InsomniaSLEEPLOSSNCT07167706
Sleep Difficulties After Loss: Exploring the Beneficial Effect of Brief Behavioral Therapy for Insomnia in a Sample of Bereaved Individuals
A study testing Brief Behavioral Therapy for Insomnia and Sleep Hygiene Therapy in people with Insomnia and Insomnia Chronic, run by University of Aarhus at 1 site in Denmark.
Trial summary
The goal of the study is to investigate whether a brief behavioral therapy for insomnia (BBTI) improves sleep in bereaved patients screened for insomnia compared to an active control group (sleep hygiene education). The study will also explore if BBTI improves symptoms of complicated grief. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Insomnia Chronic, Complicated Grief
- What is being tested?
- Brief Behavioral Therapy for Insomnia and Sleep Hygiene Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Dec 2025to 31 May 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Bereaved (experienced the death of a perceived loved one) ≥6 months ago
- Insomnia: a score of >10 on the Insomnia Severity index (ISI) and/or meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for Insomnia Disorder
Who cannot join
- Other sleep disor-ders (sleep apnea, parasomnia, narcolepsy)
- Use of drugs impacting sleep
- Severe psychological or physical disorders that may confound sleep (symptoms of CGR allowed)
- Neurodegenerative disorders
- Shift work
- Insufficient Danish proficiency
- Previous experience with BBTI or cognitive behavioral therapy for insomnia (CBT-I)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Aarhus University
Aarhus, Jutland, 8000
Ali Amidi, Associate Professor, +4587165305, ali@psy.au.dk
Alexander D Castro-Pavlik, PhD-student, MSc in Psychology, +4529122219, acp@psy.au.dk
About this study
Official title: Sleep Difficulties After Loss (SLEEPLOSS): Exploring the Beneficial Effect of Brief Behavioral Therapy for Insomnia in a Sample of Bereaved Individuals
The goal of the study is to investigate whether a brief behavioral therapy for insomnia (BBTI) improves sleep in bereaved patients screened for insomnia compared to an active control group (sleep hygiene education). The study will also explore if BBTI improves symptoms of complicated grief. The investigators will recruit approximately 58 bereaved participants with insomnia.
Read the detailed description
The study is a randomized controlled trial comparing the effect of a brief behavioral therapy for insomnia (BBTI) on insomnia with an active control group (sleep hygiene). Participants will be 58 bereaved individuals who experience insomnia. After baseline assessment, participants will be randomized to either BBTI or sleep hygiene (active control). Both groups will undergo post-treatment assessments as well as 3- and 6-months follow-up assessments. The primary outcomes will be insomnia assessed with the Insomnia Severity Index (ISI) and improvements in sleep quality using the Pittsburgh Sleep Quality Index (PSQI) and sleep parameters using the consensus sleep diary. The secondary outcome will be complicated grief reactions (CGR) using the Aarhus Prolonged Grief Disorder scale (A-PGDs, prolonged grief). the Center of Epidemiological Studies Depression Scale (CESD-10, depression), the General Anxiety Disorder-7 questionnaire (GAD-7; anxiety), and the short-form PTSD Checklist for DSM-5 (PCL-5; PTSD).
The study has the following aims and hypotheses:
PRIMARY AIM: To investigate whether BBTI improves sleep in bereaved patients screened for insomnia when compared to an active control group.
PRIMARY HYPOTHESIS: Compared with the active control group, participants receiving BBTI will show statistically significant reductions in insomnia using the ISI, as well as improvements in sleep quality using the PSQI and sleep parameters using the consensus sleep diary.
SECONDARY AIM: To explore whether BBTI improves CGR in bereaved patients screened for insomnia when compared to an active control group.
SECONDARY HYPOTHESIS: Compared with the active control group, participants receiving BBTI will show statistically significant reductions in CGR using the A-PGDs, the CESD-10, the GAD-7, and the PCL-5.
- Conditions
- Insomnia, Insomnia Chronic, Complicated Grief
- Being tested
- Brief Behavioral Therapy for Insomnia, Sleep Hygiene Therapy
- Keywords
- Insomnia, Insomnia Chronic, Brief Behavioral Therapy for Insomnia, BBTI, Sleep, Sleep Quality, Complicated Grief, Grief, Bereavement, Complicated Grief Reactions
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief Behavioral Therapy for InsomniaBehavioural
Also called BBTI
BBTI is a multi-component intervention consisting of techniques from sleep restriction and stimulus control therapy. It targets behavioral elements of insomnia using four techniques: 1) reduce time in bed, 2) get up at the same time every day, 3) do not go to bed unless sleepy, and 4) do not stay in bed unless asleep.
Sleep Hygiene TherapyBehavioural
SHE consists of education on lifestyle factors (diet, exercise, substance use) and enviromental variables (noise, light, temperature) affecting sleep quality.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (group 1) | Experimental | Participants will retrieve individually administered BBTI by therapists through face-to-face meetings and phone-calls. Treatment will take 4 weeks. Receives: Behavioral: Brief Behavioral Therapy for Insomnia |
| Active control group (group 2) | Sham comparator | Participants will receive access to sleep hygiene education (SHE) through written educational material. Treatment will take 4 weeks. Receives: Behavioral: Sleep Hygiene Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
The ISI measures the severity of insomnia symptoms and the associated impact on daytime functioning and distress. The questionnaire consists of 7 questions the sum of which makes up a total score. The ISI has a range of 0-28, with higher scores indicate worse insomnia severity.
Measured: Time Frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16) 6-months follow-up (approximately week 28).
Secondary outcomes (14)
Pittsburgh Sleep Quality Index (PSQI)
Changes in sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), with scores ranging from a minimum of 0, indicating no difficulty, to a maximum of 21, indicating severe difficulties in all areas related to sleep.
Measured: Time Frame: Time Frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16) 6-months follow-up (approximately week 28).
Consensus Sleep Diary
The Consensus Sleep Diary measures self-reported sleep providing various sleep parameters such as sleep duration, sleep onset latency (SOL), time in bed (TIB), total sleep time (TST), wake after sleep onset (WASO) and sleep efficiency (SE).
Measured: Time Frame: Time Frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16) 6-months follow-up (approximately week 28).
Morningness-Eveningness Questionnaire - Revised (MEQr)
The Morningness-Eveningness Questionnaire-reduced (MEQr) will be used to assess circadian rhythm preferences (chronotype). This 5-item questionnaire evaluates sleep-wake patterns, preferred activity times, and subjective alertness at different times of the day. Scores categorize individuals as morning types, evening types, or intermediate types, with higher scores indicating a preference for morningness and lower scores indicating a preference for eveningness.
Measured: Time Frame: Time Frame: Baseline (week 0)
Aarhus Prolonged Grief Disorder Scale (A-PGDs)
The A-PGDs is a validated self-report instrument that will be used to measure symptoms of prolonged grief disorder, including yearning, emotional pain, difficulty moving on, and functional impairment. Items are rated on a Likert scale, and higher scores reflect more severe grief symptoms.
Measured: Time Frame: Time Frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16) 6-months follow-up (approximately week 28).
Center for Epidemiological Studies Depression Scale - 10 Item Version (CESD-10)
The CESD-10 is a short self-report questionnaire that will be used to measure the frequency of depressive symptoms over the past week. Scores range from 0 to 30, with higher scores indicating greater depressive symptom severity.
Measured: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).
Generalized Anxiety Disorder - 7 Item Scale (GAD-7)
The GAD-7 will be used to measure generalized anxiety symptoms. It consists of 7 items rated on a 4-point Likert scale. Total scores range from 0 to 21, with higher scores reflecting greater anxiety severity.
Measured: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).
PTSD Checklist for DSM-5 - Short Form (PCL-5 - Short Form)
The PCL-5 - Short Form is an abbreviated version of the PTSD Checklist that assesses core symptoms of post-traumatic stress disorder based on DSM-5 criteria. Items are rated on a Likert scale, with higher scores indicating greater PTSD symptom severity.
Measured: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).
My Grief
MyGrief is a self-report questionnaire designed to evaluate grief-related symptoms and coping, specifically in relation to bereavement. It includes 33 items on emotional, cognitive, and functional aspects of grief, with higher scores reflecting greater grief-related difficulties.
Measured: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).
The perceived stress scale (PSS)
The Perceived Stress Scale (PSS) will be used to measure the perception of stress. This 10-item questionnaire assesses how unpredictable, uncontrollable, and overloaded respondents find their lives. Higher scores indicate higher levels of perceived stress.
Measured: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).
The Short-Form (12) Health Survey (SF-12)
The Short-Form (12) Health Survey (SF-12) will be used to assess health-related quality of life. This questionnaire comprises 12 items that evaluate eight domains of health: physical functioning, role limitations due to physical health problems, bodily pain, general health perceptions, vitality (energy/fatigue), social functioning, role limitations due to emotional problems, and mental health (psychological distress and well-being). Scores from these domains are combined to yield two summary measures: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores indicate better health-related quality of life across the evaluated domains.
Measured: Time Frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).
World Health Organization-Five Well-Being Index (WHO-5)
The WHO-5 is a brief measure of subjective psychological well-being, consisting of 5 positively worded items. Higher scores indicate better well-being.
Measured: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).
NEO Personality Inventory - Revised (NEO-PI-R), Neuroticism Only
The Neuroticism domain of the NEO-PI-R assesses the tendency to experience negative emotions such as anxiety, anger, and depression. It is a self-report measure derived from the full NEO-PI-R personality inventory. Higher scores indicate greater neuroticism.
Measured: Baseline (week 0)
Experiences in Close Relationships Scale - Short Form (ECR-S)
The ECR-S is a 12-item self-report questionnaire that measures adult attachment patterns, specifically attachment anxiety and attachment avoidance in close relationships. Higher scores reflect higher levels of attachment insecurity.
Measured: Baseline (week 0)
Expectancy/Credibility Questionnaire (CEQ)
Treatment expectancy and rationale credibility will be measured with the Expectancy/Credibility Questionnaire (CEQ). Scores for each question range from 1 to 9 or 0% to 100%, with higher scores indicating greater treatment expectancy and credibility.
Measured: Baseline (week 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start30 Dec 2025 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Model description
- Randomized Controlled Trial with two arms. Participants are randomized to either an intervention group receiving BBTI or an an intervention group receiving sleep hygiene. The sleep hygiene group functions as an active control group, as sleep hygiene is not expected to improve sleep.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander D Castro-Pavlik, PhD-student, MSc in Psychology, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167706
- Sponsor's protocol ID
- 116242
- Acronym
- SLEEPLOSS
- Status last verified
- Aug 2025
- First submitted
- 4 Sep 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (e.g., outcome measure data underlying published analyses) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Difficulties After Loss (SLEEPLOSS): Exploring the Beneficial Effect of Brief Behavioral Therapy for Insomnia in a Sample of Bereaved Individuals
- ClinicalTrials.gov ID
- NCT07167706
- Acronym / sponsor ID
- SLEEPLOSS / 116242
- Conditions
- Insomnia, Insomnia Chronic, Complicated Grief
- Keywords
- Insomnia, Insomnia Chronic, Brief Behavioral Therapy for Insomnia, BBTI, Sleep, Sleep Quality, Complicated Grief, Grief
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 11 Sep 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.
The goal of the study is to investigate whether a brief behavioral therapy for insomnia (BBTI) improves sleep in bereaved patients screened for insomnia compared to an active control group (sleep hygiene education). The study will also explore if BBTI improves symptoms of complicated grief. The investigators will recruit approximately 58 bereaved participants with insomnia.
Detailed description
The study is a randomized controlled trial comparing the effect of a brief behavioral therapy for insomnia (BBTI) on insomnia with an active control group (sleep hygiene). Participants will be 58 bereaved individuals who experience insomnia. After baseline assessment, participants will be randomized to either BBTI or sleep hygiene (active control). Both groups will undergo post-treatment assessments as well as 3- and 6-months follow-up assessments. The primary outcomes will be insomnia assessed with the Insomnia Severity Index (ISI) and improvements in sleep quality using the Pittsburgh Sleep Quality Index (PSQI) and sleep parameters using the consensus sleep diary. The secondary outcome will be complicated grief reactions (CGR) using the Aarhus Prolonged Grief Disorder scale (A-PGDs, prolonged grief). the Center of Epidemiological Studies Depression Scale (CESD-10, depression), the General Anxiety Disorder-7 questionnaire (GAD-7; anxiety), and the short-form PTSD Checklist for DSM-5 (PCL-5; PTSD).
The study has the following aims and hypotheses:
PRIMARY AIM: To investigate whether BBTI improves sleep in bereaved patients screened for insomnia when compared to an active control group.
PRIMARY HYPOTHESIS: Compared with the active control group, participants receiving BBTI will show statistically significant reductions in insomnia using the ISI, as well as improvements in sleep quality using the PSQI and sleep parameters using the consensus sleep diary.
SECONDARY AIM: To explore whether BBTI improves CGR in bereaved patients screened for insomnia when compared to an active control group.
SECONDARY HYPOTHESIS: Compared with the active control group, participants receiving BBTI will show statistically significant reductions in CGR using the A-PGDs, the CESD-10, the GAD-7, and the PCL-5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial with two arms. Participants are randomized to either an intervention group receiving BBTI or an an intervention group receiving sleep hygiene. The sleep hygiene group functions as an active control group, as sleep hygiene is not expected to improve sleep.
| Arm | Type | Receives |
|---|---|---|
| Intervention group (group 1) | Experimental | Behavioral: Brief Behavioral Therapy for InsomniaParticipants will retrieve individually administered BBTI by therapists through face-to-face meetings and phone-calls. Treatment will take 4 weeks. |
| Active control group (group 2) | Sham comparator | Behavioral: Sleep Hygiene TherapyParticipants will receive access to sleep hygiene education (SHE) through written educational material. Treatment will take 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Bereaved (experienced the death of a perceived loved one) ≥6 months ago
- Insomnia: a score of >10 on the Insomnia Severity index (ISI) and/or meet the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria for Insomnia Disorder
Key exclusion criteria (7 listed)
- Other sleep disor-ders (sleep apnea, parasomnia, narcolepsy)
- Use of drugs impacting sleep
- Severe psychological or physical disorders that may confound sleep (symptoms of CGR allowed)
- Neurodegenerative disorders
- Shift work
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 |
|---|---|---|
| Brief Behavioral Therapy for InsomniaAlso: BBTIBBTI is a multi-component intervention consisting of techniques from sleep restriction and stimulus control therapy. It targets behavioral elements of insomnia using four techniques: 1) reduce time in bed, 2) get up at the same time every day, 3) do not go to bed unless sleepy, and 4) do not stay in bed unless asleep. | Behavioural | Intervention group (group 1) |
| Sleep Hygiene TherapySHE consists of education on lifestyle factors (diet, exercise, substance use) and enviromental variables (noise, light, temperature) affecting sleep quality. | Behavioural | Active control group (group 2) |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Time Frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16) 6-months follow-up (approximately week 28).
The ISI measures the severity of insomnia symptoms and the associated impact on daytime functioning and distress. The questionnaire consists of 7 questions the sum of which makes up a total score. The ISI has a range of 0-28, with higher scores indicate worse insomnia severity.
14 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Time Frame: Time Frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16) 6-months follow-up (approximately week 28).
Consensus Sleep Diary
Time frame: Time Frame: Time Frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16) 6-months follow-up (approximately week 28).
Morningness-Eveningness Questionnaire - Revised (MEQr)
Time frame: Time Frame: Time Frame: Baseline (week 0)
Aarhus Prolonged Grief Disorder Scale (A-PGDs)
Time frame: Time Frame: Time Frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16) 6-months follow-up (approximately week 28).
Center for Epidemiological Studies Depression Scale - 10 Item Version (CESD-10)
Time frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).
Generalized Anxiety Disorder - 7 Item Scale (GAD-7)
Time frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).
PTSD Checklist for DSM-5 - Short Form (PCL-5 - Short Form)
Time frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).
My Grief
Time frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).
The perceived stress scale (PSS)
Time frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).
The Short-Form (12) Health Survey (SF-12)
Time frame: Time Frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).
World Health Organization-Five Well-Being Index (WHO-5)
Time frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16), 6-months follow-up (approximately week 28).
NEO Personality Inventory - Revised (NEO-PI-R), Neuroticism Only
Time frame: Baseline (week 0)
Experiences in Close Relationships Scale - Short Form (ECR-S)
Time frame: Baseline (week 0)
Expectancy/Credibility Questionnaire (CEQ)
Time frame: Baseline (week 0)
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 17 Nov 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (e.g., outcome measure data underlying published analyses) will be shared.
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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.
Alexander D Castro-Pavlik, PhD-student, MSc in Psychology principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Behavioral Therapy for Insomnia and Sleep Hygiene Therapy in people with Insomnia and Insomnia Chronic, run by University of Aarhus at 1 site in Denmark.
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 7 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: opening soon, as of the sponsor's last update on 17 Nov 2025. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Contact Alexander D Castro-Pavlik, PhD Student, MSc in Psychology (+4529122219, acp@psy.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: Time Frame: Baseline (week 0), post-treatment (approximately week 4), 3-months follow-up (approximately week 16) 6-months follow-up (approximately week 28).). 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 17 Nov 2025.