NCT06063278

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2022

Completed
8 days until next milestone

Study Start

First participant enrolled

May 6, 2022

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 6, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2024

Completed
Last Updated

January 20, 2026

Status Verified

November 1, 2024

Enrollment Period

1.9 years

First QC Date

April 28, 2022

Last Update Submit

January 16, 2026

Conditions

Bulimia Nervosa

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (7)

  • Working alliance Inventory -short, WAIS.

    3 months

  • Autism-Spectrum Quotient, AQ

    3 months

  • Quality of Life Enjoyment and Satisfaction Questionnaire, Q-LES-Q.

    3 months

  • Beck Depression Inventory, BDI-II

    3 months

  • Rosenberg Self-Esteem Scale, RSE.

    3 months

  • +2 more secondary outcomes

Study Arms (2)

BN Group

EXPERIMENTAL

Patients will take part of a Therapeutic BN Group

Behavioral: l Group Therapy for BN.

Waiting List

NO INTERVENTION

Participants will be in the waiting list.

Interventions

l Group Therapy for BN.BEHAVIORAL

9 to 10 group sessions of 90 to 120min each

BN Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnostic of Bulimia Nervosa

You may not qualify if:

  • Not understanding Spanish or Catalan Language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Related Publications (5)

  • 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.

    PMID: 26942768BACKGROUND

  • - Andrade-González, N., & Fernández-Liria, A. (2016). Spanish adaptation of the working alliance inventory-short (WAI-S). Current Psychology, 35(1), 169-177.

    BACKGROUND

  • 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.

    PMID: 26000757BACKGROUND

  • 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.

    PMID: 23658093BACKGROUND

  • 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.

    PMID: 24238470BACKGROUND

MeSH Terms

Conditions

Bulimia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2022

First Posted

October 2, 2023

Study Start

May 6, 2022

Primary Completion

April 6, 2024

Study Completion

November 12, 2024

Last Updated

January 20, 2026

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)