A new clinical trial (NCT05840055) will investigate the effectiveness of Acceptance and Commitment Therapy (ACT) at reducing anxiety and depression levels for patients with neuromyelitis optica spectrum disorder (NMOSD) and their caregiver loved ones.
ACT is a “third wave” behavioral therapy designed to help patients gain acceptance as well as encourage life changes to align with their purpose in life. It uses experiential, contextual talk therapy and can help patients reduce avoidance-based coping strategies, internalization of symptoms, and increase quality of life.
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According to the study description, NMOSD can lead to a psychological burden for many patients and includes experiences of pain, stigma, sexual dysfunction, depression, problems sleeping, and impacts on partners. An estimated 30% to 50% of patients were found to have clinically significant depressive symptoms, while chronic pain affects roughly 80% of patients.
Bowel dysfunction, pain, bladder, visual impairment, and reduced sexual function, along with an inability to work all cause emotional and psychological burdens for patients.
The primary outcomes of the study will measure changes in the Patient Health Questionnaire (PHQ-9), the Generalized Anxiety Disorder Questionnaire (GAD-7), the Beck Depression Inventory (BDI-2), and the Beck Anxiety Inventory (BAI),). These will be measured at baseline, 10 weeks, and 3 months after study completion.
A participant satisfaction questionnaire will also be used to elicit the participants’ opinions about the relevance and satisfaction of the therapy and determine if there are any changes the participants would recommend to the study structure or content.
The study, sponsored by Thomas Jefferson University in collaboration with Alexion, will aim to recruit around 50 participants once enrollment begins. Enrollment will be open to patients over 18 years of age diagnosed with NMOSD, and their caregiver loved ones. The patients must have a PHQ-9 score or a GAD-7 score greater than 4 with no history of suicidal attempts and no presence of psychiatric or psychotic disorders.
ACT has previously been shown to help manage substance abuse, depression, and anxiety in participants with HIV, somatic problems, chronic pain, cystic fibrosis, and pancreatic cancer.
Reference
ACT with NMOSD patients and caregivers pilot study. ClinicalTrials.gov. May 3, 2023. Accessed May 9, 2023.
