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NCT Number: NCT00663663

Telephone Intervention for Pain Study (TIPS)

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.

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Key information

Conditions

Chronic Pain Amputation Autoimmune Diseases Autoimmune Diseases of the Nervous System Central Nervous System Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Telephone-Delivered Intervention 1

Behavioral

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

Behavioral

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 outcomes

  1. 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 outcomes

  1. 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).

  2. 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).

  3. Pain Catastrophizing Scale (Sullivan et al., 1995)

    Time frame: pre-treatment, mid-treatment, post-treatment, and followup (6 and 12 months post-randomization)

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Efficacy of Telephone-Delivered Cognitive Behavioral Therapy for Chronic Pain

Acronym: TIPS

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Apr 22, 2008
Registry last updated
Aug 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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