Recruiting

Brief Trial of ACT-i for Adults With Chronic Insomnia

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.

ClinicalTrials.gov IDNCT07048600

PhaseNA

Enrollment76

SponsorBabes-Bolyai University

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Chronic Insomnia

About this study

Interventions

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.

Primary outcomes

Change in the score of Insomnia Severity Index (ISI); (baseline, 2 weeks after the intervention)

Eligibility information

Inclusion Criteria: * 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; Exclusion Criteria: * 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);

Study locations

Babes Bolyai University, Cluj-Napoca, Romania

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.