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Telephone Intervention for Pain Study (TIPS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Dawn Ehde, University of Washington
ClinicalTrials.gov Identifier:
NCT00663663
First received: April 18, 2008
Last updated: May 8, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention
Chronic Pain
Multiple Sclerosis
Amputation
Spinal Cord Injury
 Behavioral: Telephone-Delivered Intervention 1
Behavioral: Telephone-Delivered Intervention 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Telephone-Delivered Cognitive Behavioral Therapy for Chronic Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Average pain intensity [ Time Frame: Four times in a 7-day period Pre-Treatment, Mid-Treatment, Post-Treatment, and Follow-up (6 and 12 months post-randomization). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical Functioning-Brief Pain Inventory (Cleeland & Ryan, 1994) [ Time Frame: pre-treatment, mid-treatment, post-treatment, and follow-up (6 and 12 months post-randomization). ] [ Designated as safety issue: No ]
  • Patient Health Questionnaire-8 (PHQ-8) (Kroenke & Spitzer, 2002) [ Time Frame: pre-treatment, mid-treatment, post-treatment, and follow-up (6 and 12 months post-randomization). ] [ Designated as safety issue: No ]
  • Pain Catastrophizing Scale (Sullivan et al., 1995) [ Time Frame: pre-treatment, mid-treatment, post-treatment, and followup (6 and 12 months post-randomization) ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Definitive diagnosis of AMP, MS, or 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663663

Locations
United States, Washington
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
  More Information

No publications provided

Responsible Party: Dawn Ehde, Principal Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT00663663     History of Changes
Other Study ID Numbers: 33597-G, R01HD057916-04
Study First Received: April 18, 2008
Last Updated: May 8, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Spinal Cord Injuries
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
 Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 16, 2013