Brief Trial of ACT-i for Adults With Chronic Insomnia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acceptance and Commitment Therapy for Insomnia, Attentional Control Group.
- Who it may be relevant to
- Registry conditions: Chronic Insomnia, Depression - Major Depressive Disorder, Anxiety. Basic parameters: 18 years — 59 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Romania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Brief Group Acceptance and Commitment Therapy for Insomnia: Study Protocol for a Randomized Controlled Trial
Overview
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.
Detailed description
Insomnia is the most prevalent sleep disorder. It is associated with impairments both physically and psychologically. Therefore, it usually causes a suite of durable stressors in numerous aspects of life, such as academically, professionally, socially, and financially. Given its widespread impact, early effective treatments are crucial to prevent long-term consequences.
The first line of treatment is Cognitive-Behavioral Therapy for Insomnia (CBT-i). Despite its effectiveness, approximately 60% of individuals with chronic insomnia and comorbidities do not go into remission after treatment or simply do not adhere to it. Acceptance and Commitment Therapy for Insomnia (ACT-i) has great potential for overcoming this limitation, as it focuses on accepting the feelings and thoughts associated with insomnia, through value-based actions. However, more studies on ACT-i as a monotherapy are needed.
This study aims to evaluate the efficacy of brief, group ACT-i for chronic insomnia in adults, versus an attentional control group. Participants will be aged between 18 and 59 years, diagnosed with chronic insomnia who will be randomly assigned to either ACT-i, or the control group. To limit age-related sleep changes, only participants aged up to 59 will be included, as sleep difficulties tend to increase after the age of 60. The interventions will be performed in groups, in 2 weekly sessions. Their effects will be investigated for the primary outcome related to the severity of insomnia, and secondary outcomes related to depression, anxiety, cognitive functioning, psychological flexibility, and beliefs about sleep at pre-test, post-test at two weeks and three-month follow-up. After the interventions, participants will complete an inventory regarding the adherence and satisfaction to both interventions. This is the first attempt to investigate a group-based ACT-i as monotherapy with an attentional control group delivered in an accessible, brief-group format. Specifically, the sessions are implemented briefly in 2 group sessions, unlike other studies that have (at least) 4 group sessions. Furthermore, the investigators will also compare their adherence rates and patients' satisfaction.
Interventions
- 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. An adapted, brief and online version of the intervention was developed by the authors of this study. Both interventions were matched i - Behavioral Attentional 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.
Primary outcome measures
- Change in the score of Insomnia Severity Index (ISI); [Time frame: baseline, 2 weeks after the intervention]
Secondary outcome measures (7)
- Change in the score of Insomnia Severity Index (ISI) [Time frame: 3 months after the intervention]
- Change in the score of Patient Health Questionnaire-9 [Time frame: 3 months after the intervention]
- Change in the score of Multidimensional psychological flexibility inventory (MPFI-24; Gregoire et al., 2020) [Time frame: 3 months after the intervention]
- Change in the score of the Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) [Time frame: 3 months after the intervention]
- Change in the score of The Cognitive Failures Questionnaire (CFQ) [Time frame: 3 months after the intervention]
- Change in the score of Barkley Deficits in Executive Functioning Scale (BDEFS-SF) [Time frame: 3 months after the intervention]
- Change in the score of The Generalised Anxiety Disorder 7 (GAD-7) [Time frame: 3 months after the intervention]
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);
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Romania · 1 center
- Babes Bolyai University — Cluj-Napoca
Identifiers
NCT: NCT07048600 · 407/25.04.2025