View Clinical Trial (Medical Research Study)
IVR-based Cognitive Behavior Therapy for Chronic Low Back
| City: |
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West Haven |
| State: |
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Connecticut |
| Zip Code: |
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06516 |
| Conditions: |
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Chronic Low Back Pain |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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).
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| NCT ID: |
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NCT01025752 |
| Primary Contact: |
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Principal Investigator
Alicia Ann Heapy, PhD
VA Connecticut Health Care System (West Haven)
Rebecca A Czlapinski, BA MA
Phone: (203) 932-5711 ext. 3357
Email: rebecca.czlapinski@va.gov
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| Backup Contact: |
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Email: joseph.kirlin@va.gov
Joseph Kirlin, BA
Phone: (203) 932-5711 ext. 3543
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| Location Contact: |
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West Haven, Connecticut 06516
United States
Rebecca A Czlapinski, BA MA
Phone: (203) 932-5711
Email: rebecca.czlapinski@va.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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