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

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Blood CancersMindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying a new approach to treating insomnia for patients with hematologic cancer who frequently report significant difficulties with sleep. The new approach is called Mindfulness-Based Therapy for Insomnia (MBTI) and it is a group-based intervention that combines sleep restriction and stimulus control with mindfulness principles and exercises to reduce worry and promote positive responses to insomnia. 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,

Eligible Conditions
  • Blood Cancers

Treatment Effectiveness

Study Objectives

5 Primary · 6 Secondary · Reporting Duration: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

Week 16
Change in anxiety and depression
Change in fatigue
Change in hyperarousal
Change in insomnia symptoms
Change in mindfulness
Change in pain
Change in self-efficacy for symptom management
12 weeks (post-intervention)
Acceptability as measured by the Client Satisfaction Questionnaire (CSQ)
Feasibility as measured by adherence
Feasibility as measured by study accrual
Feasibility as measured by study attrition

Trial Safety

Trial Design

1 Treatment Group

Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping ...
1 of 1

Experimental Treatment

53 Total Participants · 1 Treatment Group

Primary Treatment: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills · No Placebo Group · N/A

Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills
Behavioral
Experimental Group · 1 Intervention: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention)

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,175 Previous Clinical Trials
3,199,999 Total Patients Enrolled
Tamara J Somers, PhDPrincipal InvestigatorDuke University
3 Previous Clinical Trials
206 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are able to communicate in English, and you have the ability to understand and complete assessments.