Mindfulness and CBT for Sleep

October 14, 2024 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
57

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility as Measured by Number of Participants Accrued to Single-arm Pilot
Time Frame: 12 weeks (post-intervention)
Treatment feasibility will be indicated by meeting target study accrual (i.e., 30 participants consented and enrolled for single-arm pilot).
12 weeks (post-intervention)
Feasibility as Measured by Study Attrition at Post-intervention Follow-up
Time Frame: 12 weeks (post-intervention)
Treatment feasibility will be indicated by less than or equal to 20% study attrition at post-intervention follow-up.
12 weeks (post-intervention)
Feasibility as Measured by Adherence to the Intervention
Time Frame: 12 weeks (post-intervention)
Adherence will be indicated by at least 80% of the participants completing all 6 intervention sessions.
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 participants who completed the intervention protocol reporting satisfaction with the protocol on the CSQ (i.e., mean of at least 3 out of 4). The CSQ is a 10 item self-report measure with item responses ranging from 1 to 4, with higher scores indicating greater satisfaction. All 10 items were averaged to obtain a mean score (range: 1 - 4). The number of participants with a mean CSQ score of at least 3 out of 4 was tabulated and then converted to a percentage of patients.
12 weeks (post-intervention)
Insomnia Symptoms as Measured by the Insomnia Symptom Index (ISI)
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). Scores on the ISI range from 0 to 28 with higher scores indicating more severe insomnia symptoms.
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI)
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). Four items measure fatigue severity. Seven items measure fatigue interference. Scores on the FSI for fatigue severity and interference range from 0 to 10 with higher scores indicating higher fatigue severity and interference.
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Fatigue Interference as Measured by the Fatigue Symptom Inventory (FSI)
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). Four items measure fatigue severity. Seven items measure fatigue interference. Scores on the FSI for fatigue severity and interference range from 0 to 10 with higher scores indicating higher fatigue severity and interference.
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Pain Severity as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
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). Four items measure pain severity. Scores on the BPI-SF for pain severity range from 0 to 10 with higher scores indicating higher pain severity.
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Pain Interference as Measured by the Brief Pain Inventory-Short Form (BPI-SF)
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). Seven items measure pain interference. Scores on the BPI-SF for pain interference range from 0 to 10 with higher scores indicating higher pain interference.
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Severity of Anxiety Symptoms as Measured by the Hospital Anxiety and Depression Scale (HADS)
Time Frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Anxiety symptoms will be measured using the 14-item Hospital Anxiety and Depression Scale (HADS). Seven items measure severity of anxiety symptoms. Scores for anxiety symptom severity range from 0 to 21 with higher scores indicating more severe anxiety.
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Severity of Depressive Symptoms as Measured by the Hospital Anxiety and Depression Scale (HADS)
Time Frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Depressive symptoms will be measured using the 14-item Hospital Anxiety and Depression Scale (HADS). Seven items measure severity of depressive symptoms. Scores for depressive symptom severity range from 0 to 21 with higher scores indicating more severe depressive symptoms.
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Severity of Somatic Hyperarousal Symptoms
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). Eight items measure severity of somatic hyperarousal symptoms. Scores for somatic hyperarousal symptom severity range from 8 to 40 with higher scores indicating worse somatic hyperarousal severity.
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Severity of Cognitive Hyperarousal Symptoms
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). Eight items measure severity of cognitive hyperarousal symptoms. Scores for cognitive hyperarousal symptom severity range from 8 to 40 with higher scores indicating worse cognitive hyperarousal severity.
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Observing
Time Frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Mindfulness skills (i.e., observing, describing, acting with awareness, and accepting/non-judgement) will be measured using the 39-item Kentucky Inventory of Mindfulness Skills (KIMS). Observing (range: 12-60) is measured by 12 items. Higher scores indicate higher levels of observing skills.
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Describing
Time Frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Mindfulness skills (i.e., observing, describing, acting with awareness, and accepting/non-judgement) will be measured using the 39-item Kentucky Inventory of Mindfulness Skills (KIMS). Describing (range: 8-40) is measured by eight items. Higher scores indicate higher levels of describing skills.
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Acting With Awareness
Time Frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Mindfulness skills (i.e., observing, describing, acting with awareness, and accepting/non-judgement) will be measured using the 39-item Kentucky Inventory of Mindfulness Skills (KIMS). Acting with awareness (range: 10-50) is measured by ten items. Higher scores indicate higher levels of acting with awareness skills.
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Mindfulness Skills as Measured by the Kentucky Inventory of Mindfulness Skills (KIMS): Accepting/Non-judgement
Time Frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Mindfulness skills (i.e., observing, describing, acting with awareness, and accepting/non-judgement) will be measured using the 39-item Kentucky Inventory of Mindfulness Skills (KIMS). Accepting is measured by nine items (range: 9-45). Higher scores indicate higher levels of accepting skills.
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Self-efficacy for Symptom Management as Measured by the Self-Efficacy for Management Chronic Disease Scale (SEMCD)
Time Frame: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
SEMCD scores range from 0 to 10 with higher scores indicating greater self-efficacy for symptom management.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 19, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 19, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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