Self System Therapy and Chronic Low Back Pain Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Use of Self-System Therapy to Alter Self-Discrepancies in Chronic Low Back Pain Patients

Conditions
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Low Back Pain, Depression

Intervention / Treatment
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* Behavioral: Self-System Therapy
* Behavioral: Education
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Psychotherapy | Behavioral: Self-System Therapy<br>* 12 sessions of structured Self-System Therapy<br>|
| Active Comparator: 2<br>Spine Education | Behavioral: Education<br>* 12 sessions of spine and muscle education including life style changes and medical treatments.<br>|
| Placebo Comparator: 3<br>Standard Care | Other: Standard Care<br>* Study participants continue with their usual medical care, no changes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression levels |  | Post and 6 mo and 12 mo follow-up evaluations | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic low back pain accompanied by depression