Telehealth Therapy for Chronic Pain: Comparison of In-person vs. Video-administered ACT for Pain

NCT ID: NCT01055639

Last Updated: 2016-08-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2013-09-30

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

In-person ACT

8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.

Group Type: ACTIVE_COMPARATOR

In-Person ACT

Intervention Type: BEHAVIORAL

8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action

Telehealth ACT

8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.

Group Type: EXPERIMENTAL

Telehealth ACT

Intervention Type: BEHAVIORAL

8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action

Interventions

In-Person ACT

8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action

Intervention Type: BEHAVIORAL

Telehealth ACT

8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie L Wetherell, PhD

Role: PRINCIPAL_INVESTIGATOR

VA San Diego Healthcare System, San Diego

Locations

VA San Diego Healthcare System, San Diego

San Diego, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27838498 (View on PubMed)

Other Identifiers

091019

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

F6891-R

Identifier Type: -

Identifier Source: org_study_id