Telehealth Outreach for Chronic Back Pain

NCT00608530 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2018-02-19

Study results available
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Summary

Two separate double double blind, randomized, parallel groups, two-arm, 8 week clinical trials with 6-moth follow-up were conducted using identical inclusion/exclusion criteria and assessment batteries. In both studies patients had chronic low back pain of non-neoplastic origin. In both studies patients were randomized to one of two conditions, either a Cognitive Behavioral-based Therapy or a control condition, a supportive (Rogerian) psychotherapy. Both the cognitive-behavioral and supportive psychotherapy conditions consisted of home-based, telephone supported treatment, with 10 hours of contact time delivered over 8 weeks. In the first study (Study 1) the behavioral and Rogerian interventions were delivered by a licensed psychologist. In the second (Study 2) the interventions were delivered by a medical primary care nurse.

Conditions

Interventions

BEHAVIORAL

Cognitive Behavioral Therapy-Psychologist-Delivered

Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms; treatment was delivered by a psychologist

BEHAVIORAL

Supportive Psychotherapy-Psychologist-Delivered

Supportive Psychotherapy was based on Rogerian Therapy techniques. Rogerian therapy encourages self-identification of goals and solutions using a supportive but not didactic approach; it was administered by a psychologist

BEHAVIORAL

Cognitive Behavioral Therapy Nurse-Delivered

Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms; treatment was delivered by a nurse

BEHAVIORAL

Supportive Psychotherapy-Nurse-Delivered

Supportive Psychotherapy was based on Rogerian Therapy techniques. Rogerian Therapy encourages self-identification of goals and solutions using a supportive but not didactic approach; it was delivered by a nurse

Sponsors & Collaborators

Principal Investigators

  • Joseph H. Atkinson, MD · VA San Diego Healthcare System, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00608530 on ClinicalTrials.gov