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Telephone Intervention for Pain Study (TIPS) (TIPS)

Primary Purpose

Chronic Pain, Multiple Sclerosis, Amputation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone-Delivered Intervention 1
Telephone-Delivered Intervention 2
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm 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.

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.

Outcomes

Primary Outcome Measures

Average pain intensity

Secondary Outcome Measures

Physical Functioning-Brief Pain Inventory (Cleeland & Ryan, 1994)
Patient Health Questionnaire-8 (PHQ-8) (Kroenke & Spitzer, 2002)
Pain Catastrophizing Scale (Sullivan et al., 1995)

Full Information

First Posted
April 18, 2008
Last Updated
August 29, 2013
Sponsor
University of Washington
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT00663663
Brief Title
Telephone Intervention for Pain Study (TIPS)
Acronym
TIPS
Official Title
Efficacy of Telephone-Delivered Cognitive Behavioral Therapy for Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Multiple Sclerosis, Amputation, Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm 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.
Arm Title
2
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Telephone-Delivered Intervention 1
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Telephone-Delivered Intervention 2
Intervention 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.
Primary Outcome Measure Information:
Title
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).
Secondary Outcome Measure Information:
Title
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).
Title
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).
Title
Pain Catastrophizing Scale (Sullivan et al., 1995)
Time Frame
pre-treatment, mid-treatment, post-treatment, and followup (6 and 12 months post-randomization)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn M. Ehde, Ph.D
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

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Telephone Intervention for Pain Study (TIPS)

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