Back to resultsInternet-delivered Cognitive-Behavioral Intervention for Insomniac Cancer Survivors
Primary Purpose
Insomnia, Survivorship, Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Insomnia
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia focused on measuring insomnia, cancer, survivorship, CBTI, iCBTI
Eligibility Criteria
Inclusion Criteria:
- Age 18+ years
- Provided informed consent
- Ability to read and write in Portuguese
- Ability to use a computer and/or smartphone, and the internet
- History of cancer, any type or stage
- An interval of 1 or more months from the end of active treatment (chemotherapy and/or radiotherapy)
- Subclinical or significant symptoms of insomnia (ISI scores>8) and positive screen for probable ICSD-3 insomnia disorder
- Ongoing sleep medication only accepted if the dosage has been stable during the last 3 months
- No participation in any other interventional study or clinical trial
Exclusion Criteria:
- Age ≤ 18 years
- Absence of clinically or subclinical significant symptoms
- No history of cancer
- Inability to provide informed consent
- Inability to use a computer and/or smartphone
- No access to the internet
- Another untreated sleep diagnosis
- Current major psychiatric or medical condition
- Pregnancy
- Parallel ongoing psychological treatment for insomnia
- Habitual night shift, or rotating shift-workers
Sites / Locations
- Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
OncoSleep intervention (internet-delivered cognitive-behavioral treatment for insomnia)
waitlist control
Arm Description
Participants assigned to the experimental group receive immediate access to the OncoSleep program, a web-based self-guided cognitive-behavioral intervention for insomnia consisting of 6 weekly sessions. A certified psychologist will monitor the participant's progress and provide feedback.
Participants assigned to the waitlist control group receive access to the OncoSleep program after 8 weeks.
Outcomes
Primary Outcome Measures
Insomnia severity
Insomnia Severity Index (overall score 0-28 interpreted as follows: 0-7 absence of insomnia; 8-14 sub-threshold insomnia; 15-21 moderate insomnia; 22-28 severe insomnia)
Secondary Outcome Measures
Sleep efficiency
Sleep Diary
Total sleep time
Sleep Diary
Number of nocturnal awakenings
Sleep Diary
Wake after sleep onset
Sleep Diary
Sleep onset latency
Sleep Diary
Cancer-related fatigue
Multidimensional Fatigue Symptom Inventory-Short Form (overall score 24-96, higher scores denote higher levels of cancer-related fatigue)
Health-related quality of life
European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30; World Health Organization Quality of Life - Brief (overall scores 0-100, higher scores indicate higher quality of life)
Anxiety
Hospital Anxiety and Depression Scale (total subscale 0-21, higher scores denote highest anxiety level)
Depression
Hospital Anxiety and Depression Scale (total subscale 0-21, higher scores denote highest depression level)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04898855
Brief Title
Internet-delivered Cognitive-Behavioral Intervention for Insomniac Cancer Survivors
Official Title
Programa Online de intervenção Cognitivo-Comportamental Para o Tratamento da Insónia em Sobreviventes Oncológicos
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Coimbra
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to determine the treatment effects, feasibility, and acceptability of an internet-based cognitive-behavioral therapy intervention to improve the sleep of Portuguese cancer survivors with insomnia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Survivorship, Cancer
Keywords
insomnia, cancer, survivorship, CBTI, iCBTI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OncoSleep intervention (internet-delivered cognitive-behavioral treatment for insomnia)
Arm Type
Experimental
Arm Description
Participants assigned to the experimental group receive immediate access to the OncoSleep program, a web-based self-guided cognitive-behavioral intervention for insomnia consisting of 6 weekly sessions. A certified psychologist will monitor the participant's progress and provide feedback.
Arm Title
waitlist control
Arm Type
No Intervention
Arm Description
Participants assigned to the waitlist control group receive access to the OncoSleep program after 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia
Other Intervention Name(s)
OncoSleep
Intervention Description
Treatment includes sleep hygiene, sleep restriction, stimulus control, and cognitive therapy.
Primary Outcome Measure Information:
Title
Insomnia severity
Description
Insomnia Severity Index (overall score 0-28 interpreted as follows: 0-7 absence of insomnia; 8-14 sub-threshold insomnia; 15-21 moderate insomnia; 22-28 severe insomnia)
Time Frame
Changes from baseline to post-intervention (8 weeks after enrollment); 3- and 6- months follow-ups
Secondary Outcome Measure Information:
Title
Sleep efficiency
Description
Sleep Diary
Time Frame
Changes from baseline to post-intervention (8 weeks after enrollment); 3- and 6- months follow-ups
Title
Total sleep time
Description
Sleep Diary
Time Frame
Changes from baseline to post-intervention (8 weeks after enrollment); 3- and 6- months follow-ups
Title
Number of nocturnal awakenings
Description
Sleep Diary
Time Frame
Changes from baseline to post-intervention (8 weeks after enrollment); 3- and 6- months follow-ups
Title
Wake after sleep onset
Description
Sleep Diary
Time Frame
Changes from baseline to post-intervention (8 weeks after enrollment); 3- and 6- months follow-ups
Title
Sleep onset latency
Description
Sleep Diary
Time Frame
Changes from baseline to post-intervention (8 weeks after enrollment); 3- and 6- months follow-ups
Title
Cancer-related fatigue
Description
Multidimensional Fatigue Symptom Inventory-Short Form (overall score 24-96, higher scores denote higher levels of cancer-related fatigue)
Time Frame
Changes from baseline to post-intervention (8 weeks after enrollment); 3- and 6- months follow-ups
Title
Health-related quality of life
Description
European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30; World Health Organization Quality of Life - Brief (overall scores 0-100, higher scores indicate higher quality of life)
Time Frame
Changes from baseline to post-intervention (8 weeks after enrollment); 3- and 6- months follow-ups
Title
Anxiety
Description
Hospital Anxiety and Depression Scale (total subscale 0-21, higher scores denote highest anxiety level)
Time Frame
Changes from baseline to post-intervention (8 weeks after enrollment); 3- and 6- months follow-ups
Title
Depression
Description
Hospital Anxiety and Depression Scale (total subscale 0-21, higher scores denote highest depression level)
Time Frame
Changes from baseline to post-intervention (8 weeks after enrollment); 3- and 6- months follow-ups
Other Pre-specified Outcome Measures:
Title
Feasibility as assessed by recruitment, retention/attrition data
Description
Computed as the number of participants that registered to enroll, dropped out before completing the intervention and completed the intervention
Time Frame
Post-intervention (8 weeks after enrollment)
Title
Feasibility as assessed by usage (program visit length, completion of activities)
Description
Computed as the average duration of participants' visits to the intervention, sleep diary logs, homework activities
Time Frame
Post-intervention (8 weeks after enrollment)
Title
Acceptability
Description
Self-report scales of satisfaction, adherence and perceived helpfulness rated on 4-point Likert scales adapted from Manber et al. (2011)
Time Frame
Post-intervention (8 weeks after enrollment)
Title
Usability
Description
User Experience Questionnaire
Time Frame
Post-intervention (8 weeks after enrollment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18+ years
Provided informed consent
Ability to read and write in Portuguese
Ability to use a computer and/or smartphone, and the internet
History of cancer
Have completed primary cancer treatment (survivors who are on hormone and/or other long-term maintenance therapy agencies are eligible to participate)
Subclinical or significant symptoms of insomnia (ISI scores>8)
Ongoing sleep medication accepted if the dosage has been stable during the last 3 months
No participation in any other interventional study or clinical trial
Exclusion Criteria:
Age ≤ 18 years
Absence of clinically or subclinical significant symptoms
No history of cancer
Inability to provide informed consent
Inability to use a computer and/or smartphone
No access to the internet
Another untreated sleep diagnosis
Current major psychiatric or medical condition
Pregnancy or breastfeeding
Parallel ongoing psychological treatment for insomnia
Habitual night shift, or rotating shift-workers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Clara
Phone
+351 911820289
Email
mclara@uc.pt
Facility Information:
Facility Name
Center for Research in Neuropsychology and Cognitive and Behavioral Intervention (CINEICC)
City
Coimbra
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Clara
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Internet-delivered Cognitive-Behavioral Intervention for Insomniac Cancer Survivors
We'll reach out to this number within 24 hrs