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Cognitive Behavioral Treatment-Insomnia for Insomnia (SPIN-II Trial)

N/A

Recruiting

Led By Christina McCrae, PhD

Research Sponsored by University of Missouri-Columbia

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 baseline to follow-up (approximately 60 weeks)

Awards & highlights

SPIN-II Trial Summary

This trial will compare the effects of two cognitive behavioral sleep treatments in women with fibromyalgia and insomnia. The results will provide information about the roles of sleep, arousal, and brain structure and function in chronic pain development and maintenance in women with fibromyalgia.

Who is the study for?

This trial is for women over 18 with fibromyalgia and insomnia who can read English. They shouldn't be taking pain or sleep medications for at least a month, have no major psychological issues besides depression or anxiety, no cognitive impairments, other sleep disorders, or be pregnant.Check my eligibility

What is being tested?

The SPIN II study compares two types of cognitive behavioral treatments focused on improving sleep in women with fibromyalgia. It aims to understand how better sleep might affect chronic pain by looking at brain function and arousal levels.See study design

What are the potential side effects?

Since the interventions are non-pharmacological focusing on behavior therapy and education, significant side effects are not expected. However, participants may experience changes in mood or stress due to alterations in their sleeping patterns.

SPIN-II Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to follow-up (approximately 60 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to follow-up (approximately 60 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to follow-up (approximately 60 weeks) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Bedtime, Wake time, Sleep Onset Latency, and Wake After Sleep Onset measured by Actigraphy

Change in Dysfunctional Beliefs and Attitudes about Sleep (DBAS)

Change in Insomnia Severity Index (ISI)

+7 more

Secondary outcome measures

Activities of Daily Living (ADL) - Katz ADL Scale

Biomarkers - Neurodegeneration and Inflammation

Anxiety

+13 more

SPIN-II Trial Design

2Treatment groups

Experimental Treatment

Group I: Sleep Hygiene EducationExperimental Treatment1 Intervention

Sleep Hygiene Education. 8 Session treatment focusing on sleep hygiene education.

Group II: Cognitive Behavioral Treatment-InsomniaExperimental Treatment1 Intervention

Cognitive Behavioral Treatment-Insomnia. 8 Session treatment focusing on behavior and cognitions related to sleep and pain.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sleep Hygiene Education

2005

Completed Phase 3

~1480

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor

362 Previous Clinical Trials

627,984 Total Patients Enrolled

9 Trials studying Insomnia

904 Patients Enrolled for Insomnia

University of FloridaOTHER

1,341 Previous Clinical Trials

715,557 Total Patients Enrolled

4 Trials studying Insomnia

200 Patients Enrolled for Insomnia

National Institute of Nursing Research (NINR)NIH

580 Previous Clinical Trials

10,376,431 Total Patients Enrolled

7 Trials studying Insomnia

366 Patients Enrolled for Insomnia

Frequently Asked Questions

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

Are there any open enrolment spots in this experiment?

"This medical experiment is actively recruiting volunteers, as indicated by the clinicaltrials.gov portal. The trial was first posted on February 7th 2019 and has been revised to reflect new information most recently on October 28th 2022."

Answered by AI

What is the maximum cohort size for this clinical investigation?

"Affirmative. Records on clinicaltrials.gov declare that this research project, which was originally published on February 7th 2019, is currently accepting patients. 130 subjects must be enrolled across a single site."

Answered by AI

What are the crucial aims of this investigation?

"The primary endpoints of this 60-week trial are changes in bedtime, wake time, sleep onset latency and wake after sleep onset as recorded by actigraphy. Secondary outcomes include hair extraction for biomarker analysis (cortisol, estradiol and testosterone) alongside global cognition scores from the Mini Mental Status Exam (MMSE) and McGill Pain Questionnaire measurements to assess pain severity."

Answered by AI