Clinical trial NCT01055639: Telehealth Therapy for Chronic Pain: Comparison of In-person vs. Video-administered ACT for Pain
Official title: Telehealth Therapy for Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Pain
Keywords: Chronic Pain
Acceptance and Commitment Therapy (ACT)
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2010-01-25
Enrollment: 126
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: 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 the VA San Diego Healthcare System (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 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 Computerized Patient Record System (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.

Primary outcomes:
measure: Brief Pain Inventory-interference Subscale
timeFrame: 8 weeks
Secondary outcomes:
measure: Brief Pain Inventory-severity Subscale
timeFrame: 8 weeks
measure: West Haven-Yale Multidimensional Pain Inventory - Activity Subscales
timeFrame: 8 weeks
measure: SF-12 MCS
timeFrame: 8 weeks
measure: SF-12 PCS
timeFrame: 8 weeks
measure: Patient Health Questionnaire-9
timeFrame: 8 weeks
measure: Pain Anxiety Symptom Scale - 20
timeFrame: 8 weeks
measure: PTSD Checklist
timeFrame: 8 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 8 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego
name: Julie L Wetherell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herbert MS, Afari N, Liu L, Heppner P, Rutledge T, Williams K, Eraly S, VanBuskirk K, Nguyen C, Bondi M, Atkinson JH, Golshan S, Wetherell JL. Telehealth Versus In-Person Acceptance and Commitment Therapy for Chronic Pain: A Randomized Noninferiority Trial. J Pain. 2017 Feb;18(2):200-211. doi: 10.1016/j.jpain.2016.10.014. Epub 2016 Nov 9.