Step by Step Group Therapy for Bulimia Nervosa: Effectiveness and Mechanisms of Change.

Not Applicable

Recruiting

• Conditions: Bulimia Nervosa
• Interventions: Behavioral: l Group Therapy for BN.

• Registration Number: NCT06063278
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

This a pseudo-randomized clinical trial that examines if a specific group therapy for BN is effective in improving its symptomatology, and what variables mediate such improvements. To do so a sample of 100 patients with BN will be pseudorandomized in a Group Therapy for BN or in a control waiting list group. Patients will be assessed at baseline, at the end of the group therapy and at 2 year follow up.

Detailed Description

This is a controlled non randomized study that will compare a group of patients with BN that participate in the SBS group therapy with a group of BN patients who will be in wait list as a control condition.

Patients for this single center trial will be recruited from the outpatient facility of the Hospital de la Santa Creu I Sant Pau (Barcelona, Spain).

After assessed for eligibility participants will be given a set of self -report questionnaires. After the questionnaires are completed participants will be allocated to wait list condition or to the treatment arm. Time between assessment and starting the SBS group will be a month or least. Participants will be administered the same questionnaires the following month after finishing the treatment or after 3 to 4 months after the first assessment for the control condition.

Study Timeline

• Study First Submitted: 2022-04-28
• Study Start: 2022-05-06
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-26
• Last Update Submitted: 2023-09-26
• Study First Posted: 2023-10-02
• Last Update Posted: 2023-10-02
• Primary Completion: 2024-05-06
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Diagnostic of Bulimia Nervosa

Exclusion Criteria

• Not understanding Spanish or Catalan Language

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BN Group	l Group Therapy for BN.	Patients will take part of a Therapeutic BN Group

Primary Outcome Measures

Name	Time	Method
Eating Attitudes Test, E-40.	3 months	A self report questionarie that assesses eating disorder symptomatology. The range of scores is 0-78. Higher scores mean higher eating disorders sympthoms.
Bulimic Investigatory Test Edinburgh, BITE	3 months	A self report questionarie that assesses bulimia nervosa symptomatology.The range of scores is 0-30. Higher scores mean higher bulimic sympthoms
Body Shape Questionnaire, BSQ-34	3 months	A self report questionarie that assesses eating disorder symptomatology. The score is ranging between 34-204 points. Higher scores point to an increased level of concern on body shape.
Eating Disorder Inventory, EDI	3 months	A self report questionarie that assesses eating disorder symptomatology. The range of scores is 0-192. Higher scores mean higher eating disorders sympthoms

Secondary Outcome Measures

Name	Time	Method
Working alliance Inventory -short, WAIS.	3 months	A self report questionarie that assesses bulimia nervosa symptomatology. Values range from 12 to 84. Hihger scores meaning higher therapeutic alliance.
Autism-Spectrum Quotient, AQ	3 months	A self report questionarie that assesses autistic traits. The range of scores is 0 to 50. Higher scores mean higher autistic traits.
Rosenberg Self-Esteem Scale, RSE.	3 months	A self report questionarie that assesses self steem. The scale ranges from 0-30. Higher scores mean higher self-esteem. The range scores is 0-60.
Quality of Life Enjoyment and Satisfaction Questionnaire, Q-LES-Q.	3 months	A self report questionarie that assesses quality of life. The range of scores is 0-100. Higher scores mean higher quality of life.
Difficulties in Emotion Regulation Scale (DERS).	3 months	A self report questionarie that assesses emotion regulation difficulties. The scale ranges from 28-40. H igher scores indicate more difficulty in emotion regulation.
State -Trait Anxiety Inventory, STAI.	3 months	A self report questionarie that assesses anxiety. Higher scores mean higher anxiety.
Beck Depression Inventory, BDI-II	3 months	A self report questionarie that assesses depressive symptoatology. The range of scores is 0-83. Higher scores mean higher depressive symptoms.

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain