Telephone Intervention for Pain Study (TIPS)
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 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. |
Behavioral: Telephone-Delivered Intervention 1
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.
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| Experimental: 2 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. |
Behavioral: Telephone-Delivered Intervention 2
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.
|
Outcome Measures
Primary Outcome Measures
- Average pain intensity [Four times in a 7-day period Pre-Treatment, Mid-Treatment, Post-Treatment, and Follow-up (6 and 12 months post-randomization).]
Secondary Outcome Measures
- Physical Functioning-Brief Pain Inventory (Cleeland & Ryan, 1994) [pre-treatment, mid-treatment, post-treatment, and follow-up (6 and 12 months post-randomization).]
- Patient Health Questionnaire-8 (PHQ-8) (Kroenke & Spitzer, 2002) [pre-treatment, mid-treatment, post-treatment, and follow-up (6 and 12 months post-randomization).]
- Pain Catastrophizing Scale (Sullivan et al., 1995) [pre-treatment, mid-treatment, post-treatment, and followup (6 and 12 months post-randomization)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Definitive diagnosis of acquired amputation (AMP), multiple sclerosis (MS), or spinal cord injury (SCI) confirmed by participants' primary care physicians
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Average pain intensity in the past month of greater than 3 on 0-10 numeric rating scale;
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Pain is either worse or started since the onset of the disability;
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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;
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Read, write and understand English;
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Must be able to communicate over the phone (i.e., must be verbal);
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Age 18 years or older.
Exclusion Criteria:
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Cognitive impairment defined as one or more errors on the Six-Item screener (Callahan et al., 2002).
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Current or previous participation in a psychological treatment for pain (obtained via self-report).
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Current participation in a psychological treatment for any reason on a regular basis(obtained via self-report).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Washington | Seattle | Washington | United States | 98104 |
Sponsors and Collaborators
- University of Washington
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
- Principal Investigator: Dawn M. Ehde, Ph.D, University of Washington
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 33597-G
- R01HD057916-04