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

Primary Purpose

Insomnia

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
iCBT for Insomnia
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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) .

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

iCBT for Insomnia

Control

Arm Description

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)

The control group will be offered the intervention AFTER the study

Outcomes

Primary Outcome Measures

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).
The Pittsburgh Sleep Quality Index
The Insomnia Severity Index

Secondary Outcome Measures

Functional Assessment of Chronic Illness Therapy (FACIT)
Beck's Depression Inventory (BDI-II)
State-Trait Anxiety Inventory (STAI)
EQ-5D
SF-12
Quality of life (QoL) is measured with the SF-12
Cognitive Failures Questionnaire (CFQ)
Sleep habits and sleep-relevant lifestyle
Is assessed by adapting, further developing, and testing in the first phase of the study an existing instrument (Suzuki E, Tsuchiya M, Hirokawa K, Taniguchi T, Mitsuhashi T, Kawakami N. Evaluation of an internet-based self-help program for better quality of sleep among Japanese workers: a randomized controlled trial. J Occup Health 2008;50(5):387-99.), that measures: activities before bedtime, eating habits before bedtime, use of stimulants (coffee, tea, cola), alcohol, activities in the bedroom, exercise, thought patterns concerning sleep, etc.
Use of health services, self-help methods, sleep medication,fatigue, morningness-eveningness type, and complementary and alternative medicine/treatment
Pain (questionnaire)
A short questionnaire assessing pain is included

Full Information

First Posted
December 10, 2014
Last Updated
May 13, 2015
Sponsor
University of Aarhus
Collaborators
Danish Breast Cancer Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT02444026
Brief Title
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Danish Breast Cancer Cooperative Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iCBT for Insomnia
Arm Type
Experimental
Arm Description
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)
Arm Title
Control
Arm Type
No Intervention
Arm Description
The control group will be offered the intervention AFTER the study
Intervention Type
Behavioral
Intervention Name(s)
iCBT for Insomnia
Intervention Description
Internet-delivered Cognitive Behavioural Therapy for Insomnia
Primary Outcome Measure Information:
Title
Sleep diary
Description
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).
Time Frame
Up to 7 month
Title
The Pittsburgh Sleep Quality Index
Time Frame
Up to 7 month
Title
The Insomnia Severity Index
Time Frame
Up to 7 month
Secondary Outcome Measure Information:
Title
Functional Assessment of Chronic Illness Therapy (FACIT)
Time Frame
Up to 7 month
Title
Beck's Depression Inventory (BDI-II)
Time Frame
Up to 7 month
Title
State-Trait Anxiety Inventory (STAI)
Time Frame
Up to 7 month
Title
EQ-5D
Time Frame
Up to 7 month
Title
SF-12
Description
Quality of life (QoL) is measured with the SF-12
Time Frame
Up to 7 month
Title
Cognitive Failures Questionnaire (CFQ)
Time Frame
Up to 7 month
Title
Sleep habits and sleep-relevant lifestyle
Description
Is assessed by adapting, further developing, and testing in the first phase of the study an existing instrument (Suzuki E, Tsuchiya M, Hirokawa K, Taniguchi T, Mitsuhashi T, Kawakami N. Evaluation of an internet-based self-help program for better quality of sleep among Japanese workers: a randomized controlled trial. J Occup Health 2008;50(5):387-99.), that measures: activities before bedtime, eating habits before bedtime, use of stimulants (coffee, tea, cola), alcohol, activities in the bedroom, exercise, thought patterns concerning sleep, etc.
Time Frame
Up to 7 month
Title
Use of health services, self-help methods, sleep medication,fatigue, morningness-eveningness type, and complementary and alternative medicine/treatment
Time Frame
Up to 7 month
Title
Pain (questionnaire)
Description
A short questionnaire assessing pain is included
Time Frame
Up to 7 month
Other Pre-specified Outcome Measures:
Title
Moderator - Fear of Cancer Recurrence (FCR)
Time Frame
Up to 7 month
Title
Moderator - Depressive symptoms (BDI-II)
Time Frame
Up to 7 month
Title
Moderator - Charlson comorbidity index
Time Frame
Up to 7 month
Title
Moderator -Emotional Control Scale (ECQ-R)
Time Frame
Up to 7 month
Title
Moderator - The expected effects of and motivation to complete the intervention
Description
A short questionnaire has been developed to assess the expected effects of and motivation to complete the intervention
Time Frame
Up to 7 month
Title
Moderator - Use of health services, self-help methods, sleep medication, and complementary and alternative medicine/treatment
Time Frame
Up to 7 month
Title
Moderator - Pain
Description
A short questionnaire assessing pain has been developed
Time Frame
Up to 7 month
Title
Moderator - Subjective response to a specific traumatic event
Description
The impact of event scale-revised (Weiss, D.S. The Impact of Event Scale-Revised. In J.P. Wilson, & T.M. Keane (Eds.), Assessing psychological trauma and PTSD: A practitioner'shandbook (2nd ed., pp. 168-189).2004. New York: Guilford Press ) is included as a measure of subjective response to a specific traumatic event. This scale approximates the DSM-IV criteria for posttraumatic stress disorder. Subjective response to both breast cancer and one other self-chosen traumatic event is assessed. The delineation of the self-chosen traumatic event is based on the traumatic life event questionnaire (TLEQ)
Time Frame
Up to 7 month
Title
Moderator - Traumatic Life Events Questionnaire (TLEQ)
Time Frame
Up to 7 month
Title
Mediator - Changes in sleep habits and sleep-related lifestyle from baseline to post-intervention
Time Frame
Up to 7 month
Title
Mediator - The experience of and satisfaction with the intervention
Description
Weiss, D.S. The Impact of Event Scale-Revised. In J.P. Wilson, & T.M. Keane (Eds.), Assessing psychological trauma and PTSD: A practitioner'shandbook (2nd ed., pp. 168-189).2004. New York: Guilford Press Weiss, D.S. The Impact of Event Scale-Revised. In J.P. Wilson, & T.M. Keane (Eds.), Assessing psychological trauma and PTSD: A practitioner'shandbook (2nd ed., pp. 168-189).2004. New York: Guilford Press Measured by the instrument developed in the first trials of the SHUTi intervention (Thorndike FP, Saylor DK, Bailey ET, Gonder-Frederick L, Morin CM, Ritterband LM. Develop- ment and Perceived Utility and Impact of an Internet Intervention for Insomnia. E J Appl Psychol 2008;4(2):32-42. )
Time Frame
Up to 7 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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) .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Zachariae, MDSci
Phone
+45 871 65878
Email
bzach@aarhus.rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Jesper Dahlgaard, PhD
Phone
+45 8716 5494 / +45 23254157
Email
jesper@psy.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Zachariae, MDSci
Organizational Affiliation
Unit for Psychooncology and Health Psychology Dept. of Oncology, Aarhus University Hospital and Dept of Psychology and Behavioural Science, Aarhus University
Official's Role
Study Director
Facility Information:
Facility Name
Unit for Psychooncology and Health Psychology, Dept. of Oncology, Aarhus University Hospital and Dept of Psychology and Behavioural Science, Aarhus University
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Zachariae, DMSci
Phone
+45 871 65878
Email
bzach@aarhus.rm.dk
First Name & Middle Initial & Last Name & Degree
Jesper Dahlgaard, PhD
Phone
+45 8716 5494 / +45 23254157
Email
jesper@psy.au.dk

12. IPD Sharing Statement

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

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