[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596679":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":30,"responsibleParty":53,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":26,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":26,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":33,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Babes-Bolyai University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Acceptance and Commitment Therapy for Insomnia (ACT-i)","EXPERIMENTAL","The intervention is available in its individual and group format, which can be adapted to an online context in \"Acceptance and Commitment Therapy for Insomnia: A Session-By-Session Guide\", by Renatha El Rafihi-Ferreira (Rafihi-Ferreira, 2024). It comprises the details of each ACT-i group session with illustrations and examples for the trained therapists.\n\nParticipants will be requested to register to an Online Platform, such as Google Meet, to attend the two sessions which will be guided by a trained therapists. Each session will have approximately 120 minutes. They will receive instructions from the therapists and handouts at the end of each session. Facilitators will receive training from a specialized mental health professional.",[13],"Behavioral: Acceptance and Commitment Therapy for Insomnia",{"label":15,"type":16,"description":17,"interventionNames":18},"Attentional Control Group","ACTIVE_COMPARATOR","Participants will receive this intervention in an online platform by a trained professional. His training will be provided by a mental health expert with experience in carrying out psychoeducational and non-directive group sessions. This group will match the ACT-i intervention in terms of session duration, delivery format, group interaction, facilitator contact, time and handouts\u002F homework.",[19],"Behavioral: Attentional Control Group",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.\n\nAn 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.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"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.",[15],[31],{"facility":32,"status":33,"city":34,"state":26,"zip":26,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Babes Bolyai University","RECRUITING","Cluj-Napoca","Romania","RO",{"type":38,"coordinates":39},"Point",[40,41],23.6,46.76667,{"lat":41,"lon":40},[44,49],{"name":45,"role":46,"phone":47,"phoneExt":26,"email":48},"Roxana Cardoș, PhD","CONTACT","+40 751 477 323","roxanaoltean@psychology.ro",{"name":50,"role":46,"phone":51,"phoneExt":26,"email":52},"Larisa C.I. Tînc, PhD Student","077459079","larisa.tinc@ubbcluj.ro",{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Roxana Cardos","Lect. Univ. Dr.","100596679","brief-trial-of-act-i-for-adults-with-chronic-insomnia-100596679",false,"NCT07048600","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","Inclusion Criteria:\n\n* clinical\u002F subclinical diagnosis of chronic insomnia either already diagnosed by a professional, or identified with SCISD-R by our team of clinicians\n* age over 18 and older, but not over 59 years old;\n* minimal\u002F mild symptomatology of depression (scores ≤ 9 on PHQ-9) and\u002F or anxiety (scores ≤ 9 on GAD-7) or as diagnosed with SCID-5-CV;\n\nExclusion Criteria:\n\n* diagnosed with a neurological degenerative disorder, or any moderate\u002F severe psychiatric disorder;\n* diagnosed with other sleep disorder (e.g., sleep apnea, restless legs\u002F periodic limb movements, circadian-based sleep disorder);\n* diagnosed with cognitive impairments;\n* unable to understand Romanian;\n* unable to attend to online-sessions (e.g., no laptop, microphone, camera);","ALL","18 Years","59 Years",{"count":68,"type":69},76,"ESTIMATED","INTERVENTIONAL",[72],"NA","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.",[75,76,77],"Chronic Insomnia","Depression - Major Depressive Disorder","Anxiety",[79,80,81,82,83,84],"acceptance and commitment therapy","chronic insomnia","cognitive functions","depression","anxiety","randomized controlled trial","2026-04-03",{"date":87,"type":88},"2026-04-07","ACTUAL",{"date":90,"type":88},"2025-05-23",{"date":92,"type":69},"2026-06",{"name":5,"class":6},1]