Telehealth Therapy for Chronic Pain

Chronic Pain Clinical Trial

— TTCP  

Official title:

Telehealth Therapy for Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01055639
• Other study ID #: F6891-R
• Secondary ID: 091019
• Status: Completed
• Phase: Phase 2
• First received: January 21, 2010
• Last updated: November 24, 2014
• Start date: February 2010
• Est. completion date: September 2013

Study information

• Verified date: November 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• In-Person Acceptance and Commitment Therapy
8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action
• Telehealth Acceptance and Commitment Therapy
8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief Pain Inventory		6 months	No
Secondary	West Haven-Yale Multidimensional Pain Inventory - Activity subscales		6 months	No
Secondary	West Haven-Yale Multidimensional Pain Inventory - Interference subscales		6 months	No
Secondary	SF-12		6 months	No
Secondary	Pain Anxiety Symptom Scale - 20		6 months	No
Secondary	Pittsburgh Sleep Quality Index		6 months	No
Secondary	Actigraphy		6 months	No
Secondary	Patient Health Questionnaire-9		6 months	No
Secondary	Valued Living Questionnaire		6 months	No
Secondary	Client Satisfaction Questionnaire		8 weeks	No
Secondary	Patient Global Impression of Change Scale		8 weeks	No
Secondary	National Health Interview Survey		6 months	No