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

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.

Study Overview

• Status: Recruiting
• Conditions: Bulimia Nervosa
• Intervention / Treatment: Behavioral: l Group Therapy for BN.

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cristina Carmona, PhD; Phone Number: +34935537761; Email: ccarmonaf@santpau.cat

Study Locations

• Spain
  • Barcelona, Spain, 08041
    • Recruiting
    • Hospital de la Santa Creu i Sant Pau
    • Contact: Cristina Carmona, Phd; Phone Number: 650003427; Email: ccarmonaf@santpau.cat
    • Contact: Cristina Carmona, Phd; Phone Number: +34935537813; Email: CDelgadoE@santpau.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnostic of Bulimia Nervosa

Exclusion Criteria:

• Not understanding Spanish or Catalan Language

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BN Group; Patients will take part of a Therapeutic BN Group	Behavioral: l Group Therapy for BN.; 9 to 10 group sessions of 90 to 120min each
No Intervention: Waiting List; Participants will be in the waiting list.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eating Attitudes Test, E-40.	A self report questionarie that assesses eating disorder symptomatology. The range of scores is 0-78. Higher scores mean higher eating disorders sympthoms.	3 months
Eating Disorder Inventory, EDI	A self report questionarie that assesses eating disorder symptomatology. The range of scores is 0-192. Higher scores mean higher eating disorders sympthoms	3 months
Bulimic Investigatory Test Edinburgh, BITE	A self report questionarie that assesses bulimia nervosa symptomatology.The range of scores is 0-30. Higher scores mean higher bulimic sympthoms	3 months
Body Shape Questionnaire, BSQ-34	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.	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Polnay A, James VA, Hodges L, Murray GD, Munro C, Lawrie SM. Group therapy for people with bulimia nervosa: systematic review and meta-analysis. Psychol Med. 2014 Aug;44(11):2241-54. doi: 10.1017/S0033291713002791. Epub 2013 Nov 15.
• Fairburn CG, Bailey-Straebler S, Basden S, Doll HA, Jones R, Murphy R, O'Connor ME, Cooper Z. A transdiagnostic comparison of enhanced cognitive behaviour therapy (CBT-E) and interpersonal psychotherapy in the treatment of eating disorders. Behav Res Ther. 2015 Jul;70:64-71. doi: 10.1016/j.brat.2015.04.010. Epub 2015 Apr 22.
• Agh T, Kovacs G, Supina D, Pawaskar M, Herman BK, Voko Z, Sheehan DV. A systematic review of the health-related quality of life and economic burdens of anorexia nervosa, bulimia nervosa, and binge eating disorder. Eat Weight Disord. 2016 Sep;21(3):353-364. doi: 10.1007/s40519-016-0264-x. Epub 2016 Mar 4.
• - Andrade-González, N., & Fernández-Liria, A. (2016). Spanish adaptation of the working alliance inventory-short (WAI-S). Current Psychology, 35(1), 169-177.
• Hay P. A systematic review of evidence for psychological treatments in eating disorders: 2005-2012. Int J Eat Disord. 2013 Jul;46(5):462-9. doi: 10.1002/eat.22103.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2022
• Primary Completion (Estimated): May 6, 2024
• Study Completion (Estimated): December 20, 2025

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: September 26, 2023
• First Posted (Actual): October 2, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Feeding and Eating Disorders; Hyperphagia; Bulimia; Bulimia Nervosa
• Other Study ID Numbers: IIBSP-BUL-2021-144

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No