Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT02688569
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02688569
Study Brief:
Protocol Section:
NCT02688569