Back on Track to Healthy Living Study

Summary

Chronic pain is a significant problem affecting millions of Americans. Research has shown that psychological treatments can help people with chronic pain manage their pain and improve their quality of life. Three common psychological treatments for chronic pain are Cognitive Therapy (CT), Mindfulness Meditation (MM), and Behavioral Activation (BA). While research has shown these treatments are helpful for people with chronic pain, there is little research explaining why these treatments are helpful. The purpose of this study is to understand the specific ways these treatments work. Increasing our understanding of how these treatments work will help researchers and clinicians improve treatments for people with chronic pain in the future. As a secondary aim, this study will also examine the post-treatment mechanisms that explain relapse, maintenance, and continued gains associated with these treatments. Treatment moderators will also be explored.

Conditions

• Chronic Pain

Interventions

BEHAVIORAL

Cognitive Therapy (CT)

The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs.

BEHAVIORAL

Mindfulness Meditation (MM)

Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.

BEHAVIORAL

Behavioral Activation (BA)

Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.

Sponsors & Collaborators

• Rush University

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• The University of Queensland

  collaborator OTHER

• National Center for Complementary and Integrative Health (NCCIH)

  collaborator NIH

• University of Washington

  lead OTHER

Principal Investigators

• Mark Jensen, Ph.D. · University of Washington

• Melissa Day, Ph.D. · The University of Queensland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-07

Primary Completion

2023-01-25

Completion

2023-01-25

Countries

• United States

Study Locations