Mindfulness and CBT for Sleep

May 25, 2023 updated by: Duke University

Mindfulness and Cognitive Behavioral Therapy for Sleep in Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills
Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility as measured by study accrual
Time Frame: 12 weeks (post-intervention)
Treatment feasibility will be shown by meeting targeted study accrual (N = 30 for single-arm pilot).
12 weeks (post-intervention)
Feasibility as measured by study attrition
Time Frame: 12 weeks (post-intervention)
Treatment feasibility will be shown by no more than 20% study attrition.
12 weeks (post-intervention)
Feasibility as measured by adherence
Time Frame: 12 weeks (post-intervention)
Adherence will be indicated by at least 80% of study sessions completed.
12 weeks (post-intervention)
Acceptability as measured by the Client Satisfaction Questionnaire (CSQ)
Time Frame: 12 weeks (post-intervention)
Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the protocol on the CSQ.
12 weeks (post-intervention)
Change in insomnia symptoms
Time Frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Insomnia symptoms will be measured using the 7-item Insomnia Symptom Index (ISI).
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in fatigue
Time Frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Fatigue symptoms will be assessed using the 11-item Fatigue Symptom Inventory (FSI).
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Change in pain
Time Frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Pain symptoms will be measured using the 11-item Brief Pain Inventory-Short Form (BPI-SF).
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Change in anxiety and depression
Time Frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Anxiety and depressive symptoms will be measured using the 14-item Hospital Anxiety and Depression Scale (HADS).
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Change in hyperarousal
Time Frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Hyperarousal symptoms will be measured using the 16-item Pre-Sleep Arousal Scale (PSAS).
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Change in mindfulness
Time Frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Mindfulness skills will be measured using the 39-item Kentucky Inventory of Mindfulness Skills (KIMS).
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Change in self-efficacy for symptom management
Time Frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Self-efficacy for symptom management will be measured using the Self-Efficacy for Management Chronic Disease Scale.
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Investigators

  • Principal Investigator: Tamara J Somers, PhD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Actual)

May 19, 2023

Study Completion (Actual)

May 19, 2023

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 3, 2021

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00107338

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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