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Search / Trial NCT07048600

Brief Trial of ACT-i for Adults With Chronic Insomnia

Launched by BABES-BOLYAI UNIVERSITY · Jun 30, 2025

Trial Information

Current as of July 26, 2025

Recruiting

Keywords

Acceptance And Commitment Therapy Chronic Insomnia Cognitive Functions Depression Anxiety Randomized Controlled Trial

ClinConnect Summary

This clinical trial is studying a type of therapy called Acceptance and Commitment Therapy (ACT-i) to see if it can help adults who have chronic insomnia, which means ongoing difficulty sleeping. The study will compare this therapy to another group that receives attention but not the therapy itself. Researchers want to find out if ACT-i can reduce problems with sleep, improve thinking skills, and help with symptoms of depression and anxiety. They will check how participants are doing before treatment, two weeks after, and again three months later.

Adults between 18 and 59 years old who have been diagnosed with chronic insomnia, or show signs of it during the study, may be eligible to join. People with mild or minimal depression or anxiety symptoms can participate, but those with more serious mental health issues, other sleep disorders, or cognitive problems cannot. Participants will take part in online sessions, so they need access to a computer with a camera and microphone, and must understand Romanian. This study is currently recruiting people interested in trying this brief therapy to see if it can improve their sleep and overall well-being.

Gender

ALL

Eligibility 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);

About Babes Bolyai University

Babes-Bolyai University, a prestigious institution located in Cluj-Napoca, Romania, is dedicated to advancing research and innovation in various fields, including healthcare. With a strong emphasis on interdisciplinary collaboration, the university engages in cutting-edge clinical trials aimed at improving patient outcomes and enhancing medical knowledge. Leveraging a robust network of experts and state-of-the-art facilities, Babes-Bolyai University is committed to conducting high-quality research that adheres to ethical standards and contributes to the global scientific community. Through its clinical trial initiatives, the university seeks to foster advancements in treatment methodologies and promote evidence-based practices in medicine.

Locations

Cluj Napoca, , Romania

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported