NMO Spectrum Disorder Clinical Trial
Official title:
Acceptance and Commitment Therapy With Neuromyelitis Optica Spectrum Disorder Patient and Caregiver Pilot Study
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | September 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Thomas Jefferson University | Alexion Pharmaceuticals, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Generalized Anxiety Disorder Questionnaire (GAD7) | Generalized Anxiety Disorder 7 is a self-reported questionnaire for screening | Baseline, 6 weeks, and three months after study completion. | |
Primary | Changes in Patient Health Questionnaire (PHQ-9) | The PHQ-9 (Patient Health Questionnaire-9) objectifies and assesses degree of depression severity via questionnaire. | Baseline, 6 weeks, and three months after study completion. | |
Primary | 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. | Baseline, 6 weeks, and three months after study completion. | |
Primary | 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. | Baseline, 6 weeks, and three months after study completion. | |
Secondary | Acceptance and Action Questionnaire | AAQ-II is a 7 item measure of acceptance and committed action | Baseline, 6 weeks, and three months after study completion. | |
Secondary | Cognitive Fusion Questionnaire - 13 item version | The CFQ-13 is a 13 item measure of cognitive fusion: rigid attachment to thoughts as truth | Baseline, 6 weeks, and three months after study completion. | |
Secondary | Brief Fatigue Inventory | The BFI is a 4-item measure of self-reported fatigue - Item #4 measures the extent to which fatigue has impacted each of 6 life domains | 3 months prior to baseline to baseline, baseline to 3 months post-treatment | |
Secondary | Telephone EDSS | The Telephone Assessment of the Expanded Disability Status Scale is a self-administered assessment of difficulty and interference of 8 neurologic categories associated w MS and w NMOSD | Baseline, 6 weeks, and three months after study completion. | |
Secondary | Valued Living Questionnaire | The VLQ is a 10-item measure of how important each of 10 valued domains are to the respondent, and to what extent the responded has been living according to these values | Baseline, 6 weeks, and three months after study completion. | |
Secondary | EHR data re. NMOSD flares, hospitalization, appointments kept/missed | EHR data re. presence/absence of flares, hospitalizations, clinic visits missed/kept, infusion appts missed/delayed/kept, initiation of steroid Rx, etc. | 3 months prior to baseline to baseline, baseline to 3 months post-treatment |
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