Chronic Low Back PainNCT01025752

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

A study testing Face to face cognitive behavior therapy and IVR based cognitive behavioral therapy in people with Chronic Low Back Pain, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Low Back Pain
What is being tested?: Face to face cognitive behavior therapy and IVR based cognitive behavioral therapy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 134 participants
Where: 1 siteUnited States
Study dates: May 2011to Apr 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516

Other trials in United States

About this study

Official title: IVR-based Cognitive Behavior Therapy for Chronic Low Back

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.

Read the 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.

Conditions: Chronic Low Back Pain
Being tested: Face to face cognitive behavior therapy, IVR based cognitive behavioral therapy
Keywords: chronic pain, cognitive behavior therapy, low back pain
Medical subject headings: Chronic Pain, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01025752
Study group	Role	What they receive
Arm 1	Experimental	Ten session IVR-based cognitive behavior therapy intervention for chronic low back pain Receives: Behavioral: IVR based cognitive behavioral therapy
Arm 2	Active comparator	Ten session face to face cognitive behavior therapy for chronic low back pain Receives: Behavioral: Face to face cognitive behavior therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: post-treatment (12 weeks), 3 and 6 months post-baseline

Secondary outcomes (6)

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.
Measured: post-treatment (12 weeks), 3 and 6 months post-baseline
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.
Measured: post-treatment (12 weeks), 3 and 6 months post-baseline
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.
Measured: post-treatment (12 weeks), 3 and 6 months post-baseline
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.
Measured: post-treatment (12 weeks), 3 and 6 months post-baseline
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.
Measured: post-treatment (12 weeks), 3 and 6 months post-baseline
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.
Measured: post-treatment (12 weeks), 3 and 6 months post-baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Apr 2016

First posted4 Dec 2009 (estimated)
Study startMay 2011
Primary completionApr 2016
Study completionApr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 134 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01025752
Sponsor's protocol ID: IIR 09-058
Status last verified: Oct 2017
First submitted: 3 Dec 2009
Last updated: 3 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 26879051
MacLean RR, Buta E, Higgins DM, Driscoll MA, Edmond SN, LaChappelle KM, Ankawi B, Krein SL, Piette JD, Heapy AA. Using Daily Ratings to Examine Treatment Dose and Response in Cognitive Behavioral Therapy for Chronic Pain: A Secondary Analysis of the Co-Operative Pain Education and Self-Management Clinical Trial. Pain Med. 2023 Jul 5;24(7):846-854. doi: 10.1093/pm/pnac192.
PubMed 36484691
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.
PubMed 33386530
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.
PubMed 28384682

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: IVR-based Cognitive Behavior Therapy for Chronic Low Back
ClinicalTrials.gov ID: NCT01025752
Acronym / sponsor ID: IIR 09-058
Conditions: Chronic Low Back Pain
Keywords: chronic pain, cognitive behavior therapy, low back pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 134 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Collaborators: University of Michigan
Study start: May 2011
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 4 Dec 2009 (estimated)
Results: Posted 3 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm 1	Experimental	Behavioral: IVR based cognitive behavioral therapyTen session IVR-based cognitive behavior therapy intervention for chronic low back pain
Arm 2	Active comparator	Behavioral: Face to face cognitive behavior therapyTen session face to face cognitive behavior therapy for chronic low back pain

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Face to face cognitive behavior therapyTen session face to face cognitive behavior therapy for chronic low back pain	Behavioural	Arm 2
IVR based cognitive behavioral therapyTen session cognitive behavior therapy for chronic low back pain using interactive voice response therapy	Behavioural	Arm 1

Primary outcome

Change in Numeric Rating Scale of Pain Intensity
Time frame: post-treatment (12 weeks), 3 and 6 months post-baseline
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.

6 secondary outcomes

Change in Multidimensional Pain Inventory Interference Subscale
Time frame: post-treatment (12 weeks), 3 and 6 months post-baseline
Change in Roland Morris Disability Questionnaire
Time frame: post-treatment (12 weeks), 3 and 6 months post-baseline
Change in Veterans Short Form-36 Health Status Questionnaire: Physical Component Scale
Time frame: post-treatment (12 weeks), 3 and 6 months post-baseline
Change in Veterans Short Form-36 Health Status Questionnaire: Mental Component Scale
Time frame: post-treatment (12 weeks), 3 and 6 months post-baseline
Change in Beck Depression Inventory-II
Time frame: post-treatment (12 weeks), 3 and 6 months post-baseline
Change in Pittsburgh Sleep Quality Index
Time frame: post-treatment (12 weeks), 3 and 6 months post-baseline

Results and safety

Results posted to the registry on 3 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm 1: IVR CBT	62	54
Arm 2: F2F CBT	63	50

Primary outcome: Change in Numeric Rating Scale of Pain Intensity

Time frame: post-treatment (12 weeks), 3 and 6 months post-baseline. Least squares mean (95% Confidence Interval). Unit: units on a scale

Measure	Arm 1: IVR CBT n = 54	Arm 2: F2F CBT n = 50
post-treatment (12 weeks)	-0.77 (-1.29 to -0.26)	-0.84 (-1.39 to -0.29)
3 months post-baseline	-1.23 (-1.73 to -0.72)	-1.00 (-1.52 to -0.48)
6 months post-baseline	-0.51 (-1.06 to 0.04)	-0.44 (-1.01 to 0.14)

Arm 1: IVR CBT vs Arm 2: F2F CBT: Mean Difference (Final Values): 0.07 (95% CI -0.67 to 0.80), p = 0.007, Mixed Models Analysis
Arm 1: IVR CBT vs Arm 2: F2F CBT: Mean Difference (Final Values): -0.23 (95% CI -0.94 to 0.49), p <0.0001, Mixed Models Analysis
Arm 1: IVR CBT vs Arm 2: F2F CBT: Mean Difference (Final Values): -0.08 (95% CI -0.86 to 0.71), p = 0.004, Mixed Models Analysis

Population analysed: The number analyzed in rows differs because we analyzed the available follow-up questionnaire data for each participant (some participants did not complete the questionnaires at all time points).

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: IVR CBT	1 of 62 (1.6%)	14 of 62 (22.6%)	Not reported
Arm 2: F2F CBT	1 of 63 (1.6%)	19 of 63 (30.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 26879051Heapy 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.
Derived from this study: PubMed 36484691MacLean RR, Buta E, Higgins DM, Driscoll MA, Edmond SN, LaChappelle KM, Ankawi B, Krein SL, Piette JD, Heapy AA. Using Daily Ratings to Examine Treatment Dose and Response in Cognitive Behavioral Therapy for Chronic Pain: A Secondary Analysis of the Co-Operative Pain Education and Self-Management Clinical Trial. Pain Med. 2023 Jul 5;24(7):846-854. doi: 10.1093/pm/pnac192.
Derived from this study: PubMed 33386530Heapy 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.
Derived from this study: PubMed 28384682Heapy 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alicia A. Heapy, PhD principal investigator

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Numeric Rating Scale of Pain Intensity (time frame: post-treatment (12 weeks), 3 and 6 months post-baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01025752, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.