Heart FailureCBTI-HFNCT02827799
Cognitive Behavioral Therapy for Insomnia in Stable Heart Failure
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) and Heart Failure Self-Management Education in people with Heart Failure and Insomnia, run by Yale University at 1 site in United States.
Trial summary
The purpose of this exploratory developmental study is to test the feasibility, acceptability, and preliminary efficacy of cognitive behavioral therapy for insomnia (CBT-I) among adults who have stable Heart Failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Insomnia, Cardiomyopathy
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia (CBT-I) and Heart Failure Self-Management Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Stable chronic heart failure
- reports of difficulty initiating or maintaining sleep or waking too early in the morning
- English speaking/reading
Who cannot join
- untreated sleep disordered breathing or restless legs syndrome
- rotating/night shift work
- active illicit drug use
- bipolar disorder
- neuromuscular conditions affecting the non-dominant arm
- end-stage renal failure
- significant cognitive impairment
- unstable medical or psychiatric disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Nursing
West Haven, Connecticut, 06516-7399
About this study
The purpose of this exploratory developmental study is to test the feasibility, acceptability, and preliminary efficacy of cognitive behavioral therapy for insomnia (CBT-I) among adults who have stable Heart Failure. Participants were randomized either to a treatment (CBT-I) or attention-control condition (heart failure self management education).
Read the detailed description
Insomnia is common in adults with chronic heart failure (HF), a condition associated with functional performance deficits, symptom burden, and high levels of morbidity and mortality. To date there has been little study of strategies to improve sleep in this large population. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia comorbid with several medical and psychiatric disorders, but has not been tested in HF. The purpose of this exploratory developmental research is to test the feasibility, acceptability, and size of the effects of CBT-I on subjective and objective characteristics of sleep and insomnia symptoms and functional performance in patients with stable HF. Forty patients with stable HF will be randomized to 7 weeks of CBT-I or 7-weeks of HF self-management education with sleep hygiene (attention control). Subjective (diaries, questionnaires) and objective (wrist actigraphy) characteristics of sleep; symptoms, and self-reported functional performance will be measured pre- and post-intervention. The investigators will also obtain day and night measures of urinary free cortisol, free epinephrine/norepinephrine, and melatonin sulfate. They will: 1) refine the protocol, procedures, patient materials, and training manual for the CBT-I intervention and a group HF self-management class (attention-control); 2) evaluate the feasibility and acceptability of the CBT-I intervention and the attention-control conditions; 3) evaluate the size of the effects of group CBT-I, compared with attention-control, on objective (actigraph) and subjective (questionnaire and sleep diary) sleep characteristics, self-report of insomnia symptoms, and beliefs and attitudes about sleep; and 4) evaluate the size of the effects of CBT-I, compared with attention-control, on daytime symptoms (fatigue, depression, anxiety, excessive daytime sleepiness) and functional performance. The primary outcome will be self-reported sleep continuity (sleep efficiency). Investigators will also explore the effects of changes in characteristics of sleep and insomnia symptoms on symptoms and daytime function; the effects of CBT-I, compared with attention control, on nocturnal symptoms, and the effects of CBT-I, compared with attention control, on biological indicators of nocturnal and daytime Hypothalamic Adrenal Pituitary axis (urinary free cortisol), sympathetic nervous system (urinary epinephrine/norepinephrine, and pineal (urinary melatonin) function. The results will be used to support design decisions for a future larger scale efficacy study and may ultimately lead to translation of CBT-I into the care of patients with HF.
- Conditions
- Heart Failure, Insomnia, Cardiomyopathy
- Being tested
- Cognitive Behavioral Therapy for Insomnia (CBT-I), Heart Failure Self-Management Education
- Keywords
- heart failure, insomnia, sleep disorders, actigraphy, cardiomyopathy, depression, sleepiness, anxiety, fatigue
- Medical subject headings
- Heart Failure, Sleep Initiation and Maintenance Disorders, Cardiomyopathies, Sleep Wake Disorders, Depression, Sleepiness, Anxiety Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Insomnia (CBT-I)Behavioural
This behavioral intervention includes training on managing the sleep environment (stimulus control), managing dysfunctional beliefs and attitudes about sleep (cognitive therapy), relaxation (progressive muscle relaxation), changing sleep behaviors (sleep hygiene), and managing sleep duration and continuity (sleep restriction).
Heart Failure Self-Management EducationBehavioural
This intervention includes learning about how to manage one's heart failure. This includes understanding when to seek treatment, monitoring oneself for daily signs and symptoms, daily weight, dietary changes, physical activity, and adherence to medication taking.
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure Self-Management Education | Placebo comparator | This treatment includes participation in 4 one hour biweekly face-face sessions of education on heart failure self-management, as well as a 15 minute telephone call on intervening weeks. The total intervention is 8 weeks. Receives: Behavioral: Heart Failure Self-Management Education |
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Experimental | This treatment includes participation in 4 one hour biweekly face-face sessions of cognitive behavioral therapy for insomnia, as well as a 15 minute telephone call on intervening weeks. The total intervention is 8 weeks. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia severity
Insomnia severity will be measured with the Insomnia Severity Index, a brief self-report instrument measuring patients' perception of their insomnia. The instrument includes 7 items assessing the severity of sleep onset and sleep maintenance difficulties, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a 0-4 scale (4 indicates greater severity) with a total score ranging from 0 to 28. Scores are categorized as not clinically significant, subthreshold insomnia, moderate insomnia or severe insomnia.
Measured: baseline two weeks after completing treatment or attention/control
Secondary outcomes (12)
Depressive symptoms
Depressive symptoms will be measured with the Center for Epidemiological Studies Depression Scale, a 20 item self-report instrument used to measure symptoms of depression in nine different groups as defined by the American Psychiatric Association Diagnostic and Statistical Manual, fifth edition. These symptom groups include sadness, loss of Interest, appetite, sleep, thinking/concentration, guilt, fatigue, agitation, and suicidal ideation. Possible scores range from 0-60, and determination of depressive symptom category (no clinical significance, subthreshhold depression symptoms, possible major depressive episode, probable major depressive episode, and meets criteria for major depressive episode) is based upon an algorithm.
Measured: Baseline and two weeks after completing treatment or attention control
Sleepiness
Sleepiness will be measured using the Epworth Sleepiness Scale (ESS) a report instrument used to measure general levels of daytime sleepiness or sleep propensity in adults. The instrument asks subjects to rate on a scale of 0 to 3 the chances that he or she would doze in each of eight different situations. ESS scores can range from 0 to 24, with higher scores indicating higher levels of daytime sleepiness.
Measured: Baseline and two weeks after completing treatment or attention control
Anxiety
Anxiety will be measured with the Spielberger State Anxiety Inventory (STAI), a self-report instrument to measure the presence and severity of current symptoms of anxiety. The instrument includes 20 items to evaluate the current state of anxiety, using items that measure subjective feelings of apprehension, tension, nervousness, worry, and activation/arousal of the autonomic nervous system. Scores range from 20-80, with higher scores indicating greater anxiety.
Measured: Baseline and two weeks after completing treatment or attention-control
Fatigue
The symptom of fatigue will be measured with the Multidimensional Assessment of Fatigue Scale, a 16 item self-report instrument that measures fatigue according to four dimensions: degree and severity, distress that it causes, timing of fatigue, and its impact on various activities of daily living. The items are used to calculate scores for each of the four dimensions listed, as well as a global fatigue index (GFI). A higher score indicates more severe fatigue, fatigue distress, or impact on activities of daily living.
Measured: baseline and two weeks after completing treatment or attention-control
Sleep efficiency
Sleep efficiency refers the ratio of time spent asleep to the amount of time spent in bed. Sleep efficiency will be subjectively measured with the Pittsburgh Sleep Quality Index, an instrument used to calculate self-reported sleep duration, sleep efficiency sleep latency, sleep disturbances, and global sleep quality. The 19 self-rated items are calculated to provide a global score ranging from 0-21, with "0" indicating no difficulty, and "21" indicating severe difficulty in all areas. Sleep efficiency will also be objectively measured using actigraphy, a method of inferring sleep from the presence or absence of wrist movement. Participants will wear the Respironics Minimitter Actiwatch AW2, a wrist-worn actigraph, to elicit objective sleep efficiency for a two week period. Participants will also complete a daily diary (lights out/on, times/purpose of removal, hypnotic use) for use in interpretation of actigraphy data.
Measured: baseline and two weeks after completing treatment or attention control
Functional Performance
Functional performance will be measured with the Medical Outcomes Study (MOS) SF36v2 Physical Functioning Scale. The SF36v2 is a multi-purpose self-reported health survey that yields an 8-scale profile of functional health and well-being. The physical functioning scale assesses performance of daily activities, with the lowest score indicating an individual who is very limited in performing all physical activities, including bathing or dressing, and the highest score indicating an individual who can perform all types of vigorous physical activity without limitations due to health.
Measured: baseline and two weeks after completing treatment or attention control
Thoughts and beliefs about sleep
This will be measured with a 16 item likert scale. The Dysfunctional Beliefs and Attitudes about Sleep Scale
Measured: Baseline and two weeks after completing treatment or attention control.
Cortisol
We will measure urinary free cortisol as a biological measure of stress. Participants will provide urine specimens in the morning (from the previous night) and again late in the afternoon (reflecting the afternoon). This will enable understanding of both day and night levels of stress.
Measured: baseline and two weeks after completing treatment or attention control.
Melatonin
We will measure melatonin as a biological measure of the circadian rhythm. Participants will provide urine specimens in the morning (from the previous night) and again late in the afternoon (reflecting the afternoon). This will enable understanding of both day and night levels of stress.
Measured: baseline and two weeks after completing treatment or attention control.
Epinephrine
We will measure epinephrine ("adrenaline") as a biological measure of stress. Participants will provide urine specimens in the morning (from the previous night) and again late in the afternoon (reflecting the afternoon). This will enable understanding of both day and night levels of stress.
Measured: baseline and two weeks after completing treatment or attention control.
Norepinephrine
We will measure norepinephrine as a biological measure of stress. Participants will provide urine specimens in the morning (from the previous night) and again late in the afternoon (reflecting the afternoon). This will enable understanding of both day and night levels of stress.
Measured: baseline and two weeks after completing treatment or attention control.
Nocturnal symptoms
We will measure shortness of breath, nocturnia, and pain. Participants will complete a daily diary each morning upon awakening and indicate on a 10 item numeric scale the degree to which they experienced these symptoms during the past night.
Measured: baseline and two weeks after completing treatment or attention control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startAug 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Nancy S. Redeker, PhD, RN, Principal investigator, Yale University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827799
- Sponsor's protocol ID
- 0904005041_B
- Other IDs
- R21NR011387
- Acronym
- CBTI-HF
- Status last verified
- Apr 2020
- First submitted
- 5 Jul 2016
- Last updated
- 3 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Redeker NS, Jeon S, Andrews L, Cline J, Jacoby D, Mohsenin V. Feasibility and Efficacy of a Self-Management Intervention for Insomnia in Stable Heart Failure. J Clin Sleep Med. 2015 Oct 15;11(10):1109-19. doi: 10.5664/jcsm.5082.
PubMed 25979100Breazeale S, Jeon S, Hwang Y, O'Connell M, Nwanaji-Enwerem U, Linsky S, Yaggi HK, Jacoby DL, Conley S, Redeker NS. Sleep Characteristics, Mood, Somatic Symptoms, and Self-Care Among People With Heart Failure and Insomnia. Nurs Res. 2022 May-Jun 01;71(3):189-199. doi: 10.1097/NNR.0000000000000585.
PubMed 35149627Redeker NS, Jeon S, Andrews L, Cline J, Mohsenin V, Jacoby D. Effects of Cognitive Behavioral Therapy for Insomnia on Sleep-Related Cognitions Among Patients With Stable Heart Failure. Behav Sleep Med. 2019 May-Jun;17(3):342-354. doi: 10.1080/15402002.2017.1357120. Epub 2017 Aug 22.
PubMed 28745520
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Insomnia in Stable Heart Failure
- ClinicalTrials.gov ID
- NCT02827799
- Acronym / sponsor ID
- CBTI-HF / 0904005041_B
- Conditions
- Heart Failure, Insomnia, Cardiomyopathy
- Keywords
- heart failure, insomnia, sleep disorders, actigraphy, cardiomyopathy, depression, sleepiness, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Aug 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 11 Jul 2016 (estimated)
- 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 purpose of this exploratory developmental study is to test the feasibility, acceptability, and preliminary efficacy of cognitive behavioral therapy for insomnia (CBT-I) among adults who have stable Heart Failure. Participants were randomized either to a treatment (CBT-I) or attention-control condition (heart failure self management education).
Detailed description
Insomnia is common in adults with chronic heart failure (HF), a condition associated with functional performance deficits, symptom burden, and high levels of morbidity and mortality. To date there has been little study of strategies to improve sleep in this large population. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia comorbid with several medical and psychiatric disorders, but has not been tested in HF. The purpose of this exploratory developmental research is to test the feasibility, acceptability, and size of the effects of CBT-I on subjective and objective characteristics of sleep and insomnia symptoms and functional performance in patients with stable HF. Forty patients with stable HF will be randomized to 7 weeks of CBT-I or 7-weeks of HF self-management education with sleep hygiene (attention control). Subjective (diaries, questionnaires) and objective (wrist actigraphy) characteristics of sleep; symptoms, and self-reported functional performance will be measured pre- and post-intervention. The investigators will also obtain day and night measures of urinary free cortisol, free epinephrine/norepinephrine, and melatonin sulfate. They will: 1) refine the protocol, procedures, patient materials, and training manual for the CBT-I intervention and a group HF self-management class (attention-control); 2) evaluate the feasibility and acceptability of the CBT-I intervention and the attention-control conditions; 3) evaluate the size of the effects of group CBT-I, compared with attention-control, on objective (actigraph) and subjective (questionnaire and sleep diary) sleep characteristics, self-report of insomnia symptoms, and beliefs and attitudes about sleep; and 4) evaluate the size of the effects of CBT-I, compared with attention-control, on daytime symptoms (fatigue, depression, anxiety, excessive daytime sleepiness) and functional performance. The primary outcome will be self-reported sleep continuity (sleep efficiency). Investigators will also explore the effects of changes in characteristics of sleep and insomnia symptoms on symptoms and daytime function; the effects of CBT-I, compared with attention control, on nocturnal symptoms, and the effects of CBT-I, compared with attention control, on biological indicators of nocturnal and daytime Hypothalamic Adrenal Pituitary axis (urinary free cortisol), sympathetic nervous system (urinary epinephrine/norepinephrine, and pineal (urinary melatonin) function. The results will be used to support design decisions for a future larger scale efficacy study and may ultimately lead to translation of CBT-I into the care of patients with HF.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heart Failure Self-Management Education | Placebo comparator | Behavioral: Heart Failure Self-Management EducationThis treatment includes participation in 4 one hour biweekly face-face sessions of education on heart failure self-management, as well as a 15 minute telephone call on intervening weeks. The total intervention is 8 weeks. |
| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Experimental | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)This treatment includes participation in 4 one hour biweekly face-face sessions of cognitive behavioral therapy for insomnia, as well as a 15 minute telephone call on intervening weeks. The total intervention is 8 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)
- Stable chronic heart failure
- reports of difficulty initiating or maintaining sleep or waking too early in the morning
- English speaking/reading
Key exclusion criteria (8 listed)
- untreated sleep disordered breathing or restless legs syndrome
- rotating/night shift work
- active illicit drug use
- bipolar disorder
- neuromuscular conditions affecting the non-dominant arm
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 |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-I)This behavioral intervention includes training on managing the sleep environment (stimulus control), managing dysfunctional beliefs and attitudes about sleep (cognitive therapy), relaxation (progressive muscle relaxation), changing sleep behaviors (sleep hygiene), and managing sleep duration and continuity (sleep restriction). | Behavioural | Cognitive Behavioral Therapy for Insomnia (CBT-I) |
| Heart Failure Self-Management EducationThis intervention includes learning about how to manage one's heart failure. This includes understanding when to seek treatment, monitoring oneself for daily signs and symptoms, daily weight, dietary changes, physical activity, and adherence to medication taking. | Behavioural | Heart Failure Self-Management Education |
Primary outcome
Insomnia severity
Time frame: baseline two weeks after completing treatment or attention/control
Insomnia severity will be measured with the Insomnia Severity Index, a brief self-report instrument measuring patients' perception of their insomnia. The instrument includes 7 items assessing the severity of sleep onset and sleep maintenance difficulties, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. Each item is rated on a 0-4 scale (4 indicates greater severity) with a total score ranging from 0 to 28. Scores are categorized as not clinically significant, subthreshold insomnia, moderate insomnia or severe insomnia.
12 secondary outcomes
Depressive symptoms
Time frame: Baseline and two weeks after completing treatment or attention control
Sleepiness
Time frame: Baseline and two weeks after completing treatment or attention control
Anxiety
Time frame: Baseline and two weeks after completing treatment or attention-control
Fatigue
Time frame: baseline and two weeks after completing treatment or attention-control
Sleep efficiency
Time frame: baseline and two weeks after completing treatment or attention control
Functional Performance
Time frame: baseline and two weeks after completing treatment or attention control
Thoughts and beliefs about sleep
Time frame: Baseline and two weeks after completing treatment or attention control.
Cortisol
Time frame: baseline and two weeks after completing treatment or attention control.
Melatonin
Time frame: baseline and two weeks after completing treatment or attention control.
Epinephrine
Time frame: baseline and two weeks after completing treatment or attention control.
Norepinephrine
Time frame: baseline and two weeks after completing treatment or attention control.
Nocturnal symptoms
Time frame: baseline and two weeks after completing treatment or attention control
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2020.
- Results publication: PubMed 25979100Redeker NS, Jeon S, Andrews L, Cline J, Jacoby D, Mohsenin V. Feasibility and Efficacy of a Self-Management Intervention for Insomnia in Stable Heart Failure. J Clin Sleep Med. 2015 Oct 15;11(10):1109-19. doi: 10.5664/jcsm.5082.
- Derived from this study: PubMed 35149627Breazeale S, Jeon S, Hwang Y, O'Connell M, Nwanaji-Enwerem U, Linsky S, Yaggi HK, Jacoby DL, Conley S, Redeker NS. Sleep Characteristics, Mood, Somatic Symptoms, and Self-Care Among People With Heart Failure and Insomnia. Nurs Res. 2022 May-Jun 01;71(3):189-199. doi: 10.1097/NNR.0000000000000585.
- Derived from this study: PubMed 28745520Redeker NS, Jeon S, Andrews L, Cline J, Mohsenin V, Jacoby D. Effects of Cognitive Behavioral Therapy for Insomnia on Sleep-Related Cognitions Among Patients With Stable Heart Failure. Behav Sleep Med. 2019 May-Jun;17(3):342-354. doi: 10.1080/15402002.2017.1357120. Epub 2017 Aug 22.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Nancy S. Redeker, PhD, RN principal investigator
Yale University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) and Heart Failure Self-Management Education in people with Heart Failure and Insomnia, run by Yale University at 1 site in United States.
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 8 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: finished, as of the sponsor's last update on 3 Apr 2020. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia severity (time frame: baseline two weeks after completing treatment or attention/control). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02827799, which also lists 3 linked publications.
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 3 Apr 2020.