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Sleep and Pain Intervention for Chronic Widespread Pain Pilot Study (SPIN-CWP)

Primary Purpose

Chronic Widespread Pain, Chronic Insomnia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cognitive Behavioral Therapy for Chronic Widespread Pain

About this trial

This is an interventional treatment trial for Chronic Widespread Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18+ years old
Be willing to be randomly assigned to either the treatment condition or the control condition
Be able to read and understand English
Have Chronic Widespread Pain (CWP) and Insomnia based on the criteria below:
o CWP:
Complaints of pain in upper, lower body, on both sides and the back that lasts for 3+ months.
Not explained by other illnesses except somatic disorders.
o Insomnia:
Insomnia complaints for 6+ months
Occur despite adequate opportunity and circumstances for sleep
Consist of 1 or more of the following: difficulty falling asleep, staying asleep, waking up too early, nonrestorative sleep
Daytime dysfunction (mood, cognitive, social, occupational) due to insomnia
Baseline diaries indicate >30 minutes of sleep latency or wake after sleep onset combined on 6+ nights.

Exclusion Criteria:

Be unable to provide informed consent
Be unwilling to undergo randomization
Be unable to complete forms and implement treatment due to cognitive impairment (Mini Mental State Examination <26)
Sleep disorder other than insomnia (i.e., sleep apnea [apnea/hypopnea index, AHI >15]; Periodic Limb Movement Disorder-PLMD [myoclonus arousals per hour >15])
bipolar or seizure disorder
other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders)
severe untreated psychiatric comorbidity that renders randomization unethical,
psychotropic or other medications (e.g., beta-blockers) that alter pain or sleep
participation in any nonpharmacological treatment (including CBT) for pain, sleep, fatigue, or mood outside the current study,
internal metal objects or electrical devices
pregnancy

Sites / Locations

Department of Health Psychology, University of Missouri-Columbia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

CBT-CWP

Control

Arm Description

Participants in this condition will receive Cognitive Behavioral Therapy for Chronic Widespread Pain (CBT-CWP)

Participants in the Control condition will not receive CBT-CWP. They will however, continue completing the weekly assessments.

Outcomes

Primary Outcome Measures

Change in self-reported ratings of Pain Sensitivity and Pain Unpleasantness on Daily Diaries

Participants will rate how much pain they experience and how unpleasant the pain is on a scale of 1 to 100 on the daily dairies. Analysis will involve examining the trend of changes in these ratings.

Change in pain severity assessed by the McGill Pain Questionnaire

The McGill Pain Questionnaire will be administered three times - baseline, post-treatment, and follow-up. Analysis will involve examining the trend of change in the scores in McGill Pain Questionnaire.

Change in pain-associated disability assessed by the Pain Disability Questionnaire

The Pain Disability Questionnaire will be administered three times - baseline, post-treatment, and follow-up. Analysis will involve examining the trend of change in the scores in Pain Disability Questionnaire.

Change in Self-Reported Bedtime, Wake time, Sleep Onset Latency, Wake After Sleep Onset, Sleep Quality on the Daily Diaries

Participants will answer the following questions on the daily diaries: I napped for ____________ minutes yesterday. I napped ______ times yesterday. I napped in the ___morning ___afternoon ____evening (check all that apply) I went to bed last night at ____________ AM/PM. It took me ____________ minutes to fall asleep. I woke up ____________ times last night. I was awake for ____________ minutes in the middle of the night. My final wake up time was ____________ AM/PM. I got out of bed at ____________ AM/PM. I would rate my quality of sleep last night as ____________. 1. very poor 2. poor 3. fair. 4 good 5. Excellent

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

Actiwatch-L (ACT-L; Mini Mitter, Inc.) will be used to obtain a behavioral measure of sleep outcome. ACT-L is a wristwatch-like device that provides long-term monitoring of ambient light exposure and gross motor activity in human subjects. The Actiware-Sleep software provides behavioral estimates for several sleep variables: (1) sleep onset latency-interval between bedtime and sleep start; (2) total sleep time-sum of all sleep epochs within the sleep period; (3) sleep efficiency percentage- ratio of total sleep time to total time spent in bed × 100; and (4) total wake time-sum of all wake epochs within the sleep period.

Change in Insomnia Severity Index

The Insomnia Severity Index will be administered three times - baseline, post-treatment, and follow-up. Analysis will involve examining the trend of change in the Insomnia Severity Index.

Secondary Outcome Measures

Change in heart rate variability

Change in Body Mass Index

Change in Cognitive Functioning measured by the NIH toolbox Cognitive Domain

Day-to-day change in Cognitive Functioning measured by the Cognitive Diary

Change in daily substance use

Participants will answer these questions: Drug Used________________ Prescription Drug? Y/N If yes, used as directed? Y/N Amount taken______________ Time taken________________

Change in Thermal Pain Response

Participants will undergo quantitative sensory testing using a contact thermode applied to the volar surface of the forearm. The protocol that will assess both first pain (primarily A-delta function) and second pain (primarily C-fiber input). All thermal stimuli will be delivered using a computer-controlled Medoc Thermal Sensory Analyzer (TSA-2001, Ramat Yishai, Israel). Visual Analog Scale (VAS) ratings of 4 graded intensities (45, 47, 49, 51° C) of 5 second temperature stimuli will be obtained in the following fashion: Stimulus presentation will be timed such that no site is stimulated with less than a 3-minute interval to avoid sensitization of the site. Participants will rate 8 stimuli (2 at each intensity) using a VAS for pain intensity anchored at the right end by "the most intense pain imaginable." A second random sequence of 8 stimuli (2 at each intensity) will be rated by VAS for pain unpleasantness.

Change in food habits measured by 24-hour dietary recall

Change in waist-to-hip ratio

Change in blood pressure

Change in alcohol use frequency as measured by the Alcohol Use Questionnaire

Change in alcohol problems as measured by the Alcohol Use Disorders Identification Test

Change in grey matter volume as measured by Structural MRI

Change in cortical thickness as measured by Structural MRI

Change in functional connectivity in response to thermal pain stimuli as measured by Functional MRI

Full Information

NCT ID

NCT02688569

First Posted

January 22, 2016

Last Updated

March 14, 2023

Sponsor

University of Missouri-Columbia

1. Study Identification

Unique Protocol Identification Number

NCT02688569

Brief Title

Sleep and Pain Intervention for Chronic Widespread Pain Pilot Study

Acronym

SPIN-CWP

Official Title

Sleep and Pain Intervention for Chronic Widespread Pain Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Completed

Study Start Date

October 2016 (Actual)

Primary Completion Date

December 2022 (Actual)

Study Completion Date

December 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Missouri-Columbia

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This randomized controlled clinical trial will examine the effects of Cognitive Behavioral Therapy (CBT-) in patients with comorbid chronic widespread pain (CWP) and insomnia. Specific Aims: To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in patients with comorbid CWP and insomnia. To examine changes in the primary clinical outcomes, including chronic pain, complaints of poor sleep, and fatigue compared to the waitlist control (WLC). To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health compared WLC. To examine the mechanistic variables, including arousal (heart rate variability, HRV), CS (thermal response) and neural plasticity (brain function and structure) - compared to WLC.

Detailed Description

This randomized controlled clinical trial will examine the effects of CBT in patients with chronic widespread pain and insomnia. Sample will include 20 patients ([18]-65 years) who satisfy criteria for chronic widespread pain and insomnia. Participants will be randomly assigned to CBT or waitlist control. All participants randomized to the cognitive-behavioral interventions will receive 4 treatment sessions (~50 minutes each). Baseline, posttreatment, [& 3-mo.] follow-up assessments will include measures of sleep, pain, thermal pain response, heart rate variability, brain structure and functions, affect, cognitive functioning, cardiovascular health, and substance use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Widespread Pain, Chronic Insomnia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CBT-CWP

Arm Type

Experimental

Arm Description

Participants in this condition will receive Cognitive Behavioral Therapy for Chronic Widespread Pain (CBT-CWP)

Arm Title

Control

Arm Type

No Intervention

Arm Description

Participants in the Control condition will not receive CBT-CWP. They will however, continue completing the weekly assessments.

Intervention Type

Behavioral

Intervention Name(s)

Cognitive Behavioral Therapy for Chronic Widespread Pain

Other Intervention Name(s)

CBT-CWP

Intervention Description

CBT-CWP in this study involves 4 sessions of one-hour non-drug behavioral intervention. Session 1 involves education about pain and insomnia and the relationship between the two. Participants will also learn sleep hygiene and stimulus control skills. Session 3 involves teaching participants skills to limit non-sleep time in bed and thus increase sleep efficiency. Participants will also learn the relationship between pain and activity. Session 4 involves teaching participants cognitive restructuring and mindfulness skills to manage maladaptive thoughts related to pain and insomnia. Participants will also review the skills they learned and discuss the maintenance of treatment gains.

Primary Outcome Measure Information:

Title

Change in self-reported ratings of Pain Sensitivity and Pain Unpleasantness on Daily Diaries

Description

Participants will rate how much pain they experience and how unpleasant the pain is on a scale of 1 to 100 on the daily dairies. Analysis will involve examining the trend of changes in these ratings.

Time Frame

Participants will complete the pain ratings daily for 56 days from Baseline to Post-Treatment , and for 14 days in 3-month Follow-Up (Week 21-22)

Title

Change in pain severity assessed by the McGill Pain Questionnaire

Description

Time Frame

Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)

Title

Change in pain-associated disability assessed by the Pain Disability Questionnaire

Description

Time Frame

Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)

Title

Change in Self-Reported Bedtime, Wake time, Sleep Onset Latency, Wake After Sleep Onset, Sleep Quality on the Daily Diaries

Description

Time Frame

Participants will complete the sleep questions daily for 56 days from Baseline to Post-Treatment , and for 14 days in 3-month Follow-Up (Week 21-22)

Title

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

Description

Time Frame

Daily from the start of the study to post-treatment (week1 to week8), two-week daily reports in 3-mo follow up (week21,week22)

Title

Change in Insomnia Severity Index

Description

The Insomnia Severity Index will be administered three times - baseline, post-treatment, and follow-up. Analysis will involve examining the trend of change in the Insomnia Severity Index.

Time Frame

Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)

Secondary Outcome Measure Information:

Title

Change in heart rate variability

Time Frame

Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)

Title

Change in Body Mass Index

Time Frame

Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)

Title

Change in Cognitive Functioning measured by the NIH toolbox Cognitive Domain

Time Frame

Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)

Title

Day-to-day change in Cognitive Functioning measured by the Cognitive Diary

Time Frame

Participants will complete cognitive diary daily for 56 days from Baseline to Post-Treatment , and for 14 days in 3-month Follow-Up (Week 21-22)

Title

Change in daily substance use

Description

Participants will answer these questions: Drug Used________________ Prescription Drug? Y/N If yes, used as directed? Y/N Amount taken______________ Time taken________________

Time Frame

Participants will report daily substance use for 56 days from Baseline to Post-Treatment , and for 14 days in 3-month Follow-Up (Week 21-22)

Title

Change in Thermal Pain Response

Description

Time Frame

Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)

Title

Change in food habits measured by 24-hour dietary recall

Time Frame

Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)

Title

Change in waist-to-hip ratio

Time Frame

Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)

Title

Change in blood pressure

Time Frame

Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)

Title

Change in alcohol use frequency as measured by the Alcohol Use Questionnaire

Time Frame

Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)

Title

Change in alcohol problems as measured by the Alcohol Use Disorders Identification Test

Time Frame

Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)

Title

Change in grey matter volume as measured by Structural MRI

Time Frame

Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)

Title

Change in cortical thickness as measured by Structural MRI

Time Frame

Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)

Title

Change in functional connectivity in response to thermal pain stimuli as measured by Functional MRI

Time Frame

Pre-treatment (week1 or 2), post-treatment (week7 or 8), follow-up (week 21 or 22)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18+ years old Be willing to be randomly assigned to either the treatment condition or the control condition Be able to read and understand English Have Chronic Widespread Pain (CWP) and Insomnia based on the criteria below: o CWP: Complaints of pain in upper, lower body, on both sides and the back that lasts for 3+ months. Not explained by other illnesses except somatic disorders. o Insomnia: Insomnia complaints for 6+ months Occur despite adequate opportunity and circumstances for sleep Consist of 1 or more of the following: difficulty falling asleep, staying asleep, waking up too early, nonrestorative sleep Daytime dysfunction (mood, cognitive, social, occupational) due to insomnia Baseline diaries indicate >30 minutes of sleep latency or wake after sleep onset combined on 6+ nights. Exclusion Criteria: Be unable to provide informed consent Be unwilling to undergo randomization Be unable to complete forms and implement treatment due to cognitive impairment (Mini Mental State Examination <26) Sleep disorder other than insomnia (i.e., sleep apnea [apnea/hypopnea index, AHI >15]; Periodic Limb Movement Disorder-PLMD [myoclonus arousals per hour >15]) bipolar or seizure disorder other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders) severe untreated psychiatric comorbidity that renders randomization unethical, psychotropic or other medications (e.g., beta-blockers) that alter pain or sleep participation in any nonpharmacological treatment (including CBT) for pain, sleep, fatigue, or mood outside the current study, internal metal objects or electrical devices pregnancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christina S McCrae, Ph.D.

Organizational Affiliation

University of Missouri-Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Health Psychology, University of Missouri-Columbia

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65203

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

Citation

Atkinson, J. H., Ancoli-Israel, S., Slater, M., Garfin, S. R., & Gillin, J. C. (1988). Subjective sleep disturbance in chronic pain. Clinical Journal of Pain, 4, 225-232.

Results Reference

background

PubMed Identifier

10883557

Citation

Currie SR, Wilson KG, Pontefract AJ, deLaplante L. Cognitive-behavioral treatment of insomnia secondary to chronic pain. J Consult Clin Psychol. 2000 Jun;68(3):407-16. doi: 10.1037//0022-006x.68.3.407.

Results Reference

background

PubMed Identifier

17974868

Citation

McCrae CS, McGovern R, Lukefahr R, Stripling AM. Research Evaluating Brief Behavioral Sleep Treatments for Rural Elderly (RESTORE): a preliminary examination of effectiveness. Am J Geriatr Psychiatry. 2007 Nov;15(11):979-82. doi: 10.1097/JGP.0b013e31813547e6.

Results Reference

background

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Sleep and Pain Intervention for Chronic Widespread Pain Pilot Study

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