Clinical trial NCT02444026: Feasibility and Efficacy of Internet-delivered CBT for Insomnia in a National Cohort of Danish Breast Cancer Survivors
Official title: Feasibility and Efficacy of an Internet-delivered Cognitive-behavioral Intervention for Insomnia in a National Cohort of Danish Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Danish Breast Cancer Cooperative Group
First posted: 2015-05-14
Enrollment: 225
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Detailed description: METHODS PARTICIPANTS

The participants are able, legally competent women, 18 years or older, from a national cohort of Danish women treated for primary breast cancer between 1st of June 2011 and 1st of Juli 2014:

Inclusion criteria: 1) Reported moderate-to-severe sleep disturbances, defined as a score\> 5 on the Pittsburgh Sleep Quality Index (PSQI) (32;33) (see below), and 2) are found to be disease free. Furthermore, participants 3) are required to have access to the Internet.

Exclusion criteria: 1) Recurrence of breast cancer, 2) a second cancer, 3) and other serious physical or psychological comorbidity (e.g. depression, cardiovascular disease, and COPD), 4) shift work schedule, 5) other sleep disorders (sleep apnea, narcolepsy).

PROCEDURE INFORMATION AND REQUEST TO PARTICIPATE Women who fulfill the inclusion criteria and indicate an interest in receiving further information receive an information folder by post informing.

BASELINE MEASURES:

The baseline questionnaires contains questions about sleep quality, fatigue, depression, anxiety, quality of life, sleep habits and sleep-relevant lifestyles, together with use of health care services, sleep medication, and use of alternative medicine with the aim of treating sleep problems.

INTERVENTION:

The intervention program is designed to be completed in 6 weeks. To ensure that all participants have opportunity to complete the program they are granted access to the program for nine weeks .

POST-INTERVENTION:

After the intervention, participants in both groups are asked to complete a post-intervention questionnaire package and then to fill in the sleep diary for a 2-week period.

FOLLOW-UP:

After an additional 4 weeks both groups complete two sleep questionnaires (PSQI and the insomnia severity index) after which the waiting list group is offered the intervention.

INTERVENTION 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) (34).

CONTROL GROUP Participants randomly assigned to the control condition are told that for practical reasons, they have to wait 15 weeks before partaking in the intervention.

PRIMARY ENDPOINTS A) Sleep diary (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).

B) The Pittsburgh Sleep Quality Index (PSQI) (33). C) The Insomnia Severity Index (ISI) (39).

NUMBER OF PARTICIPANTS The combined effects found in the meta-analysis of published randomized trials of Internet-based treatment for insomnia (30) are: sleep quality (d=0.41), sleep efficiency (d=0.40), number of awakenings (d=-0.45), sleep onset latency (d=-0.55), total minutes slept (d=.22), time spent in bed (d=.25). If the investigators aim to detect an effect corresponding to an average of the effects above (d = 0.38) with 80% statistical power, at least 2 x 109 participants are required.

ETHICAL CONSIDERATIONS The investigators will adhere to the general ethical guidelines for human trials. All participants receive oral and written information about the project. They are informed that they can withdraw at any time from the study with no consequence for their current or future treatment. Participants are advised to continue any medical treatment for insomnia, and to consult a doctor before changing medical regimen.

PRIVACY AND DATA SECURITY The SHUT-I program stores any personal information in a separate one-way system that cannot be accessed from the Internet but only locally by the SHUT-i administrators. Connections between personal information and other data are encrypted. Data is stored physically on servers in locked facilities, in the United States.

ADVERSE EFFECTS, INCONVENIENCES, BENEFITS, AND RISKS The investigators do not expect Internet-based cognitive behavioral therapy to be associated with any adverse health effects or risks as no adverse effects has been reported for conventional CBT for insomnia.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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) .

Primary outcomes:
measure: Sleep diary
timeFrame: Up to 7 month
measure: The Pittsburgh Sleep Quality Index
timeFrame: Up to 7 month
measure: The Insomnia Severity Index
timeFrame: Up to 7 month
Secondary outcomes:
measure: Functional Assessment of Chronic Illness Therapy (FACIT)
timeFrame: Up to 7 month
measure: Beck's Depression Inventory (BDI-II)
timeFrame: Up to 7 month
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Up to 7 month
measure: EQ-5D
timeFrame: Up to 7 month
measure: SF-12
timeFrame: Up to 7 month
measure: Cognitive Failures Questionnaire (CFQ)
timeFrame: Up to 7 month
measure: Sleep habits and sleep-relevant lifestyle
timeFrame: Up to 7 month
measure: Use of health services, self-help methods, sleep medication,fatigue, morningness-eveningness type, and complementary and alternative medicine/treatment
timeFrame: Up to 7 month
measure: Pain (questionnaire)
timeFrame: Up to 7 month
Other outcomes:
measure: Moderator - Fear of Cancer Recurrence (FCR)
timeFrame: Up to 7 month
measure: Moderator - Depressive symptoms (BDI-II)
timeFrame: Up to 7 month
measure: Moderator - Charlson comorbidity index
timeFrame: Up to 7 month
measure: Moderator -Emotional Control Scale (ECQ-R)
timeFrame: Up to 7 month
measure: Moderator - The expected effects of and motivation to complete the intervention
timeFrame: Up to 7 month
measure: Moderator - Use of health services, self-help methods, sleep medication, and complementary and alternative medicine/treatment
timeFrame: Up to 7 month
measure: Moderator - Pain
timeFrame: Up to 7 month
measure: Moderator - Subjective response to a specific traumatic event
timeFrame: Up to 7 month
measure: Moderator - Traumatic Life Events Questionnaire (TLEQ)
timeFrame: Up to 7 month
measure: Mediator - Changes in sleep habits and sleep-related lifestyle from baseline to post-intervention
timeFrame: Up to 7 month
measure: Mediator - The experience of and satisfaction with the intervention
timeFrame: Up to 7 month
Locations:
city: Aarhus
country: Denmark
facility: Unit for Psychooncology and Health Psychology, Dept. of Oncology, Aarhus University Hospital and Dept of Psychology and Behavioural Science, Aarhus University
Study officials:
affiliation: Unit for Psychooncology and Health Psychology Dept. of Oncology, Aarhus University Hospital and Dept of Psychology and Behavioural Science, Aarhus University
name: Robert Zachariae, MDSci
role: STUDY_DIRECTOR
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