Telehealth Therapy for Chronic Pain (TTCP)
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 21, 2010 | ||||
| Last Updated Date | May 1, 2013 | ||||
| Start Date ICMJE | February 2010 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Brief Pain Inventory [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01055639 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE |
|
||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Telehealth Therapy for Chronic Pain | ||||
| Official Title ICMJE | Telehealth Therapy for Chronic Pain | ||||
| Brief Summary | 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. |
||||
| 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||
| Condition ICMJE | Chronic Pain | ||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 196 | ||||
| Estimated Completion Date | September 2013 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
|
||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01055639 | ||||
| Other Study ID Numbers ICMJE | F6891-R, 091019 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Department of Veterans Affairs | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | May 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||