InsomniaRESET-BRAINNCT06553235
RESET-BRAIN: REhabilitation of SleEp and CogniTive Impairment in BReast Cancer Survivors Using an App-based Intervention
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-I) and Sleep hygiene education in people with Insomnia and Cognitive Impairment, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
The goal of the study is to investigate whether treating insomnia using app-based cognitive behavioral therapy for insomnia (CBT-I) can improve cognitive impairment in breast cancer survivors compared to an active control group (sleep hygiene education). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Insomnia, Cognitive Impairment, Breast Cancer
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia (CBT-I) and Sleep hygiene education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Dec 2024to 28 Mar 2030
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Have completed primary breast cancer (BC) treatment within 1-5 years (endocrine therapies allowed)
- 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
- Cognitive impairment: a score of "quite a bit" or "very much" on at least 1 of the 2 items measuring concentration and memory on The European Organization for Research and Treatment of Cancer Core Quality of Life (EORCT-QLQ-C30) and/or <54 on the Cancer Therapy-Cognitive (FACT-Cog) perceived cognitive impairment (PCI) subscale
Who cannot join
- Other sleep disorders than insomnia that may confound sleep and/or cognitive function
- Use of drugs impacting that may confound sleep and/or cognitive function (endocrine therapies allowed)
- Neurodegenerative and psychiatric disorders that may confound sleep and/or cognitive function
- Shift work
- Pregnancy or maternity leave
- Recurrence of BC or new cancer
Show all 10Show fewer
- Insufficient Danish proficiency
- Substance abuse that may confound sleep and/or cognitive function
- Previous experience with CBT-I
- Other cancer than breast cancer
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, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus N
Ali Amidi, +4587165305, ali@psy.au.dk
About this study
The goal of the study is to investigate whether treating insomnia using app-based cognitive behavioral therapy for insomnia (CBT-I) can improve cognitive impairment in breast cancer survivors compared to an active control group (sleep hygiene education). The study will also explore if CBT-I is associated with changes in the brain and in inflammation. The investigators will recruit approximately 84 participants with insomnia and cognitive impairment who have completed breast cancer treatment within 1-5 years.
Read the detailed description
The study is a randomized controlled trial comparing the effect of app-based cognitive behavioral therapy for insomnia (CBT-I) on cognitive function and insomnia to an active control group (sleep hygiene). Participants will be 84 breast cancer survivors who have completed primary treatment within 1-5 years and experience insomnia and cognitive impairment. After baseline assessment, participants will be randomized to either app-based CBT-I or sleep hygiene (active control). Both groups will undergo post-treatment assessments and 6-months follow-up assessments. The primary outcomes will be cognitive impairment assessed with the Conners Continuous Performance Test (CCPT) and insomnia assessed with the Insomnia Severity Index (ISI). To explore potential neurobiological and inflammatory mechanisms, structural magnetic resonance imaging (MRI) and inflammatory markers will be secondary outcomes. To provide a broader insight into cognitive function, participants will undergo further neuropsychological assessment with various standardized neuropsychological tests.
The study has the following aims and hypotheses:
PRIMARY AIM: To investigate whether an app-based CBT-I is associated with improved sleep and cognitive function in BC survivors screened for insomnia and CI when compared with an active control group. PRIMARY HYPOTHESIS: Compared with an active control group, CBT-I will be associated with a statistically significantly greater reduction in insomnia severity using the ISI and improvement of sustained attention and executive function assessed objectively using the CCPT. Effects on secondary sleep outcomes will also be tested. Exploratory hypothesis: Improvements in sustained attention and executive function will be mediated by improved insomnia severity and sleep outcomes.
SECONDARY AIM 1: To investigate whether CBT-I is associated with altered structural brain outcomes when compared with an active control group. HYPOTHESIS: Compared with an active control group, CBT-I will be associated with changes in brain gray and white matter properties, structural network topology, as well as glymphatic function as operationalized with the diffusion tensor image along the perivascular space (DTI-ALPS) approach.
SECONDARY AIM 2: To explore whether CBT-I is associated with changes in inflammatory immune function (IL-1β, IL-6, TNF-α, IFN-γ) when compared with an active control group. HYPOTHESIS: Compared with an active control group, CBT-I will be associated with a statistically significantly greater reduction in inflammatory markers. Improvements in sustained attention and executive function will be mediated by changes in inflammatory markers.
- Conditions
- Insomnia, Cognitive Impairment, Breast Cancer
- Being tested
- Cognitive Behavioral Therapy for Insomnia (CBT-I), Sleep hygiene education
- Keywords
- Cognitive behavioral therapy for insomnia, CBT-I, Breast cancer, Insomnia, Sleep, Cognitive function, Magnetic resonance imaging, White matter, Gray matter, Glymphatic function, Diffusion tensor image along the perivascular space, Structural brain networks, Inflammation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Cognitive Dysfunction, Breast Neoplasms, Inflammation
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
Also called CBT-I
CBT-I is a multi-component intervention consisting of sleep restriction, stimulus control therapy, relaxation therapy, cognitive therapy, and sleep hygiene education
Sleep hygiene educationBehavioural
- Sleep hygiene education includes information on lifestyle factors (diet, exercise, substance use) and environmental variables (noise, light, temperature) affecting sleep quality.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (group 1) | Experimental | Participants will receive individualized digital CBT-I through an app called Hvil®. Treatment will take 6-9 weeks. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I) |
| Active control group (group 2) | Active comparator | Participants will receive the sleep hygiene education component of CBT-I through Hvil®. Treatment will take 6-9 weeks. Receives: Behavioral: Sleep hygiene education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conners continuous performance test 3rd edition
Conners continuous performance test is a computerized test. It measures a combination of vigilance, sustained attention, and the inhibition component of executive function.
Measured: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
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: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Secondary outcomes (35)
Psychomotor Vigilance Test (PVT)
Changes in vigilance will be measured with the Psychomotor Vigilance Test (PVT).
Measured: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Trail-Making Test Part A (TMT-A)
Changes in processing speed will be measured using the Trail Making Test A with the outcome measured as time in seconds.
Measured: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) - Coding
Changes in processing speed will be measured with the WAIS-IV Digit Symbol Coding subtest. Scores range from 0 to 135, with higher scores indicating better outcomes.
Measured: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) - Digit span
Changes in attention will be measured using the Digit Span Forwards subtest of the WAIS-IV. Scores range from a minimum of 0 points to a maximum of 16 points, with higher scores indicating better outcomes.
Changes in working memory will be measured using the WAIS-IV Digit Span Backwards and Ranking. Both have scores range from a minimum of 0 points to a maximum of 16 points, with higher scores indicating better out-comes.
Measured: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Paced Auditory Serial Addition Test (PASAT)
Changes in attention will be measured with the Paced Auditory Serial Addition Test, with scores from 0-60 with higher scores indicating better attention.
Measured: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Hopkins Verbal Learning Test-Revised (HVLT-R)
The Hopkins Verbal Learning Test-Revised (HVLT-R) assesses verbal learning and memory through immediate recall, delayed recall, and delayed recognition tasks. Part 1 has a scoring range from 0 to 36, where higher scores represent better outcomes. Part 2 has a scoring range from 0 to 12, with higher scores also indicating better outcomes.
Measured: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Brief Visuospatial Memory Test-Revised (BVMT-R)
Changes in learning and visual memory will be assessed using the Brief Visuospatial Memory Test - Revised (BVMT-R).
Measured: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Controlled Oral Word Association Test (COWAT)
Changes in verbal fluency will be evaluated using the Controlled Oral Word Association Test (COWAT), assessing both letter and animal categories. Participants will be instructed to generate as many words as possible within a specified time limit for each category. A higher number of words produced indicates a better outcome in verbal fluency for both letter and animal categories.
Measured: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Trail-Making Test Part B (TMT-B)
Changes in executive function will be measured using the Trail Making Test B with the outcome measured as time in seconds.
Measured: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Stroop Color and Word Test
The Stroop Color and Word Test will be used to measure cognitive processing speed, selective attention, and executive function.
Measured: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) - Information
Pre-morbid intelligence will be measured using the Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) - Information subtest. Higher scores indicate better performance.
Measured: Baseline (week 0)
Glymphatic function
Glymphatic function will be assessed using diffusion tensor image analysis along the perivascular space (DTI-ALPS). This involves the calculation of an ALPS-index with higher indices indicating better glymphatic function.
Measured: Baseline (week 0), 6-months follow-up (approximately week 33)
Structural brain networks
Changes in structural brain network organization based on MRI.
Measured: Baseline (week 0), 6-months follow-up (approximately week 33)
Brain gray matter
Changes in brain gray matter as measured with T1-weighted MRI.
Measured: Baseline (week 0), 6-months follow-up (approximately week 33)
Brain white matter
Changes in white matter as measured with T1-weighted MRI.
Measured: Baseline (week 0), 6-months follow-up (approximately week 33)
Brain white matter microstructure
Changes in brain white matter as measured with diffusion-weighted MRI.
Measured: Baseline (week 0), 6-months follow-up (approximately week 33)
Tumor necrosis factor alpha (TNF-α)
The concentration of tumor necrosis factor alpha (TNF-α) will be extracted from blood samples.
Measured: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Interleukin 1 beta (Il-1β)
The concentration of interleukin 1 beta (Il-1β) will be extracted from blood samples.
Measured: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Interleukin 6 (IL-6)
The concentration of interleukin 6 (IL-6)will be extracted from blood samples.
Measured: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Interferon gamma (IFN-γ)
Changes in the concentration of interferon gamma (IFN-γ) will be extracted from blood samples.
Measured: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
High sensitivity C-reactive protein (hsCRP)
Changes in high sensitivity C-reactive protein (hsCRP) will be extracted from blood samples.
Measured: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Objective sleep
Objective sleep recorded with wrist actigraphy.
Measured: Baseline (week 0), post-treatment (approximately week 9)
Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog)
The FACT-Cog will be used as the measure of perceived cognitive impairment. It is a 37-item questionnaire with four subscales: perceived cognitive impairments, impact on quality of life, comments from others, and perceived cognitive abilities. Responses range from 0, ''never,'' to 4, ''several times a day,'' in the previous 7 days, and negatively worded items are reverse scored to create subscale scores.
Measured: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Patient Assessment of Own Functioning Inventory (PAOFI)
Changes in perceived cognitive functioning will be evaluated using The Patient Assessment of Own Functioning Inventory (PAOFI). Scores on this inventory range from a minimum of 35 to a maximum of 210, where higher scores indicate better perceived cognitive functioning.
Measured: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
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: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
The European Organization for Research and Treatment of Cancer Core Quality of Life (EORCT-QLQ-C30)
Changes in health-related quality of life will be evaluated using The European Organization for Research and Treatment of Cancer, Quality of Life questionnaire for cancer patients (EORTC QLQ-C30). All scales and single-item measures on this questionnaire range from 0 to 100, where a higher score indicates a higher level of response in health-related quality of life.
Measured: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Morningness-Eveningness Questionnaire-reduced (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: Baseline (week 0)
The Functional Assessment of Chronic Illness Therapy (FACIT Fatigue) scale
Changes in fatigue severity will be measured using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) scale, which ranges from 0 to 52. Items are reverse scored as needed, resulting in a scale where higher scores denote better functioning or less fatigue.
Measured: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Hospital Anxiety and Depression Scale (HADS)
Changes in depression and anxiety will be assessed using the Hospital Anxiety and Depression Scale (HADS). Scores on this scale range from a minimum of 0 to a maximum of 21, with higher scores indicating higher levels of depression and anxiety.
Measured: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
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 9), 6-months follow-up (approximately week 33)
The numeric rating scale (NRS)
The Numeric Rating Scale (NRS) will be used to measure pain intensity. Participants will rate their pain on a scale ranging from 0 (no pain) to 10 (worst possible pain).
Measured: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Brief Pain Inventory (pain interference (subscale))
The pain interference subscale from the Brief Pain Inventory (BPI) will be used to measure how pain affects various aspects of daily life. This subscale consists of 7 items, each scored on a scale from 0 to 10, where higher scores indicate greater interference of pain.
Measured: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
The Short-Form (36) Health Survey (SF -36)
The Short-Form (36) Health Survey (SF-36) will be used to assess health-related quality of life. This questionnaire comprises 36 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: Baseline (week 0)
Charlson Comorbidity Index (CCI)
The Charlson Comorbidity Index (CCI) will be used to assess the severity of comorbid medical conditions. It consists of 19 medical conditions, each assigned a weighted score based on its impact on mortality. The total score is calculated by summing these weighted scores, with higher totals indicating a greater burden of comorbidities.
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 posted14 Aug 2024
- Study start6 Dec 2024
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Mar 2030 (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 Aarhus University HospitalThe 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus
- Responsible party
- Principal investigator, Ali Amidi, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553235
- Sponsor's protocol ID
- R366 A21617
- Acronym
- RESET-BRAIN
- Status last verified
- Dec 2024
- First submitted
- 26 Jul 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESET-BRAIN: REhabilitation of SleEp and CogniTive Impairment in BReast Cancer Survivors Using an App-based Intervention
- ClinicalTrials.gov ID
- NCT06553235
- Acronym / sponsor ID
- RESET-BRAIN / R366 A21617
- Conditions
- Insomnia, Cognitive Impairment, Breast Cancer
- Keywords
- Cognitive behavioral therapy for insomnia, CBT-I, Breast cancer, Insomnia, Sleep, Cognitive function, Magnetic resonance imaging, White matter
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- University of Aarhus
- Study start
- 6 Dec 2024 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Mar 2030 (estimated)
- First posted
- 14 Aug 2024 (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 treating insomnia using app-based cognitive behavioral therapy for insomnia (CBT-I) can improve cognitive impairment in breast cancer survivors compared to an active control group (sleep hygiene education). The study will also explore if CBT-I is associated with changes in the brain and in inflammation. The investigators will recruit approximately 84 participants with insomnia and cognitive impairment who have completed breast cancer treatment within 1-5 years.
Detailed description
The study is a randomized controlled trial comparing the effect of app-based cognitive behavioral therapy for insomnia (CBT-I) on cognitive function and insomnia to an active control group (sleep hygiene). Participants will be 84 breast cancer survivors who have completed primary treatment within 1-5 years and experience insomnia and cognitive impairment. After baseline assessment, participants will be randomized to either app-based CBT-I or sleep hygiene (active control). Both groups will undergo post-treatment assessments and 6-months follow-up assessments. The primary outcomes will be cognitive impairment assessed with the Conners Continuous Performance Test (CCPT) and insomnia assessed with the Insomnia Severity Index (ISI). To explore potential neurobiological and inflammatory mechanisms, structural magnetic resonance imaging (MRI) and inflammatory markers will be secondary outcomes. To provide a broader insight into cognitive function, participants will undergo further neuropsychological assessment with various standardized neuropsychological tests.
The study has the following aims and hypotheses:
PRIMARY AIM: To investigate whether an app-based CBT-I is associated with improved sleep and cognitive function in BC survivors screened for insomnia and CI when compared with an active control group. PRIMARY HYPOTHESIS: Compared with an active control group, CBT-I will be associated with a statistically significantly greater reduction in insomnia severity using the ISI and improvement of sustained attention and executive function assessed objectively using the CCPT. Effects on secondary sleep outcomes will also be tested. Exploratory hypothesis: Improvements in sustained attention and executive function will be mediated by improved insomnia severity and sleep outcomes.
SECONDARY AIM 1: To investigate whether CBT-I is associated with altered structural brain outcomes when compared with an active control group. HYPOTHESIS: Compared with an active control group, CBT-I will be associated with changes in brain gray and white matter properties, structural network topology, as well as glymphatic function as operationalized with the diffusion tensor image along the perivascular space (DTI-ALPS) approach.
SECONDARY AIM 2: To explore whether CBT-I is associated with changes in inflammatory immune function (IL-1β, IL-6, TNF-α, IFN-γ) when compared with an active control group. HYPOTHESIS: Compared with an active control group, CBT-I will be associated with a statistically significantly greater reduction in inflammatory markers. Improvements in sustained attention and executive function will be mediated by changes in inflammatory markers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (group 1) | Experimental | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)Participants will receive individualized digital CBT-I through an app called Hvil®. Treatment will take 6-9 weeks. |
| Active control group (group 2) | Active comparator | Behavioral: Sleep hygiene educationParticipants will receive the sleep hygiene education component of CBT-I through Hvil®. Treatment will take 6-9 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Have completed primary breast cancer (BC) treatment within 1-5 years (endocrine therapies allowed)
- 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
- Cognitive impairment: a score of "quite a bit" or "very much" on at least 1 of the 2 items measuring concentration and memory on The European Organization for Research and Treatment of Cancer Core Quality of Life (EORCT-QLQ-C30) and/or <54 on the Cancer Therapy-Cognitive (FACT-Cog) perceived cognitive impairment (PCI) subscale
Key exclusion criteria (10 listed)
- Other sleep disorders than insomnia that may confound sleep and/or cognitive function
- Use of drugs impacting that may confound sleep and/or cognitive function (endocrine therapies allowed)
- Neurodegenerative and psychiatric disorders that may confound sleep and/or cognitive function
- Shift work
- Pregnancy or maternity leave
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)Also: CBT-ICBT-I is a multi-component intervention consisting of sleep restriction, stimulus control therapy, relaxation therapy, cognitive therapy, and sleep hygiene education | Behavioural | Intervention group (group 1) |
| Sleep hygiene education- Sleep hygiene education includes information on lifestyle factors (diet, exercise, substance use) and environmental variables (noise, light, temperature) affecting sleep quality. | Behavioural | Active control group (group 2) |
Primary outcome
Conners continuous performance test 3rd edition
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Conners continuous performance test is a computerized test. It measures a combination of vigilance, sustained attention, and the inhibition component of executive function.
Insomnia Severity Index (ISI)
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
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.
35 secondary outcomes
Psychomotor Vigilance Test (PVT)
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Trail-Making Test Part A (TMT-A)
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) - Coding
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) - Digit span
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Paced Auditory Serial Addition Test (PASAT)
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Hopkins Verbal Learning Test-Revised (HVLT-R)
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Brief Visuospatial Memory Test-Revised (BVMT-R)
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Controlled Oral Word Association Test (COWAT)
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Trail-Making Test Part B (TMT-B)
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Stroop Color and Word Test
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) - Information
Time frame: Baseline (week 0)
Glymphatic function
Time frame: Baseline (week 0), 6-months follow-up (approximately week 33)
Structural brain networks
Time frame: Baseline (week 0), 6-months follow-up (approximately week 33)
Brain gray matter
Time frame: Baseline (week 0), 6-months follow-up (approximately week 33)
Brain white matter
Time frame: Baseline (week 0), 6-months follow-up (approximately week 33)
Brain white matter microstructure
Time frame: Baseline (week 0), 6-months follow-up (approximately week 33)
Tumor necrosis factor alpha (TNF-α)
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Interleukin 1 beta (Il-1β)
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Interleukin 6 (IL-6)
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Interferon gamma (IFN-γ)
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
High sensitivity C-reactive protein (hsCRP)
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Objective sleep
Time frame: Baseline (week 0), post-treatment (approximately week 9)
Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog)
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Patient Assessment of Own Functioning Inventory (PAOFI)
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
The European Organization for Research and Treatment of Cancer Core Quality of Life (EORCT-QLQ-C30)
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Morningness-Eveningness Questionnaire-reduced (MEQr)
Time frame: Baseline (week 0)
The Functional Assessment of Chronic Illness Therapy (FACIT Fatigue) scale
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
The perceived stress scale (PSS)
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
The numeric rating scale (NRS)
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
Brief Pain Inventory (pain interference (subscale))
Time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)
The Short-Form (36) Health Survey (SF -36)
Time frame: Baseline (week 0)
Charlson Comorbidity Index (CCI)
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 8 Jan 2025.
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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 Cognitive Behavioral Therapy for Insomnia (CBT-I) and Sleep hygiene education in people with Insomnia and Cognitive Impairment, run by Aarhus University Hospital 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 4 inclusion and 10 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 8 Jan 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. 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 Ali Amidi (+4587165305, ali@psy.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conners continuous performance test 3rd edition (time frame: Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)). The study lists 2 primary outcomes in all. 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 8 Jan 2025.