Facilitating Implementation of Evidence-based Psychological Therapy for Posttraumatic Stress Disorder in Health Care Services Through a Digital Support - A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Acceptability of treatment among patients and therapists
研究概览
简要总结
Feasibility and pilot study using within-group design with the aim of examining whether the blended psychological treatment for PTSD is acceptable for patients and therapists. 20 patients will be included and 4 therapists. Semi-structured interviews will be conducted after treatment with a selection of therapists and patients with questions regarding the helpfulness and feasibility of the treatment. Effects of the treatment will be assessed via standardized self-report outcome measures regarding PTSD, depression, anxiety, sleep, quality of life, function and patient satisfaction / acceptance. Measurements are conducted before, during, immediately after and 6 months after treatment. The study is conducted at 2 psychiatric outpatient clinics in the Stockholm Region.
详细描述
Research question and hypothesis
The research question is: Is blended psychological treatment for PTSD via a digital support acceptable and applicable to patients and clinicians? The hypothesis is that testing the digital support and blended delivery format in a smaller scale pilot study will bring to light how the support and treatment could be augmented to better adhere to patients and clinicians needs.
Procedure
The feasibility study will be carried out in collaboration with 2 psychiatric care units in the Stockholm region. In these clinics a handful of therapists will implement the treatment with altogether 20 PTSD patients and assess the digital support and treatment modules. A task group of 3 psychologists will develop the treatment platform and the inherent modules and work materials. The therapists will work closely with the task group and regularly provide feedback of their experiences of working with the platform. Learning obtained from the study will be utilized to improve and adjust the digital support and treatment procedure in preparation for a larger randomized study.
To enable implementation of the digital support in health care services it will be integrated into the digital health care platform Support and Treatment (SOB). SOB is a well-established national health system available to clinicians via the patient medical journals. The support will be internet-based and consist of self-help modules that incorporates similar treatment components as those found in evidence-based trauma-focused cognitive behavioural therapy (TF-CBT) protocols. The treatment modules will consist of educational texts, filmed illustrations, case examples, and relevant worksheets. The purpose of the support is to function as a treatment foundation, both for face-to-face appointments and as guided self-help.
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
- •PTSD according to DSM-5 criteria (American Psychiatric Association, 2013) as a primary problem
- •have basic knowledge of speaking and writing in Swedish,
- •not undergo other psychological treatment for PTSD during the course of the study;
- •be at least 18 years old
- •not be exposed to ongoing violence or threats
- •if antidepressants for depression / anxiety are available, the dose must have been stable for at least 6 weeks before starting treatment.
- •Patients who express an interest in participating receive information about the study. Patients who subsequently carry out the assessment and meet the inclusion criteria receive accurate oral and written information about what participation includes and handling of personal data and data. If the patient wants to participate and gives written consent, the person is included in the study.
排除标准
- 未提供
研究组 & 干预措施
Blended treatment for PTSD
A trauma-focused CBT where internet-based treatment is blended with face-to-face sessions with a therapist.
干预措施: Trauma-focused cognitive behavioural therapy via a digital support (Behavioral)
结局指标
主要结局
Acceptability of treatment among patients and therapists
时间窗: Post treatment, 12-20 weeks after enrollment
Semi-structured interviews
次要结局
- The Client Satisfaction Questionnaire-8 (CSQ-8)(post treatment, 8-12 weeks after enrollment)
- The Credibility/Expectancy Questionnaire (CEQ)(Week 1 of treatment)
- Internet Intervention Patient Adherence Scale (IIPAS)(Post treatment 8-12 weeks after enrollment)
- Generalised Anxiety Disorder 7-item scale (GAD-7)(Pre-treatment, Post treatment 8-12 weeks after enrollment, and 6-month follow up)
- The Posttraumatic stress disorder checklist 5 (PCL-5)(Pre-treatment, weekly, post treatment 8-12 weeks after enrollment, and 6-month follow up)
- Negative effects questionnaire (NEQ 20)(Post treatment 8-12 weeks after enrollment)
- Patient Health Questionnaire 9 (PHQ-9)(Pre-treatment, weekly, post treatment 8-12 weeks after enrollment, and 6-month follow up)
- Insomnia Severity Index (ISI)(Pre-treatment, Post treatment 8-12 weeks after enrollment, and 6-month follow up)
- World health organization disability assessment schedule (WHODAS 2.0)(Pre-treatment, Post treatment 8-12 weeks after enrollment, and 6-month follow up)
- Brunnsviken Brief Quality of Life Questionnaire (BBQ)(Pre-treatment, Post treatment 8-12 weeks after enrollment, and 6-month follow up)
研究者
Sigrid Salomonsson
Principal Investigator and PhD
Karolinska Institutet