Telephone Intervention for Pain Study (TIPS) - Full Text View

Sponsored by:	University of Washington
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT00663663

Purpose

Treatments focusing on providing education about chronic pain and how to change how a person thinks and behaves regarding his/her pain have been used to treat chronic pain in the general population. The purpose of this study is to see if these treatments conducted over the telephone can help reduce the negative consequences that pain often causes in terms of a person's mood, daily activities, and enjoyment of life can help reduce pain in persons with multiple sclerosis, spinal cord injury or an acquired amputation. We are also interested to find out if these treatments decrease a person's pain.

Condition	Intervention
Chronic Pain Multiple Sclerosis Amputation Spinal Cord Injuries	Behavioral: Telephone-Delivered Cognitive Behavioral Therapy (T-CBT) Behavioral: Telephone Delivered Education Control Intervention (T-Ed)

MedlinePlus related topics: Multiple Sclerosis Spinal Cord Injuries

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Telephone-Delivered Cognitive Behavioral Therapy for Chronic Pain

Further study details as provided by University of Washington:

Primary Outcome Measures:

Average pain intensity in the past week [ Time Frame: Four times in a 7-day period Pre-Treatment, Mid-Treatment, Post-Treatment, and 3,6 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 (3-, 6-, 12-months post-randomization) ] [ Designated as safety issue: No ]
Patient Health Questionnaire-9 (PHQ-9) (Kroenke et al., 2001) [ Time Frame: pre-treatment, mid-treatment, post-treatment, and follow-up (3-, 6-, 12-months post-randomization) ] [ Designated as safety issue: No ]
Global Impression of Change scale (Guy, 1976) [ Time Frame: pre-treatment, mid-treatment, post-treatment, and followup (3, 6 and 12 months post-randomization) ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	February 2009
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental T-CBT will consist of eight 60-minute sessions conducted by phone over eight weeks (1 session/week on average). The T-CBT intervention 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 T-CBT session will include a brief relaxation exercise practiced over the phone.	Behavioral: Telephone-Delivered Cognitive Behavioral Therapy (T-CBT) T-CBT will consist of eight 60-minute sessions conducted by phone over eight weeks. The T-CBT intervention 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 T-CBT session will include a brief relaxation exercise practiced over the phone.
2: Active Comparator The telephone-delivered education intervention (T-Ed) 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 Education Control Intervention (T-Ed) The T-Ed was designed to be a credible intervention comparable to the T-CBT in terms of control for the effects of natural history/time, treatment dosing, measurement processes, attention, the nonspecific effects of therapeutic alliance, and effects of having a manualized treatment with specific therapist procedures. T-Ed 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.

Arms

Assigned Interventions

1: Experimental

T-CBT will consist of eight 60-minute sessions conducted by phone over eight weeks (1 session/week on average). The T-CBT intervention 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 T-CBT session will include a brief relaxation exercise practiced over the phone.

Behavioral: Telephone-Delivered Cognitive Behavioral Therapy (T-CBT)

T-CBT will consist of eight 60-minute sessions conducted by phone over eight weeks. The T-CBT intervention 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 T-CBT session will include a brief relaxation exercise practiced over the phone.

2: Active Comparator

The telephone-delivered education intervention (T-Ed) 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 Education Control Intervention (T-Ed)

The T-Ed was designed to be a credible intervention comparable to the T-CBT in terms of control for the effects of natural history/time, treatment dosing, measurement processes, attention, the nonspecific effects of therapeutic alliance, and effects of having a manualized treatment with specific therapist procedures. T-Ed 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;
Reads and speaks 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 CBT intervention (e.g., psychotherapy, relaxation training, hypnosis, biofeedback) for pain or other psychological disorder such as a mood disorder, anxiety disorder, or substance abuse (obtained via self-report).
Previous participation in a CBT RCT for pain such as the RCT described above ( "The Role of Catastrophizing in Adjustment to Pain", HSRC# 02-2016 V06) or Dr Jensen's current hypnosis RCT, "Relaxation and Hypnotic Treatment of Disability-Related Pain", HSRC#02-2481 G/B 06 (obtained via self-report).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663663

Contacts

Contact: Amy E Kupper, B.A.	206-616-1750	akupper@u.washington.edu
Contact: Kevin J Gertz, B.A.	206-616-9058	kjgertz@u.washington.edu

Locations

United States, Washington
University of Washington
Seattle, Washington, United States, 98195

Sponsors and Collaborators

University of Washington

Investigators

Principal Investigator:

Dawn M. Ehde, Ph.D

University of Washington

More Information

No publications provided

Responsible Party:	University of Washington ( Dawn M. Ehde, Ph.D, Professor )
Study ID Numbers:	33597-G, R01 HD 57916-01
Study First Received:	April 18, 2008
Last Updated:	January 30, 2009
ClinicalTrials.gov Identifier:	NCT00663663 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Autoimmune Diseases
Demyelinating Diseases
Spinal Cord Diseases
Wounds and Injuries
Central Nervous System Diseases
Disorders of Environmental Origin
Pain

Sclerosis
Trauma, Nervous System
Spinal Cord Injuries
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

Additional relevant MeSH terms:

Autoimmune Diseases
Demyelinating Diseases
Immune System Diseases
Spinal Cord Diseases
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases

Sclerosis
Trauma, Nervous System
Spinal Cord Injuries
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System

ClinicalTrials.gov processed this record on May 07, 2009