Brief group Acceptance and Commitment Therapy (ACT-i) for adults with chronic insomnia
Brief Group Acceptance and Commitment Therapy for Insomnia: Study Protocol for a Randomized Controlled Trial
This project will test whether a short, group Acceptance and Commitment Therapy program (ACT-i) helps adults aged 18–59 with chronic insomnia compared with an attentional control program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Sponsor | Babes-Bolyai University Academic / other |
| Locations | 1 site (Cluj-Napoca) |
| Trial ID | NCT07048600 on ClinicalTrials.gov |
What this trial studies
This is a randomized, controlled, group-based intervention comparing a brief ACT-i program to an attentional control in adults with chronic insomnia. Participants aged 18–59 will attend two weekly group sessions and complete measures before treatment, two weeks after treatment, and at a three-month follow-up. Outcomes include insomnia severity plus cognitive function, depression, anxiety, psychological flexibility, and sleep-related beliefs. Sessions require Romanian language comprehension and the ability to join online with a camera and microphone, and the trial is coordinated at Babeș-Bolyai University in Cluj-Napoca.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–59 with chronic insomnia who can understand Romanian, attend online group sessions, and do not have moderate-to-severe psychiatric, neurodegenerative, or other primary sleep disorders.
Not a fit: Patients with moderate or severe psychiatric disorders, neurodegenerative disease, other primary sleep disorders (like sleep apnea), significant cognitive impairment, inability to use online sessions, or who do not understand Romanian are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, a brief group ACT-i could offer a shorter, more accessible behavioral option to reduce insomnia symptoms and related mood or cognitive problems.
How similar studies have performed: Cognitive-behavioral therapy for insomnia (CBT-i) has strong evidence, and early ACT-i studies are promising but ACT-i as a standalone brief group treatment remains relatively limited and needs more randomized trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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);
Where this trial is running
Cluj-Napoca
- Babes Bolyai University — Cluj-Napoca, Romania (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.