Mindfulness and CBT for Sleep

Sponsor
Duke University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04736056
Collaborator
(none)
53
1
1
36
1.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
53 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single Group AssignmentSingle Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Mindfulness and Cognitive Behavioral Therapy for Sleep in Cancer
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Feasibility as measured by study accrual [12 weeks (post-intervention)]

    Treatment feasibility will be shown by meeting targeted study accrual (N = 30 for single-arm pilot).

  2. Feasibility as measured by study attrition [12 weeks (post-intervention)]

    Treatment feasibility will be shown by no more than 20% study attrition.

  3. Feasibility as measured by adherence [12 weeks (post-intervention)]

    Adherence will be indicated by at least 80% of study sessions completed.

  4. Acceptability as measured by the Client Satisfaction Questionnaire (CSQ) [12 weeks (post-intervention)]

    Acceptability will be indicated by at least 80% of the participants reporting satisfaction with the protocol on the CSQ.

  5. Change in insomnia symptoms [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).

Secondary Outcome Measures

  1. Change in fatigue [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).

  2. Change in pain [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).

  3. Change in anxiety and depression [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).

  4. Change in hyperarousal [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).

  5. Change in mindfulness [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).

  6. Change in self-efficacy for symptom management [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Duke Cancer Institute Durham North Carolina United States 27710

Sponsors and Collaborators

  • Duke University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT04736056
Other Study ID Numbers:
  • Pro00107338
First Posted:
Feb 3, 2021
Last Update Posted:
Jan 31, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 31, 2022