Brief Trial of ACT-i for Adults With Chronic Insomnia

NCT07048600 | Recruiting

• 1 other identifier: 407/25.04.2025
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Insomnia; Depression - Major Depressive Disorder; Anxiety

Keywords

acceptance and commitment therapy; chronic insomnia; cognitive functions; depression; anxiety; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Change in the score of Insomnia Severity Index (ISI);

  The Insomnia Severity Index (ISI) is a brief tool of chronic insomnia. It consists of 7 items about the severity of insomnia, its noticeability, and daytime functioning. Total scores range from 0 to 28, with higher scores reflecting more severe clinical insomnia.

  baseline, 2 weeks after the intervention

Secondary Outcomes (6)

• Change in the score of Insomnia Severity Index (ISI)

  3 months after the intervention

• Change in the score of Patient Health Questionnaire-9

  3 months after the intervention

• Change in the score of Multidimensional psychological flexibility inventory (MPFI-24; Gregoire et al., 2020)

  3 months after the intervention

• Change in the score of the Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16)

  3 months after the intervention

• Change in the score of The Cognitive Failures Questionnaire (CFQ)

  3 months after the intervention

Other Outcomes (2)

• Satisfaction: Client Satisfaction Questionnaire (CSQ-8)

  one day after the intervention

• Adherence: Adherence and satisfaction questionnaire (Ferreira et al., 2024)

  one day after the intervention

Study Arms (2)

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. 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.

Behavioral: Acceptance and Commitment Therapy for Insomnia

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/ homework.

Behavioral: Attentional Control Group

Interventions

Acceptance and Commitment Therapy for Insomnia BEHAVIORAL

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.

Acceptance and Commitment Therapy for Insomnia (ACT-i)

Attentional Control Group BEHAVIORAL

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.

Attentional Control Group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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);

Sponsors & Collaborators

• Babes-Bolyai University: lead

Study Sites (1)

Babes Bolyai University

Cluj-Napoca, Romania

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The main investigator and statistician of the study will be blinded to the randomization schedule, as a third party will perform the randomization and assign participants to the treatment groups. The online platform will generate the allocation after the inclusion and exclusion criteria are met and the pre-test forms are performed. Participants will be blind to their group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lect. Univ. Dr.

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: July 2, 2025
• Study Start: June 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The IPD may be shared after publication upon request, with no end date.

Locations

RO (1)