Randomized Controlled Dismantling Trial of Exposure Therapy for Reactivity to Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Somatic Symptom Disorder-B Criteria Scale (SSD-12)
研究概览
简要总结
It is unclear to what degree systematic exposure exercises contribute to the overall effects of exposure therapy (exposure and response prevention). This trial recruits individuals with high somatic symptom burden or reactivity to symptoms who, based on previous work, are likely to benefit specifically from exposure therapy. The aim of the study is to evaluate to what degree the effect of exposure therapy for this group is driven by the addition of structured exposure exercises to response prevention. This will be evaluated on the basis of a randomized controlled trial (N=360) where participants are enrolled either in response prevention (n=180), or exposure and response prevention (n=180). Primary outcome will be the between-group differences in the reduction in reactivity to symptoms, as measured week-by-week using the somatic symptom disorder B-criteria scale (SSD-12). Results from this project will be informative for exposure-based and various multicomponent behavioral treatments for individuals with persistent physical symptoms worldwide.
详细描述
Persistent physical symptoms refers to somatic complaints that persist for months or more and give rise to significant distress, regardless of etiology. Common complaints such as gastrointestinal symptoms, fatigue, and pain have been estimated to account for up to half of primary care consultations, can be difficult to classify, and often defy straightforward medical explanation. In light of substantial personal and socioeconomic repercussions, effective clinical interventions are needed. The investigators recently completed a randomized controlled trial in primary care (SOMEX1) where individuals with persistent physical symptoms were randomized to 10 weeks of exposure therapy or healthy lifestyle promotion. Based on that trial, exposure therapy appears to have a small average advantage over healthy lifestyle promotion in mean effect on symptom preoccupation, i.e., the patient's tendency to respond strongly to, and engage in behaviors contingent on, somatic symptoms, and also on patient satisfaction. In line with a priori hypotheses, this added effect on symptom preoccupation was larger, and an advantage in the effect on somatic symptom burden was also seen, when patients reported a very high general somatic symptom burden or symptom preoccupation before treatment. For example, a patient with a PHQ-15 score of 10 could expect a near-zero added effect of exposure therapy on somatic symptom burden (d = 0.08) and a small added effect on symptom preoccupation (d = 0.31), whereas a patient with a PHQ-15 score of 15 could expect a small to moderate added effect on somatic symptom burden (d = 0.37) and a moderate added effect on symptom preoccupation (d = 0.62). An unexpected finding, however, was that in exposure therapy, the correlation between the participant's number of exposure exercises and reduction in symptom preoccupation was weak (rs=0.21-0.26). This highlights the fact that it is yet unclear to what degree the two main components of exposure therapy - exposure and response prevention - contribute to the treatment effects. It is also unclear what patient- and contextual factors moderate the added effect of exposure.
The aim of the present project is to focus on the aforementioned subgroup of patients who benefit specifically from exposure therapy, and to determine to what degree this is driven by the addition of exposure to response prevention. This will be evaluated on the basis of a randomized controlled trial (N=360; SOMEX2) where participants with a high general somatic symptom burden or high symptom preoccupation are enrolled in response prevention (n=180), or exposure and response prevention (n=180). Primary outcome will be between-group differences in the reduction in symptom preoccupation as measured week-by-week using the somatic symptom disorder B-criteria scale (SSD-12). The participants will be blinded to the study design and the hypotheses of the investigators. Results from this project will be informative for exposure-based and various multicomponent behavioral treatments for primary care patients with persistent physical symptoms worldwide.
- Primary research question:
Is there a significant average advantage, d≥0.30, of exposure and response prevention, as compared to response prevention only, with regard to the reduction in symptom preoccupation (SSD-12) up to the post-treatment assessment? Hypothesis: Yes.
- Key secondary research questions:
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
Blinding to trial design, but not assigned 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
- •Bothered by at least one somatic symptom for at least 4 months.
- •High symptom burden, defined as a PHQ-15≥15 or SSD-12≥
- •Adult (≥18 years old).
- •Living in Stockholm County (catchment area of the clinic).
- •Sufficient technical knowledge with web-enabled device and fluent in Swedish.
- •Complete pre-treatment assessment.
排除标准
- •A maximum of half the sample (180 participants) will be included with health anxiety, i.e., a fear of or preoccupation with serious illness, as their principal clinical problem.
- •Clinical picture dominated by non-somatoform psychiatric disorder such as depression, panic disorder, or primary insomnia. Comorbidities are allowed.
- •Severe psychiatric condition (e.g., ongoing manic episode, psychotic disorder, severe depression) or markers for suicidality beyond sporadic ideation.
- •Clear medical risk in taking part in exposure-based treatment (e.g., pregnancy), or somatic condition, or treatment for somatic condition, makes treatment unfeasible.
- •Continuous psychotropic medication (antidepressants, anticonvulsants, mood-stabilizers, antipsychotics) is present and has either not been stable for at least 4 weeks, or is not expected to remain stable.
- •Other psychotherapy or planned absence >1 week during intended main phase.
研究组 & 干预措施
Response prevention
Response prevention without conventional, planned, exposure exercises.
干预措施: Response prevention (Behavioral)
Exposure with response prevention
Full exposure therapy, i.e., exposure with response prevention.
干预措施: Planned, systematic, exposure exercises (Behavioral)
Exposure with response prevention
Full exposure therapy, i.e., exposure with response prevention.
干预措施: Response prevention (Behavioral)
结局指标
主要结局
Somatic Symptom Disorder-B Criteria Scale (SSD-12)
时间窗: Change over the main phase, as modeled using data from all 11 assessments from the baseline assessment to the primary endpoint (≤45 days after treatment). Additional analyses incorporate 6- and 12-months follow-up assessments.
Theoretical range: 0-48. A higher score indicates higher degree of reactivity to symptoms.
次要结局
- Somatic Symptom Scale 8 (SSS-8)(Change over the main phase, as modeled using data from all 11 assessments from the baseline assessment to the primary endpoint (≤45 days after treatment). Secondary analyses incorporate 6- and 12-months follow-up assessments.)
- GAD-7(Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment). Additional analyses incorporate 6- and 12-months follow-up assessments.)
- Patient Health Questionnaire 9 (PHQ-9)(Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment). Additional analyses incorporate 6- and 12-months follow-up assessments.)
- 12-item WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)(Change over the main phase, as modeled using data from the baseline assessment and primary endpoint (≤45 days after treatment). Additional analyses incorporate 6- and 12-months follow-up assessments.)
- Seven questions probing into basic emotions related to somatic symptoms(Change over the main phase, as modeled using data from the baseline assessment and primary endpoint (≤45 days after treatment).)
- 14-item Health Anxiety Inventory (HAI-14)(Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment).)
- Adapted 11-item version of the Catastrophizing about Asthma Scale (CAS)(Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment).)
- Reactivity to fatigue (study-specific)(Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment).)
- Visceral Sensitivity Index (VSI)(Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment).)
- Pain Catastrophizing Scale (PCS)(Change over the main phase, as modelled using data from the baseline assessment and primary endpoint (≤45 days after treatment).)