ACT with NMOSD Patients and Caregivers Pilot Study

NCT05840055 | Completed DMC

• 1 other identifier: iRISID-2023-1442
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the effectiveness of a neuromyelitis optics spectrum disorder (NMOSD) specific Acceptance and Commitment Therapy (ACT) intervention at reducing anxiety and depression in individuals with NMOSD and their caregivers/loved ones and improving overall health outcomes in individuals with NMOSD.

Conditions

NMO Spectrum Disorder

Outcome Measures

Primary Outcomes (4)

• Changes in Generalized Anxiety Disorder Questionnaire (GAD7)

  The Generalized Anxiety Disorder Questionnaire-7 is a seven item self-report questionnaire of anxiety symptom severity, with possible scores ranging from 0-21. Higher scores indicate higher anxiety symptom severity.

  Baseline, 6 weeks, and three months after study completion.

• Changes in Patient Health Questionnaire (PHQ-9)

  The Patient Health Questionnaire-9 is a nine item self-report questionnaire of depression symptom severity, with possible scores ranging from 0-27. Higher scores indicate higher depression symptom severity.

  Baseline, 6 weeks, and three months after study completion.

• Changes in Beck Anxiety Inventory (BAI)

  The Beck Anxiety Inventory (BAI) is a widely used 21-item self-report inventory used to assess anxiety levels in adults and adolescents. Scores range from 0-63, with higher scores indicating more severe anxiety.

  Baseline, 6 weeks, and three months after study completion.

• Changes in Beck Depression Inventory (BDI-II)

  The Beck Depression Inventory is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. Scores range from 0-63, with higher scores indicating more severe depression.

  Baseline, 6 weeks, and three months after study completion.

Secondary Outcomes (6)

• Acceptance and Action Questionnaire- version 2 (AAQ-II)

  Baseline, 6 weeks, and three months after study completion.

• Cognitive Fusion Questionnaire - 13 item version

  Baseline, 6 weeks, and three months after study completion.

• Brief Fatigue Inventory

  3 months prior to baseline to baseline, baseline to 3 months post-treatment

• Telephone EDSS

  Baseline, 6 weeks, and three months after study completion.

• Valued Living Questionnaire

  Baseline, 6 weeks, and three months after study completion.

Study Arms (1)

Acceptance and Commitment Therapy

EXPERIMENTAL

Behavioral: Acceptance and Commitment Therapy

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

Acceptance and Commitment Therapy is one potential intervention for reducing internalizing symptoms, increasing purpose in life, and reducing avoidance-based coping among people with NMOSD and their caregiver loved ones. ACT is a "third wave" behavioral therapy which balances encouraging life changes in the service of one's values (purpose in life) with a strong acceptance component. This novel, experiential, contextual talk therapy is an empirically supported treatment for anxiety and depression, substance use, and has proven successful in managing chronic pain, somatic problems, HIV, Pancreatic Cancer and Cystic Fibrosis.

Acceptance and Commitment Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals ages 18 and up with a diagnosis of NMOSD and caregiver loved ones willing to participate in the intervention.
• PHQ-9 score \>4, or GAD-7 score \>4
• Webcam access

You may not qualify if:

• History of suicidal attempts or acute suicidal ideation on clinical assessment
• Presence of psychotic disorder or symptoms
• Presence of psychiatric disorders that interfere with the participation of the study, judged by the study or treating clinician. The presence of other medical conditions that interfere with participation in the study, judged by the study or treating clinician

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Alexion Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19103, United States

Location

Related Publications (1)

• Esiason DC, Smith PJ, Peppers CL, Wakschal E, Andrews L, Nurse CN, Kushner HM, Drescher CF, Bruschwein H, Erler W, Hattrich T, Deshpande A, Levy M, Leist T, O'Hayer CV. ACT with NMOSD: A targeted, telehealth-delivered mental health intervention for patients & caregivers. Mult Scler Relat Disord. 2025 Oct;102:106630. doi: 10.1016/j.msard.2025.106630. Epub 2025 Jul 22.

  PMID: 40716235 DERIVED

MeSH Terms

Conditions

Neuromyelitis Optica

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor & Director, Jefferson Center City Clinic for Behavioral Medicine

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 3, 2023
• Study Start: August 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: November 21, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)