Brief Group Acceptance and Commitment Therapy for Insomnia: Study Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change in the score of Insomnia Severity Index (ISI);
研究概览
简要总结
This is a prospective, randomized-controlled trial that assesses the efficacy of a brief Acceptance and Commitment Therapy (ACT-i), compared to an attentional control group, in adults with chronic insomnia. The interventions will be evaluated for their impact on insomnia severity, cognitive function, depression, anxiety, psychological flexibility, and sleep beliefs - measured before treatment, two weeks after and at a three-month follow-up.
详细描述
Insomnia is the most prevalent sleep disorder. It is associated with impairments both physically and psychologically. Therefore, it usually causes a suite of durable stressors in numerous aspects of life, such as academically, professionally, socially, and financially. Given its widespread impact, early effective treatments are crucial to prevent long-term consequences.
The first line of treatment is Cognitive-Behavioral Therapy for Insomnia (CBT-i). Despite its effectiveness, approximately 60% of individuals with chronic insomnia and comorbidities do not go into remission after treatment or simply do not adhere to it. Acceptance and Commitment Therapy for Insomnia (ACT-i) has great potential for overcoming this limitation, as it focuses on accepting the feelings and thoughts associated with insomnia, through value-based actions. However, more studies on ACT-i as a monotherapy are needed.
This study aims to evaluate the efficacy of brief, group ACT-i for chronic insomnia in adults, versus an attentional control group. Participants will be aged between 18 and 59 years, diagnosed with chronic insomnia who will be randomly assigned to either ACT-i, or the control group. To limit age-related sleep changes, only participants aged up to 59 will be included, as sleep difficulties tend to increase after the age of 60. The interventions will be performed in groups, in 2 weekly sessions. Their effects will be investigated for the primary outcome related to the severity of insomnia, and secondary outcomes related to depression, anxiety, cognitive functioning, psychological flexibility, and beliefs about sleep at pre-test, post-test at two weeks and three-month follow-up. After the interventions, participants will complete an inventory regarding the adherence and satisfaction to both interventions. This is the first attempt to investigate a group-based ACT-i as monotherapy with an attentional control group delivered in an accessible, brief-group format. Specifically, the sessions are implemented briefly in 2 group sessions, unlike other studies that have (at least) 4 group sessions. Furthermore, the investigators will also compare their adherence rates and patients' satisfaction.
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 (Outcomes Assessor)
盲法说明
The outcome assessor actually reflects the data analyst that will be blinded to the randomization schedule. A third party will perform the randomization and assign participants to the treatment groups. The online platform will generate the allocation after the inclusion and exclusion criteria are met and the pre-test forms are performed.
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical/ subclinical diagnosis of chronic insomnia either already diagnosed by a professional, or identified with SCISD-R by our team of clinicians
- •age over 18 and older, but not over 59 years old;
- •minimal/ mild symptomatology of depression (scores ≤ 9 on PHQ-9) and/ or anxiety (scores ≤ 9 on GAD-7) or as diagnosed with SCID-5-CV;
排除标准
- •diagnosed with a neurological degenerative disorder, or any moderate/ severe psychiatric disorder;
- •diagnosed with other sleep disorder (e.g., sleep apnea, restless legs/ periodic limb movements, circadian-based sleep disorder);
- •diagnosed with cognitive impairments;
- •unable to understand Romanian;
- •unable to attend to online-sessions (e.g., no laptop, microphone, camera);
研究组 & 干预措施
Acceptance and Commitment Therapy for Insomnia (ACT-i)
The intervention is available in its individual and group format, which can be adapted to an online context in "Acceptance and Commitment Therapy for Insomnia: A Session-By-Session Guide", by Renatha El Rafihi-Ferreira (Rafihi-Ferreira, 2024). It comprises the details of each ACT-i group session with illustrations and examples for the trained therapists.
Participants will be requested to register to an Online Platform, such as Google Meet, to attend the two sessions which will be guided by a trained therapists. Each session will have approximately 120 minutes. They will receive instructions from the therapists and handouts at the end of each session. Facilitators will receive training from a specialized mental health professional.
干预措施: Acceptance and Commitment Therapy for Insomnia (Behavioral)
Attentional Control Group
Participants will receive this intervention in an online platform by a trained professional. His training will be provided by a mental health expert with experience in carrying out psychoeducational and non-directive group sessions. This group will match the ACT-i intervention in terms of session duration, delivery format, group interaction, facilitator contact, time and handouts/ homework.
干预措施: Attentional Control Group (Behavioral)
结局指标
主要结局
Change in the score of Insomnia Severity Index (ISI);
时间窗: baseline, 2 weeks after the intervention
The Insomnia Severity Index (ISI) is a brief tool of chronic insomnia. It consists of 7 items about the severity of insomnia, its noticeability, and daytime functioning. Total scores range from 0 to 28, with higher scores reflecting more severe clinical insomnia.
次要结局
- Change in the score of Patient Health Questionnaire-9(two weeks after the intervention and 3 months after the intervention)
- Change in the score of Multidimensional psychological flexibility inventory (MPFI-24; Gregoire et al., 2020)(two weeks after the intervention and 3 months after the intervention)
- Change in the score of the Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16)(two weeks after the intervention and 3 months after the intervention)
- Change in the score of The Cognitive Failures Questionnaire (CFQ)(two weeks after the intervention and 3 months after the intervention)
- Change in the score of Barkley Deficits in Executive Functioning Scale (BDEFS-SF)(two weeks after the intervention and 3 months after the intervention)
- Change in the score of The Generalised Anxiety Disorder 7 (GAD-7)(two weeks after the intervention and 3 months after the intervention)
- Change in the score of The Generalised Anxiety Disorder 7 (GAD-7)(3 months after the intervention)
- Change in the score of the Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16)(3 months after the intervention)
- Change in the score of Insomnia Severity Index (ISI)(3 months after the intervention)
- Change in the score of The Cognitive Failures Questionnaire (CFQ)(3 months after the intervention)
- Change in the score of Patient Health Questionnaire-9(3 months after the intervention)
- Change in the score of Barkley Deficits in Executive Functioning Scale (BDEFS-SF)(3 months after the intervention)
- Change in the score of Multidimensional psychological flexibility inventory (MPFI-24; Gregoire et al., 2020)(3 months after the intervention)
研究者
Roxana Cardos
Lect. Univ. Dr.
Babes-Bolyai University