Mindfulness and CBT for Sleep

NCT ID: NCT04736056

Last Updated: 2024-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2023-05-19

Brief 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. MBTI+ will consist of six, 60- to 75-minute therapy sessions delivered either in-person or via videoconferencing technology. Study measures will be collected at baseline, immediately post-intervention, and 1-month post-intervention.

Conditions

Hematologic Malignancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills

Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills (MBTI+)

The MBTI+ intervention will train participants in mindfulness-based sleep strategies and behavioral symptom management techniques. The MBTI+ intervention will consist of 6 weekly sessions that will last between 60 and 75 minutes.

Group Type: EXPERIMENTAL

Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills

Intervention Type: BEHAVIORAL

Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.

Interventions

Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills

Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• an initial or recurrent diagnosis of hematologic malignancy
• within 8 weeks of discharge home after inpatient chemotherapy or CAR-T therapy
• total score of 8 or greater on the Insomnia Severity Index (ISI)
• score of 5 or greater on the MD Anderson Symptom Inventory Scale for "worst" fatigue, pain, or distress, and report that these symptoms interfered with at least two activities of living (i.e., general activity, mood, work) in the last week at 3 or greater on a 0="Did not interfere" to 10="Interfered completely" scale
• ability to speak and read English, and hearing and vision that allows for completion of sessions and assessments

Exclusion Criteria

• reported or suspected cognitive impairment subsequently informed by a Folstein Mini-Mental Status Examination of <25
• presence of a serious psychiatric (e.g., schizophrenia, suicidal intent) or medical condition (e.g., seizure disorder, narcolepsy) indicated by medical chart, treating oncologist or other medical provider that would contraindicate safe participation
• expected survival of 6 months or less

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tamara J Somers, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Cancer Institute

Durham, North Carolina, United States

Countries

United States

References

Fisher HM, Hyland KA, Miller SN, Amaden GH, Diachina A, Ulmer CS, Danforth M, LeBlanc TW, Somers TJ, Keefe FJ. Mindful Night-to-Day: A Pilot Feasibility Trial of a Mindfulness-Based Insomnia and Symptom Management Intervention for Patients with Hematologic Cancer. Behav Sleep Med. 2024 Sep-Oct;22(5):674-696. doi: 10.1080/15402002.2024.2339819. Epub 2024 Apr 10.

Reference Type: DERIVED

PMID: 38597262 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00107338

Identifier Type: -

Identifier Source: org_study_id