Interactive Voice Response (IVR)-Based Treatment for Chronic Low Back Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01025752
First received: December 3, 2009
Last updated: February 19, 2014
Last verified: February 2014
  Purpose

The proposed study will test how well an innovative method, interactive voice response (IVR), can be used for delivering an treatment for chronic low back pain. The use of IVR will improve the accessibility of treatment to veterans. IVR is a computerized interface that allows patients to use their telephone to: 1) obtain pre-recorded didactic information, 2) report data regarding pain-related symptoms and adherence to pain coping skill practice, and 3) receive personalized therapist feedback. Although CBT has been shown to be effective in reducing pain intensity, traditional CBT requires patients to make frequent office visits. The use of IVR will allow veterans to access CBT from their home via a touch-tone telephone, thereby allowing them to access treatment at their convenience without travel to the VA for an outpatient appointment. Veterans with chronic low back pain will be randomized in equal numbers to receive either standard CBT or IVR-based CBT. Veterans in both conditions will receive 10 session of treatment designed to help them manage their chronic pain using pain coping skills. The primary outcome measure will be pain intensity.


Condition Intervention
Chronic Low Back Pain
Behavioral: Face to face cognitive behavior therapy
Behavioral: IVR based cognitive behavioral therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: IVR-based Cognitive Behavior Therapy for Chronic Low Back

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Numeric Rating Scale of Pain Intensity [ Time Frame: post-treatment (12 weeks), 3 and 6 months post-baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Multidimensional Pain Inventory Interference subscale [ Time Frame: post-treatment (12 weeks), 3 and 6 months post-baseline ] [ Designated as safety issue: No ]
  • Roland Morris Disability Questionnaire [ Time Frame: post-treatment (12 weeks), 3 and 6 months post-baseline ] [ Designated as safety issue: No ]
  • SF36V [ Time Frame: post-treatment (12 weeks), 3 and 6 months post-baseline ] [ Designated as safety issue: No ]
  • Profile of Mood States [ Time Frame: post-treatment (12 weeks), 3 and 6 months post-baseline ] [ Designated as safety issue: No ]
  • Beck Depression Inventory [ Time Frame: post-treatment (12 weeks), 3 and 6 months post-baseline ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index [ Time Frame: post-treatment (12 weeks), 3 and 6 months post-baseline ] [ Designated as safety issue: No ]
  • Pain Stages of Change Questionnaire [ Time Frame: post-treatment (12 weeks), 3 and 6 months post-baseline ] [ Designated as safety issue: No ]
  • Pain Catastrophizing Scale [ Time Frame: post-treatment (12 weeks), 3 and 6 months post-baseline ] [ Designated as safety issue: No ]
  • Survey of Pain Attitudes [ Time Frame: post-treatment (12 weeks), 3 and 6 months post-baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 230
Study Start Date: May 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Ten session IVR-based cognitive behavior therapy for chronic low back pain
Behavioral: IVR based cognitive behavioral therapy
Ten session cognitive behavior therapy for chronic low back pain using interactive voice response therapy
Active Comparator: Arm 2
Ten session face to face cognitive behavior therapy for chronic low back pain
Behavioral: Face to face cognitive behavior therapy
Ten session face to face cognitive behavior therapy for chronic low back pain

Detailed Description:

OBJECTIVES: The primary purpose of this study is to test the efficacy of an innovative method, interactive voice response (IVR), for delivering an empirically validated psychological (cognitive behavior therapy [CBT]) treatment for chronic pain in order to improve access and sustainability of this intervention. The primary clinical equivalence hypothesis states that veterans with chronic low back pain (CLBP) receiving IVR-based CBT (ICBT) will demonstrate, relative to standard face-to-face CBT (CBT), equivalent declines in reports of pain intensity as measured by the numeric rating scale at post-treatment and follow-up. The secondary hypothesis states that veterans with CLBP receiving ICBT, relative to CBT, will demonstrate equivalent declines in reports of pain-related interference and emotional distress at post-treatment and follow-up.

RESEARCH DESIGN: A randomized design will be employed in which standard CBT (CBT) is compared to an Interactive CBT (ICBT) treatment condition. Participants will be randomized in equal numbers to both conditions. Repeated assessments of key outcome domains will occur at pretreatment/baseline and at 3 and 6 months following baseline.

METHODOLOGY: Subjects will be 230 patients receiving care at the VACHS who report chronic low back pain. The primary criteria for inclusion are constant pain of at least three months duration with at least a moderate level of average pain (i.e., scores of 4 or greater on a 0 (no pain) to 10 (worst pain imaginable) on a numerical rating scale of average pain. All patients must have access to a touch-tone telephone. Excluded will be patients with life threatening or acute physical illness, current alcohol or substance abuse or dependence, current psychosis, suicidal ideation, dementia, and individuals seeking surgical pain treatment. Comprehensive evaluations will be conducted at each assessment interval. Following completion of written consent and an initial baseline evaluation, participants will be randomized to one of the two treatments. Sessions will be audiotaped to ensure the fidelity of the face-to-face CBT sessions and the personalized therapist feedback in the IVR-based CBT condition. Both conditions will involve 10 outpatient therapy sessions with a psychologist trained experienced in the delivery of these treatments. Adherence to coping skill practice will be assessed using IVR for both treatment groups. Analysis of primary and secondary outcome measures will employ mixed-effects models, which will account for the clustering induced by repeated measures on individual patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • presence of at least a moderate level of pain (i.e., pain scores of > or = 4) and presence of pain for a period of > or = 3 months
  • ability to participate safely in the walking portion of the intervention as evidenced by ability to walk at least one block
  • availability of a touch-tone telephone and computer with internet access in the participant's residence
  • Veteran receiving care at VA Connecticut Healthcare System

Exclusion Criteria:

  • life threatening or acute medical condition that could impair participation (e.g., severe COPD, lower limb amputation, terminal cancer);
  • psychiatric condition (e.g., active substance abuse, psychosis or suicidality) that could impair participation
  • surgical interventions for pain during their participation in this study
  • sensory deficits that would impair participation (e.g., hearing loss to a degree that telephone usage is not possible).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01025752

Contacts
Contact: Rebecca A Czlapinski, BA MA (203) 932-5711 ext 3357 rebecca.czlapinski@va.gov
Contact: Joseph P Kirlin, BA (203) 932-5711 ext 3543 joseph.kirlin2@va.gov

Locations
United States, Connecticut
VA Connecticut Health Care System (West Haven) Recruiting
West Haven, Connecticut, United States, 06516
Contact: Rebecca A Czlapinski, BA MA    (203) 932-5711 ext 3357    rebecca.czlapinski@va.gov   
Contact: Alicia A Heapy, PhD    (203) 932-5711 ext 2299    alicia.heapy@va.gov   
Principal Investigator: Alicia Ann Heapy, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Alicia Ann Heapy, PhD VA Connecticut Health Care System (West Haven)
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01025752     History of Changes
Other Study ID Numbers: IIR 09-058
Study First Received: December 3, 2009
Last Updated: February 19, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
chronic pain
cognitive behavior therapy
low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014