Feasibility and Clinical Usefulness of the Unified Protocol in Online Group Format for Bariatric Surgery Candidates: Study Protocol for a Multiple Baseline Experimental Design
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Mini International Neuropsychiatric Interview (MINI)
研究概览
简要总结
The present pilot study with a multiple baseline experimental desing will verify the feasibility and clinical utility of the Unified Protocol, applied in an online group format in a mental health setting of the Spanish national health system to patients waiting for bariatric surgery with diagnosis or symptoms of Emotional Disorders
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will know the baseline condition they have been assigned to: 3, 5 or 8 evaluation days before the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Mini International Neuropsychiatric Interview (MINI)
时间窗: Only before of the treatment to check inclusion criteria, an average of 3 months
This interview contains structured questions that evaluate major psychiatric disorders based on the Diagnostic and Statistical Manual of Mental Disorders
Beck Anxiety Inventory (BAI)
时间窗: Only before of the treatment to check inclusion criteria, an average of 3 months
The BAI is composed of 21 items that evaluate anxiety symptoms. Responses use a 4-point Likert scale ranging from 0 (Not at all) to 3 (Severely). The total score can range from 0 to 63. Higher scores are indicative of greater severity and functional impairment as a result of anxious symptoms.
Beck Depression Inventory (BDI-II)
时间窗: Only before of the treatment to check inclusion criteria, an average of 3 months
It consists of 21 items, each with four different statements that reflect an increase in the degree of depression. A score of 0 indicates the absence of depressive symptoms and 3 reflects the most severe levels of depression. The scale has a 0-to-63 range. Higher scores are indicative of greater severity and functional impairment as a result of depressive symptoms.
Overall Depression Severity and Impairment Scale (ODSIS)
时间窗: Up to 24 months
Consist of five items that evaluate the frequency and the intensity of depressive symptoms and their interference with the person's work or school life and social life. The total score range from 0 to 20 and responses use a 5-point Likert scale ranging from 0 to 4. Higher scores are indicative of greater severity and functional impairment as a result of depressive symptoms.
Overall Anxiety Severity and Impairment Scale (OASIS)
时间窗: Up to 24 months
Consist of five items that evaluate the frequency and the intensity of anxious symptoms and their interference with the person's work or school life and social life. The total score range from 0 to 20 and responses use a 5-point Likert scale ranging from 0 to 4. Higher scores are indicative of greater severity and functional impairment as a result of anxious symptoms.
次要结局
- Positive and Negative Affect Scale (PANAS)(Up to 24 months)
- NEO Five-Factor Inventory (NEO-FFI)(Up to 24 months)
- Quality of Life Index (QLI)(Up to 24 months)
- Maladjustment Inventory (MI)(Up to 24 months)
- Difficulties in Emotion Regulation Scale (DERS)(Up to 24 months)
- EuroQol(Up to 24 months)
- Bulimic Investigatory Test Edinburgh (BITE)(Up to 24 months)
- Body Shape Questionnaire (BSQ)(Up to 24 months)
- Emotional Eating Scale (EES)(Up to 24 months)
- Mensual Body Mass Index (BMI)(Up to 24 months)
- Satisfaction with Treatment(Through study completion, an average of 3 months)
研究者
Jorge Javier Osma López
Principal Investigator
Instituto de Investigación Sanitaria Aragón