Clinical trial · Interventional
A Comparison of MBSR and CBT for the Treatment of Insomnia in Cancer
An Objective Comparison of Cognitive Behavioral Therapy and Mindfulness-based Stress Reduction for the Treatment of Insomnia in Cancer Survivors Using Wrist Actigraphy: A Randomized Noninferiority Trial
- 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)
Sleep disturbance in cancer patients is often overlooked despite its documented high prevalence and negative impact. There are few empirically validated non-pharmacological treatments for insomnia and many patients are unwilling to rely on sleeping medications. This study will determine whether Mindfulness-Based Stress Reduction (a program that teaches meditation and yoga) produces equivalent results with the additional benefits of reduced stress and mood disturbance, to an already established treatment for insomnia, Cognitive-Behavioral Therapy. This will allow for the expansion of treatment options for insomnia beyond what is currently available and improve quality of life for millions of cancer survivors.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive Behavior Therapy | Behavioral | — | UNRESOLVED |
| Mindfulness-Based Stress Reduction | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cognitive Behavior Therapy
- description
- Cognitive Behavior Therapy for insomnia consists of stimulus control therapy, sleep restriction therapy, cognitive therapy and relaxation.
- interventionNames
- Behavioral: Cognitive Behavior Therapy
- type
- EXPERIMENTAL
- label
- Mindfulness-Based Stress Reduction
- description
- The program consists of three primary components: theoretical material related to relaxation, meditation, and the mind-body connection; experiential practice of meditation and yoga and home based practice; group process focused on problem solving and support.
- interventionNames
- Behavioral: Mindfulness-Based Stress Reduction
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * English speaking * Non metastatic cancer * 1 month post chemotherapy/radiation treatment (hormone treatment okay) * Diagnosis of Primary or Secondary Insomnia Exclusion Criteria: * Presence of another sleep disorder * Presence of another Axis I diagnosis (not in remission) * Inability to attend at least 5 out of the 8 treatment sessions * Randomization Refusal * Previous participation in CBT-I or MBSR * Shift work
References
Publications (2)
- DERIVEDCai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2. PMID 41170811
- DERIVEDGarland SN, Carlson LE, Stephens AJ, Antle MC, Samuels C, Campbell TS. Mindfulness-based stress reduction compared with cognitive behavioral therapy for the treatment of insomnia comorbid with cancer: a randomized, partially blinded, noninferiority trial. J Clin Oncol. 2014 Feb 10;32(5):449-57. doi: 10.1200/JCO.2012.47.7265. Epub 2014 Jan 6. PMID 24395850