Self System Therapy and Chronic Low Back Pain Trial

NCT ID: NCT00672880

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2008-12-31

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.

Conditions

Low Back Pain; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Psychotherapy

Group Type: EXPERIMENTAL

Self-System Therapy

Intervention Type: BEHAVIORAL

12 sessions of structured Self-System Therapy

2

Spine Education

Group Type: ACTIVE_COMPARATOR

Education

Intervention Type: BEHAVIORAL

12 sessions of spine and muscle education including life style changes and medical treatments.

3

Standard Care

Group Type: PLACEBO_COMPARATOR

Standard Care

Intervention Type: OTHER

Study participants continue with their usual medical care, no changes.

Interventions

Self-System Therapy

12 sessions of structured Self-System Therapy

Intervention Type: BEHAVIORAL

Education

12 sessions of spine and muscle education including life style changes and medical treatments.

Intervention Type: BEHAVIORAL

Standard Care

Study participants continue with their usual medical care, no changes.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francis Keefe, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

NINDS Grant: RO 1NSO46422

Identifier Type: -

Identifier Source: secondary_id

Pro00006455

Identifier Type: -

Identifier Source: org_study_id