Telephone Intervention for Pain Study (TIPS) (TIPS)

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Chronic Pain; Amputation; Spinal Cord Injury
• Intervention / Treatment: Behavioral: Telephone-Delivered Intervention 1; Behavioral: Telephone-Delivered Intervention 2

• Study Type: Interventional
• Enrollment (Actual): 207
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Dawn M. Ehde, Ph.D, University of Washington

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: April 18, 2008
• First Submitted That Met QC Criteria: April 18, 2008
• First Posted (Estimate): April 22, 2008

Study Record Updates

• Last Update Posted (Estimate): August 30, 2013
• Last Update Submitted That Met QC Criteria: August 29, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Multiple Sclerosis; Chronic Pain; Spinal Cord Injuries
• Other Study ID Numbers: 33597-G; R01HD057916-04 (U.S. NIH Grant/Contract)