Single-Arm Feasibility Study of Exposure-Based Treatment for Undifferentiated Somatic Symptom Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Feasibility 1: Distribution of Physical Symptoms
研究概览
简要总结
This study investigates the feasibility of a general exposure-based treatment protocol that is intended to work for a large variety of patient groups with a clinically significant preoccupation with physical symptoms. This is a prospective single-group study based at Karolinska Institutet, Stockholm, Sweden, where 40 adults with DSM-5 somatic symptom disorder are enrolled in 8 weeks of therapist-guided exposure-based treatment via the Internet. Exposure is based on general principles but tailored to suit the needs of each patient. Outcomes include patient-reported credibility and expectancy, adherence to the treatment protocol, client satisfaction, and negative events. Within-group effects will also be quantified and discussed in relation to the existing literature.
详细描述
Background:
A substantial portion of patients in routine care suffer from a recurrent preoccupation with physical symptoms, which often leads to substantial suffering and impairment. Exposure-based treatment - where the patient systematically seeks out that which gives rise to unwanted sensations, cognitions, or behavior - has been found to lead to beneficial effects in several types of symptom preoccupation. Yet, this form of treatment is rarely offered in routine care. This may be partially because existing treatment protocols have been developed for specific symptom clusters (e.g., functional somatic syndromes such as irritable bowel syndrome and fibromyalgia) or specific unwanted responses to symptoms (e.g., the fear of having a severe illness), and that many clinics do not have the resources to offer all these specialized protocols in parallel. An alternative approach could be to base exposure treatment on a more general protocol that may be tailored to suit a larger variety of patient groups who suffer from a recurrent preoccupation with physical symptoms. However, it is yet unclear if the use of such a general treatment protocol for symptom preoccupation would be feasible, for example in terms of patient-reported credibility, adherence, identification with the rationale, and general client satisfaction.
Aim:
To investigate the feasibility of delivering exposure-based treatment using a general protocol for clinically significant symptom preoccupation, without selecting patients based on any specific symptom cluster (such as a functional somatic syndrome) or specific unwanted response to physical symptoms (such as a frequent fear of illness).
Design:
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
盲法说明
Psychological intervention, patient-reported outcomes
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
- •DSM-5 somatic symptom disorder
- •Interest in 8-week intensive psychological treatment to reduce distress and the impact of physical symptoms
- •At least 18 years old
- •Living in Sweden
- •Fluent in Swedish
- •Complete pre-treatment assessment
排除标准
- •Preoccupation with physical symptoms better explained by another psychiatric condition such as illness anxiety disorder, panic disorder, or obsessive-compulsive disorder
- •Severe psychiatric condition, such as bipolar disorder, suicidal ideation, or psychosis
- •Medical risks associated with participating in exposure-based treatment, or somatic condition - or treatment for somatic condition - that is an obstacle to participating in exposure-based treatment
- •Non-stable continuous pharmacotherapy (dosage changed during the past 4 weeks) and the drug is likely to affect outcome measures (primarily: antidepressants, anticonvulsants, benzodiazepines, nonbenzodiazepines, opioids)
- •Alcohol or substance use that is a clear obstacle to therapy
- •Planned absence for more than 1 week of the treatment period
结局指标
主要结局
Feasibility 1: Distribution of Physical Symptoms
时间窗: Pre-treatment assessment (within 2 weeks before treatment)
According to the Patient Health Questionnaire-15 (PHQ-15, theoretical range: 0-30, higher score indicates more distressing physical symptoms)
Feasibility 2: Credibility/Expectancy Based on the Credibility/Expectancy Scale
时间窗: Week 3 of treatment
Theoretical range: 0-50, higher score indicates higher credibility/expectancy
Feasibility 3: Adherence to the Protocol #1: Percentage Completed Modules in the Sample as a Whole
时间窗: Adherence data collected over the entire course of the treatment, up to 8 weeks.
Preregistered target: at least 60% completed modules in the sample as a whole. In this study, all participants were enrolled in the same type of treatment and were thus offered to work with the same treatment modules. This outcome was the proportion of modules completed in total by all participants, out of the total modules available to all participants.
Feasibility 4: Patient-reported Adequacy of Rationale as Assessed Using a Questionnaire Developed Specifically for This Purpose (Theoretical Range: 0-10)
时间窗: Post-treatment assessment (immediately after treatment, completed within 45 days)
From 0 ("not at all relevant") to 10 ("extremely relevant"). Was originally intended to be administered at week 3, but was administered post-treatment due to an administrative error
Feasibility 7b: Adverse Events Measured Using the 20-item Negative Effects Questionnaire (NEQ-20)
时间窗: Post-treatment assessment (immediately after treatment, completed within 45 days)
Theoretical range: 0-80, higher score indicates more severe adverse events
Feasibility 5: Adequacy of the Measurement Strategy
时间窗: Post-treatment assessment (immediately after treatment, completed within 45 days)
Preregistered target: less than 30% missing data at post-treatment, and at least 75% finding the measurement strategy acceptable (less than 7 on a scale from 0 \["Not at all stressful/bothering"\] to 10 \["Extremely stressful/bothering"\])
Feasibility 6: Satisfaction With Treatment as Indicated by a Mean Client Satisfaction Questionnaire (CSQ-8) Score of at Least 22
时间窗: Post-treatment assessment (immediately after treatment, completed within 45 days)
Theoretical range: 8-32, higher score indicates higher satisfaction. This sum score is based on 8 items, each scored 1-4.
Feasibility 7a: Adverse Events Measured Using Free-text Items #1: Total Number of Reported Events
时间窗: Post-treatment assessment (immediately after treatment, completed within 45 days)
The respondent was instructed to describe up to three adverse events.
Feasibility 3: Adherence to the Protocol #2: Percentage of Participants Completing at Least 2 Exposure Exercises
时间窗: Adherence data collected over the entire course of the treatment, up to 8 weeks.
Preregistered target: at least 50% of participants completing at least 2 exposure exercises
Feasibility 7a: Adverse Events Measured Using Free-text Items #2: Number of Participants Who Reported at Least One Adverse Event
时间窗: Post-treatment assessment (immediately after treatment, completed within 45 days)
The respondent was instructed to describe up to three adverse events.
次要结局
- Anxiety Sensitivity Index (ASI)(Screening, pre-treatment assessment (within 2 weeks before treatment), post-treatment assessment Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment)
- GAD-7(Pre-treatment assessment (within 2 weeks before treatment), post-treatment assessment Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment)
- Patient Health Questionnaire (PHQ-9)(Screening, pre-treatment assessment (within 2 weeks before treatment), weekly during treatments (suicidality), post-treatment assesment (immediately after treatment, completed within 45 days), 3 months after treatment)
- Drug Use Disorders Identification Test (DUDIT)(Screening only)
- Alcohol Use Disorders Identification Test (AUDIT)(Screening only)
- Symptom Preoccupation Scale (Preliminary Scale)(Screening, pre-treatment assessment (within 2 weeks before treatment), weekly during treatment, Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment)
- 14-item Health Anxiety Inventory (HAI-14)(Screening, pre-treatment assessment (within 2 weeks before treatment), Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment)
- Somatic Symptom Disorder-B Criteria Scale (SSD-12)(Screening, pre-treatment assessment (within 2 weeks before treatment), weekly during treatment, Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment)
- Patient Health Questionnaire-15 (PHQ-15)(Screening, pre-treatment assessment (within 2 weeks before treatment), weekly during treatment, Post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment)
- Working Alliance Inventory (WAI)(Week 3 of treatment)
- 12-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)(Screening, pre-treatment assessment (within 2 weeks before treatment), post-treatment assessment (immediately after treatment, completed within 45 days), 3 months after treatment)
研究者
Erland Axelsson
Principal Investigator
Karolinska Institutet