Self System Therapy and Chronic Low Back Pain Trial (Low Back Pain)
Primary Purpose
Low Back Pain, Depression
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Self-System Therapy
Education
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Chronic low back pain accompanied by depression
Eligibility Criteria
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.
Sites / Locations
- Duke University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
1
2
3
Arm Description
Psychotherapy
Spine Education
Standard Care
Outcomes
Primary Outcome Measures
Depression levels
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00672880
Brief Title
Self System Therapy and Chronic Low Back Pain Trial
Acronym
Low Back Pain
Official Title
The Use of Self-System Therapy to Alter Self-Discrepancies in Chronic Low Back Pain Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Depression
Keywords
Chronic low back pain accompanied by depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Psychotherapy
Arm Title
2
Arm Type
Active Comparator
Arm Description
Spine Education
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Standard Care
Intervention Type
Behavioral
Intervention Name(s)
Self-System Therapy
Intervention Description
12 sessions of structured Self-System Therapy
Intervention Type
Behavioral
Intervention Name(s)
Education
Intervention Description
12 sessions of spine and muscle education including life style changes and medical treatments.
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Study participants continue with their usual medical care, no changes.
Primary Outcome Measure Information:
Title
Depression levels
Time Frame
Post and 6 mo and 12 mo follow-up evaluations
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis Keefe, Ph.D
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Self System Therapy and Chronic Low Back Pain Trial
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