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

NCT07685483 | Recruiting

• 1 other identifier: 2025-A02244-45
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity & Overweight; Eating Disorders; Bariatric Surgery; Obesity (Disorder)

Keywords

Obesity; Eating Disorders; Bariatric Surgery; Dramatherapy; Art Therapy; Adapted Physical Activity; Body image; Quality of life; Psychosocial Well-Being; Psychosocial intervention; Body Mapping

Outcome Measures

Primary Outcomes (1)

• Change in Quality of Life Assessed by the Échelle Qualité de Vie, Obésité et Diététique / Quality of Life, Obesity and Dietetics Global Score

  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.

  Baseline and end of care 6 weeks, 6 months, 12 months

Secondary Outcomes (10)

• Change in Eating Disorder Screening Score Assessed by the SCOFF Questionnaire

  Baseline, end of care approximately 6 weeks, 6 months, and 12 months

• Change in Eating Behaviors Assessed by the Three-Factor Eating Questionnaire-Revised 18-Item Version

  Baseline, end of care (6 weeks), 6 months, and 12 months

• Change in Body Image-Related Quality of Life Assessed by the Body Image Quality of Life Inventory

  Baseline, end of care (6 weeks), 6 months, and 12 months

• Change in Self-Efficacy Assessed by the General Self-Efficacy Scale

  Baseline, end of care (6 weeks), 6 months, and 12 months

• Change in Depressive Symptoms Assessed by the Beck Depression Inventory-Second Edition

  Baseline, end of care (6 weeks), 6 months, and 12 months

Other Outcomes (4)

• Semi-Structured Interview Themes and Theme Frequencies Related to Treatment Experience and Perceived Change

  Baseline, end of care (6 weeks), 6 months, and 12 months

• Ethnographic Observation Themes and Theme Frequencies Related to Engagement and Group Dynamics

  From baseline through study completion, approximately 12 months

• Participant-Reported Body Mapping Themes Related to Body Perception and Emotional Experience

  Baseline, end of care (6 weeks), 6 months, and 12 months

Study Arms (2)

Adapted Physical Activity

ACTIVE COMPARATOR

Participants allocated to the control group will receive the standard adapted physical activity (APA) program routinely implemented within the obesity care pathway. The intervention consists of 12 supervised sessions over 6 weeks, including cardiovascular exercises, muscle strengthening, and progressive movement activities adapted to the physical capacities and clinical condition of patients with obesity. Sessions are delivered by qualified APA professionals as part of the multidisciplinary obesity and bariatric care program.

Behavioral: Adapted Physical Activity

Adapted Physical Activity + Dramatherapy

OTHER

Participants allocated to the experimental group will receive the standard adapted physical activity (APA) program combined with a complementary dramatherapy intervention. In addition to the 12 supervised APA sessions delivered over 6 weeks, participants will take part in weekly group dramatherapy sessions led by a qualified art therapist. The intervention includes 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, psychosocial well-being, and long-term adherence to care.

Behavioral: Adapted Physical Activity; Behavioral: Dramatherapy

Interventions

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.

Adapted Physical Activity; Adapted Physical Activity + Dramatherapy

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.

Adapted Physical Activity + Dramatherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universite du Littoral Cote d'Opale: lead
• ELSAN Clinic in Saint Omer, France: collaborator

Study Sites (1)

Clinique Elsan de Saint Omer

Blendecques, Hauts-de-France, 62575, France

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Feeding and Eating Disorders

Interventions

Psychodrama

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy, Group; Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Alessandro Porrrovecchio, PhD HDR

  Université du Littoral Cote d'Opale

  PRINCIPAL INVESTIGATOR

• Morgane Carton

  ELSAN Clinic in Saint Omer

  PRINCIPAL INVESTIGATOR

• Ariane Martinez, Full Professor

  Lille University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessandro Porrovecchio, PhD HDR

CONTACT

0033647120423; alessandro.porrovecchio@univ-littoral.fr

Suzanne Vanachter, PhD Student

CONTACT

0033672481842; vanachter.s@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, participants and care providers cannot be blinded to group allocation. However, outcome assessors and data analysts will remain blinded to allocation in order to reduce assessment bias. All physical and questionnaire-based evaluations will be conducted using standardized procedures at each study timepoint.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a monocentric randomized controlled parallel-group study comparing a standardized adapted physical activity (APA) program alone versus APA combined with dramatherapy (DT) in adult patients with obesity enrolled in medical or bariatric care pathways. Randomization is stratified according to care pathway type (medical versus bariatric). Participants are followed longitudinally with assessments conducted at baseline, at the end of care, and at 6- and 12-month follow-up.

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: July 6, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: July 6, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)