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

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VA Office of Research and Development

Status

Completed

Conditions

Chronic Low Back Pain

Treatments

Behavioral: IVR based cognitive behavioral therapy
Behavioral: Face to face cognitive behavior therapy

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT01025752
IIR 09-058

Details and patient eligibility

About

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.

Full 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 VA Connecticut Healthcare System 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.

Enrollment

134 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 chronic obstructive pulmonary disease, 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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

134 participants in 2 patient groups

Arm 1
Experimental group
Description:
Ten session IVR-based cognitive behavior therapy intervention for chronic low back pain
Treatment:
Behavioral: IVR based cognitive behavioral therapy
Arm 2
Active Comparator group
Description:
Ten session face to face cognitive behavior therapy for chronic low back pain
Treatment:
Behavioral: Face to face cognitive behavior therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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