Chronic InsomniaNCT07048600
Brief Trial of ACT-i for Adults With Chronic Insomnia
A study testing Acceptance and Commitment Therapy for Insomnia in people with Chronic Insomnia, run by Babes-Bolyai University at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Acceptance and Commitment Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteRomania
- Study dates
- 23 May 2025to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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;
Who cannot join
- 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);
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site, 1 recruiting
- Recruiting
Babes Bolyai University
Cluj-Napoca
Roxana Cardoș, PhD, +40 751 477 323, roxanaoltean@psychology.ro
Larisa C.I. Tînc, PhD Student, 077459079, larisa.tinc@ubbcluj.ro
About this study
Official title: Brief Group Acceptance and Commitment Therapy for Insomnia: Study Protocol for a Randomized Controlled 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.
Read the 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.
- Conditions
- Chronic Insomnia
- Being tested
- Acceptance and Commitment Therapy for Insomnia, Attentional Control Group
- Keywords
- acceptance and commitment therapy, chronic insomnia, cognitive functions, depression, anxiety, randomized controlled trial
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy for InsomniaBehavioural
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.
Attentional Control GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Attentional Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 2 weeks after the intervention
Secondary outcomes (7)
Change in the score of Insomnia Severity Index (ISI)
Follow-up evaluation of the severity of insomnia using ISI
Measured: 3 months after the intervention
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.
Measured: two weeks after the intervention and 3 months after the intervention
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.
Measured: two weeks after the intervention and 3 months after the intervention
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.
Measured: two weeks after the intervention and 3 months after the intervention
Change in the score of The Cognitive Failures Questionnaire (CFQ)
The Cognitive Failures Questionnaire (CFQ) is a self-report tool of the frequency of daily cognitive failures, such as forgetfulness or lapses in attention. It has 25 items and total scores range from 0 to 100, with higher scores indicating more subjective cognitive failure.
Measured: two weeks after the intervention and 3 months after the intervention
Change in the score of Barkley Deficits in Executive Functioning Scale (BDEFS-SF)
The Barkley Deficits in Executive Functioning Scale (BDEFS-SF) is a 20-item self-report measure of executive functioning deficits. Each item is rated on a 4-point Likert scale, ranging from 1 ("never or rarely") to 4 ("very often"). Total scores range from 20 to 80.
Measured: two weeks after the intervention and 3 months after the intervention
Change in the score of The Generalised Anxiety Disorder 7 (GAD-7)
The Generalised Anxiety Disorder 7 (GAD-7) is a 7-item self-report measure of the severity of anxiety. Each item is rated on a 4-point Likert scale, ranging from 0 ("not at all") to 4 ("nearly every day"). Total scores range from 20 to 80.
Measured: two weeks after the intervention and 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start23 May 2025
- Primary completion15 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roxana Cardos, Babes-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07048600
- Sponsor's protocol ID
- 407/25.04.2025
- Status last verified
- Apr 2026
- First submitted
- 20 May 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will share IPD used in the results of the publication, upon request.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Group Acceptance and Commitment Therapy for Insomnia: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07048600
- Acronym / sponsor ID
- 407/25.04.2025
- Conditions
- Chronic Insomnia
- Keywords
- acceptance and commitment therapy, chronic insomnia, cognitive functions, depression, anxiety, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Study start
- 23 May 2025 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 2 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy for Insomnia (ACT-i) | Experimental | Behavioral: Acceptance and Commitment Therapy for InsomniaThe 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. |
| Attentional Control Group | Active comparator | Behavioral: Attentional Control GroupParticipants 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (5 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment Therapy for InsomniaMonotherapy 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. | Behavioural | Acceptance and Commitment Therapy for Insomnia (ACT-i) |
| Attentional Control GroupThe 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. | Behavioural | Attentional Control Group |
Primary outcome
Change in the score of Insomnia Severity Index (ISI);
Time frame: baseline, 2 weeks after the intervention
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.
7 secondary outcomes
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: two weeks after the intervention and 3 months after the intervention
Change in the score of Multidimensional psychological flexibility inventory (MPFI-24; Gregoire et al., 2020)
Time frame: two weeks after the intervention and 3 months after the intervention
Change in the score of the Dysfunctional Beliefs and Attitudes about Sleep (DBAS-16)
Time frame: two weeks after the intervention and 3 months after the intervention
Change in the score of The Cognitive Failures Questionnaire (CFQ)
Time frame: two weeks after the intervention and 3 months after the intervention
Change in the score of Barkley Deficits in Executive Functioning Scale (BDEFS-SF)
Time frame: two weeks after the intervention and 3 months after the intervention
Change in the score of The Generalised Anxiety Disorder 7 (GAD-7)
Time frame: two weeks after the intervention and 3 months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: Yes. Will share IPD used in the results of the publication, upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy for Insomnia in people with Chronic Insomnia, run by Babes-Bolyai University at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the score of Insomnia Severity Index (ISI); (time frame: baseline, 2 weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.