Programa Online de intervenção Cognitivo-Comportamental Para o Tratamento da Insónia em Sobreviventes Oncológicos

University of Coimbra1 site in 1 country154 target enrollmentAugust 19, 2023

ConditionsInsomnia Cancer Cancer Survivors

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Insomnia
Sponsor: University of Coimbra
Enrollment: 154
Locations: 1
Primary Endpoint: Insomnia severity
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 19, 2023

End Date

July 31, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Coimbra

Responsible Party

Principal Investigator

Maria Inês Clara

PhD fellowship at Center for Research in Neuropsychology and Cognitive and Behavioral Intervention

University of Coimbra

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

Outcomes

Primary Outcomes

Insomnia severity

Time Frame: Changes from baseline to post-intervention (8 weeks after randomization)

Insomnia Severity Index: validated questionnaire among cancer survivors; a 7-item scale with total scores between 0 and 28 where higher scores indicate greater severity

Secondary Outcomes

Anxiety(Changes from baseline to post-intervention (8 weeks after randomization))
Depression(Changes from baseline to post-intervention (8 weeks after randomization))
Health-related quality of life(Changes from baseline to post-intervention (8 weeks after randomization))
Cancer-related fatigue(Changes from baseline to post-intervention (8 weeks after randomization))
Sleep efficiency(Changes from baseline to post-intervention (8 weeks after randomization))
Total sleep time(Changes from baseline to post-intervention (8 weeks after randomization))
Sleep onset latency(Changes from baseline to post-intervention (8 weeks after randomization))
Number of nocturnal awakenings(Changes from baseline to post-intervention (8 weeks after randomization))
Wake after sleep onset(Changes from baseline to post-intervention (8 weeks after randomization))