Feasibility Evaluation of a Self-guided Exposure-based Digital Intervention for Health Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in Health anxiety symptoms
研究概览
简要总结
This study investigates the feasibility and preliminary efficacy of a self-guided, exposure-based intervention for individuals who suffer from severe health anxiety. The study is a prospective single-group study based at Karolinska Institutet, Stockholm, Sweden, where 20-25 adults with DSM-5 Illness anxiety disorder or Somatic symptom disorder are enrolled in 8 weeks of unguided exposure-based treatment via the Internet. Outcomes include self-reported health anxiety symptoms, credibility and expectancy, adherence to the treatment protocol, client satisfaction, and negative events.
详细描述
Background
Severe health anxiety (Corresponding to a DSM-5-diagnosis of Illness anxiety disorder or somatic symptom disorder) is a condition associated with high distress, disability and increased health service utilization. Therapist guided Internet delivered cognitive behavioural therapy (ICBT) is efficacious in the treatment of severe health anxiety and has the advantage of requiring less treatment support per patient compared to traditional CBT, thus making the treatment more cost effective. Despite this, the access to ICBT is limited as it requires the active participation of a therapist. Given the relatively high prevalence of individuals experiencing excessive health anxiety, there is need for research on more accessible treatment options.
Unguided self-care interventions have the potential to improve access to treatment and increase cost-effectiveness and have a more immediate scalability. Also, unguided interventions have the advantage of being more easily disseminated outside the traditional mental health care systems and thus, have the potential to reach patients with subclinical, yet distressful, health anxiety.
Aim
The overall aim of this study is to develop a new internet-delivered CBT program based on exposure and response prevention - without therapist support - for patients with severe health anxiety and to examine its feasibility and potential clinical efficacy.
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
- •Age ≥ 18 years
- •A principal diagnosis Illness anxiety disorder or somatic symptom disorder (DSM-V)
- •Access to a computer and the internet
- •No serious medical illness
- •Participants on psychotropic medication must have been on a stable dose for the last 4 weeks prior to baseline assessment
排除标准
- •Difficulties to read or write that makes it hard to understand the content of the intervention
- •Currently receiving similar psychological treatment for anxiety
- •High risk of suicide
- •Diagnosed with psychosis disorder or bipolar disorder
- •Ongoing substance dependence
- •Have an urgent need for more intensive psychiatric care
结局指标
主要结局
Change in Health anxiety symptoms
时间窗: pre-treatment assessment to 12 weeks after post-treatment assessment
The Short health anxiety inventory - 14 item (SHAI-14). Higher scores indicate greater severity of health anxiety. Scores range from 0 to 42.
Adherence to the treatment: types of exposure
时间窗: Post-treatment assessment (immediately after treatment)
Will be determined by the number of different types of exposure exercises performed by participants. At the end of the program, participants will answer yes or no to whether they engaged in each component (type of exposure exercise) of the intervention.
Satisfaction with treatment
时间窗: Post-treatment assessment (immediately after treatment)
Client Satisfaction Questionnaire (CSQ-8). Scores range from 8-32 with higher scores indicating greater satisfaction. An average Client Satisfaction Questionnaire-8 score of at least 22 will provide support for the acceptability and feasibility of this intervention.
Adherence to the treatment: amount of exposures
时间窗: Post-treatment assessment (immediately after treatment)
Will be determined by the amount of exposure exercises reported in the program and in a weekly questionnaire. Acceptable level of adherence will be set to at least 50 % of participants working actively with exposure a majority of the days during a week for 4 weeks or more.
Adherence to the treatment: number of modules
时间窗: Post-treatment assessment (immediately after treatment)
Will be determined by the number of modules completed by the participants.
Unintended treatment effects
时间窗: Post-treatment assessment (immediately after treatment)
Participants will be asked to state whether they had experienced any negative or unwanted effects of the treatment. If answering 'Yes', participants will be asked to specify the adverse event in free text. Adverse events will primarily be reported as the total number of reported events.
次要结局
- Change in depressive symptoms(pre-treatment assessment to 4 weeks after post-treatment assessment)
- Change in anxiety symptoms(pre-treatment assessment to 4 weeks after post-treatment assessment)
- Experience with the program(Post-treatment assessment (immediately after treatment))
- Change in diagnostic status(Change from baseline interview to 12 weeks after post-treatment assessment)
- Change in life quality(pre-treatment assessment to Post-treatment assessment (immediately after treatment))
- Usability(Post-treatment assessment (immediately after treatment))
- Credibility/expectancy(week 3 of treatment)
- Post-treatment adherence to exposure exercises(12 weeks after post-treatment assessment)
- Change in Health anxiety symptoms(pre-treatment assessment to 4 weeks after post-treatment assessment)
研究者
Martin Kraepelien
Licensed clinical psychologist, Principal investigator, PhD
Karolinska Institutet