"One Step at a Time" - an Internet-delivered Treatment for Patients Moderately Impaired by Bodily Distress Syndrome. A Feasibility Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Changes in physical Health
研究概览
简要总结
This uncontrolled feasibility pilot study explores the acceptability and potential effect of a 14 week, 11-module, therapist-assisted, internet-delivered treatment program, "One step at the time", for patients moderately affected by Bodily Distress Syndrome. The study includes 25 participants aged 18-60 with multiple functional somatic symptoms for a duration of minimum 6 months. The focus of the feasibility trial is evaluation of treatment response, treatment satisfaction, program utility, recruitment and retention rates, data completion rates, and time requirement. The primary feasibility criterion is a +2.0 points change in patient-rated physical health measured by the SF-36 aggregate score physical health from before to after treatment.
详细描述
"One Step at the Time" - Internet-delivered Treatment for Patients Moderately Impaired by Bodily Distress Syndrome. A Feasibility Pilot Study.
Lisbeth Frostholm, Andreas Schröder, Johanne Liv Agger, Heidi Frølund Pedersen
Objective The objective of this uncontrolled pilot study is to test the feasibility of a future RCT by exploring the acceptability and effect of an internet-delivered treatment program, "One step at the time", for patients moderately affected by Bodily Distress Syndrome (BDS). The focus of the feasibility trial is evaluation of treatment response, treatment satisfaction, program utility, recruitment and retention rates, data completion rates, and time requirement. The primary feasibility criterion is an a priori defined change in patient-rated physical health from before to after treatment.
Design This study is designed as an uncontrolled, single-arm, single-center feasibility pilot study.
Participants The study includes 25 participants included from February to July 2020. The participants are recruited from The Research Clinic for Functional Disorders and Psychosomatics and The Pain and Headache Clinic, Aarhus University Hospital, Denmark, to which patients with multiple functional somatic symptoms are consecutively referred from GPs, medical specialists and hospital departments. Patients moderately affected by multiple symptoms are screened for eligibility by the eligibility criteria below. They undergo thorough diagnostic assessment by a medical doctor specialized in functional disorders after a thorough physical and psychological assessment including diagnostic interview (Schedules for Clinical Assessment in Neuropsychiatry), physical examination including blood pressure, blood test and a review of all medical records.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for Bodily distress syndrome (BDS) with 2-3 of 4 symptom clusters
- •Moderate impact on daily life (self-reliant at home, can participate in activities outside the home)
- •Symptoms lasting for at least 6 months
- •18-60 years at the time of inclusion
- •Previous stable educational or occupational attachment until at least 2 years prior to enrollment and expecting to return to occupational or educational activity
- •Motivation and time to participate in a psychological treatment program for treatment of BDS
- •IT skills and access to internet and computer/tablet
- •Willingness to engage in working with illness perception and behavioral change
排除标准
- •Presence of other physical condition if the symptoms of this condition can not clearly be separated from symptoms of BDS or the condition is unstable/untreated
- •Current moderate or severe psychiatric disorder that substantially impacts daily life or demands special, individualized treatment, or clinical suspicion hereof, e.g. treatment-demanding depression or personality disorder
- •Current continuous treatment with opioids and drugs with opioid-like properties
- •Previous psychological treatment targeting BDS
结局指标
主要结局
Changes in physical Health
时间窗: Baseline, before treatment (2 weeks), after treatment (16 weeks) and at 3 month follow up (28 months)
Patient-rated physical health measured by the SF-36 aggregate score Physical Health
次要结局
- 5-point clinical global improvement scale (CGI)(after treatment (14 weeks))
- The Numeric Rating Scale(every 2 weeks during treatment)
- The BDS Checklist(Baseline, before treatment (2 weeks), after treatment (16 weeks) and at 3 month follow up (28 weeks))
- Brief-Illness perception questionnaire(Baseline, before treatment (2 weeks), after treatment (16 weeks) and at 3 month follow up (28 weeks))
- SF-36 physical health(Baseline, before treatment (2 weeks), after treatment (16 weeks) and at 3 month follow up (28 weeks))
- The Behavioural Responses to Illness Questionnaire (BRIQ) Changes in illness behaviour(Baseline, before treatment (2 weeks), after treatment (16 weeks) and at 3 month follow up (28 weeks))
- Costs associated with Psychiatric Illness (TiC-P)(Before treatment (2 weeks) and at 3 month follow up (16 weeks))
- The inventory for the assessment of negative effects of psychotherapy (INEP)(After treatment (16 weeks))
- The credibility/expectancy questionnaire(Before treatment (2 weeks) and after treatment (16 weeks))
- The Internet Evaluation and Utility Questionnaire(after treatment (16 weeks))
- Relevant subscores of the 92-item Danish version of the Symptom Checklist (SCL-92)(Baseline, before treatment (2 weeks), after treatment (16 weeks) and at 3 month follow up (28 weeks))
- Whiteley-7(Baseline, before treatment, after treatment and at 3 month follow up)
- The Sources of Meaning and Meaning in Life Questionnaire (SoMe short version)(Baseline, before treatment (2 weeks), after treatment (16 weeks) and at 3 month follow up (28 weeks))