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Mindfulness and CBT for Sleep
NCT04736056 · View on ClinicalTrials.gov ↗
Study Summary
Patients with hematologic cancer frequently report significant difficulties with sleep in the months after discharge from inpatient chemotherapy. Poor sleep quality can contribute to and perpetuate problems with daytime fatigue, pain, and distress that are common among patients with hematologic cancer. There is a need for behavioral interventions that address insomnia and daytime fatigue, pain, and distress once hematologic cancer patients have returned home after inpatient chemotherapy. Mindfulness-Based Therapy for Insomnia (MBTI) is a new approach to treating insomnia. This group-based intervention combines sleep restriction and stimulus control with mindfulness principles and exercises to reduce worry and promote positive responses to insomnia. To date, MBTI has not been applied to patients with hematologic cancer. If MBTI is to meet the needs of hematologic cancer patients, it must be adapted in several ways. First, because hematologic cancer patients are immunosuppressed, MBTI needs to be adapted for one-to-one delivery. Second, because hematologic cancer patients experience significant daytime fatigue, pain, and distress, MBTI needs to be adapted to include systematic training in coping skills for these symptoms. The investigators propose to develop and pilot test an adapted MBTI (MBTI+) protocol for hematologic cancer patients reporting insomnia, fatigue, pain, and/or distress after inpatient chemotherapy. The study will be conducted in two phases. In Phase I, the study team will use focus groups with hematologic cancer patients and hematology-oncology providers to guide development along with user testing with hematologic cancer patients reporting insomnia and daytime symptoms of fatigue, pain, and/or distress. Phase II will involve a small single-arm pilot to examine the feasibility, acceptability, and examine pre- to post-intervention primary (insomnia) and secondary (fatigue, pain, distress, mindfulness, self-efficacy) outcomes of the MBTI+ protocol. MBT
Conditions Studied
Interventions
- BEHAVIORAL Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills
Study Locations (1)
North Carolina
- Duke Cancer Institute — Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2021-04-01 |
| Est. Completion | 2023-05-19 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04736056
The ClinicalTrials.gov registry entry for NCT04736056 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,129 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hematologic Malignancy appearing as the primary indexed condition, and to 1 intervention — of which Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04736056 reports 1 study location spanning 1 distinct geographic area — top geographies include North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04736056 about?
NCT04736056 is a clinical study titled "Mindfulness and CBT for Sleep". Patients with hematologic cancer frequently report significant difficulties with sleep in the months after discharge from inpatient chemotherapy. Poor sleep quality can contribute to and perpetuate problems with daytime fatigue, pain, and distress that are common among patients with hematologic canc...
What is the current status of trial NCT04736056?
This trial is currently completed. It is a NA study. The enrollment target is 57 participants. The study started on 2021-04-01. Estimated completion is 2023-05-19.
What conditions does trial NCT04736056 study?
This clinical trial studies the following conditions: Hematologic Malignancy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04736056?
The interventions under investigation include: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04736056?
This trial is sponsored by Duke University, which has 1,129 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04736056 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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