A Comparison of Two Ultra-brief Interventions in Primary Care for Patients With Anxiety, Depression, and Stress: a Pilot Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
This pilot randomized controlled trial evaluated the feasibility of a Swedish translation of an Acceptance and Commitment Therapy protocol targeting repetitive negative thinking (RNT-ACT) compared with therapist-supported internet-based cognitive behavioral therapy (iCBT) in Swedish primary care. Feasibility was assessed in terms of recruitment, intervention completion, and patient satisfaction. Symptoms of depression, anxiety and stress, rumination, psychological flexibility, valued living, and cognitive fusion were assessed as secondary outcomes.
详细描述
This pilot randomized controlled trial was conducted to evaluate the feasibility of RNT-ACT in Swedish primary care, using therapist-supported iCBT as an active comparator. Participants were randomized to either RNT-ACT or iCBT.
RNT-ACT consisted of two 60-minute therapy sessions and audio exercises for participants to use between sessions. Participants allocated to iCBT received an internet-based cognitive behavioral therapy program for anxiety or depression, delivered through the secure Stöd och Behandling platform used in Region Skåne, with therapist support available through the platform.
The primary feasibility outcomes were recruitment rate, intervention non-completion, and patient satisfaction measured with the Client Satisfaction Questionnaire (CSQ-8). Secondary outcomes included symptoms of depression, anxiety and stress, rumination, psychological flexibility, valued living, and cognitive fusion. Secondary outcomes were included to describe the sample and patterns of change and were not intended to provide evidence of comparative treatment efficacy.
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
- 否
入选标准
- •DASS-21 total score >20
- •Ability to communicate in spoken and written Swedish
排除标准
- •Physical illness requiring further medical assessment identified during routine screening
- •Ongoing psychological or psychiatric treatment
- •A level of suicide risk considered clinically incompatible with study participation
- •Substance abuse
- •Anorexia nervosa
- •Psychotic disorder
- •Bipolar disorder
- •Attention-deficit/hyperactivity disorder (ADHD)
- •Antisocial personality disorder
- •A level of exhaustion considered incompatible with study participation
研究组 & 干预措施
RNT-ACT protocol
Participants randomized to RNT-ACT will receive a total of 2 sessions of 60 minutes each as well as audio files to listen to between the occasions administered via internet. Previous studies have indicated that it doesn't make much of a difference whether the temporal distance between session 1 and session 2 is between 1 week and up to 3 months. At occasion 1, the time for occasion 2 is set. The temporal distance in days will noted for each patient. The treatment is inserted into the therapist's regular diary with 60 minutes session time and appropriate break before and after the treatment (e.g. at least 5-10 minutes) for preparation and post-administration where journal writing is included.
干预措施: RNT-ACT Protocol (Behavioral)
iCBT treatment
The people randomized to Internet treatment will be offered based on M.I.N.I 7.0 a suitable iCBT program in the Stöd och Behandling (SoB) platform. The patients follow a structured self-help material which can be seen as a standard treatment option in Region Skåne, "treatment as usual". The therapist has access to the material and the patient and the therapist can communicate via a chat function. The patients are matched to iCBT programs based on whether they are most likely to show symptoms of depression or anxiety. The main component of Internet processing consists of a structured self-help program in approximately eight modules, somewhat varying depending on which program in use. The program is based on proven CBT interventions for each problem area with a strong emphasis on psychoeducation but where different intervention elements is included.
干预措施: iCBT Treatment (Behavioral)
结局指标
主要结局
Recruitment rate
时间窗: At screening and enrolment.
Percentage of participants enrolled among all individuals screened for participation. Calculated as the number of participants enrolled divided by the total number of individuals screened, multiplied by 100.
Intervention non-completion rate
时间窗: From randomization through completion of the allocated intervention, up to approximately 3 months.
Percentage of randomized participants who did not complete their allocated intervention. Intervention completion was assessed as a binary outcome.
CSQ-8
时间窗: At the main post-treatment follow-up; if not completed, at the 3-month follow-up.
Client Satisfaction Questionnaire (CSQ-8). Min 8, Max 32 with higher values indicating higher satisfaction.
次要结局
- DASS-21(At baseline, main post-treatment follow-up, and 3-month follow-up.)
- RRS-BR(At baseline, main post-treatment follow-up, and 3-month follow-up.)
- SAAQ(At baseline, main post-treatment follow-up, and 3-month follow-up.)
- Valuing Questionnaire (VQ)(At baseline, main post-treatment follow-up, and 3-month follow-up.)
- CFQ-7(At baseline, main post-treatment follow-up, and 3-month follow-up.)