Abstract
BACKGROUND: Chronic spinal (back/neck) pain is common and costly. Psychosocial treatments are available but have modest effects. Knowledge of treatment mechanisms (mediators and moderators) can be used to enhance efficacy. Trials that directly compare different treatments are needed to determine which mechanisms are treatment-specific, which are shared across treatments, and which contribute the most to outcomes. METHODS: We will conduct a 4-arm randomized, controlled clinical trial to compare the main effects, mediators, and moderators of three pain therapies: Cognitive-Behavioral Therapy, Acceptance and Commitment Therapy, and Emotional Awareness and Expression Therapy in adults with chronic spinal pain. Following baseline assessment of outcomes variables (two primary outcomes: pain intensity and pain interference) and potential mediators and moderators, we will randomize participants (up to 460) to one of the treatments or usual care control. Treatments will be conducted individually each week for 8 weeks via telehealth. We will conduct weekly assessments of both potential mediators and outcomes, as well as post-treatment and 6-month follow-up assessments. We will test whether any of the therapies is superior to the others (Aim 1); identify mediators that are specific to treatments and those that are shared across treatments (Aim 2); and identify baseline moderators that are specific to treatments or shared across treatments, and moderated mediators of treatments (Aim 3). DISCUSSION: The findings from this project can be used to improve the effects of psychosocial chronic pain treatments by identifying the most powerful specific and shared mechanisms and revealing for whom the mediator-outcome pathways are strongest.