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

Tracking Information
First Submitted Date  ICMJE May 4, 2008
First Posted Date  ICMJE May 6, 2008
Last Update Posted Date October 9, 2018
Study Start Date  ICMJE October 2003
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2008)
Depression levels [ Time Frame: Post and 6 mo and 12 mo follow-up evaluations ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Self System Therapy and Chronic Low Back Pain Trial
Official Title  ICMJE The Use of Self-System Therapy to Alter Self-Discrepancies in Chronic Low Back Pain Patients
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Low Back Pain
  • Depression
Intervention  ICMJE
  • Behavioral: Self-System Therapy
    12 sessions of structured Self-System Therapy
  • Behavioral: Education
    12 sessions of spine and muscle education including life style changes and medical treatments.
  • Other: Standard Care
    Study participants continue with their usual medical care, no changes.
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Behavioral: Self-System Therapy
  • Active Comparator: 2
    Spine Education
    Intervention: Behavioral: Education
  • Placebo Comparator: 3
    Standard Care
    Intervention: Other: Standard Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2008)
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00672880
Other Study ID Numbers  ICMJE Pro00006455
NINDS Grant: RO 1NSO46422
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francis Keefe, Ph.D Duke University
PRS Account Duke University
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP