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Completed

NCT Number: NCT06063278

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnostic of Bulimia Nervosa

Exclusion criteria

  • Not understanding Spanish or Catalan Language

Treatment and study plan

l Group Therapy for BN.

Behavioral

9 to 10 group sessions of 90 to 120min each

Primary outcomes

  1. Eating Attitudes Test, E-40.

    Time frame: 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.

  2. Eating Disorder Inventory, EDI

    Time frame: 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

  3. Bulimic Investigatory Test Edinburgh, BITE

    Time frame: 3 months

    A self report questionarie that assesses bulimia nervosa symptomatology.The range of scores is 0-30. Higher scores mean higher bulimic sympthoms

  4. Body Shape Questionnaire, BSQ-34

    Time frame: 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.

Secondary outcomes

  1. Working alliance Inventory -short, WAIS.

    Time frame: 3 months

    A self report questionarie that assesses bulimia nervosa symptomatology. Values range from 12 to 84. Hihger scores meaning higher therapeutic alliance.

  2. Autism-Spectrum Quotient, AQ

    Time frame: 3 months

    A self report questionarie that assesses autistic traits. The range of scores is 0 to 50. Higher scores mean higher autistic traits.

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

    Time frame: 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.

  4. Beck Depression Inventory, BDI-II

    Time frame: 3 months

    A self report questionarie that assesses depressive symptoatology. The range of scores is 0-83. Higher scores mean higher depressive symptoms.

  5. Rosenberg Self-Esteem Scale, RSE.

    Time frame: 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.

  6. State -Trait Anxiety Inventory, STAI.

    Time frame: 3 months

    A self report questionarie that assesses anxiety. Higher scores mean higher anxiety.

  7. Difficulties in Emotion Regulation Scale (DERS).

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: SBSBN

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 2, 2023
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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