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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

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.

Study 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.

Eligibility

Primary outcome measure(s)

• Insomnia Severity as assessed by the Insomnia Severity Index (ISI) — Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (post intervention)(T2), and at 6 months post-intervention (T3) and 12 months post-intervention (T4).
  Insomnia severity is assessed using the Insomnia Severity Index (ISI), a validated 7-item questionnaire with a total score ranging from 0 to 28. Higher scores indicate greater insomnia severity (worse outcome).
• Insomnia Remission Rate assesed by use of the Insomnia Severity Index (ISI) — Baseline before the intervention (T0), within 4 weeks after the start of the intervention (T1), after 10 weeks of intervention (post-intervention, T2), and at 6 months (T3) and 12 months (T4) post-intervention.
  Insomnia remission is defined as an ISI total score of 11 or lower (≤11). The remission rate is expressed as the percentage of participants achieving remission, with higher percentages indicating a better outcome.

Trial sites (1)

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