Telephone Intervention for Pain Study (TIPS)

Multiple Sclerosis Clinical Trial

— TIPS  

Official title:

Efficacy of Telephone-Delivered Cognitive Behavioral Therapy for Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00663663
• Other study ID #: 33597-G
• Secondary ID: R01HD057916-04
• Status: Completed
• Phase: N/A
• First received: April 18, 2008
• Last updated: August 29, 2013
• Start date: September 2009
• Est. completion date: June 2013

Study information

• Verified date: August 2013
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amputation
• Chronic Pain
• Multiple Sclerosis
• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	No
Secondary	Physical Functioning-Brief Pain Inventory (Cleeland & Ryan, 1994)		pre-treatment, mid-treatment, post-treatment, and follow-up (6 and 12 months post-randomization).	No
Secondary	Patient Health Questionnaire-8 (PHQ-8) (Kroenke & Spitzer, 2002)		pre-treatment, mid-treatment, post-treatment, and follow-up (6 and 12 months post-randomization).	No
Secondary	Pain Catastrophizing Scale (Sullivan et al., 1995)		pre-treatment, mid-treatment, post-treatment, and followup (6 and 12 months post-randomization)	No