Telephone Intervention for Pain Study (TIPS)

University of Washington

Status: Completed

Conditions: Multiple Sclerosis; Chronic Pain; Amputation; Spinal Cord Injury

Treatments: Behavioral: Telephone-Delivered Intervention 1; Behavioral: Telephone-Delivered Intervention 2

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00663663

33597-G

R01HD057916-04 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 207 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

207 participants in 2 patient groups

1

Experimental group

Description:

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.

Treatment:

Behavioral: Telephone-Delivered Intervention 1

2

Experimental group

Description:

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.

Treatment:

Behavioral: Telephone-Delivered Intervention 2