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PainTELENCT00608530

Telehealth Outreach for Chronic Back Pain

A study testing Cognitive Behavioral Therapy-Psychologist-Delivered, Supportive Psychotherapy-Psychologist-Delivered and Cognitive Behavioral Therapy Nurse-Delivered in people with Pain and 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

Two separate double double blind, randomized, parallel groups, two-arm, 8 week clinical trials with 6-moth follow-up were conducted using identical inclusion/exclusion criteria and assessment batteries. In both studies patients had chronic low back pain of non-neoplastic origin. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pain, Back Pain
What is being tested?
Cognitive Behavioral Therapy-Psychologist-Delivered, Supportive Psychotherapy-Psychologist-Delivered and Cognitive Behavioral Therapy Nurse-Delivered
Could I receive a placebo?
No, everyone receives an active treatment
How many people
127 participants
Where
1 siteUnited States
Study dates
Mar 2008to 31 Dec 2015
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ages 18-75 inclusive;
  • chronic musculoskeletal low back pain (pain "on a daily basis" for at least six months) as the primary pain problem;
  • not eligible for back surgery;
  • presently lives in the San Diego area and will do so six months after baseline examination;
  • English-speaking, literate, with stable residence and phone.

Who cannot join

  • Major medical illness (e.g., insulin-dependent diabetes mellitus with neuropathy or "poor control", heart disease with New York Heart Association Functional Class III or IV, or chronic obstructive pulmonary disease requiring supplemental oxygen which might confound effects of pain on function);
  • candidate for spine surgery;
  • back pain associated with pregnancy, rheumatoid arthritis, neoplastic disease, osteomyelitis, or neural arch lesions, since their treatment and prognosis differs from the usual back pain population, or spinal stenosis, since increased physical activity would be contraindicated;
  • history of Diagnostic and Statistical Manual (DSM)-IV bipolar disorder, dementia, or schizophrenia;
  • current active DSM-IV diagnosed alcohol or non-prescribed substance dependence;
  • current active DSM-IV major depressive episode or post-traumatic stress disorder since specialty mental health care would be indicated;
  • non-opioid and opioid analgesics are permitted, except we will exclude patients on a hospital-initiated opioid treatment "contract," since at this medical center "contracting" identifies patients with history of opioid diversion, multiple VA and non-VA opioid prescribers, and repeated dose escalation in the absence of evidence of disease progression.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA San Diego Healthcare System, San Diego

    San Diego, California, 92161

Other trials in United States

About this study

Two separate double double blind, randomized, parallel groups, two-arm, 8 week clinical trials with 6-moth follow-up were conducted using identical inclusion/exclusion criteria and assessment batteries. In both studies patients had chronic low back pain of non-neoplastic origin. In both studies patients were randomized to one of two conditions, either a Cognitive Behavioral-based Therapy or a control condition, a supportive (Rogerian) psychotherapy. Both the cognitive-behavioral and supportive psychotherapy conditions consisted of home-based, telephone supported treatment, with 10 hours of contact time delivered over 8 weeks. In the first study (Study 1) the behavioral and Rogerian interventions were delivered by a licensed psychologist. In the second (Study 2) the interventions were delivered by a medical primary care nurse.

Read the detailed description

Chronic low back pain (CLBP) is a major medical problem for the VA, affecting up to 15% of all veterans in primary care. Furthermore, prior surveys indicate CLBP is a leading cause of medical discharge of active duty personnel, and of medical disability costs. Given current demands on military personnel it is likely the burden of chronic pain will increase. The VA has adopted the Agency for Health Care Policy and Research Guidelines for evaluation of back pain but these guidelines do not provide specifics for true rehabilitation. It is acknowledged that most back pain patients are not surgical candidates, that medications provide only limited analgesia, and that symptom control and improved function require a comprehensive approach addressing the cognitive, affective, and behavioral aspects of chronic pain. Fortunately, structured, specific interventions to both address the multidimensional nature of pain and operationalize treatment principles in primary care settings are available. These interventions, which reflect the VA emphasis on patient-centered care, can be effective in reducing disability and pain, but are a frequently overlooked component of effective care. One reason is that most clinics lack appropriately trained psychologists. Moreover, even when specialists are available, the prevailing clinic-based service model is either too resource-intensive, or presents barriers to access.

One approach to addressing some these barriers is the use of "telehealth" outreach. Studies in diverse medical disorders and some chronic pain syndromes suggest that care can be delivered efficiently and effectively with minimal therapist contact in home-based treatment models, using telephone consultation to replace clinic visits. These approaches are fully congruent with recent VA telehealth initiatives to improve access and cost efficiency. In VA Pain Clinic settings our face-to-face, 8-week, 8-hours contact time Cognitive Behavioral Self-Management Skills Training (CBSST) program appears to be effective in reducing disability and pain, and improving mood in chronic back pain. Given the scarcity of specialized psychologists, a second approach is to train non-specialists (eg, primary care medical nurse personnel) instead of psychologists to deliver treatment, to help improve access to the intervention.

We conducted two double blind, randomized assignment, two-arm, parallel groups, six-month clinical trials. Patients with CLBP were recruited from VA San Diego primary care clinics and the community. Participants received either CBSST or Rogerian Psychotherapy in a home-based, telephone- delivered format for a total of 10 hours of therapist contact time. The methodological difference between the two studies was the discipline of the interventionist. In Study 1 the intervention was delivered by a psychologist with specific training in cognitive behavioral therapy; in Study 2 the intervention was was done by a medical primary care nurse who had been trained to deliver a version of CBSST modified to be suitable for delivery by an individual without specific expertise in cognitive behavioral therapy. The control condition was a supportive psychotherapy, again suitably modified in the case of the medical nurse interventionist. Assessments were conducted at baseline and at end of treatment, and at one, three and six months post-treatment. The primary data analytic strategy was an intent-to-treat analysis (last observation carried forward) of all participants as randomized. The primary end point was physical function (Roland \& Morris Disability) at end of 8-week treatment; secondary end points were pain intensity (Numeric Rating Scale) and patient-reported clinical global impression of change. The aim of the research was to develop more accessible and more cost-efficient back pain treatment.

Key Words: Back Pain, Cognitive-Behavioral Treatment, Clinical Trial

Conditions
Pain, Back Pain
Being tested
Cognitive Behavioral Therapy-Psychologist-Delivered, Supportive Psychotherapy-Psychologist-Delivered, Cognitive Behavioral Therapy Nurse-Delivered, Supportive Psychotherapy-Nurse-Delivered
Keywords
pain, chronic pain, chronic back pain, randomized clinical trial
Medical subject headings
Pain, Back Pain, Chronic Pain

What participants receive

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

  • Cognitive Behavioral Therapy-Psychologist-DeliveredBehavioural

    Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms; treatment was delivered by a psychologist

  • Supportive Psychotherapy-Psychologist-DeliveredBehavioural

    Supportive Psychotherapy was based on Rogerian Therapy techniques. Rogerian therapy encourages self-identification of goals and solutions using a supportive but not didactic approach; it was administered by a psychologist

  • Cognitive Behavioral Therapy Nurse-DeliveredBehavioural

    Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms; treatment was delivered by a nurse

  • Supportive Psychotherapy-Nurse-DeliveredBehavioural

    Supportive Psychotherapy was based on Rogerian Therapy techniques. Rogerian Therapy encourages self-identification of goals and solutions using a supportive but not didactic approach; it was delivered by a nurse

Study groups in NCT00608530
Study groupRoleWhat they receive
Cognitive Behavioral Therapy-Psychologist-DeliveredExperimental10 hours of Cognitive Behavioral Training delivered by a psychologist over 8 weeks by telephone and face-to-face contact
Receives: Behavioral: Cognitive Behavioral Therapy-Psychologist-Delivered
Supportive Psychotherapy-Psychologist-DeliveredActive comparator10 hours of Rogerian Psychotherapy delivered by a psychologist over 8 weeks by telephone and face-to-face contact
Receives: Behavioral: Supportive Psychotherapy-Psychologist-Delivered
Cognitive Behavioral Therapy-Nurse-DeliveredExperimental10 hours of Cognitive Behavioral Training delivered by a primary care medical nurse over 8 weeks by telephone and face-to-face contact
Receives: Behavioral: Cognitive Behavioral Therapy Nurse-Delivered
Supportive Psychotherapy-Nurse-DeliveredActive comparator10 hours of Rogerian Psychotherapy delivered by a primary care medical nurse over 8 weeks by telephone and face-to-face contact
Receives: Behavioral: Supportive Psychotherapy-Nurse-Delivered

What is being measured

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

  1. Roland and Morris Disability Questionnaire Psychologist-Delivered Treatment Study

    The Roland and Morris is a 24-item self-report measure of interference of back pain on everyday function at the present time. Each item is qualified by the phrase "because of my back pain" (e.g., "Because of my back I walk more slowly than usual . . . ; Because of my back I lie down to rest more often"). Scoring the measure involves summing the number of items endorsed (from 0 to 24). Lower scores indicate less disability.

    Measured: Baseline, End of Treatment (8 weeks)

  2. Roland and Morris Disability Questionnaire Nurse-Delivered Treatment Study

    The Roland and Morris is a 24-item self-report measure of interference of back pain on everyday function at the present time. Each item is qualified by the phrase "because of my back pain" (e.g., "Because of my back I walk more slowly than usual . . . ; Because of my back I lie down to rest more often"). Scoring the measure involves summing the number of items endorsed (from 0 to 24). Lower scores indicate less disability.

    Measured: Baseline, End of Treatment for Nurse-Delivered Treatment Study (8 weeks)

Secondary outcomes (4)
  1. Numeric Pain Rating Scale (Numerical Rating Scale, 0-10) Psychologist-Delivered Treatment Study

    The Numeric Pain Rating Scale asks the patient to rate their current intensity of pain on a scale from "0" to "1 0" where "0" indicates "no pain" and "10" indicates the "worst imaginable pain."

    Measured: Baseline, End of Treatment (8 weeks)

  2. Numeric Pain Rating Scale (Numerical Rating Scale, 0-10) Nurse-Delivered Treatment Study

    The Numeric Pain Rating Scale asks the patient to rate their current intensity of pain on a scale from "0" to "1 0" where "0" indicates "no pain" and "10" indicates the "worst imaginable pain."

    Measured: Baseline, End of Treatment of Nurse-Delivered Treatment Study (8 weeks)

  3. Patient-rated Global Clinical Impression of Percent Change in Overall Pain and Function

    Participant rating of overall improvement compared to baseline in terms of back pain impact on everyday function, self-categorized as "Better," "Worse," or "About the Same." Participants then were asked to estimate the percentage of change (i.e., 0 to 100%). Participants rating themselves as "About the Same" were coded as "0%" change. The percentage of change was calculated for each Group as a whole (Cognitive Behavioral Therapy-Psychologist Delivered compared to Supportive Care Psychologist-Delivered).

    Measured: End of Treatment (8 weeks)

  4. Percentage of Participants Rating Global Impression of Change as 'Much Improved' or 'Very Much Improved'

    Participant self-rating of overall change compared to baseline, considering overall function and pain intensity, using a 7-point scale ranging from 'Very Much Worse' to 'Very Much Improved.' We compared the proportion of participants in each Group rating themselves as either 'Much Improved' or 'Very Much Improved.'

    Measured: End of Treatment (8 weeks)

Timeline

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

  1. First posted6 Feb 2008 (estimated)
  2. Study startMar 2008
  3. Primary completion31 Dec 2015
  4. Study completion31 Dec 2015

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
127 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00608530
Sponsor's protocol ID
B4767-I
Acronym
TELE
Status last verified
Jan 2018
First submitted
22 Jan 2008
Last updated
19 Feb 2018
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy-Psychologist-Delivered, Supportive Psychotherapy-Psychologist-Delivered and Cognitive Behavioral Therapy Nurse-Delivered in people with Pain and Back Pain, run by VA Office of Research and Development at 1 site in United States.

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 5 inclusion and 7 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 19 Feb 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 19 Mar 2015). 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?

Roland and Morris Disability Questionnaire Psychologist-Delivered Treatment Study (time frame: Baseline, End of Treatment (8 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 19 Feb 2018.

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