Internet-delivered Cognitive-Behavioral Intervention for Insomniac Cancer Survivors

University of Coimbra

Status: Completed

Conditions: Cancer Survivors; Insomnia; Cancer

Treatments: Behavioral: Cognitive Behavioral Therapy for Insomnia

Study type: Interventional

Funder types: Other

Identifiers

NCT04898855

2020.05728.BD

Details and patient eligibility

About

The main purpose of this study is to determine the treatment effects and acceptability of an internet-based cognitive-behavioral therapy intervention to improve the sleep of Portuguese cancer survivors with insomnia.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Having 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 4 weeks

Exclusion criteria

• Age ≤ 18 years
• Another unstable condition (e.g., sleep, psychiatric or medical condition)
• Pregnancy or breastfeeding
• Concurrent CBT-I
• Habitual night shift, or rotating shift-workers

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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154 participants in 2 patient groups

OncoSleep intervention (internet-delivered cognitive-behavioral treatment for insomnia)

Experimental group

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.

Treatment:

Behavioral: Cognitive Behavioral Therapy for Insomnia

waitlist control

No Intervention group

Description:

Participants assigned to the waitlist control group receive access to the OncoSleep program after 8 weeks.