Telehealth Therapy for Chronic Pain (TTCP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01055639
First received: January 21, 2010
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

The purpose of the study is to test a brief, individual psychosocial in-person or telehealth intervention to reduce interference of pain with daily life, emotional distress, and pain intensity, and improve quality of life and physical activity levels in individuals with chronic pain.


Condition Intervention Phase
Chronic Pain
Behavioral: In-Person Acceptance and Commitment Therapy
Behavioral: Telehealth Acceptance and Commitment Therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Telehealth Therapy for Chronic Pain

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Brief Pain Inventory [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • West Haven-Yale Multidimensional Pain Inventory - Activity subscales [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • West Haven-Yale Multidimensional Pain Inventory - Interference subscales [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • SF-12 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Pain Anxiety Symptom Scale - 20 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Actigraphy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Patient Health Questionnaire-9 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Valued Living Questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Client Satisfaction Questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • National Health Interview Survey [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 131
Study Start Date: February 2010
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
8 individual in-person sessions of Acceptance and Commitment Therapy (ACT)
Behavioral: In-Person Acceptance and Commitment Therapy
8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
Experimental: Arm 2
8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT)
Behavioral: Telehealth Acceptance and Commitment Therapy
8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action

Detailed Description:

Chronic pain affects at least 15% of the veteran population and represents a high priority for the VA. In addition to primary pain conditions, chronic pain is a common secondary condition resulting from battlefield injuries, traumatic accidents, and congenital and acquired disorders. Unlike most forms of acute pain, treatment options available for patients suffering from chronic pain frequently offer only short-term or partial relief from symptoms. The focus of rehabilitative intervention thus becomes the reduction of disability and emotional distress and improvement in quality of life and activity levels.

Chronic pain rehabilitation has evolved from a primarily one dimensional, medically oriented approach to a multidisciplinary approach that incorporates a biopsychosocial formulation to pain management with physiological, cognitive, behavioral, and emotional components. This conceptualization of pain recognizes that multiple intervention modalities, including psychosocial approaches, are required when providing treatment to chronic pain patients.

A relatively new psychosocial approach to chronic pain management and rehabilitation involves acceptance of pain-related experiences. The Acceptance and Commitment Therapy (ACT) model is based on the theory that attempts to escape, avoid, or control negative experiences that cannot be changed, such as chronic pain, may paradoxically contribute to the increased experience of them. Instead of seeking to control the negative experience, ACT teaches individuals to use mindfulness strategies to enlarge the scope of experience beyond pain and to engage in behaviors that are consistent with personal values and goals when total elimination of pain or other negative experiences is not possible. Empirical support for acceptance-based approaches to chronic pain management is growing. Data from one of the first comparisons of ACT to a well-established psychosocial intervention, Cognitive-Behavioral Therapy (CBT), performed at VASDHS by the PI, suggests that ACT may be superior to CBT as an adjunctive treatment for chronic pain.

The proposed study assembles a multidisciplinary team with extensive experience in chronic pain interventions research to evaluate the benefits of a brief, individual psychosocial in-person or telehealth intervention which could be easily integrated into multidisciplinary pain rehabilitation programs throughout the VA system to reduce disability in veterans with chronic pain secondary to other conditions. Specifically, we propose to examine the effects of a promising new chronic pain intervention based on ACT principles on the primary outcome of pain interference and secondary outcomes of emotional distress, quality of life, physical activity, pain intensity, and treatment satisfaction among 196 veterans with chronic benign pain as a secondary condition. The participants are randomized to between-subjects design where in-person ACT intervention will be compared with telehealth ACT intervention. Outcomes include an objective measure of physical activity, actigraphy, as well as self-reported measures and will be evaluated at baseline, 4 weeks, 8 weeks (end of treatment), 3-month follow-up and at a 6-month follow-up period to investigate maintenance of gains. Telehealth sessions are conducted using secure video-conferencing equipment at the most convenient clinic for the participant. Thus, the proposed project has the potential to enhance the current VA standard of care as well as to add to the scientific literature on psychological models and rehabilitation of chronic pain.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic non-terminal pain condition;
  • Pain severity and interference rated > 4/10; and
  • Pain most days (> 3/week) for at least 6 months.

Exclusion Criteria:

  • Current participation in group psychotherapy for pain or any type of individual psychotherapy;
  • Previous treatment with ACT;
  • Active suicide ideation or history of suicide attempt within 5 years;
  • Serious or unstable medical or psychiatric illness or psychosocial instability that could compromise study participation; and
  • The following DSM-IV diagnoses or active problems within the past 6 months noted in the patient's CPRS medical record or diagnosed during a structured psychiatric interview:

    • schizophrenia;
    • other psychotic disorder;
    • bipolar disorder;
    • organic mental disorder;
    • borderline or antisocial personality disorder; or
    • alcohol or substance abuse or dependence.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055639

Locations
United States, California
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
Sponsors and Collaborators
Investigators
Principal Investigator: Julie Wetherell, PhD VA San Diego Healthcare System, San Diego
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01055639     History of Changes
Other Study ID Numbers: F6891-R, 091019
Study First Received: January 21, 2010
Last Updated: October 10, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Chronic Pain
Acceptance and Commitment Therapy (ACT)

ClinicalTrials.gov processed this record on July 22, 2014