Step by Step Group Therapy for Bulimia Nervosa: Effectiveness and Mechanisms of Change. (SBSBN)
Primary Purpose
Bulimia Nervosa
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
l Group Therapy for BN.
Sponsored by
About this trial
This is an interventional treatment trial for Bulimia Nervosa
Eligibility Criteria
Inclusion Criteria: Diagnostic of Bulimia Nervosa Exclusion Criteria: Not understanding Spanish or Catalan Language
Sites / Locations
- Hospital de la Santa Creu i Sant PauRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
BN Group
Waiting List
Arm Description
Patients will take part of a Therapeutic BN Group
Participants will be in the waiting list.
Outcomes
Primary Outcome Measures
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.
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
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
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
State -Trait Anxiety Inventory, STAI.
A self report questionarie that assesses anxiety. Higher scores mean higher anxiety.
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.
Full Information
NCT ID
NCT06063278
First Posted
April 28, 2022
Last Updated
September 26, 2023
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1. Study Identification
Unique Protocol Identification Number
NCT06063278
Brief Title
Step by Step Group Therapy for Bulimia Nervosa: Effectiveness and Mechanisms of Change.
Acronym
SBSBN
Official Title
Step by Step Group Therapy for Bulimia Nervosa: Effectiveness and Mechanisms of Change.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 6, 2022 (Actual)
Primary Completion Date
May 6, 2024 (Anticipated)
Study Completion Date
December 20, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BN Group
Arm Type
Experimental
Arm Description
Patients will take part of a Therapeutic BN Group
Arm Title
Waiting List
Arm Type
No Intervention
Arm Description
Participants will be in the waiting list.
Intervention Type
Behavioral
Intervention Name(s)
l Group Therapy for BN.
Intervention Description
9 to 10 group sessions of 90 to 120min each
Primary Outcome Measure Information:
Title
Eating Attitudes Test, E-40.
Description
A self report questionarie that assesses eating disorder symptomatology. The range of scores is 0-78. Higher scores mean higher eating disorders sympthoms.
Time Frame
3 months
Title
Eating Disorder Inventory, EDI
Description
A self report questionarie that assesses eating disorder symptomatology. The range of scores is 0-192. Higher scores mean higher eating disorders sympthoms
Time Frame
3 months
Title
Bulimic Investigatory Test Edinburgh, BITE
Description
A self report questionarie that assesses bulimia nervosa symptomatology.The range of scores is 0-30. Higher scores mean higher bulimic sympthoms
Time Frame
3 months
Title
Body Shape Questionnaire, BSQ-34
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Working alliance Inventory -short, WAIS.
Description
A self report questionarie that assesses bulimia nervosa symptomatology. Values range from 12 to 84. Hihger scores meaning higher therapeutic alliance.
Time Frame
3 months
Title
Autism-Spectrum Quotient, AQ
Description
A self report questionarie that assesses autistic traits. The range of scores is 0 to 50. Higher scores mean higher autistic traits.
Time Frame
3 months
Title
Quality of Life Enjoyment and Satisfaction Questionnaire, Q-LES-Q.
Description
A self report questionarie that assesses quality of life. The range of scores is 0-100. Higher scores mean higher quality of life.
Time Frame
3 months
Title
Beck Depression Inventory, BDI-II
Description
A self report questionarie that assesses depressive symptoatology. The range of scores is 0-83. Higher scores mean higher depressive symptoms.
Time Frame
3 months
Title
Rosenberg Self-Esteem Scale, RSE.
Description
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.
Time Frame
3 months
Title
State -Trait Anxiety Inventory, STAI.
Description
A self report questionarie that assesses anxiety. Higher scores mean higher anxiety.
Time Frame
3 months
Title
Difficulties in Emotion Regulation Scale (DERS).
Description
A self report questionarie that assesses emotion regulation difficulties. The scale ranges from 28-40. H igher scores indicate more difficulty in emotion regulation.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnostic of Bulimia Nervosa
Exclusion Criteria:
Not understanding Spanish or Catalan Language
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cristina Carmona, PhD
Phone
+34935537761
Email
ccarmonaf@santpau.cat
Facility Information:
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Carmona, Phd
Phone
+34935537813
Email
CDelgadoE@santpau.cat
First Name & Middle Initial & Last Name & Degree
Cristina Carmona, Phd
Phone
650003427
Email
ccarmonaf@santpau.cat
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26942768
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.
Results Reference
background
Citation
- Andrade-González, N., & Fernández-Liria, A. (2016). Spanish adaptation of the working alliance inventory-short (WAI-S). Current Psychology, 35(1), 169-177.
Results Reference
background
PubMed Identifier
26000757
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.
Results Reference
background
PubMed Identifier
23658093
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.
Results Reference
background
PubMed Identifier
24238470
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.
Results Reference
background
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Step by Step Group Therapy for Bulimia Nervosa: Effectiveness and Mechanisms of Change.
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