Brief Trial of ACT-i for Adults With Chronic Insomnia
ConditionChronic Insomnia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-59
SponsorBabes-Bolyai University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Acceptance and Commitment Therapy for Insomnia
BehavioralMonotherapy 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.
Attentional Control Group
BehavioralThe 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.
Treatment groups
76 Participants
are divided into 2 treatment groupsGroup A: Acceptance and Commitment Therapy for Insomnia (ACT-i)Experimental treatment 1 intervention
Group B: Attentional Control GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
baseline, 2 weeks after the interventionSecondary outcomes
1
Change in the score of Insomnia Severity Index (ISI)
Follow-up evaluation of the severity of insomnia using ISI
Time frame
3 months after the intervention2
Change in the score of Patient Health Questionnaire-9
The Patient Health Questionnaire-9 (PHQ-9) is a brief tool of depression. It consists of 9 items about depressive symptomatology, such as anhedonia, sadness and fatigue. Total scores range from 0 to 27.
Time frame
two weeks after the intervention and 3 months after the intervention3
Change in the score of Multidimensional psychological flexibility inventory (MPFI-24; Gregoire et al., 2020)
The Multidimensional psychological flexibility inventory (MPFI-24) is a 24-item measure of psychological flexibility, including acceptance, mindfulness, and values-based actions. Total scores range from 24 to 144.
Time frame
two weeks after the intervention and 3 months after the intervention4
Change in the score of the Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16)
The Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16) is a 16-item scale measuring dysfunctional sleep-related cognitions. Total score is added up and divided by 16, and a higher score represents higher unrealistic expectations regarding sleep.
Time frame
two weeks after the intervention and 3 months after the interventionOther outcomes
1
Satisfaction: Client Satisfaction Questionnaire (CSQ-8)
The Client Satisfaction Questionnaire (CSQ-8) is a brief tool of general satisfaction with the treatment being given. Each item is rated on a 4-point scale, ranging from 1 ("weak") to 4 ("excellent"). Total scores range from 8 to 32, with higher scores reflecting greater satisfaction.
Time frame
one day after the intervention, 3 months after the intervention2
Adherence: Adherence and satisfaction questionnaire (Ferreira et al., 2024)
Adherence and satisfaction questionnaire is a brief self-report tool of adherence and satisfaction with the provided treatment. It has 8 items, with yes and no answers.
Time frame
one day after the intervention, 3 months after the interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov