Unified Protocol for Bariatric Surgery Candidates
关键词
抽象
描述
Obesity is currently becoming a serious global public health problem due to the high prevalence and the large increase in recent years. This condition is associated with different health problems, including physical and mental diseases. The presence of anxiety or depression disorders among candidates for bariatric surgery it is very high and predicts worse results. The present study aims to explore the feasibility and clinical usefulness of an online group format application of the Unified Protocol, a transdiagnostic emotion-based intervention for patients waiting for bariatric surgery with at least one emotional disorder diagnosis or emotional symptoms.
We will conduct a pilot study with a repeated single case experimental design (multiple baseline design) in a public mental health service. The sample will consist of 45 participants who will be randomized to three baseline conditions: 8, 12 or 15 evaluation days before the intervention. Depression and anxiety symptoms and diagnostic criteria will be the primary outcome measures. Secondary measures will include evaluation of affectivity, personality traits, general fit, quality of life, and different body image and eating outcomes. An analysis of treatment satisfaction will be also performed. Assessment points include baseline, pre-treatment, post-treatment, and follow-ups every three months until two years after post-treatment.
日期
最后验证: | 04/30/2020 |
首次提交: | 05/25/2020 |
提交的预估入学人数: | 06/03/2020 |
首次发布: | 06/08/2020 |
上次提交的更新: | 06/03/2020 |
最近更新发布: | 06/08/2020 |
实际学习开始日期: | 08/31/2020 |
预计主要完成日期: | 12/30/2024 |
预计完成日期: | 12/30/2024 |
状况或疾病
干预/治疗
Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
相
手臂组
臂 | 干预/治疗 |
---|---|
Active Comparator: 3 days before intervention Participants have to complete a pre-treatment assessment (baseline) for 3 days. | |
Active Comparator: 5 days before intervention Participants have to complete a pre-treatment assessment (baseline) for 5 days. | |
Active Comparator: 8 days before intervention Participants have to complete a pre-treatment assessment (baseline) for 8 days. |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - Being of a legal age - Being a bariatric surgery candidate - Presenting anxious or depressive symptomatology (subclinical symptoms with BDI-II and BAI) or meeting the criteria for at least one emotional disorder (anxiety, mood and related disorders) from the International Neuropsychiatric Interview (MINI) - Speaking Spanish or Catalan fluently - Committing to attend the sessions - Understanding and accepting the contents of the informed consent, expressed by signing it - Having Internet to fulfill the protocol assessments online, and (8) being agree to maintain the prescribed medication regimen (including dosage) during the evaluation period, if any, and during treatment Exclusion Criteria: - Having a severe condition that would require to be prioritized for treatment, so that an interaction between both interventions cannot be ruled out. These include a severe mental disorder (bipolar disorder, personality disorder, schizophrenia, or an organic mental disorder), suicide risk at the time of assessment, or substance use in the last three months (excluding cannabis, coffee, and/or nicotine). |
结果
主要结果指标
1. Mini International Neuropsychiatric Interview (MINI) [Only before of the treatment to check inclusion criteria, an average of 3 months]
2. Beck Anxiety Inventory (BAI) [Only before of the treatment to check inclusion criteria, an average of 3 months]
3. Beck Depression Inventory (BDI-II) [Only before of the treatment to check inclusion criteria, an average of 3 months]
4. Overall Depression Severity and Impairment Scale (ODSIS) [Up to 24 months]
5. Overall Anxiety Severity and Impairment Scale (OASIS) [Up to 24 months]
次要成果指标
1. Positive and Negative Affect Scale (PANAS) [Up to 24 months]
2. NEO Five-Factor Inventory (NEO-FFI) [Up to 24 months]
3. Quality of Life Index (QLI) [Up to 24 months]
4. Maladjustment Inventory (MI) [Up to 24 months]
5. Difficulties in Emotion Regulation Scale (DERS) [Up to 24 months]
6. EuroQol [Up to 24 months]
7. Bulimic Investigatory Test Edinburgh (BITE) [Up to 24 months]
8. Body Shape Questionnaire (BSQ) [Up to 24 months]
9. Emotional Eating Scale (EES) [Up to 24 months]
10. Mensual Body Mass Index (BMI) [Up to 24 months]
11. Satisfaction with Treatment [Through study completion, an average of 3 months]