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Self System Therapy and Chronic Low Back Pain Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00672880
First received: May 4, 2008
Last updated: March 14, 2014
Last verified: March 2014

May 4, 2008
March 14, 2014
October 2003
April 2008   (final data collection date for primary outcome measure)
Depression levels [ Time Frame: Post and 6 mo and 12 mo follow-up evaluations ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00672880 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Self System Therapy and Chronic Low Back Pain Trial
The Use of Self-System Therapy to Alter Self-Discrepancies in Chronic Low Back Pain Patients

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Low Back Pain
  • Depression
  • 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.
  • Experimental: 1
    Psychotherapy
    Intervention: Behavioral: Self-System Therapy
  • Active Comparator: 2
    Spine Education
    Intervention: Behavioral: Education
  • Placebo Comparator: 3
    Standard Care
    Intervention: Other: Standard Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
137
December 2014
April 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00672880
Pro00006455, NINDS Grant: RO 1NSO46422
Yes
Duke University
Duke University
Not Provided
Principal Investigator: Francis Keefe, Ph.D Duke University
Duke University
March 2014

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