Health TrialsbyHealthPanel

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

ConditionsObesity (Disorder)Obesity & OverweightEating DisordersBariatric Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversite du Littoral Cote d'Opale

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: Adapted Physical ActivityActive comparator 1 intervention
Group B: Adapted Physical Activity + DramatherapyOther 2 interventions

Trial outcomes

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.

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

Secondary outcomes

1

Change in Eating Disorder Screening Score Assessed by the SCOFF Questionnaire

Eating disorder screening indicators will be assessed using the Sick, Control, One Stone, Fat, Food questionnaire (SCOFF). The SCOFF total score ranges from 0 to 5, with higher scores indicating more eating disorder screening indicators and a higher risk of eating disorders or problematic eating behaviors. A score of 2 or more is commonly considered indicative of possible eating disorder risk requiring further clinical assessment.

Time frame
Baseline, end of care approximately 6 weeks, 6 months, and 12 months
2

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

Eating behaviors will be assessed using the Three-Factor Eating Questionnaire-Revised 18-item version (TFEQ-R18). The TFEQ-R18 assesses three dimensions of eating behavior: cognitive restraint, uncontrolled eating, and emotional eating. Each subscale score is transformed to a 0-100 scale. Higher scores indicate a higher level of the corresponding eating behavior: greater cognitive restraint, greater uncontrolled eating, or greater emotional eating.

Time frame
Baseline, end of care (6 weeks), 6 months, and 12 months
3

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

Body image-related quality of life will be assessed using the Body Image Quality of Life Inventory (BIQLI). The BIQLI is a 19-item self-report questionnaire assessing the impact of body image on different areas of daily life and psychosocial well-being. Each item is scored from -3 to +3. The global mean score ranges from -3 to +3, with higher scores indicating a more positive impact of body image on quality of life and therefore a better outcome.

Time frame
Baseline, end of care (6 weeks), 6 months, and 12 months
4

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

Self-efficacy will be assessed using the General Self-Efficacy Scale (GSES). The GSES is a 10-item self-report questionnaire evaluating participants' perceived ability to cope with difficult situations and maintain behavioral changes related to health, physical activity, and eating behaviors. Each item is scored from 1 to 4, and the total score ranges from 10 to 40. Higher scores indicate higher perceived self-efficacy and therefore a better outcome.

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

Other outcomes

1

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

Participants will take part in semi-structured interviews exploring their lived experiences of obesity, body image, eating behaviors, psychosocial well-being, and engagement with adapted physical activity and dramatherapy interventions. Interviews will be audio-recorded, transcribed, and analyzed using thematic content analysis in order to identify psychosocial and behavioral factors associated with treatment experience and perceived changes over time.

Time frame
Baseline, end of care (6 weeks), 6 months, and 12 months
2

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

Ethnographic observation will be conducted during adapted physical activity and dramatherapy sessions to explore participants' engagement, emotional expression, social interaction, body-related behaviors, and group dynamics. Observations will be documented in structured field notes and analyzed thematically. This qualitative outcome will identify themes related to the psychosocial experience of the interventions and will not be reported as a numerical score.

Time frame
From baseline through study completion, approximately 12 months
3

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

Body mapping techniques will be used as creative and visual elicitation tools to explore participants' body perception, emotional experiences, relationship to obesity, and perceived bodily changes throughout the care pathway. Visual productions and associated narratives will be analyzed using thematic and interpretative approaches.

Time frame
Baseline, end of care (6 weeks), 6 months, and 12 months
4

Identity Box Themes and Theme Frequencies Related to Psychosocial Identity and Perceived Change

Identity boxes will be used as a qualitative elicitation tool to explore participants' experiences of body image, obesity, eating behaviors, psychosocial identity, and therapeutic trajectory. Participants will be invited to select, bring, or create personal objects that support narrative expression during interviews. The objects and associated narratives will be analyzed together as an integrated qualitative dataset using thematic analysis. This qualitative outcome will identify themes related to meaning-making processes and psychosocial changes over time and will not be reported as a numerical score.

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universite du Littoral Cote d'Opale

Lead sponsor

ELSAN Clinic in Saint Omer, France

Collaborator

Source ClinicalTrials.gov
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