CompletedNot a drug-phase studyNMOSDNCT05840055

What it found

Result in a paper, not read yet

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Acceptance and Commitment Therapy

What it measured

Main measures

  • Changes in Generalized Anxiety Disorder Questionnaire (GAD7)

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

    Mood and sleep
  • Changes in Patient Health Questionnaire (PHQ-9)

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

    Mood and sleep
  • Changes in Beck Anxiety Inventory (BAI)

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

    Mood and sleep
  • Changes in Beck Depression Inventory (BDI-II)

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

    Mood and sleep

Other measures (6)

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

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

    Bladder, bowel and sexual function
  • Cognitive Fusion Questionnaire - 13 item version

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

    Thinking and memory
  • Brief Fatigue Inventory

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

    Fatigue
  • Telephone EDSS

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

    Disability progression
  • Valued Living Questionnaire

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

  • EHR data re. NMOSD flares, hospitalization, appointments kept/missed

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

Who could take part

NMOSD · 18 and over

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

Loading reviews and guidelines…

History

    1. Started

      Aug 2023

    2. Main results due

      Sept 2024

    3. Finished

      Nov 2024

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