Clinical trial Recruiting at 1 site Interventional Ages 18 to 59

Brief group Acceptance and Commitment Therapy (ACT-i) for adults with chronic insomnia

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

Run by Babes-Bolyai University · NCT07048600 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years to 59 Years
SexAll
Enrollment76 (estimated)
SponsorBabes-Bolyai University
Academic / other
Locations1 site (Cluj-Napoca)
StatusRecruiting
StartedMay 23, 2025
Main results expectedOctober 15, 2026
Study endsOctober 30, 2026
Registry record updatedSeptember 25, 2026
Trial IDNCT07048600 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Babes Bolyai University
    Cluj-Napoca, Romania
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.