PainNCT00371267
Telephone-Delivered Cognitive Behavior Therapy for Chronic Pain
A study testing Telephone-delivered Cognitive Behavior Therapy and Telephone-delivered Patient Education in people with Pain, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to determine whether telephone-delivered cognitive behavior therapy is effective in the treatment of chronic pain. To examine the effectiveness of this approach, a two-arm randomized clinical trial was conducted with 98 individuals, 55 years of age and older, who suffered from chronic… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Telephone-delivered Cognitive Behavior Therapy and Telephone-delivered Patient Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Sep 2010
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Potential subjects must be:
- veterans enrolled in a VA primary care clinic
- at least 55 years of age
- have access to a telephone
- have documented pain for at least the past year
- a pain disorder involving muscle strain and inflammation, trauma to nerves, or central nervous system dysfunction
- Their pain condition must be stable and participants must have no clear indication for specific medical/surgical intervention.
Who cannot join
- Patients were excluded who were:
- psychotic
- cognitively impaired
- show significant suicidal risk (history of multiple suicide attempts or actively suicidal)
- currently abusing alcohol or other drugs, including prescribed opioid pain medications
- voice impairment that would prevent participation in telephone counseling
- visual impairment that would prevent use of the workbook and completion of assessment materials.
- Patients will also be excluded who have an unstable medical condition and clear indication for specific medical/surgical intervention in the near future.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Medical Center, San Francisco
San Francisco, California, 94121
About this study
The purpose of this study is to determine whether telephone-delivered cognitive behavior therapy is effective in the treatment of chronic pain. To examine the effectiveness of this approach, a two-arm randomized clinical trial was conducted with 98 individuals, 55 years of age and older, who suffered from chronic pain, recruited from a primary care clinic at the VA Medical Center in San Francisco and affiliated VA Community-based Outpatient Clinics (CBOCs) in Santa Rosa, San Bruno, Ukiah, and Eureka.
Read the detailed description
Chronic pain represents an epidemic in the United States and a serious public health problem, particularly among adults over the age of 55. In the Veterans Health Administration (VHA), nearly 50% of patients seen in primary care settings report disabling pain symptoms. Persistent pain in older adults is often associated with disability, emotional distress, and increased health care utilization and cost. Since an increase in the number of older adults is anticipated over the next two decades, the problem of chronic pain in this age group will take on increased importance.
Although cognitive behavior therapy (CBT) aimed at improving coping skills is now commonly employed within interdisciplinary pain management programs, access to these interventions is often limited due to the distance from clinical care and disabling impact of pain. In addition, the dropout rate in studies of face-to-face CBT for chronic pain further detracts from its impact in pain management. A telephone-delivered version of CBT for chronic pain overcomes these barriers to access.
To examine the effectiveness of this approach, a two-arm randomized clinical trial was conducted with 98 individuals, 55 years of age and older, who suffered from chronic pain, recruited from a primary care clinic at the VA Medical Center in San Francisco and affiliated VA Community-based Outpatient Clinics (CBOCs) in Santa Rosa, San Bruno, Ukiah, and Eureka. In Study Arm 1, patients received telephone-based cognitive behavior therapy (T-CBT); and in Study Arm 2, patients received pain education (T-ED) matched with Study Arm 1 for amount of contact time. Patients in both groups received 12 sessions of telephone-based individual therapy over a 20-week period. Pain management outcomes were measured at mid-treatment (10 weeks), post-treatment (20 weeks), and at 3-month (32 weeks) and 6-month (46 weeks) follow-up. Outcome variables included measures of pain symptoms, physical limitations, coping, emotional distress, and health-related quality of life. The study hypothesis, assessment methodology, and intervention procedures were based on the cognitive-behavioral model of chronic pain
- Conditions
- Pain
- Being tested
- Telephone-delivered Cognitive Behavior Therapy, Telephone-delivered Patient Education
- Keywords
- cognitive behavioral therapy, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-delivered Cognitive Behavior TherapyBehavioural
Telephone-delivered cognitive behavior therapy for pain management
Telephone-delivered Patient EducationOther
Also called Patient education regarding pain management
Telephone-delivered patient education regarding chronic pain
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Telephone-delivered CBT | Experimental | Telephone-delivered cognitive behavior therapy for pain management Receives: Behavioral: Telephone-delivered Cognitive Behavior Therapy |
| Arm 2: Telephone patient education | Active comparator | Telephone-delivered patient education regarding management of chronic pain Receives: Other: Telephone-delivered Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form-12 Physical Health
Level of physical functioning in daily living, health-related quality of life Range: 0-100; higher score = higher functioning Score: Sum of weighted subscale scores
Measured: 46 weeks
Short Form-12 Mental Health
Daily functioning, quality of life Range: 0-100; higher scores = higher level of functioning Score: sum of weighted subscale scores
Measured: 46 weeks
Secondary outcomes (3)
Beck Depression Inventory (BDI)-2 Total Score
Measure of symptoms of depression indicating severity of depression Total Score = sum of item scores Range: 0-63; higher scores = greater severity of depression
Measured: 46 weeks
Pain Behavior Checklist Total Score
Assessment of behavioral expression of pain Total Score = mean of item scores Range: 0-6; higher = more pain behavior
Measured: 46 weeks
Pain Intensity Rating
Measure of rated pain intensity Score = mean Range: 0-5; higher scores = more intense pain
Measured: 46 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionAug 2010
- Study completionSep 2010
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 (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Timothy Carmody, PhD, Principal investigator, VA Medical Center, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00371267
- Sponsor's protocol ID
- F4281-I
- Status last verified
- Oct 2014
- First submitted
- 31 Aug 2006
- Last updated
- 6 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Carmody TP, Duncan CL, Huggins J, Solkowitz SN, Lee SK, Reyes N, Mozgai S, Simon JA. Telephone-delivered cognitive-behavioral therapy for pain management among older military veterans: a randomized trial. Psychol Serv. 2013 Aug;10(3):265-275. doi: 10.1037/a0030944. Epub 2012 Dec 17.
PubMed 23244028
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone-Delivered Cognitive Behavior Therapy for Chronic Pain
- ClinicalTrials.gov ID
- NCT00371267
- Acronym / sponsor ID
- F4281-I
- Conditions
- Pain
- Keywords
- cognitive behavioral therapy, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2006
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 4 Sep 2006 (estimated)
- Results
- Posted 6 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether telephone-delivered cognitive behavior therapy is effective in the treatment of chronic pain. To examine the effectiveness of this approach, a two-arm randomized clinical trial was conducted with 98 individuals, 55 years of age and older, who suffered from chronic pain, recruited from a primary care clinic at the VA Medical Center in San Francisco and affiliated VA Community-based Outpatient Clinics (CBOCs) in Santa Rosa, San Bruno, Ukiah, and Eureka.
Detailed description
Chronic pain represents an epidemic in the United States and a serious public health problem, particularly among adults over the age of 55. In the Veterans Health Administration (VHA), nearly 50% of patients seen in primary care settings report disabling pain symptoms. Persistent pain in older adults is often associated with disability, emotional distress, and increased health care utilization and cost. Since an increase in the number of older adults is anticipated over the next two decades, the problem of chronic pain in this age group will take on increased importance.
Although cognitive behavior therapy (CBT) aimed at improving coping skills is now commonly employed within interdisciplinary pain management programs, access to these interventions is often limited due to the distance from clinical care and disabling impact of pain. In addition, the dropout rate in studies of face-to-face CBT for chronic pain further detracts from its impact in pain management. A telephone-delivered version of CBT for chronic pain overcomes these barriers to access.
To examine the effectiveness of this approach, a two-arm randomized clinical trial was conducted with 98 individuals, 55 years of age and older, who suffered from chronic pain, recruited from a primary care clinic at the VA Medical Center in San Francisco and affiliated VA Community-based Outpatient Clinics (CBOCs) in Santa Rosa, San Bruno, Ukiah, and Eureka. In Study Arm 1, patients received telephone-based cognitive behavior therapy (T-CBT); and in Study Arm 2, patients received pain education (T-ED) matched with Study Arm 1 for amount of contact time. Patients in both groups received 12 sessions of telephone-based individual therapy over a 20-week period. Pain management outcomes were measured at mid-treatment (10 weeks), post-treatment (20 weeks), and at 3-month (32 weeks) and 6-month (46 weeks) follow-up. Outcome variables included measures of pain symptoms, physical limitations, coping, emotional distress, and health-related quality of life. The study hypothesis, assessment methodology, and intervention procedures were based on the cognitive-behavioral model of chronic pain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Telephone-delivered CBT | Experimental | Behavioral: Telephone-delivered Cognitive Behavior TherapyTelephone-delivered cognitive behavior therapy for pain management |
| Arm 2: Telephone patient education | Active comparator | Other: Telephone-delivered Patient EducationTelephone-delivered patient education regarding management of chronic pain |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- veterans enrolled in a VA primary care clinic
- at least 55 years of age
- have access to a telephone
- have documented pain for at least the past year
- a pain disorder involving muscle strain and inflammation, trauma to nerves, or central nervous system dysfunction
Key exclusion criteria (8 listed)
- psychotic
- cognitively impaired
- show significant suicidal risk (history of multiple suicide attempts or actively suicidal)
- currently abusing alcohol or other drugs, including prescribed opioid pain medications
- voice impairment that would prevent participation in telephone counseling
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 |
|---|---|---|
| Telephone-delivered Cognitive Behavior TherapyTelephone-delivered cognitive behavior therapy for pain management | Behavioural | Arm 1: Telephone-delivered CBT |
| Telephone-delivered Patient EducationAlso: Patient education regarding pain managementTelephone-delivered patient education regarding chronic pain | Other | Arm 2: Telephone patient education |
Primary outcome
Short Form-12 Physical Health
Time frame: 46 weeks
Level of physical functioning in daily living, health-related quality of life Range: 0-100; higher score = higher functioning Score: Sum of weighted subscale scores
Short Form-12 Mental Health
Time frame: 46 weeks
Daily functioning, quality of life Range: 0-100; higher scores = higher level of functioning Score: sum of weighted subscale scores
3 secondary outcomes
Beck Depression Inventory (BDI)-2 Total Score
Time frame: 46 weeks
Pain Behavior Checklist Total Score
Time frame: 46 weeks
Pain Intensity Rating
Time frame: 46 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23244028Carmody TP, Duncan CL, Huggins J, Solkowitz SN, Lee SK, Reyes N, Mozgai S, Simon JA. Telephone-delivered cognitive-behavioral therapy for pain management among older military veterans: a randomized trial. Psychol Serv. 2013 Aug;10(3):265-275. doi: 10.1037/a0030944. Epub 2012 Dec 17.
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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.
Timothy Carmody, PhD principal investigator
VA Medical Center, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone-delivered Cognitive Behavior Therapy and Telephone-delivered Patient Education in people with Pain, run by US Department of Veterans Affairs 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 7 inclusion and 8 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 6 Nov 2014. 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 6 Nov 2014). 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?
Short Form-12 Physical Health (time frame: 46 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?
On the ClinicalTrials.gov record for NCT00371267, which also lists 1 linked publication.
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 6 Nov 2014.