Telephone Intervention for Pain Study (TIPS)

NCT00663663 | Completed

• 2 other identifiers: 33597-GR01HD057916-04
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

Study Arms (2)

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.

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.

Behavioral: Telephone-Delivered Intervention 2

Interventions

Telephone-Delivered Intervention 1 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.

1

Telephone-Delivered Intervention 2 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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Washington: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Chronic Pain; Multiple Sclerosis; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Dawn M. Ehde, Ph.D

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2008
• First Posted: April 22, 2008
• Study Start: September 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 30, 2013

Record last verified: 2013-08

Locations

US (1)