CompletedNot Applicable

ACT with NMOSD Patients and Caregivers Pilot Study

United States43 participantsStarted 2023-08-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in Generalized Anxiety Disorder Questionnaire (GAD7)

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

Changes in Patient Health Questionnaire (PHQ-9)

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

Changes in Beck Anxiety Inventory (BAI)

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

Changes in Beck Depression Inventory (BDI-II)

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

Trial details

NCT IDNCT05840055

SponsorThomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-30

View on ClinicalTrials.gov More NMO Spectrum Disorder trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Changes in Generalized Anxiety Disorder Questionnaire (GAD7)

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

Changes in Patient Health Questionnaire (PHQ-9)

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

Changes in Beck Anxiety Inventory (BAI)

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

Changes in Beck Depression Inventory (BDI-II)

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