A Pilot Randomized Trial of Brief Standalone Group Acceptance and Commitment Therapy (ACT-i) for Chronic Insomnia

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 59
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
Romania
Babes Bolyai University
RECRUITING
Cluj-napoca
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2025-10
Participants
Target number of participants: 128
Treatments
Experimental: Acceptance and Commitment Therapy for Insomnia (ACT-i)
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.~Participants 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.
Active_comparator: Attentional Control Group
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/ homework.
Related Therapeutic Areas
Sponsors
Leads: Babes-Bolyai University

This content was sourced from clinicaltrials.gov