Clinical trial NCT01025752: Interactive Voice Response (IVR)-Based Treatment for Chronic Low Back Pain
Official title: IVR-based Cognitive Behavior Therapy for Chronic Low Back
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: chronic pain
cognitive behavior therapy
low back pain
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of Michigan
First posted: 2009-12-04
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Eligibility 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 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).

Primary outcomes:
measure: Change in Numeric Rating Scale of Pain Intensity
timeFrame: post-treatment (12 weeks), 3 and 6 months post-baseline
Secondary outcomes:
measure: Change in Multidimensional Pain Inventory Interference Subscale
timeFrame: post-treatment (12 weeks), 3 and 6 months post-baseline
measure: Change in Roland Morris Disability Questionnaire
timeFrame: post-treatment (12 weeks), 3 and 6 months post-baseline
measure: Change in Veterans Short Form-36 Health Status Questionnaire: Physical Component Scale
timeFrame: post-treatment (12 weeks), 3 and 6 months post-baseline
measure: Change in Veterans Short Form-36 Health Status Questionnaire: Mental Component Scale
timeFrame: post-treatment (12 weeks), 3 and 6 months post-baseline
measure: Change in Beck Depression Inventory-II
timeFrame: post-treatment (12 weeks), 3 and 6 months post-baseline
measure: Change in Pittsburgh Sleep Quality Index
timeFrame: post-treatment (12 weeks), 3 and 6 months post-baseline
Other outcomes:
Locations:
city: West Haven
country: United States
facility: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System West Haven Campus, West Haven, CT
name: Alicia A. Heapy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heapy AA, Higgins DM, LaChappelle KM, Kirlin J, Goulet JL, Czlapinski RA, Buta E, Piette JD, Krein SL, Richardson CR, Kerns RD. Cooperative pain education and self-management (COPES): study design and protocol of a randomized non-inferiority trial of an interactive voice response-based self-management intervention for chronic low back pain. BMC Musculoskelet Disord. 2016 Feb 16;17:85. doi: 10.1186/s12891-016-0924-z.
citation: Heapy AA, Tankha H, Higgins DM, Driscoll M, LaChappelle KM, Goulet JL, Buta E, Piette JD, Kerns RD, Krein SL. Incorporating walking into cognitive behavioral therapy for chronic pain: safety and effectiveness of a personalized walking intervention. J Behav Med. 2021 Apr;44(2):260-269. doi: 10.1007/s10865-020-00193-8. Epub 2021 Jan 1.
citation: Heapy AA, Higgins DM, Goulet JL, LaChappelle KM, Driscoll MA, Czlapinski RA, Buta E, Piette JD, Krein SL, Kerns RD. Interactive Voice Response-Based Self-management for Chronic Back Pain: The COPES Noninferiority Randomized Trial. JAMA Intern Med. 2017 Jun 1;177(6):765-773. doi: 10.1001/jamainternmed.2017.0223.