Self System Therapy and Chronic Low Back Pain Trial
Condition: Low Back Pain; Depression
MeSH terms: Back Pain; Low Back Pain; Depression
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Self-System Therapy; Education; Standard Care
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): 12 sessions of structured Self-System Therapy; 12 sessions of spine and muscle education including life style changes and medical treatments.; Study participants continue with their usual medical care, no changes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic low back pain accompanied by depression