Chronic PainNCT01236196
Telephone Cognitive Behavior Therapy for OEF Veterans With Pain
A study testing Telephone cognitive behavior therapy and Telephone pain education in people with Chronic Pain, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
We conducted a randomized clinical trial comparing telephone-delivered cognitive behavior therapy and pain education control. We enrolled 41 OEF/OIF/OND veterans with chronic pain and randomizing them into one of two treatment conditions. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Telephone cognitive behavior therapy and Telephone pain education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Sep 2013
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- To be eligible to participate in this study, potential subjects must have:
- access to a telephone
- documented pain for at least the past year
- a pain disorder involving muscle strain and inflammation, trauma to nerves, or central nervous system dysfunction
- pain condition must be stable
- must have no clear indication for specific medical/surgical intervention.
Who cannot join
- Patients were excluded who were:
- acutely psychotic
- cognitively impaired
- showed significant suicidal risk (history of multiple suicide attempts or actively suicidal)
- currently abusing alcohol or other drugs, including prescribed opioid pain medications
- patients were also excluded who had 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
We conducted a randomized clinical trial comparing telephone-delivered cognitive behavior therapy and pain education control. We enrolled 41 OEF/OIF/OND veterans with chronic pain and randomizing them into one of two treatment conditions. The study sample was recruited from primary care clinics at the San Francisco VA Medical Center and affiliated VA community-based outpatient clinics (CBOCs) in downtown San Francisco, Clearlake, Eureka, San Bruno, Santa Rosa, and Ukiah. Recruitment targeted OEF/OIF/OND veterans with pain disorders that involved muscle strain and inflammation, trauma to nerves, and/or central nervous system dysfunction. Both interventions were delivered by telephone and consisted of 12 sessions scheduled over a 20-week period. Pain management outcomes were measured at 10 weeks (mid-treatment), 20 weeks (post-treatment), 32 weeks (3-month follow-up), and 46 weeks (6-month follow-up). The sample size was chosen to provide greater than 80% power at a two-tailed alpha of 0.05. The study hypothesis, assessment methodology, and intervention procedures were based on the cognitive-behavioral model of chronic pain.
Read the detailed description
In the VHA, over 50% of OEF/OIF/OND veterans who are seen in primary care settings report disabling pain symptoms. Although cognitive behavior therapy (CBT) 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.
Primary Aim: to investigate the effectiveness of telephone CBT in the management of chronic pain with OEF/OIF/OND veterans enrolled in VA primary care clinics.
Secondary Aim: to determine moderator and mediating factors by which telephone CBT facilitates pain management and successful adjustment of OEF/OIF/OND veterans to chronic pain.
Major hypothesis:
Hypothesis 1: Patients who receive telephone CBT will show significantly greater improvements in coping skills, reduced emotional distress, and increased quality of life compared with those who participate in telephone pain education (EDU).
Hypothesis 2: The dropout rate for both of the telephone interventions in this study will be significantly lower than the attrition rate found in previous studies of face-to-face CBT for chronic pain.
Secondary hypothesis:
Hypothesis 3: An increase in use of coping skills will be positively associated with treatment outcome measures reflecting improved adjustment to chronic pain.
Hypothesis 4: A decrease in catastrophizing will be positively associated with treatment outcome measures reflecting improved adjustment to chronic pain.
To accomplish these aims, we conducted a randomized clinical trial comparing telephone-delivered cognitive behavior therapy and pain education control. A total of 42 OEF/OIF/OND veterans with chronic pain were enrolled in the study and randomized into one of two treatment conditions. The study sample was recruited from primary care clinics at the San Francisco VA Medical Center and affiliated VA community-based outpatient clinics (CBOCs) in downtown San Francisco, Eureka, San Bruno, Santa Rosa, and Ukiah. Recruitment targeted OEF/OIF/OND veterans with pain disorders that involved muscle strain and inflammation, trauma to nerves, and/or central nervous system dysfunction. Both interventions were delivered by telephone and consisted of 12 sessions scheduled over a 20-week period. Pain management outcomes were measured at 10 weeks (mid-treatment), 20 weeks (post-treatment), 32 weeks (3-month follow-up), and 46 weeks (6-month follow-up). The sample size was chosen to provide greater than 80% power at a two-tailed alpha of 0.05. The study hypothesis, assessment methodology, and intervention procedures were based on the cognitive-behavioral model of chronic pain.
- Conditions
- Chronic Pain
- Being tested
- Telephone cognitive behavior therapy, Telephone pain education
- Keywords
- pain, chronic pain, cognitive therapy, telehealth
- Medical subject headings
- Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone cognitive behavior therapyBehavioural
Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period).
Telephone pain educationBehavioural
Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Telephone CBT | Experimental | telephone cognitive behavior therapy for pain management Receives: Behavioral: Telephone cognitive behavior therapy |
| Arm 2 - telephone education | Active comparator | telephone pain education Receives: Behavioral: Telephone pain education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Functioning
Physical health (quality of life), reported on the SF-12, range 0-100, higher scores reflect better quality of life and higher level of functioning
Measured: Baseline, 46 weeks
Depressive Symptoms
Depressive symptoms, measured on Beck Depression Inventory-II (total score with range from 0 to 63)
Measured: Baseline, 46 weeks
Pain Behavior
Pain behavior measured as total score on Pain Behavior Checklist (range 0-6), higher score indicating more pain behavior
Measured: Baseline, 46 weeks
Pain Intensity
Pain Intensity Rating, ranging from 0-6, higher score indicates greater pain intensity
Measured: Baseline, 46 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionSep 2013
- Study completionSep 2013
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.
- Other trials for Chronic 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
- 41 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
- NCT01236196
- Sponsor's protocol ID
- D7658-I
- Status last verified
- Dec 2014
- First submitted
- 1 Nov 2010
- Last updated
- 23 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Cognitive Behavior Therapy for OEF Veterans With Pain
- ClinicalTrials.gov ID
- NCT01236196
- Acronym / sponsor ID
- D7658-I
- Conditions
- Chronic Pain
- Keywords
- pain, chronic pain, cognitive therapy, telehealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 8 Nov 2010 (estimated)
- Results
- Posted 23 Dec 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We conducted a randomized clinical trial comparing telephone-delivered cognitive behavior therapy and pain education control. We enrolled 41 OEF/OIF/OND veterans with chronic pain and randomizing them into one of two treatment conditions. The study sample was recruited from primary care clinics at the San Francisco VA Medical Center and affiliated VA community-based outpatient clinics (CBOCs) in downtown San Francisco, Clearlake, Eureka, San Bruno, Santa Rosa, and Ukiah. Recruitment targeted OEF/OIF/OND veterans with pain disorders that involved muscle strain and inflammation, trauma to nerves, and/or central nervous system dysfunction. Both interventions were delivered by telephone and consisted of 12 sessions scheduled over a 20-week period. Pain management outcomes were measured at 10 weeks (mid-treatment), 20 weeks (post-treatment), 32 weeks (3-month follow-up), and 46 weeks (6-month follow-up). The sample size was chosen to provide greater than 80% power at a two-tailed alpha of 0.05. The study hypothesis, assessment methodology, and intervention procedures were based on the cognitive-behavioral model of chronic pain.
Detailed description
In the VHA, over 50% of OEF/OIF/OND veterans who are seen in primary care settings report disabling pain symptoms. Although cognitive behavior therapy (CBT) 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.
Primary Aim: to investigate the effectiveness of telephone CBT in the management of chronic pain with OEF/OIF/OND veterans enrolled in VA primary care clinics.
Secondary Aim: to determine moderator and mediating factors by which telephone CBT facilitates pain management and successful adjustment of OEF/OIF/OND veterans to chronic pain.
Major hypothesis:
Hypothesis 1: Patients who receive telephone CBT will show significantly greater improvements in coping skills, reduced emotional distress, and increased quality of life compared with those who participate in telephone pain education (EDU).
Hypothesis 2: The dropout rate for both of the telephone interventions in this study will be significantly lower than the attrition rate found in previous studies of face-to-face CBT for chronic pain.
Secondary hypothesis:
Hypothesis 3: An increase in use of coping skills will be positively associated with treatment outcome measures reflecting improved adjustment to chronic pain.
Hypothesis 4: A decrease in catastrophizing will be positively associated with treatment outcome measures reflecting improved adjustment to chronic pain.
To accomplish these aims, we conducted a randomized clinical trial comparing telephone-delivered cognitive behavior therapy and pain education control. A total of 42 OEF/OIF/OND veterans with chronic pain were enrolled in the study and randomized into one of two treatment conditions. The study sample was recruited from primary care clinics at the San Francisco VA Medical Center and affiliated VA community-based outpatient clinics (CBOCs) in downtown San Francisco, Eureka, San Bruno, Santa Rosa, and Ukiah. Recruitment targeted OEF/OIF/OND veterans with pain disorders that involved muscle strain and inflammation, trauma to nerves, and/or central nervous system dysfunction. Both interventions were delivered by telephone and consisted of 12 sessions scheduled over a 20-week period. Pain management outcomes were measured at 10 weeks (mid-treatment), 20 weeks (post-treatment), 32 weeks (3-month follow-up), and 46 weeks (6-month follow-up). The sample size was chosen to provide greater than 80% power at a two-tailed alpha of 0.05. 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 CBT | Experimental | Behavioral: Telephone cognitive behavior therapytelephone cognitive behavior therapy for pain management |
| Arm 2 - telephone education | Active comparator | Behavioral: Telephone pain educationtelephone pain education |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- access to a telephone
- documented pain for at least the past year
- a pain disorder involving muscle strain and inflammation, trauma to nerves, or central nervous system dysfunction
- pain condition must be stable
- must have no clear indication for specific medical/surgical intervention.
Key exclusion criteria (6 listed)
- acutely psychotic
- cognitively impaired
- showed significant suicidal risk (history of multiple suicide attempts or actively suicidal)
- currently abusing alcohol or other drugs, including prescribed opioid pain medications
- patients were also excluded who had an unstable medical condition and clear indication for specific medical/surgical intervention in the near future.
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 cognitive behavior therapyCognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period). | Behavioural | Arm 1 - Telephone CBT |
| Telephone pain educationParticipants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period). | Behavioural | Arm 2 - telephone education |
Primary outcome
Level of Functioning
Time frame: Baseline, 46 weeks
Physical health (quality of life), reported on the SF-12, range 0-100, higher scores reflect better quality of life and higher level of functioning
Depressive Symptoms
Time frame: Baseline, 46 weeks
Depressive symptoms, measured on Beck Depression Inventory-II (total score with range from 0 to 63)
Pain Behavior
Time frame: Baseline, 46 weeks
Pain behavior measured as total score on Pain Behavior Checklist (range 0-6), higher score indicating more pain behavior
Pain Intensity
Time frame: Baseline, 46 weeks
Pain Intensity Rating, ranging from 0-6, higher score indicates greater pain intensity
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 cognitive behavior therapy and Telephone pain education in people with Chronic 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 6 inclusion and 6 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 23 Dec 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 23 Dec 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?
Level of Functioning (time frame: Baseline, 46 weeks). The study lists 4 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 23 Dec 2014.