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Mindfulness and CBT for Sleep

Primary Purpose

Hematologic Malignancy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hematologic Malignancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • an initial diagnosis of hematologic malignancy
  • within 8 weeks of discharge home after inpatient chemotherapy
  • 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

Sites / Locations

  • Duke Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 29, 2021
Last Updated
May 25, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT04736056
Brief Title
Mindfulness and CBT for Sleep
Official Title
Mindfulness and Cognitive Behavioral Therapy for Sleep in Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
May 19, 2023 (Actual)
Study Completion Date
May 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills
Intervention Description
Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
Primary Outcome Measure Information:
Title
Feasibility as measured by study accrual
Description
Treatment feasibility will be shown by meeting targeted study accrual (N = 30 for single-arm pilot).
Time Frame
12 weeks (post-intervention)
Title
Feasibility as measured by study attrition
Description
Treatment feasibility will be shown by no more than 20% study attrition.
Time Frame
12 weeks (post-intervention)
Title
Feasibility as measured by adherence
Description
Adherence will be indicated by at least 80% of study sessions completed.
Time Frame
12 weeks (post-intervention)
Title
Acceptability as measured by the Client Satisfaction Questionnaire (CSQ)
Description
Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the protocol on the CSQ.
Time Frame
12 weeks (post-intervention)
Title
Change in insomnia symptoms
Description
Insomnia symptoms will be measured using the 7-item Insomnia Symptom Index (ISI).
Time Frame
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Secondary Outcome Measure Information:
Title
Change in fatigue
Description
Fatigue symptoms will be assessed using the 11-item Fatigue Symptom Inventory (FSI).
Time Frame
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Title
Change in pain
Description
Pain symptoms will be measured using the 11-item Brief Pain Inventory-Short Form (BPI-SF).
Time Frame
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Title
Change in anxiety and depression
Description
Anxiety and depressive symptoms will be measured using the 14-item Hospital Anxiety and Depression Scale (HADS).
Time Frame
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Title
Change in hyperarousal
Description
Hyperarousal symptoms will be measured using the 16-item Pre-Sleep Arousal Scale (PSAS).
Time Frame
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Title
Change in mindfulness
Description
Mindfulness skills will be measured using the 39-item Kentucky Inventory of Mindfulness Skills (KIMS).
Time Frame
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)
Title
Change in self-efficacy for symptom management
Description
Self-efficacy for symptom management will be measured using the Self-Efficacy for Management Chronic Disease Scale.
Time Frame
0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamara J Somers, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Cancer Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Mindfulness and CBT for Sleep

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