A Comparison of Two Ultra-brief Interventions in Primary Care for Patients With Anxiety, Depression, and Stress: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Region Skane
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- DASS-21
研究概览
简要总结
The goal of this clinical trial is to compare the effect and time consumption of the Swedish translation of the protocol for RNT-ACT with the internet administrated self-help treatment with therapist support (iCBT) for patients seeking medical care for depression, anxiety or stress at their primary care unit. The trial consists of a feasibility study and a randomized controlled trial with 3- and 12-month follow ups.
详细描述
The main question it aims to answer are: Is the Swedish translation of a psychological treatment protocol targeting Repetitive Negative Thinking (RNT) based on Acceptance and Commitment therapy (ACT), RNT-ACT, an effective treatment in Swedish primary care for the treatment of people with a high proportion of negative repetitive thoughts, who meet diagnostic criteria for depression and/or anxiety? The question is planned to be elaborated into the following parts:
A feasibility study in which the material and the system are tested at a single care center.
A randomized controlled trial conducted at several health centers where the comparison group is patients who are actualized for traditional psychological treatment in the form of iCBT for either anxiety or depression programs and where they are offered the second treatment arm after 3- and 12-month follow-ups.
A follow-up study where time consumption and patient satisfaction are evaluated in both branches.
Participants will be given either RNT-ACT or iCBT as treatment. The group who are given RNT-ACT will receive 2*60 minutes of therapy along with mindfulness files to listen to daily between sessions. The group who are given iCBT will receive internet-based Cognitive Behavioral Therapy, one of the forms of delivering Cognitive behavioral therapy that is implemented in Region Skåne and can thus be seen as treatment as usual. Patients will access the treatment through a secure website and communicate with their therapist by text when needed. Researchers will compare the RNT-ACT and iCBT groups to see if there are differences in depressive, anxiety- and stress- related symptoms, rumination, psychological flexibility, client satisfaction and therapist-rated time consumption. In the feasibility study researchers will also evaluate drop-out and recruitment rate.
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
- None
盲法说明
Patients are made aware of the study through information material at the primary care unit in the waiting room and on the therapists door. There they can notify the contact person about their interest. Letter with information about the study will be sent out to the interested patient. If the patient chooses to participate by answering positively on the information letter, they will be contacted by telephone by a psychologist at the respective primary care unit for the opportunity to ask questions and to book an appointment for a baseline measurement at the unit. After the baseline measurement the patient is randomly assigned to one of the treatment arms. Measurements with all self-assessment scales are carried out at week 0, at the end of treatment and 3 months after the end of treatment. The participants are then offered the opportunity for a follow-up 12 months after completion of treatment using the same scales as the 3-month follow-up.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DASS-21 >25
- •Ability to communicate in Swedish orally and in writing
排除标准
- •Routine blood tests are carried out including blood count, thyroid hormone, liver status and fluid balance in order to be able to differentially diagnose any physical illness.
- •In addition to physical illness are exclusion criteria
- •Other psychological or psychiatric treatment,
- •Suicidality, substance abuse, Anorexia Nervosa, psychosis, bipolar disorder, attention deficit hyperactivity disorder (ADHD) and antisocial personality disorder (as verified based on M.I.N.I 7.0).
结局指标
主要结局
DASS-21
时间窗: From assessment to 3 month follow up.
Depression, Anxiety and Stress Scale-21 (DASS-21); Min 0, Max 63 with high values associated with more Depression/Anxiety/Stress.
次要结局
- Drop Out rate(Up to three months.)
- Recruitment rate(one month.)
- Self registered time consumption(Up to three months.)
- WAI(From assessment to 3 month follow up.)
- CSQ-8(From assessment to 3 month follow up.)
- RRS-BR(From assessment to 3 month follow up.)
- SAAQ(From assessment to 3 month follow up.)
- BSRI(From assessment to 3 month follow up.)
- CFQ-7(From assessment to 3 month follow up.)
- AFQ-Y8(From assessment to 3 month follow up.)