Clinical trial · Interventional
Implementation of CBT-I in Cancer Clinics
Implementation of a Stepped Care Cognitive-Behavioral Therapy for Insomnia in Routine Cancer Care
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Insomnia affects 30-60% of cancer patients, thus making it one of the most common disturbances in this population. When untreated, which is the rule rather than the exception, insomnia often becomes chronic. Chronic insomnia is associated with numerous negative consequences (e.g., increased risk for psychological disorders, health care costs). A large body of evidence supports the efficacy of cognitive-behavioral therapy for insomnia (CBT-I) in cancer patients, but CBT-I is still not offered routinely in cancer clinics. Self-administered CBT-I (e.g., video-based intervention) has been developed to increase patients' access to this treatment. However, results of clinical trials have suggested that these minimal treatments would be better used as a first step of a stepped care model. In stepped care, patients receive only the level of intervention they need. Generally, the entry level is a minimal, less costly, intervention (e.g., self-help intervention) followed by a more intensive form of treatment if needed (if the patient is still symptomatic). The investigators have recently assessed the efficacy of a stepped care model to administer CBT-I in cancer patients, which includes a web-based CBT-I (called Insomnet) followed by up to 3 sessions with a psychotherapist if the patient is still symptomatic. Results of this study suggest that this model of care is non-inferior to a standard face-to-face treatment (Savard, Ivers, et al., in revision), while being more cost-effective. A stepped care CBT-I could therefore be offered in routine cancer care clinics. This project will assess the feasibility and effectiveness of implementing a stepped care CBT-I in real-world cancer clinics, using a non-randomized stepped wedge design to compare the effects of our program (active phase) with a passive phase. The program is called Insomnia in Patients with Cancer - Personalized Treatment (IMPACT). The stepped care CBT-I (active intervention) is being implemented sequentially in the four participating hospitals over a number of equally spaced time periods of 4 months (wedges), for a total of 5 time points, over a period of 20 months.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Professionally-administered booster face-to-face CBT-I sessions | Behavioral | — | UNRESOLVED |
| Web-based cognitive-behavioral therapy for insomnia (CBT-I) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stepped care CBT-I
- interventionNames
- Behavioral: Web-based cognitive-behavioral therapy for insomnia (CBT-I)
- Behavioral: Professionally-administered booster face-to-face CBT-I sessions
Primary outcomes (13)
- measure
- Implementation (organizational) measures
- timeFrame
- Passive phase (4 months) vs. active phase (20 months), through study completion, an average of 24 months
- description
- Referral, enrolment and completion rates to the stepped care CBT-I in each clinical setting.
- measure
- 1) Change in Insomnia Severity Index Scores
- timeFrame
- Pre-treatment and post-treatment (6-8 weeks later)
- description
- Change in Insomnia Severity Index Scores from pre- to post-intervention. The ISI is a 7-item questionnaire designed to evaluate insomnia severity. A score greater than or equal to 8 indicates the presence of insomnia symptoms.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * have received a diagnosis of non-metastatic cancer (any type) * to be aged 18 years and older * to be readily able to read and understand French or English * having the minimum cognitive abilities to read, understand and memorize information * having access to Internet Exclusion Criteria: * having a psychological comorbidity needing clinical attention (e.g., major depressive disorder) * having severe cognitive impairments (e.g., diagnosis of Parkinson's disease, dementia) * having insomnia due to a temporary condition (e.g., acute pain, short-term medication side effects, environmental factors)
References
Publications (0)
Data not yet available