RecruitingNot ApplicableNCT07048600

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


Sponsor

Babes-Bolyai University

Enrollment

76 participants

Start Date

May 23, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 59 Years

Plain Language Summary

Simplified for easier understanding

This study tests a brief online therapy called ACT-i (based on Acceptance and Commitment Therapy) for adults who struggle with chronic insomnia — difficulty falling or staying asleep that has lasted for a long time. The therapy is delivered via video sessions. **You may be eligible if:** - You are between 18 and 59 years old - You have been diagnosed with chronic insomnia (or have been identified as having insomnia symptoms by our clinical team) - You have mild or no symptoms of depression and anxiety (based on standard screening questionnaires) - You can attend online video sessions and have access to a laptop with a microphone and camera - You can understand Romanian **You may NOT be eligible if:** - You have a moderate or severe psychiatric disorder, or a neurological degenerative condition - You have another sleep disorder such as sleep apnea, restless legs, or a circadian rhythm disorder - You have cognitive impairments - You do not have access to a laptop, microphone, or camera - You cannot understand Romanian Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALAcceptance 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.

BEHAVIORALAttentional 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.


Locations(1)

Babes Bolyai University

Cluj-Napoca, Romania

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NCT07048600


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