Self System Therapy and Chronic Low Back Pain Trial (Low Back Pain)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00672880|
Recruitment Status : Completed
First Posted : May 6, 2008
Last Update Posted : March 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain Depression||Behavioral: Self-System Therapy Behavioral: Education Other: Standard Care||Phase 4|
Patients with chronic low back pain cope with numerous life challenges, including the ability to work and decrements in physical and emotional well being. These changes impact the patients' abilities to pursue and achieve not only important personal and professional goals, but also make it difficult to maintain one's general standards of quality of daily life with personal tasks.
This study aims to address the feelings and attitudes associated with these shortfalls which frequently result in depression.
Eligible participants have been undergoing treatment for low back pain and have been identified as depressed. Study participants are randomized into one of three arms:
Self System Therapy-Patients receive 12 sessions (90 Min) one-on-one with a specialized treatment regimen designed to help patients foster a better self-image and re-evaluate their life's goals in light of their new physical limitations. Modifications in goal unavailability, goal activation, and goal accomplishments are key components in this therapy delivered by a therapist.
Low Back Pain Education-Patients receive 12 sessions (90 min) of detailed information about chronic low back pain, its causes and varied treatments, delivered by a research nurse.
Standard Care-Patients receive their routine medical care and serve as a treatment control group. They receive the same follow up evaluations as the other two groups.
Measures- Before each of the 4 evaluations, 30 day diaries are completed which measure daily pain coping, daily life events, daily mood and unpleasantness, and daily goal setting and accomplishments.
Patients are evaluated at 4 times, before treatment, after treatment, and at a 6 month and 12 month intervals. An interview version of the Selves Questionnaire is used to measure self-discrepancies. Pain behaviors are assessed by means of structured observation involving videotaping. Other outcome measures include questionnaires for depression, psychosocial disability, physical disability, and cognitive, affective, motivational, and physiological areas of depressive symptomology.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||137 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Use of Self-System Therapy to Alter Self-Discrepancies in Chronic Low Back Pain Patients|
|Study Start Date :||October 2003|
|Primary Completion Date :||April 2008|
|Study Completion Date :||December 2008|
Behavioral: Self-System Therapy
12 sessions of structured Self-System Therapy
Active Comparator: 2
12 sessions of spine and muscle education including life style changes and medical treatments.
Placebo Comparator: 3
Other: Standard Care
Study participants continue with their usual medical care, no changes.
- Depression levels [ Time Frame: Post and 6 mo and 12 mo follow-up evaluations ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00672880
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Francis Keefe, Ph.D||Duke University|