Patient-driven Internet Delivered Psychological Treatment in a Primary Care Context: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Questions of perceptions in how much one has been able to control the treatment
研究概览
简要总结
The effect of iCBT for adults with anxiety disorders is well-known. However, drop-out rates are common. In recent years more focus has been directed to the importance of patients being active agents in their own care and to increase the patient´s involvement in health care. Studies show that involving patients´ in treatment decisions and management of their own health care can contribute to better treatment outcomes and more appropriate use of health care service.
Few studies have evaluated patient involvement in iCBT-treatment. This study aims to evaluate the effect of patient-driven iCBT-treatment for patients with anxiety disorders seeking primary care in a randomized controlled trial. The study investigates the effect of patient-driven iCBT treatment of perceptions of being able to control the treatment and on drop-out from treatment. In addition, secondary research questions investigate measures of empowerment, anxiety and depression symptoms, general disability, satisfaction with treatment and feelings of being able to cope with one's mental illness in patient-driven iCBT.
详细描述
The following research questions will be examined:
Primary research questions:
- Is there a difference between participants in patient-driven digital psychological treatment, compared to standardized internet CBT, in perceptions of how much they've been able to control their treatment (measured with a questionnaire developed by the researchers for this study)?
- What is the effect of patient-driven digital psychological treatment, compared to standardized internet CBT, on frequency of completers and completed modules among adults with anxiety disorders?
Secondary research questions: 3. What is the effect of patient-driven digital psychological treatment, compared to standardized internet CBT, on the experience of empowerment, (measured by the "Empowerment Scale"), for adults with anxiety disorders? 4. What is the effect of patient-driven digital psychological treatment, compared to standardized internet CBT, on anxiety (measured with GAD-7), depression (measured with MADRS-S), general disability (measured with WHODAS 2.0) and steps in "valued direction" (measured with "Bull´s Eye compass") for adults with anxiety disorders?
Associations: 5. Is there a correlation between perceptions of how much one has been able to control the treatment (measured with a questionnaire developed by the researchers for this study), feelings of being able to cope with one's mental illness (measured with Patient Enablement Instrument), how satisfied participants are with their treatment (measured vid CSQ-8), perceptions of empowerment (measured with the "Empowerment Scale") and changes in anxiety symptoms (measured with GAD-7)? 6. Does perceptions of how much participants have been affected by the pandemic of Covid-19 in their daily life correlate with anxiety symptoms (measured with GAD-7) 3 months after termination of treatment?
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 (Investigator)
盲法说明
The groups are predetermined based on the tool randomizer.org and blinded to the researcher assigning the participants to groups.
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
- •Has reached the age of 18
- •Has access to a computer with internet connection
- •Speak and understand Swedish
- •Meets the diagnostic criteria for an anxiety disorder (social anxiety, GAD (Generalized Anxiety Disorder), panic disorder, obsessive-compulsive disorder or unspecified anxiety disorder)
排除标准
- •has started medication for mental illness or made major changes regarding the medication during the past 4 weeks
- •has serious suicidal thoughts or suicidal plans
- •has complex comorbidity or is in need of other care for mental illness in addition to iCBT
- •is receiving other psychological treatment during the treatment period
研究组 & 干预措施
Patient-driven iCBT
Participants who are randomized to the experimental condition are asked to make choices regarding the structure of their treatment program
干预措施: Patient-driven iCBT (Behavioral)
Standardized iCBT (TAU)
Patients who are randomized to the control condition undergo the usual iCBT program available for anxiety disorders for a standardized time period of 8 weeks
干预措施: Standardized iCBT (TAU) (Behavioral)
结局指标
主要结局
Questions of perceptions in how much one has been able to control the treatment
时间窗: At the end of treatment (after 8-16 weeks depending on treatment condition)
Perceptions in how much one has been able to control the treatment is measured by a questionnaire developed by the researchers for this study. The questionnaire consists of 9 items and each item is answered on a seven-point scale, from "Not at all" to "To a large extent".
Adherence to treatment
时间窗: At the end of treatment (after 8-16 weeks depending on treatment condition)
Adherence to treatment is measured by counting number of completed modules in the treatment program for each participant
次要结局
- Changes in General disabillity(Baseline (Pre-treatment), Middle of treatment, At the end of treatment (after 8-16 weeks depending on treatment condition) and by 3 months follow up)
- Perceptions of being able to cope with one's mental illness(At the end of treatment (after 8-16 weeks depending on treatment condition) and by 3 months follow up)
- Satisfaction with treatment(At the end of treatment (after 8-16 weeks depending on treatment condition) and by 3 months follow up)
- 10. Questions about how much one has been affected by the pandemic of Covid-19(By 3 months follow up)
- Changes in Depressive symptoms(Baseline (Pre-treatment), middle of treatment, At the end of treatment (after 8-16 weeks depending on the treatment condition) and by 3 months follow up)
- Changes in feelings of empowerment(Baseline (Pre-treatment), Middle of treatment, At the end of treatment (after 8-16 weeks depending on treatment condition) and by 3 months follow up)
- Changes in Anxiety symptoms(Baseline (Pre-treatment), Middle of treatment, At the end of treatment (after 8-16 weeks depending on treatment condition) and by 3 months follow up)
- Changes in steps towards "valued direction"(Baseline (Pre-treatment), Middle of treatment, At the end of treatment (after 8-16 weeks depending on treatment condition) and by 3 months follow up)