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

NCT01055639 | Completed Phase 2 Results DMC

• 2 other identifiers: F6891-R091019
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Chronic Pain; Acceptance and Commitment Therapy (ACT)

Outcome Measures

Primary Outcomes (1)

• Brief Pain Inventory-interference Subscale

  The primary outcome measure for the proposed study is the Brief Pain Inventory Short Form Interference subscale (BPI; Cleeland \& Ryan, 1994). This 7-item scale, recommended by the IMMPACT group as a measure of functioning (Dworkin et al., 2005), measures the degree to which pain interferes with various aspects of life, including mobility, social activities, and mood. Scores range from 0 (least interference due to pain) to 10 (most interference due to pain).

  8 weeks

Secondary Outcomes (8)

• Brief Pain Inventory-severity Subscale

  8 weeks

• West Haven-Yale Multidimensional Pain Inventory - Activity Subscales

  8 weeks

• SF-12 MCS

  8 weeks

• SF-12 PCS

  8 weeks

• Patient Health Questionnaire-9

  8 weeks

Study Arms (2)

In-person ACT

ACTIVE COMPARATOR

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

Behavioral: In-Person ACT

Telehealth ACT

EXPERIMENTAL

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.

Behavioral: Telehealth ACT

Interventions

In-Person ACT BEHAVIORAL

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

In-person ACT

Telehealth ACT BEHAVIORAL

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

Telehealth ACT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego

San Diego, California, 92161, United States

Location

Related Publications (1)

• 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.

  PMID: 27838498 DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Julie Wetherell
• Organization: VA San Diego Healthcare System

jwetherell@ucsd.edu

858-552-8585

Study Officials

• Julie L Wetherell, PhD

  VA San Diego Healthcare System, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2010
• First Posted: January 25, 2010
• Study Start: February 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: September 1, 2013
• Last Updated: August 12, 2016
• Results First Posted: August 12, 2016

Record last verified: 2015-06

Locations

US (1)