NCT07048600

Brief Trial of ACT-i for Adults With Chronic Insomnia

Brief Group Acceptance and Commitment Therapy for Insomnia: Study Protocol for a Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Babes-Bolyai University · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Chronic Insomnia
• Depression - Major Depressive Disorder
• Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	Acceptance and Commitment Therapy for Insomnia	Monotherapy ACT-i, with no behavioral components, is a brief and low-intensity treatment that has recently been detailed by experts in the field in a session-by-session guideline, intending to help people affected by chronic insomnia. The key components of the sessions are psychoeducation, mindfulness, values and actions derived from chosen values, and defusion. An adapted, brief and online version of the intervention was developed by the authors of this study. Both interventions were matched in terms of overall duration and delivery format. Each session was tailored to follow a comparable format. Therapeutic alliance, psychoeducation, sleep hygiene, relaxation training and homework was targeted in the first session. In the second session, ACT-i focused on values, acceptance strategies and psychological flexibility. This version will be published online upon request. Each session will last 120 min. They will be delivered once per week, for two consecutive weeks.
BEHAVIORAL	Attentional Control Group	The focus of the sessions will be on participants, on general topics. It will not include any active, psychological intervention components, such as cognitive restructuring or ACT processes. No recommendations or psychological guidance will be given. Each session will last 120 minutes. It will be held once per week, for two weeks.

Timeline

• Start date: 2025-05-23
• Primary completion: 2026-05-01
• Completion: 2026-06-01
• First posted: 2025-07-02
• Last updated: 2026-04-07

Locations

1 site across 1 country: Romania