Time Intensive Cognitive Behavioural Therapy for a Specific Phobia of Vomiting Using a Single Case Experimental Design
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Specific Phobia of Vomiting Inventory (SPOVI)
研究概览
简要总结
The aims of this project are to determine the effectiveness of a time intensive form of Cognitive Behavioural Therapy (CBT) for Specific Phobia of Vomiting (SPOV). Current research shows that this brief format can be effective in other specific phobias e.g. insects and animals. However, to date limited research has been conducted on the effectiveness of time intensive forms of CBT for SPOV. A single case experimental design will be used to analyse specific and idiosyncratic outcome measures in 6-8 cases of SPOV, referred to the Centre for Anxiety Disorders and Trauma (CADAT) for treatment. Specifically, the project will explore the effectiveness of CBT delivered in a time-intensive format and imagery rescripting elements of the treatment. This initial study will provide important information about which elements of CBT are most effective at reducing targeted symptoms and whether symptom reduction can be achieved in a shorter number of sessions. It represents a crucial step before this format of CBT can be more rigorously evaluated and compared to other treatment approaches by Randomised Controlled Trial.
详细描述
Design A single case experimental design (ABACADA) will be used. A, B, C etc represents points of intervention and clinical contact with participants when standardised outcome measures will be administered by the treating clinician at each session. Phases A1, A2, A3 represent time between contact during which participants will undertake daily monitoring of idiosyncratic symptoms on Visual Analogue Scales (VAS) e.g. degree of avoidance, degree of worry, degree of nausea etc, so change between phases across time can be measured.
Participants will be randomly allocated to differing lengths of baseline phase (initial clinical assessment to first clinical session) with 4 potential arms (7, 10, 14, or 17 days). The first three clinical sessions (formulation, imagery rescripting and planning of intensive days) will take place weekly and last up to 1.5 hours. The two intensive days will last up to 4 hours each and take place shortly after the planning session and within a few days of each other. Three additional follow up sessions will be offered within 10 days of the intensive days (2 within one week, and the final session one week after). Follow up data will be collected by phone or post 3, 6 and 12 months post intervention.
Participants Participants will be recruited from consecutive referrals to CADAT for treatment of SPOV. Clients will have a diagnosis of SPOV as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) as their main presenting problem. They will be drawn from the CADAT waiting list, and if necessary from Improving Access to Psychological Therapy (IAPT) services at Southwark, Lambeth and Lewisham. These cases will be picked up by and treated at CADAT by qualified clinicians.
Participants are expected to be involved in the study for up to 8 weeks for the treatment phase, and 12 months for follow up data to be collected.
Recruitment Consultant Psychiatrist for the team at the Centre for Anxiety Disorders and Trauma will identify potential participants from the waiting list at CADAT who meet the inclusion criteria to take part in the study. Potential participants will then be asked if they would like to participate at the initial clinical assessment. They will be provided with an information sheet and the opportunity to ask questions before making a decision and giving informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adults aged 18 years or over with a diagnosis of SPOV as defined by DSM-5
- •The individual describes the SPOV as their main psychological problem
- •The individual is able to read materials written in English and answer written questions
- •Individuals must have capacity to provide written informed consent
排除标准
- •Involvement in active CBT (imagery rescripting and/or exposure) within 2 years or inactive CBT within 1 year previous to this study
- •Individuals with a diagnosis of any other mental health disorder that required treatment in its own right
- •Individuals currently taking anti-anxiolytic medication where the dose has not been stable over one month prior to entering the study
结局指标
主要结局
Specific Phobia of Vomiting Inventory (SPOVI)
时间窗: 1 week
A 14-item self-report measure that focuses on cognitive processes, safety seeking and avoidance behaviours (Veale et al, 2013). The total score ranges from 0 to 56. The scale has a two-factor structure, with one factor of 7 items characterized by avoidance (e.g. "I have been trying to avoid or control any thoughts or images about vomiting") and a second factor of 7 items comprised of threat monitoring (e.g. "I have been focused on whether I feel ill and could vomit rather than on my surroundings"). Cronbach's α is .91.
次要结局
- Patient Health Questionnaire (PHQ-9)(1 week)
- Generalised Anxiety Disorder (GAD7)(1 week)
- Emetophobia Questionnaire(1 week)
- Work and Social Adjustment Scale(1 week)
- IAPT Employment Status Questions(1 week)