Clinical trial NCT00663663: Telephone Intervention for Pain Study (TIPS)
Official title: Efficacy of Telephone-Delivered Cognitive Behavioral Therapy for Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Multiple Sclerosis
Amputation
Spinal Cord Injury
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2008-04-22
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Average pain intensity
timeFrame: Four times in a 7-day period Pre-Treatment, Mid-Treatment, Post-Treatment, and Follow-up (6 and 12 months post-randomization).
Secondary outcomes:
measure: Physical Functioning-Brief Pain Inventory (Cleeland & Ryan, 1994)
timeFrame: pre-treatment, mid-treatment, post-treatment, and follow-up (6 and 12 months post-randomization).
measure: Patient Health Questionnaire-8 (PHQ-8) (Kroenke & Spitzer, 2002)
timeFrame: pre-treatment, mid-treatment, post-treatment, and follow-up (6 and 12 months post-randomization).
measure: Pain Catastrophizing Scale (Sullivan et al., 1995)
timeFrame: pre-treatment, mid-treatment, post-treatment, and followup (6 and 12 months post-randomization)
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Dawn M. Ehde, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: