Completed

POPPsychological Treatment of Disability-Related Pain: Efficacy and Mechanisms

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What is being tested

Pain Self-Management Intervention #1

+ Pain Self-Management Intervention #2

+ Pain Self-Management Intervention #3

Behavioral
Who is being recruted

Autoimmune Diseases+23

+ Back Pain

+ Central Nervous System Diseases

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorUniversity of Washington
Last updated: October 17, 2018
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

Individuals from the study's recruitment sources with the diagnoses listed above will be contacted by research staff via telephone and invited to be screened for participation. In addition, individuals interested in participating may contact research staff upon learning about the study through a description listed on an approved website or a referral. Research staff will use a recruitment script for purposes of screening subjects and explaining the study. In addition, the initial screening process will also include conducting a cognitive screening known as the 6-item cognitive screener. Research staff will verify the diagnoses (MS, SCI, AMP, MD or LBP) of prospective subjects who have not been 'pre-verified' in one of three ways during the recruitment process: Research staff will attempt to determine whether a subject from has a University of Washington Medical Center (UWMC)/Harborview Medical Center (HMC) medical record by conducting a simple search using a secure application. If research staff are unable to locate a medical record for the prospective subject from recruitment strategy #1, or if the individual is part of recruitment strategy #4 (i.e. if individual sees description of study on clinicaltrials.gov and contacts research staff), then one of two options will be pursued: Subjects will be asked during the initial screening process if staff may review their medical records if they have received services at the UWMC/HMC since their diagnosis; Subjects will be asked during the initial screening process if staff may contact a physician of their choice to verify their diagnosis if (a) they have not received services at the UWMC/HMC since their diagnosis; (b) they refuse to give staff permission to review their UWMC/HMC medical records; or (c) staff for some reason cannot find a UWMC/HMC medical record despite the subject attesting to being a patient at one time at the UWMC/HMC and giving staff permission to review his/her records. Only individuals whose diagnosis has been verified (either via medical record review prior to/during screening or through verification via the subject's physician depending on recruitment source) will proceed with the psychological screening assessment. Once a prospective subject has been screened and deemed eligible to participate, research staff will arrange a time and date for all subjects recruited into the study to participate in a telephone psychological screening assessment with one of the study's licensed clinicians (Drs. Jensen, Ehde, Molton, or Dillworth) or senior fellow (Elena Mendoza, a clinical psychologist). The study clinician will ask potential subjects some questions to assess the presence of active suicidal ideation or paranoid thoughts using an assessment sheet. Individuals who do have these types of thoughts will not be eligible for the study. Individuals will be referred to a mental health professional if he or she needs immediate attention. Research staff will then arrange a time with the subject to attend in person what we call the initial intake session. At the beginning of the initial intake session, research staff will review a consent form with the subject and answer any questions he/she may have. The subject will complete and sign the consent form if he/she would like to participate. If the subject decides to enroll in the study, he/she will then be asked to complete a set of tasks testing memory and processing speed, participate in a relaxation and hypnotic exercise, and provide basic demographic information, as well as information about diagnosis and pain problem(s) he/she experiences. The initial intake session will last about 1.5 hours depending on the subject's answers. The subject will then participate in a brain activity assessment at the Integrated Brain Imaging Center (IBIC) at the University of Washington that will take about one hour to complete. The brain activity assessment consists of an electroencephalogram (EEG), which measures the electrical activity in the brain through electrodes placed on the scalp. There is no risk of electrical shock. Research staff will place a damp electrode net on the subject's head that contains the electrodes that will measure the subject's brain activity. EEG activity will be collected with the subject's eyes closed. The research staff member will collect the data and ask the subject to remain as still as possible during the assessment. A research staff member will ask the subject his/her pain intensity during and after the assessment. Subjects will be randomly assigned (by chance, like flipping a coin) to one of four treatment interventions. All four treatment interventions involve educating subjects about pain, discussing the impact of pain, and discussing different ways to manage it in hopes of decreasing subjects' pain and its impact on their lives. Two treatment interventions will also involve self-hypnosis. During self-hypnosis, subjects learn to enter a state of focused attention, and then change how they experience pain. All four treatment interventions are called "self-management" approaches to pain management. All of these treatments are commonly used in pain clinics and have been used to treat pain in persons with MS and SCI. We are interested in comparing the four different approaches to treating chronic pain. A research staff member will also contact each subject six times by telephone during his/her participation in the study to complete three short interviews or assessments, 3-5 minutes long, and one longer assessment, about 30-40 minutes long, in a period of one week. These assessments will be completed one week prior to treatment, about halfway through the treatment period, after the completion of treatment, and 3-, 6- and 12-months after the subject completes treatment. The three shorter assessments will include questions about pain intensity. The fourth longer assessment will include questions about such things as how the subject thinks about pain, treatments for pain the subject has received, medications or drugs the subject has used, and any depressive symptoms the subject may have experienced. We will also ask each subject to participate in a brain activity assessment following the end of treatment. The brain activity will be done the same way as described earlier and will take place at the Integrated Brain Imaging Center at the University of Washington.

NCT01800604
Principal SponsorUniversity of Washington
Last updated: October 17, 2018
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

177 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesBack PainCentral Nervous System DiseasesDemyelinating DiseasesImmune System DiseasesMuscular DiseasesMusculoskeletal DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesNeurologic ManifestationsNeuromuscular DiseasesPainSigns and SymptomsSpinal Cord DiseasesPathological Conditions, Signs and SymptomsWounds and InjuriesTrauma, Nervous SystemAutoimmune Diseases of the Nervous SystemDemyelinating Autoimmune Diseases, CNSMuscular Disorders, AtrophicGenetic Diseases, InbornMultiple SclerosisMuscular DystrophiesSpinal Cord InjuriesLow Back PainChronic Pain

Criteria

4 inclusion criteria required to participate
18 years of age or older

able to read, speak, and understand English

diagnosis of SCI, MS, AMP, MD or LBP

moderate to severe chronic pain possibly related to MS, SCI, AMP, MD, or LBP that is persistent in nature

3 exclusion criteria prevent from participating
Pre-existing medical conditions that might interfere with EEG assessments

psychiatric condition or symptoms that would interfere with participation

severe cognitive impairment defined as two or more errors on the Six-Item Screen

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Pain Self-Management Intervention #1

Group II

Experimental
Pain Self-Management Intervention #2

Group III

Experimental
Pain Self-Management Intervention #3

Group IV

Experimental
Pain Self-Management Intervention #4

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Washington, Ninth and Jefferson Building

Seattle, United StatesOpen University of Washington, Ninth and Jefferson Building in Google Maps
CompletedOne Study Center