Mindfulness and CBT for Sleep

NCT04736056 | Completed Results

• 1 other identifier: Pro00107338
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Feasibility as Measured by Number of Participants Accrued to Single-arm Pilot

  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

  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

  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)

  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)

  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 Outcomes (13)

• Fatigue Severity as Measured by the Fatigue Symptom Inventory (FSI)

  0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

• Fatigue Interference as Measured by the Fatigue Symptom Inventory (FSI)

  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)

  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)

  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)

  0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• 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.

  PMID: 38597262 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: Hannah Fisher, PhD
• Organization: Duke University

hannah.fisher@duke.edu

919-416-3471

Study Officials

• Tamara J Somers, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 3, 2021
• Study Start: April 1, 2021
• Primary Completion: May 19, 2023
• Study Completion: May 19, 2023
• Last Updated: December 2, 2024
• Results First Posted: December 2, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)