Feasibility and Efficacy of Internet-delivered CBT for Insomnia in a National Cohort of Danish Breast Cancer Survivors

NCT02444026 | Unknown DMC

• 1 other identifier: M-2012-553-12
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

The aim is, in a randomized controlled trial, to test the feasibility and evaluate the efficacy of an internet-based treatment for insomnia, previously tested in a group of 28 US cancer patients, in a large sample of Danish breast cancer survivors who are experiencing significant sleep problems 0-3 years after treatment. The investigators aim to test the following hypotheses: That a group receiving Internet-delivered cognitive-behavioral therapy (CCBT) for insomnia (CCBT-I) will experience reduced sleep latency, more hours of sleep, fewer awakenings during the night, improved sleep efficiency, increased subjective sleep quality, and improved quality of life after the intervention, when compared to a waiting list control group. The investigators also aim to explore a number of possible moderators of the effect (comorbidity, depression, fear of cancer recurrence tendency to ruminate) and mediating mechanisms (changes in sleep habits and sleep-related lifestyle factors).

Conditions

Insomnia

Outcome Measures

Primary Outcomes (3)

• Sleep diary

  The online sleep diaries contains 10 standard questions including information about bedtime, sleep onset latency (SOL), number of awakenings, total length of awakenings, wake time, arising time, daytime naps, rating of soundness of previous night's sleep, rating of refreshed feeling upon morning awakening, and information about sleep aids (medication and/or alcohol use).

  Up to 7 month

• The Pittsburgh Sleep Quality Index

  Up to 7 month

• The Insomnia Severity Index

  Up to 7 month

Secondary Outcomes (9)

• Functional Assessment of Chronic Illness Therapy (FACIT)

  Up to 7 month

• Beck's Depression Inventory (BDI-II)

  Up to 7 month

• State-Trait Anxiety Inventory (STAI)

  Up to 7 month

• EQ-5D

  Up to 7 month

• SF-12

  Up to 7 month

Other Outcomes (11)

• Moderator - Fear of Cancer Recurrence (FCR)

  Up to 7 month

• Moderator - Depressive symptoms (BDI-II)

  Up to 7 month

• Moderator - Charlson comorbidity index

  Up to 7 month

Study Arms (2)

iCBT for Insomnia

EXPERIMENTAL

The Internet intervention offered is the SHUT-i program (Sleep Healthy Using The Internet), which is based on the existing consensus concerning non-pharmacological treatment of insomnia and builds on previous validated CBT's for insomnia (CBT -I)

Behavioral: iCBT for Insomnia

Control

NO INTERVENTION

The control group will be offered the intervention AFTER the study

Interventions

iCBT for Insomnia BEHAVIORAL

Internet-delivered Cognitive Behavioural Therapy for Insomnia

iCBT for Insomnia

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Reported moderate-to-severe sleep disturbances, defined as a score\> 5 on the Pittsburgh Sleep Quality Index (PSQI).
• Disease free.
• Access to the Internet.

You may not qualify if:

• Recurrence of breast cancer
• A second cancer
• Other serious physical or psychological comorbidity (e.g. depression, cardiovascular disease, and COPD)
• Night work schedule
• Other sleep disorders (sleep apnea, narcolepsy) .

Sponsors & Collaborators

• University of Aarhus: lead
• Danish Breast Cancer Cooperative Group: collaborator

Study Sites (1)

Unit for Psychooncology and Health Psychology, Dept. of Oncology, Aarhus University Hospital and Dept of Psychology and Behavioural Science, Aarhus University

Aarhus, Denmark, 8000, Denmark

RECRUITING

Related Publications (67)

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MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Robert Zachariae, MDSci

  Unit for Psychooncology and Health Psychology Dept. of Oncology, Aarhus University Hospital and Dept of Psychology and Behavioural Science, Aarhus University

  STUDY DIRECTOR

Central Study Contacts

Robert Zachariae, MDSci

CONTACT

+45 871 65878; bzach@aarhus.rm.dk

Jesper Dahlgaard, PhD

CONTACT

+45 8716 5494 / +45 23254157; jesper@psy.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: May 14, 2015
• Study Start: December 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: May 14, 2015

Record last verified: 2014-12

Locations

DK (1)