Telephone Intervention for Pain Study (TIPS)

NCT ID: NCT00663663

Last Updated: 2013-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-06-30

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.

Conditions

Chronic Pain; Multiple Sclerosis; Amputation; Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Telephone-Delivered Intervention 1

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Telephone-Delivered Intervention 2

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Dawn Ehde

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dawn M. Ehde, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

R01HD057916-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

33597-G

Identifier Type: -

Identifier Source: org_study_id