NCT06553235

Brief 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). 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
46mo left

Started Dec 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress29%
Dec 2024Mar 2030

First Submitted

Initial submission to the registry

July 26, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 14, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

December 6, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2030

Last Updated

January 8, 2025

Status Verified

December 1, 2024

Enrollment Period

2.2 years

First QC Date

July 26, 2024

Last Update Submit

January 7, 2025

Conditions

InsomniaCognitive ImpairmentBreast Cancer

Keywords

Cognitive behavioral therapy for insomniaCBT-IBreast cancerInsomniaSleepCognitive functionMagnetic resonance imagingWhite matterGray matterGlymphatic functionDiffusion tensor image along the perivascular spaceStructural brain networksInflammation

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)

Secondary Outcomes (35)

  • Psychomotor Vigilance Test (PVT)

    Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)

  • Trail-Making Test Part A (TMT-A)

    Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)

  • Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) - Coding

    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

    Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)

  • Paced Auditory Serial Addition Test (PASAT)

    Baseline (week 0), post-treatment (approximately week 9), 6-months follow-up (approximately week 33)

  • +30 more secondary outcomes

Study Arms (2)

Intervention group (group 1)

EXPERIMENTAL

Participants will receive individualized digital CBT-I through an app called Hvil®. Treatment will take 6-9 weeks.

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.

Behavioral: Sleep hygiene education

Interventions

Cognitive Behavioral Therapy for Insomnia (CBT-I)BEHAVIORAL

CBT-I is a multi-component intervention consisting of sleep restriction, stimulus control therapy, relaxation therapy, cognitive therapy, and sleep hygiene education

Also known as: CBT-I
Intervention group (group 1)
Sleep hygiene educationBEHAVIORAL

\- Sleep hygiene education includes information on lifestyle factors (diet, exercise, substance use) and environmental variables (noise, light, temperature) affecting sleep quality.

Active control group (group 2)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Insufficient Danish proficiency
  • Substance abuse that may confound sleep and/or cognitive function
  • Previous experience with CBT-I
  • Other cancer than breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus N, Denmark

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersCognitive DysfunctionBreast NeoplasmsInflammation

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersCognition DisordersNeurocognitive DisordersNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Ali Amidi

CONTACT

+4587165305ali@psy.au.dk

Julie K. Thomadsen

CONTACT

+4587150192jtho@psy.au.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
In addition to investigator and outcome assessor masking, we aim to mask the participants as much as possible. Participants will know what treatment they will receive and that there are two groups. However, they will not know what treatment the other group will receive or that one group is the intervention group and the other an active control group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 26, 2024

First Posted

August 14, 2024

Study Start

December 6, 2024

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

March 28, 2030

Last Updated

January 8, 2025

Record last verified: 2024-12

Locations

DK(1)