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

Chronic Low Back Pain Clinical Trial

Official title:

IVR-based Cognitive Behavior Therapy for Chronic Low Back

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01025752
• Other study ID #: IIR 09-058
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: April 2016

Study information

• Verified date: October 2017
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Behavioral:
• Face to face cognitive behavior therapy
Ten session face to face cognitive behavior therapy for chronic low back pain
• IVR based cognitive behavioral therapy
Ten session cognitive behavior therapy for chronic low back pain using interactive voice response therapy

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 i — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Numeric Rating Scale of Pain Intensity	An 11-point NRS for pain was administered to patients, with 0 representing "No Pain" and 10 representing "Worst Possible Pain." Patients were asked to rate the level of pain that best represented their experience of worst pain, least pain and average pain over the past week. We computed the change from baseline.	post-treatment (12 weeks), 3 and 6 months post-baseline
Secondary	Change in Multidimensional Pain Inventory Interference Subscale	The interference subscale of the West Haven-Yale Multidimensional Pain Inventory (WHYMPI) assesses pain-related interference with quality of life. Scores ranging from 0-6, with higher scores indicating more interference. We computed the change from baseline.	post-treatment (12 weeks), 3 and 6 months post-baseline
Secondary	Change in Roland Morris Disability Questionnaire	The RMDQ (Roland & Morris, 1983) is a 24-item checklist designed for patients to identify the level of disability and functional status associated with chronic low back pain. Patients are instructed to endorse items that describe their functional status that day. Scores range from 0-24, with higher scores indicating more disability. We computed the change from baseline.	post-treatment (12 weeks), 3 and 6 months post-baseline
Secondary	Change in Veterans Short Form-36 Health Status Questionnaire: Physical Component Scale	The SF-36V is an adaptation of the Medical Outcomes Study SF-36 (Ware & Sherbourne, 1992) intended to apply to veteran-specific health-related quality of life. The SF-36 can also be divided into two aggregate summary measures the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The lower the score, the more disability, range 0-100. We computed the change from baseline.	post-treatment (12 weeks), 3 and 6 months post-baseline
Secondary	Change in Veterans Short Form-36 Health Status Questionnaire: Mental Component Scale	The SF-36V is an adaptation of the Medical Outcomes Study SF-36 (Ware & Sherbourne, 1992) intended to apply to veteran-specific health-related quality of life. The SF-36 can also be divided into two aggregate summary measures the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The lower the score, the more disability, range 0-100. We computed the change from baseline.	post-treatment (12 weeks), 3 and 6 months post-baseline
Secondary	Change in Beck Depression Inventory-II	Depressive symptom severity was assessed using the BDI-II, higher scores indicate more depressive symptomology, range 0-63. We computed the change from baseline.	post-treatment (12 weeks), 3 and 6 months post-baseline
Secondary	Change in Pittsburgh Sleep Quality Index	The PSQI assess sleep quality, with lower scores indicating better sleep, range 0 to 21.We computed the change from baseline.	post-treatment (12 weeks), 3 and 6 months post-baseline