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NOT YET RECRUITING
NCT07876661
NA

Effectiveness of a Guided, Web-based, Stepped-care-approach to Cognitive Behavioral Therapy for Insomnia in Cancer Survivors

Sponsor: Vrije Universiteit Brussel

View on ClinicalTrials.gov

Summary

The goal of this multicenter randomized clinical trial is to develop and evaluate a web-based stepped-care approach to Cognitive Behavioral Therapy for Insomnia (CBT-I), specifically tailored to adult cancer survivors experiencing insomnia. Participants will be randomly assigned to one of three study arms: stepped-care web-based CBT-I (eSTEPCBT-I), standardized web-based CBT-I (eSTANDCBT-I), or care as usual (CAU). The study aims to determine whether a stepped-care approach can improve access to effective insomnia treatment while maintaining clinical effectiveness and cost-effectiveness.

Official title: eNightfall-project: Effectiveness of a Guided, Web-based, Stepped-care-approach to Cognitive Behavioral Therapy for Insomnia in Cancer Survivors: a Multicenter Randomized Controlled Clinical Trial.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-10-15

Completion Date

2030-04-01

Last Updated

2026-10-15

Healthy Volunteers

No

Interventions

BEHAVIORAL

Stepped-care Cognitive Behavioral Therapy for Insomnia

Step 1: Participants receive access to an online self-guided CBT-I module containing educational videos, psychoeducation, and behavioural exercises and 1 online face-to-face sleep coaching session delivered by a trained healthcare provider. The intervention includes sleep education and sleep hygiene, stimulus control, and individualized behavioural advice to improve sleep. Step 2: Participants who do not achieve remission after Step 1 proceed to Step 2, consisting of the eSTANDCBT-I intervention adapted to a 6-week treatment period. Participants receive six online CBT-I modules and two online face-to-face therapy sessions delivered by a CBT-I-certified psychologist. Step 2 incorporates the same evidence-based CBT-I techniques as the eSTANDCBT-I program. All participants receive Step 1. Only participants with persistent insomnia symptoms after the 4-week assessment proceed to Step 2. Participants also complete a daily sleep diary throughout the 10-week intervention.

BEHAVIORAL

Standard web-based Cognitive Behavioral Therapy for Insomnia

The eSTANDCBT-I intervention consists of a standard web-based Cognitive Behavioral Therapy for Insomnia (CBT-I) program delivered over a 10-week period. The program includes six online self-guided sessions and two online face-to-face therapy sessions with a CBT-I-certified psychologist. Participants receive: access to an online CBT-I platform containing weekly modules with educational videos, interactive exercises, and supporting materials; and two online face-to-face therapy sessions delivered by a CBT-I-certified psychologist. The intervention incorporates evidence-based CBT-I components commonly used in face-to-face clinical practice, including: sleep education and sleep hygiene; sleep restriction therapy and stimulus control; cognitive restructuring of maladaptive sleep-related thoughts and beliefs; stress management; relaxation training; and daily-life integration and relapse prevention. Participants are asked to complete a daily sleep diary throughout the 10-week intervention.

OTHER

Control arm - Care as usual with sleep hygiene leaflet

Participants will receive an online sleep hygiene brochure and may seek additional or new sleep support from their usual healthcare providers if needed during the study. No study-specific sleep intervention will be provided, and the care received will be monitored as usual care. Participants will also complete a logbook and sleep diary throughout the study to enable comparison with the experimental groups. After all data collection has been completed, all intervention materials, including the online eSTANDCBT-I program, will be made available to them.

Locations (1)

Vrije Universiteit Brussel

Brussels, Belgium