- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03916276
Living in Full Even With Pain Study (LIFE)
Mechanisms of Psychosocial Treatments on Opioid Use in Chronic Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study involves participating in eight videoconference group treatment sessions and telephone interviews over the course of approximately eight to nine months. All study procedures will take place over videoconferencing computer software, online, or by telephone. There are no in-person visits for the study. Participants wear an activity monitor for about two and a half months starting two weeks before treatment begins. They will also complete brief online surveys twice a day, once in the morning and once in the evening, for about two and a half months starting two weeks before treatment begins. These surveys will be completed on a computer, tablet, or smartphone.
Extended Assessments
During the study, participants would also complete four extended assessments with a research staff member. The first interview is completed before treatment begins, the second is completed after treatment ends, the third is completed three months after treatment ends, and the fourth and final is completed six months after treatment ends. The first two extended assessments (Pre- and Post-Treatment) are completed with a research staff member verbally over the telephone. The final two extended assessments (3-month and 6-month Follow-up) may be completed either with a research staff member verbally over the telephone or independently online.
Online Surveys
About two weeks before treatment starts, participants begin doing brief (~2-5 minutes) online surveys twice a day. The online surveys can be completed on a smartphone, tablet, laptop, or desktop computer. Automated notifications in the morning and in the evening remind the participant to complete the brief survey twice a day.
Activity Monitor
Participants wear an activity monitor 24 hours a day for the 2.5-month Monitoring Period (which spans two weeks before treatment to one month after treatment). The activity monitor is worn on the non-dominant wrist, like a wristwatch.
Weekly Interviews
Beginning two weeks prior to treatment, participants will be contacted weekly by a staff member to complete a telephone survey. Participants complete 10 total surveys over the course of 10 weeks, concluding about one month after treatment ends. Each survey takes approximately 10-15 minutes.
Treatment
Participants are randomly assigned to one of the three treatment groups. Treatment consists of eight group treatment sessions completed remotely over a videoconferencing platform. There will be, on average, two sessions per week, and each session will take up to 90 minutes. Each treatment session will take place over the internet on a computer, tablet, or smartphone using the videoconference application. Each session will be led by the same study clinician, who is a trained clinical psychologist. Participants will be required to use a video camera and audio through either a microphone or phone for each group treatment session.
All three treatment interventions will involve educating participants about pain, discussing the impact of pain, and discussing different ways to manage it in hopes of decreasing pain and its impact. The three treatments are: (1) Mindfulness Meditation, (2) Cognitive Therapy, and (3) Activation Skills.
Each treatment intervention will have home practice activities to complete between sessions. Home practice activities may include, but are not limited to, creating thought records, listening to pre-recorded guided practices, and keeping track of activities and goals. Participants also receive a treatment workbook with materials to refer to and discuss during the group sessions as well as additional materials to read between sessions.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98104
- University of Washington, Ninth and Jefferson Building
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥18 years;
- Meet criteria for having a chronic pain problem (≥3 months, with pain experienced on ≥50% of days in past 6 months);
- Use of opioid medication in the past week;
- Daily average opioid analgesic medication use in the past week of ≥20 MMEs;
- Average intensity of chronic pain ≥3 on a 10-point scale for most days of the previous 3 months;
- Able to read, speak, and understand English; and
- Availability of a telephone, webcam, and microphone through computer or telephone, as well as daily internet access.
Exclusion Criteria:
- Primary pain condition is headache;
- Severe cognitive impairment;
- Current alcohol or substance dependence;
- Active malignancy (e.g., cancer not in remission), terminal illnesses, or serious medical conditions that may interfere with either study participation or with receiving potential treatment benefits (e.g., severe lupus);
- Inability to walk (defined as unable to walk at least 50 yards), which would limit the ability of participants to benefit from the activation skills intervention;
- Significant pain from a recent surgery or injury;
- Pain condition for which surgery has been recommended and is planned;
- Any planned surgery, procedure, hospitalization, treatment, or event that may conflict with or otherwise influence participation in the study;
- Currently receiving or had received other psychosocial treatments for any pain condition;
- Current or past participation in a research study with treatment components that may overlap, conflict, or affect those in the current study;
- Current or history of diagnosis of primary psychotic or major thought disorder within the past 5 years;
- Psychiatric hospitalization within the past 6 months;
- Psychiatric or behavioral conditions in which symptoms were unstable or severe within the past 6 months;
- Any psychiatric or behavioral issues as noted in the medical record or disclosed/observed during self-report screening that would indicate participant may be inappropriate in a group setting; and
- Presenting symptoms at the time of screening that would interfere with participation, specifically active suicidal or homicidal ideation with intent to harm oneself or others or active delusional or psychotic thinking.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Mindfulness Meditation (MM) Condition
Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research.
With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath.
This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events.
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Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research.
With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath.
This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events.
A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.
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Active Comparator: Activation Skills (AS) Condition
Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning.
They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding.
Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
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Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning.
They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding.
Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
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Active Comparator: Cognitive Therapy (CT) Condition
Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain.
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The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain.
This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts; recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Morphine Milligram Equivalent (MME) average daily dose
Time Frame: collected via phone up to 7 weeks before Tx 1, weekly starting two weeks before Tx 1 through four weeks after Tx 8, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Respondents will be asked to provide dosages and frequency of use of any opioid medications taken in the past seven days at the time of each telephone assessment.
An average daily MME dose taken in the past week will be computed for each assessment point.
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collected via phone up to 7 weeks before Tx 1, weekly starting two weeks before Tx 1 through four weeks after Tx 8, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Sleep Quality (Actigraphy)
Time Frame: Worn daily for 2 weeks before Session (Tx) 1, during 4-week treatment period, and during immediate 4 weeks after Tx 8
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Change in sleep quality will be measured by an actigraphy device worn by the participant measuring activity level and sleep.
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Worn daily for 2 weeks before Session (Tx) 1, during 4-week treatment period, and during immediate 4 weeks after Tx 8
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Change in Affect
Time Frame: Assessed via EMA twice daily during 2 weeks before Session (Tx) 1, 4-week tx period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Change in affect will be measured with the Positive and Negative Affect Schedule (PANAS).
When assessed via phone, responses from the positive affect items will be summed for a total positive score ranging from 5-25 while responses from the negative affect items will be separately summed for a total negative score ranging from 5-25.
When assessed with EMA, total scores will range from 1-5 for each affect schedule.
A higher positive affect sum score indicates more self-reported positive affect while a lower negative affect sum score indicates less self-reported negative affect.
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Assessed via EMA twice daily during 2 weeks before Session (Tx) 1, 4-week tx period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Change in Physical Function
Time Frame: Collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Change in extent of physical function will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form-4A.
Responses from each item will be summed to form a total t-score score based on normative data.
Higher scores indicate higher self-reported levels of physical function.
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Collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Change in Sleep Quality (PROMIS Sleep Disturbance Short Form-4A)
Time Frame: Collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Change in sleep quality will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form-4A.
Responses from each item will be summed to form a total t-score score based on normative data.
Higher scores indicate higher self-reported levels of sleep disturbance.
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Collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Change in Medication Use
Time Frame: Collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8]
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Change in medication use will be assessed by asking participants to report use of antidepressant, sedative/hypnotic, anticonvulsant, NSAID, or opioid medications within the past 7 days.
For NSAID and opioid medications, participants will be asked to report medication name, quantity per dose (e.g., 50 mg), and number of medication doses taken in the past week.
For each antidepressant, sedative/hypnotic, or anticonvulsant medication, participants will report yes or no to having taken them in the past week.
Researchers will calculate a morphine equivalent dose (MED) for opioid medications; a lower MED indicates less self-reported opioid medication use.
For all other medication types, researchers will track medication counts (if medication was used or not) at each time point.
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Collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8]
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Change in Cannabis Use
Time Frame: Collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8]
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Change in cannabis use will be assessed by 3 investigator-developed items on cannabis use.
Participants will be asked to report use of any cannabis or cannabis products in the past 7 days.
Participants will be directed to note that the term cannabis is being used to refer to marijuana, cannabis concentrates, and cannabis-infused edibles (can also refer to products with CBD).
At the Post-Treatment and Follow-up time points, participants will be asked whether they were taking any cannabis or cannabis products at the beginning of the study and for how long they had been taking those products prior to the start of the study.
Researchers will track if cannabis was used or not at each time point.
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Collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 mos after Tx 8), and at 3- and 6-mos after Tx 8]
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Change in Medication Use Attitudes
Time Frame: Collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Change in medication use attitudes will be measured with the Survey of Pain Attitudes (SOPA) Medication Beliefs sub-scale.
Responses from each item belonging to the Medication Beliefs sub-scale will be summed to form a total score ranging from 0 to 24.
A higher score indicates greater belief in the appropriateness of medications for chronic pain management.
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Collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Change in Post-Traumatic Stress Disorder (PTSD) Severity
Time Frame: Assessed via EMA twice daily during 2 weeks before Tx 1, 4-week treatment period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Change in Post-Traumatic Stress Disorder (PTSD) Severity will be measured with the PTSD CheckList - Civilian Version (PCL-C).
Responses from each of the 17 items from the PCL-C will be summed to form a total score ranging from 17 to 85.
A higher score indicates greater severity of PTSD related symptoms.
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Assessed via EMA twice daily during 2 weeks before Tx 1, 4-week treatment period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Change in Pain Interference
Time Frame: Assessed via EMA twice daily during 2 weeks before Tx 1, 4-week treatment period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Change in pain interference with different activities/aspects of life will be measured with five items from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference item bank.
Responses from each item will be summed for a total t-score score based on normative data.
Higher scores indicate more self-reported pain interference with different activities/aspects of life.
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Assessed via EMA twice daily during 2 weeks before Tx 1, 4-week treatment period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain Catastrophizing (Cognitive Content Mechanism)
Time Frame: EMA twice daily (&weekly via phone) during 2 weeks before Tx 1, 4-week treatment period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Primary Mechanism Variable Change in pain catastrophizing will be measured with items from the University of Washington (UW) Pain Appraisal Scale (PAS) item bank and the 2-item Coping Strategy Questionnaire (CSQ) Catastrophizing Scale. When assessed via phone, responses from the PAS will be summed for a total raw score from 6-30. The total raw score will then be converted to a IRT (Item Response Theory)-based T-score. Higher T scores indicate a higher level of pain catastrophizing. Similarly, the 2-item CSQ will be averaged for a mean score from 0-6. A higher mean CSQ score indicates a higher level of pain catastrophizing. The PAS is also assessed via EMA. When assessed via EMA, responses from the PAS will be summed for a total raw score from 4-20. The total raw score will then be converted to a IRT-based T-score. Higher T scores indicate a higher level of pain catastrophizing. |
EMA twice daily (&weekly via phone) during 2 weeks before Tx 1, 4-week treatment period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Change in Non-Judgment (Cognitive Process Mechanism)
Time Frame: EMA twice daily (&weekly via phone) during 2 weeks before Tx 1, 4-week treatment period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Primary Mechanism Variable Change in non-judgment will be measured with items from the Pain-Related Cognitive Process Questionnaire (PCPQ) Non-Judgmental Scale. When assessed via phone, the full 6-item scale will be used while only four items are used in the EMA. Items will be averaged for a mean score from 0-4. Higher mean PCPQ scores indicate higher frequencies of using the adaptive cognitive process of non-judgment in responding to pain. |
EMA twice daily (&weekly via phone) during 2 weeks before Tx 1, 4-week treatment period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Change in Activity Level (Actigraphy - Mechanism)
Time Frame: Worn daily for 2 weeks before Session (Tx) 1, during 4-week treatment period, and during immediate 4 weeks after Tx 8
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Primary Mechanism Variable Change in activity level will be measured by an actigraphy device worn by the participant measuring activity level and sleep. |
Worn daily for 2 weeks before Session (Tx) 1, during 4-week treatment period, and during immediate 4 weeks after Tx 8
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Change in Activity Level (Exercise Self-Report - Mechanism)
Time Frame: Assessed via EMA twice daily during 2 weeks before Tx 1, 4-week treatment period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Primary Mechanism Variable Change in time spent exercising will be measured using the Godin Leisure-Time Exercise Questionnaire, a 3-item questionnaire assessing time spent in mild, moderate, and strenuous exercise. When assessed via phone, participants will report the number of times in the past week spent in each of the three intensity levels. The number of times at each intensity level will be multiplied by MET values of 3, 5, and 9, respectively, and these values are then summed to create a total weekly exercise score. Higher total weekly exercise scores indicate higher levels of physical activity. The Godin Leisure-Time Exercise Questionnaire is also assessed via EMA. When assessed via EMA, participants are asked to report the number of minutes they spent exercising at each of the three intensity levels for that day. More time reported at each of the three exercise intensity levels indicate higher levels of physical activity. |
Assessed via EMA twice daily during 2 weeks before Tx 1, 4-week treatment period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Change in Activity Level (Hours Spent Sitting without Exercising Self-Report)
Time Frame: Assessed via EMA twice daily during 2 weeks before Tx 1, 4-week treatment period, and immediate 4 weeks after Tx 8
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Primary Mechanism Variable Change in hours spent sitting without exercising will be measured using a single self-report item. A higher number of hours spent sitting without exercising indicates a higher amount of sedentary time. |
Assessed via EMA twice daily during 2 weeks before Tx 1, 4-week treatment period, and immediate 4 weeks after Tx 8
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Change in Pain Intensity (Mechanism)
Time Frame: EMA twice daily (&weekly via phone) during 2 weeks before Tx 1, 4-week treatment period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Primary Mechanism Change in pain intensity of chronic pain will be measured using a 0-10 numerical rating scale. Participants will be asked to choose a number from 0-10 that best represents their pain intensity. Higher scores indicate higher levels of self-reported pain intensity. |
EMA twice daily (&weekly via phone) during 2 weeks before Tx 1, 4-week treatment period, and immediate 4 weeks after Tx 8; also collected via phone up to 7 weeks before Tx 1, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Change in Depression and Anxiety Severity (Mechanism)
Time Frame: collected via phone up to 7 weeks before Tx 1, weekly starting two weeks before Tx 1 through four weeks after Tx 8, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Primary Mechanism Variable Change in depression and anxiety will be measured with the respective Patient-Reported Outcomes Measurement Information System (PROMIS) Short Forms. Responses from each item will be summed to form a total t-score score based on normative data. Higher scores indicate higher self-reported levels of depression/anxiety. |
collected via phone up to 7 weeks before Tx 1, weekly starting two weeks before Tx 1 through four weeks after Tx 8, post-treatment (up to 2 months after Tx 8), and at 3- and 6-months after Tx 8
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark Jensen, Ph.D., University of Washington
- Principal Investigator: Melissa Day, Ph.D., The University of Queensland
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00006474
- R01AT008559-02S1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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