Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Reducing Disparities With Literacy-Adapted Psychosocial Treatments for Chronic Pain: A Comparative Trial
Brief Summary: Chronic pain is a significant public health problem that affects over 116 million Americans, costs $600 billion annually, and is unequally borne by people in low-income brackets, especially ethnic minorities. Many individuals also have health literacy deficits (difficulty understanding their illness and difficulty navigating the health care system for treatment) putting them at a greater disadvantage. Treatment usually relies on expensive medical interventions that often have negative side-effects. Psychosocial treatments, like Pain Education and Cognitive-Behavioral Therapy (CBT), show promise, but are usually unavailable. Clinicians are poorly equipped to provide psychosocial treatments to patients with low health literacy. CBT has not been adapted and supported for use in individuals with low health literacy, and even educational materials are often poorly adapted for their needs.

To address this problem, the PI completed a small trial showing benefits from health literacy-adapted pain education and CBT groups for chronic pain in a population with low income and low health literacy. Patients in both treatments reported lower pain by the end of treatment, and the effects were maintained at one year. Patients in the CBT group also reported less depression. The current study uses a larger sample, and directly compares these psychosocial treatments to medical treatment-as-usual to seek better evidence for or against their widespread use in community settings.

Our research questions:

1. In people with chronic pain and low income and/or low literacy, does participating in a health-literacy-adapted psychosocial treatment improve their pain and interference in daily activities due to pain by the end of treatment when compared with a group receiving typical medical care, and are these effects maintained 6 months later?
2. Does participation in the CBT pain management group improve symptoms of depression better than a pain education group by the end of treatment, and are these effects maintained 6 months later?

In partnership with a federally qualified health center, we will enroll 294 patients with chronic pain. Main outcomes will be patient-reported pain intensity, pain interference, depression, and perceived change. From an earlier trial, we expect that our participants will be \~75% female and \~70% African American, and will have low literacy and low income (\~60% in the low 15% nationally on word reading, and 90% at or below the poverty threshold).


Options:
A: Arm Label: Interdisciplinary treatment; Type: EXPERIMENTAL; Interventions: Behavioral: Interdisciplinary treatment, Behavioral: Interdisciplinary treatment of fibromyalgia | Arm Label: Usual treatment; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Interdisciplinary treatment; Assigned to Arm(s): Interdisciplinary treatment | Intervention Type: BEHAVIORAL; Name: Interdisciplinary treatment of fibromyalgia; Assigned to Arm(s): Interdisciplinary treatment
B: Arm Label: Pain Ed; Type: EXPERIMENTAL; Interventions: Behavioral: Pain Ed, Other: Usual Care | Arm Label: CBT for Pain; Type: EXPERIMENTAL; Interventions: Behavioral: CBT for Pain, Other: Usual Care | Arm Label: Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Other: Usual Care | Intervention Type: BEHAVIORAL; Name: Pain Ed; Assigned to Arm(s): Pain Ed | Intervention Type: BEHAVIORAL; Name: CBT for Pain; Assigned to Arm(s): CBT for Pain | Intervention Type: OTHER; Name: Usual Care; Assigned to Arm(s): CBT for Pain, Pain Ed, Usual Care
C: Intervention Type: BEHAVIORAL; Name: Cognitive-behavioral rehabilitation; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Traditional primary care; Assigned to Arm(s): N/A
D: Arm Label: Arm 1; Type: EXPERIMENTAL; Interventions: Drug: desipramine hydrochloride | Arm Label: Arm 2; Type: EXPERIMENTAL; Interventions: Behavioral: cognitive behavioral therapy | Arm Label: Arm 3; Type: EXPERIMENTAL; Interventions: Drug: desipramine hydrochloride, Behavioral: cognitive behavioral therapy | Arm Label: Arm 4; Type: PLACEBO_COMPARATOR; Interventions: Drug: benztropine mesylate 0.125 mg daily | Intervention Type: BEHAVIORAL; Name: cognitive behavioral therapy; Assigned to Arm(s): Arm 2 | Intervention Type: DRUG; Name: desipramine hydrochloride; Assigned to Arm(s): Arm 3 | Intervention Type: BEHAVIORAL; Name: cognitive behavioral therapy; Assigned to Arm(s): Arm 3 | Intervention Type: DRUG; Name: benztropine mesylate 0.125 mg daily; Assigned to Arm(s): Arm 4 | Intervention Type: DRUG; Name: desipramine hydrochloride; Assigned to Arm(s): Arm 1

Answer: B