Guided Self-help Based on Acceptance and Commitment Therapy to Reduce Perceived Stress
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- Perceived Stress Scale-14 (PSS-14)
研究概览
简要总结
The efficacy of guided self-help based on acceptance and commitment therapy (ACT) to reduce subjective sense of stress will be investigated in a randomised controlled trial with two condition: 1) ACT-based self-help, and 2) Wait-list control. The outcome at the end of the treatment (week 10) and 6-month follow-up will be assessed. The wail-list condition will be offered ACT-based self-help after the post-assessment.
详细描述
The efficacy of guided self-help based on acceptance and commitment therapy (ACT) to reduce subjective sense of stress will be investigated in a randomised controlled trial with two condition: 1) ACT-based self-help, and 2) Wait-list control. The outcome at the end of the treatment and 6-month follow-up will be assessed. The wail-list condition will be offered ACT-based self-help after 10 weeks (i.e. when the post-assessment is completed). Inclusion criteria are: Adults with a score above 14 on the stress sub scale of the Depression, Anxiety, Stress Scale (DASS) at screening, a score below 10 on the Patient Health Questionnaire (PHQ-9), no indication of suicidality on the PHQ-9, and no ongoing psychotherapeutic interventions, and no previous work with the self-help manual that has been published as a self-help book.
A total of 140 participants will be recruited and randomised, using services on www.random.org. Informed consent will be obtained from all the participants ahead of screening. Participants will be asked to respond to the following questionnaires at pre-, post and follow-up assessments: Perceived Stress Scale-14 (PSS-14), General Anxiety Disorder-7 (GAD-7), Shirom Melamed Burnout Measure (SMBM), and Brunnsviken Brief Quality of Life Inventory (BBQ). Initially, they will also be asked to respond to the credibility/Expectancy Questionnaire (CEQ).
At the end of the intervention (week 10), participants will also be asked to respond to the Client Satisfaction Questionnaire (CSQ), and the Negative Effects Questionnaire (NEQ).
The following two scales will be used to study mediators: Acceptance and Action Questionnaire-2 (AAQ-2), and Attention Awareness Scale (MAAS), assess at pre-treatment, as well as at third and fifth week of treatment, at post-assessment (10 weeks later), and at the 6 months follow-up. A number of moderators, including demographics, will also be investigated.
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
Given the nature of the intervention, and self-report as a main strategy for outcome assessment, nor masking is possible or necessary.
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
- •Age above 18
- •DASS score above 14
- •PHQ-9 below 9
排除标准
- •Any indications of suicidality
- •Any indication of other psychiatric disorder in need of immediate attention/treatment
- •Concurrent psychotherapy or other treatments for stress
- •Previous work with the self-help book
研究组 & 干预措施
Guided self-help based on ACT
Participants follow a self-help program and receive weekly support by trained facilitators
干预措施: Guided self-help based on ACT (Behavioral)
Wait-list control
Participants are informed that they will receive the intervention after the 6-month follow-up assessment
结局指标
主要结局
Perceived Stress Scale-14 (PSS-14)
时间窗: Pre-assessment, week 3 and 5 of intervention, post-assessment (week10), and 6 months follow-up
The PSS-14 is measure of stress. Its total score ranges from 0-56. Lower values represent a better outcome.
次要结局
- Brunnsviken Brief Quality of Life Inventory (BBQ)(Pre- and post-assessment (10 weeks later) as well as 6 months follow-up)
- Patient Health Questionnaire-9 (PHQ-9)(Pre- and post-assessment (10 weeks later) as well as 6 months follow-up)
- Shirom Melamed Burnout Measure (SMBM)(Pre- and post-assessment (10 weeks later) as well as 6 months follow-up)
- General Anxiety Disorder-7 (GAD-7)(Pre- and post-assessment (10 weeks later) as well as 6 months follow-up)
- Mindful Attention Awareness Scale (MAAS)(Pre-assessment, week 3 and 5 of intervention, post-assessment (week10), and 6 months follow-up)
- Client Satisfaction Questionnaire (CSQ)(Post-assessment, and 6 month follow-up)
- Negative Effects Questionnaire (NEQ)(Post-assessment, and 6 month follow-up)
- Acceptance and Action Questionnaire-2 (AAQ-2)(Pre-assessment, week 3 and 5 of intervention, post-assessment (week10), and 6 months follow-up)
研究者
Ata Ghaderi
Professor
Karolinska Institutet