Working… Menu

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. Identifier: NCT00672880
Recruitment Status : Completed
First Posted : May 6, 2008
Last Update Posted : October 9, 2018
Information provided by (Responsible Party):
Duke University

Brief Summary:
This study is for people with chronic low back pain who may also be feeling discouraged, frustrated, or depressed. This study is testing a new therapy that is designed to specifically help these patients foster a better self-image. We hope this therapy will help them feel less discouraged and depressed and, possibly, even help reduce their stress enough that they may feel less pain.

Condition or disease Intervention/treatment Phase
Low Back Pain Depression Behavioral: Self-System Therapy Behavioral: Education Other: Standard Care Phase 4

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Self-System Therapy to Alter Self-Discrepancies in Chronic Low Back Pain Patients
Study Start Date : October 2003
Actual Primary Completion Date : April 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: 1
Behavioral: Self-System Therapy
12 sessions of structured Self-System Therapy

Active Comparator: 2
Spine Education
Behavioral: Education
12 sessions of spine and muscle education including life style changes and medical treatments.

Placebo Comparator: 3
Standard Care
Other: Standard Care
Study participants continue with their usual medical care, no changes.

Primary Outcome Measures :
  1. Depression levels [ Time Frame: Post and 6 mo and 12 mo follow-up evaluations ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male and females 18 years and older
  • Low back pain for minimum of 6 months
  • DSM-IV diagnosis of major depressive disorder or dysthymia as determined by SCID interview, or meeting 18 or higher on Beck Depression Inventory.

Exclusion Criteria:

  • Diagnosis of schizophrenia, bipolar, organic brain syndrome, substance abuse within past 5 years
  • Hallucinations, delusions, or paranoid ideation
  • Concurrent medical disorders that may cause depression or significantly affect function (epilepsy, endocrine disease, COPD, diabetes), or intellectual impairment based on clinical interview
  • Inability to speak English; AND
  • Patients with pending litigation or in the process of seeking disability benefits.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00672880

Layout table for location information
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Layout table for investigator information
Principal Investigator: Francis Keefe, Ph.D Duke University
Layout table for additonal information
Responsible Party: Duke University Identifier: NCT00672880    
Other Study ID Numbers: Pro00006455
NINDS Grant: RO 1NSO46422
First Posted: May 6, 2008    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: March 2015
Keywords provided by Duke University:
Chronic low back pain accompanied by depression
Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Behavioral Symptoms
Neurologic Manifestations