of life. The primary endpoint is the between-group difference in EQVOD/QOLOD global score at the end of care, adjusted for baseline values. In the absence of a validated minimal clinically important difference for this population, a distribution-based approach will be used, considering a difference of 0.5 standard deviation in the global score as clinically meaningful.

Study locations

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Clinique Elsan de Saint Omer🇫🇷 Blendecques, Hauts-de-France, France

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Morgane CartonContact

Email · Call 00 33 3 91 92 50 10

Suzanne Vanachter, PhD StudentContact

Email · Call 0033672481842