Clinical trial NCT06063278: Step by Step Group Therapy for Bulimia Nervosa: Effectiveness and Mechanisms of Change.
Official title: Step by Step Group Therapy for Bulimia Nervosa: Effectiveness and Mechanisms of Change.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bulimia Nervosa
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Diagnostic of Bulimia Nervosa

Exclusion Criteria:

* Not understanding Spanish or Catalan Language

Primary outcomes:
measure: Eating Attitudes Test, E-40.
timeFrame: 3 months
measure: Eating Disorder Inventory, EDI
timeFrame: 3 months
measure: Bulimic Investigatory Test Edinburgh, BITE
timeFrame: 3 months
measure: Body Shape Questionnaire, BSQ-34
timeFrame: 3 months
Secondary outcomes:
measure: Working alliance Inventory -short, WAIS.
timeFrame: 3 months
measure: Autism-Spectrum Quotient, AQ
timeFrame: 3 months
measure: Quality of Life Enjoyment and Satisfaction Questionnaire, Q-LES-Q.
timeFrame: 3 months
measure: Beck Depression Inventory, BDI-II
timeFrame: 3 months
measure: Rosenberg Self-Esteem Scale, RSE.
timeFrame: 3 months
measure: State -Trait Anxiety Inventory, STAI.
timeFrame: 3 months
measure: Difficulties in Emotion Regulation Scale (DERS).
timeFrame: 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References:
citation: 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.
citation: - Andrade-González, N., & Fernández-Liria, A. (2016). Spanish adaptation of the working alliance inventory-short (WAI-S). Current Psychology, 35(1), 169-177.
citation: 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.
citation: 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.
citation: 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.