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

N/A

Waitlist Available

Led By Tamara J Somers, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

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

Screening ~ 3 weeks

Treatment ~ Varies

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 weeks, 12 weeks, 16 weeks (baseline, post-intervention, 4-weeks post-intervention) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability as measured by the Client Satisfaction Questionnaire (CSQ)

Change in insomnia symptoms

Feasibility as measured by adherence

+2 more

Secondary outcome measures

Change in anxiety and depression

Change in fatigue

Change in hyperarousal

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping SkillsExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

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

2021

N/A

~60

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Who is running the clinical trial?

Duke UniversityLead Sponsor

2,375 Previous Clinical Trials

3,426,866 Total Patients Enrolled

Tamara J Somers, PhDPrincipal InvestigatorDuke University

3 Previous Clinical Trials

206 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrolment of this clinical trial?

"Affirmative. Clinicaltrials.gov data is indicative of the fact that this medical investigation, which was first announced on April 1st 2021, is presently searching for research participants. The study requires 53 individuals to be recruited from one specific site."

Answered by AI

Are there any open opportunities to participate in this experiment?

"Confirmatively, data hosted on clinicaltrials.gov reveals that this medical research endeavour is presently recruiting participants. The trial was initially posted on April 1st 2021 and was recently revised as of January 27th 2022 with the aim to recruit 53 patients from a single site."

Answered by AI

What therapeutic goals is this trial attempting to accomplish?

"For the purpose of this 12-week trial, primary evaluation will be centered on feasibility as suggested by study attrition. Additional outcomes include modifications in anxiety and depression (HADS), mindfulness skills (KIMS) and self-efficacy for symptom management (SECDS)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mindfulness and CBT for Sleep

2021. "Mindfulness and CBT for Sleep". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04736056.