Chronic PainTIPSNCT00663663
Telephone Intervention for Pain Study (TIPS)
A study testing Telephone-Delivered Intervention 1 and Telephone-Delivered Intervention 2 in people with Chronic Pain and Multiple Sclerosis, run by University of Washington at 1 site in United States.
Trial summary
Treatments teaching people how to manage pain have been used to treat chronic pain in the general population. The purpose of this study is to see if these treatments delivered over the telephone can benefit persons with multiple sclerosis, spinal cord injury or an acquired amputation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Multiple Sclerosis, Amputation
- What is being tested?
- Telephone-Delivered Intervention 1 and Telephone-Delivered Intervention 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Definitive diagnosis of acquired amputation (AMP), multiple sclerosis (MS), or spinal cord injury (SCI) confirmed by participants' primary care physicians
- Average pain intensity in the past month of greater than 3 on 0-10 numeric rating scale;
- Pain is either worse or started since the onset of the disability;
- Pain of at least six months duration, with pain reportedly present greater than or equal to half of the days in the past six months;
- Read, write and understand English;
- Must be able to communicate over the phone (i.e., must be verbal);
- Age 18 years or older.
Who cannot join
- Cognitive impairment defined as one or more errors on the Six-Item screener (Callahan et al., 2002).
- Current or previous participation in a psychological treatment for pain (obtained via self-report).
- Current participation in a psychological treatment for any reason on a regular basis(obtained via self-report).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Telephone-Delivered Cognitive Behavioral Therapy for Chronic Pain
Treatments teaching people how to manage pain have been used to treat chronic pain in the general population. The purpose of this study is to see if these treatments delivered over the telephone can benefit persons with multiple sclerosis, spinal cord injury or an acquired amputation. Specifically, we want to determine if these treatments can help reduce the negative consequences that pain often causes in terms of a person's mood, daily activities, and enjoyment of life. We are also interested in finding out if these treatments decrease a person's pain.
- Conditions
- Chronic Pain, Multiple Sclerosis, Amputation, Spinal Cord Injury
- Being tested
- Telephone-Delivered Intervention 1, Telephone-Delivered Intervention 2
- Medical subject headings
- Chronic Pain, Multiple Sclerosis, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-Delivered Intervention 1Behavioural
Intervention 1 will consist of eight 60-minute sessions conducted by phone over eight weeks. Intervention 1 will include: (1) education about the role of cognitions (particularly catastrophizing) and pain beliefs (including control) in chronic pain and adjustment; (2) instruction in how to identify negative thinking and cognitive distortions about pain; (3) instruction in thought-stopping and cognitive-restructuring techniques, including challenging negative thoughts and core beliefs about pain; (4) instruction in utilization of positive coping self-statements; (5) relaxation techniques; (6) activity pacing and scheduling; (7) coping with pain flare-ups; and (8) relapse prevention/maintenance of gains. Each intervention 1 session will include a brief relaxation exercise practiced over the phone.
Telephone-Delivered Intervention 2Behavioural
Intervention 2 will consist of eight 60-minute sessions conducted by phone over eight weeks (1 session/week on average), scheduled at times convenient for participants (including evenings and weekends if necessary). The sessions will cover a variety of topics, including the definition of chronic pain, the physiological processes underlying chronic pain, common pain-related conditions such as sleep disturbance, and the effects of chronic pain.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intervention 1 will consist of eight 60-minute sessions conducted by phone over eight weeks (1 session/week on average). Intervention 1 will include: (1) education about the role of cognitions (particularly catastrophizing) and pain beliefs (including control) in chronic pain and adjustment; (2) instruction in how to identify negative thinking and cognitive distortions about pain; (3) instruction in thought-stopping and cognitive-restructuring techniques, including challenging negative thoughts and core beliefs about pain; (4) instruction in utilization of positive coping self-statements; (5) relaxation techniques; (6) activity pacing and scheduling; (7) coping with pain flare-ups; and (8) relapse prevention/maintenance of gains. Each intervention 1 session will include a brief relaxation exercise practiced over the phone. Receives: Behavioral: Telephone-Delivered Intervention 1 |
| 2 | Experimental | Intervention 2 will consist of eight 60-minute sessions conducted by phone over eight weeks (1 session/week on average), scheduled at times convenient for participants (including evenings and weekends if necessary). The sessions will cover a variety of topics, including the definition of chronic pain, the physiological processes underlying chronic pain, common pain-related conditions such as sleep disturbance, and the effects of chronic pain. Receives: Behavioral: Telephone-Delivered Intervention 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average pain intensity
Measured: Four times in a 7-day period Pre-Treatment, Mid-Treatment, Post-Treatment, and Follow-up (6 and 12 months post-randomization).
Secondary outcomes (3)
Physical Functioning-Brief Pain Inventory (Cleeland & Ryan, 1994)
Measured: pre-treatment, mid-treatment, post-treatment, and follow-up (6 and 12 months post-randomization).
Patient Health Questionnaire-8 (PHQ-8) (Kroenke & Spitzer, 2002)
Measured: pre-treatment, mid-treatment, post-treatment, and follow-up (6 and 12 months post-randomization).
Pain Catastrophizing Scale (Sullivan et al., 1995)
Measured: pre-treatment, mid-treatment, post-treatment, and followup (6 and 12 months post-randomization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startSep 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Dawn Ehde, University of Washington
- Investigators
- Dawn M. Ehde, Ph.D, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663663
- Sponsor's protocol ID
- 33597-G
- Other IDs
- R01HD057916-04
- Acronym
- TIPS
- Status last verified
- Aug 2013
- First submitted
- 18 Apr 2008
- Last updated
- 30 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Telephone-Delivered Cognitive Behavioral Therapy for Chronic Pain
- ClinicalTrials.gov ID
- NCT00663663
- Acronym / sponsor ID
- TIPS / 33597-G
- Conditions
- Chronic Pain, Multiple Sclerosis, Amputation, Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Sep 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatments teaching people how to manage pain have been used to treat chronic pain in the general population. The purpose of this study is to see if these treatments delivered over the telephone can benefit persons with multiple sclerosis, spinal cord injury or an acquired amputation. Specifically, we want to determine if these treatments can help reduce the negative consequences that pain often causes in terms of a person's mood, daily activities, and enjoyment of life. We are also interested in finding out if these treatments decrease a person's pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Telephone-Delivered Intervention 1Intervention 1 will consist of eight 60-minute sessions conducted by phone over eight weeks (1 session/week on average). Intervention 1 will include: (1) education about the role of cognitions (particularly catastrophizing) and pain beliefs (including control) in chronic pain and adjustment; (2) instruction in how to identify negative thinking and cognitive distortions about pain; (3) instruction in thought-stopping and cognitive-restructuring techniques, including challenging negative thoughts and core beliefs about pain; (4) instruction in utilization of positive coping self-statements; (5) relaxation techniques; (6) activity pacing and scheduling; (7) coping with pain flare-ups; and (8) relapse prevention/maintenance of gains. Each intervention 1 session will include a brief relaxation exercise practiced over the phone. |
| 2 | Experimental | Behavioral: Telephone-Delivered Intervention 2Intervention 2 will consist of eight 60-minute sessions conducted by phone over eight weeks (1 session/week on average), scheduled at times convenient for participants (including evenings and weekends if necessary). The sessions will cover a variety of topics, including the definition of chronic pain, the physiological processes underlying chronic pain, common pain-related conditions such as sleep disturbance, and the effects of chronic pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Definitive diagnosis of acquired amputation (AMP), multiple sclerosis (MS), or spinal cord injury (SCI) confirmed by participants' primary care physicians
- Average pain intensity in the past month of greater than 3 on 0-10 numeric rating scale;
- Pain is either worse or started since the onset of the disability;
- Pain of at least six months duration, with pain reportedly present greater than or equal to half of the days in the past six months;
- Read, write and understand English;
Key exclusion criteria (3 listed)
- Cognitive impairment defined as one or more errors on the Six-Item screener (Callahan et al., 2002).
- Current or previous participation in a psychological treatment for pain (obtained via self-report).
- Current participation in a psychological treatment for any reason on a regular basis(obtained via self-report).
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 Intervention 1Intervention 1 will consist of eight 60-minute sessions conducted by phone over eight weeks. Intervention 1 will include: (1) education about the role of cognitions (particularly catastrophizing) and pain beliefs (including control) in chronic pain and adjustment; (2) instruction in how to identify negative thinking and cognitive distortions about pain; (3) instruction in thought-stopping and cognitive-restructuring techniques, including challenging negative thoughts and core beliefs about pain; (4) instruction in utilization of positive coping self-statements; (5) relaxation techniques; (6) activity pacing and scheduling; (7) coping with pain flare-ups; and (8) relapse prevention/maintenance of gains. Each intervention 1 session will include a brief relaxation exercise practiced over the phone. | Behavioural | 1 |
| Telephone-Delivered Intervention 2Intervention 2 will consist of eight 60-minute sessions conducted by phone over eight weeks (1 session/week on average), scheduled at times convenient for participants (including evenings and weekends if necessary). The sessions will cover a variety of topics, including the definition of chronic pain, the physiological processes underlying chronic pain, common pain-related conditions such as sleep disturbance, and the effects of chronic pain. | Behavioural | 2 |
Primary outcome
Average pain intensity
Time frame: Four times in a 7-day period Pre-Treatment, Mid-Treatment, Post-Treatment, and Follow-up (6 and 12 months post-randomization).
3 secondary outcomes
Physical Functioning-Brief Pain Inventory (Cleeland & Ryan, 1994)
Time frame: pre-treatment, mid-treatment, post-treatment, and follow-up (6 and 12 months post-randomization).
Patient Health Questionnaire-8 (PHQ-8) (Kroenke & Spitzer, 2002)
Time frame: pre-treatment, mid-treatment, post-treatment, and follow-up (6 and 12 months post-randomization).
Pain Catastrophizing Scale (Sullivan et al., 1995)
Time frame: pre-treatment, mid-treatment, post-treatment, and followup (6 and 12 months post-randomization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2013.
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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.
Dawn M. Ehde, Ph.D principal investigator
University of Washington
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 Intervention 1 and Telephone-Delivered Intervention 2 in people with Chronic Pain and Multiple Sclerosis, run by University of Washington 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 3 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 30 Aug 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Average pain intensity (time frame: Four times in a 7-day period Pre-Treatment, Mid-Treatment, Post-Treatment, and Follow-up (6 and 12 months post-randomization).). 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 30 Aug 2013.