Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05840055
Status:
RECRUITING
Last Update Posted:
2024-04-15
First Post:
2023-04-11
Brief Title:
ACT With NMOSD Patients and Caregivers Pilot Study
Sponsor:
Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
Acceptance and Commitment Therapy With Neuromyelitis Optica Spectrum Disorder Patient and Caregiver Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 caregiversloved ones and improving overall health outcomes in individuals with NMOSD
Detailed Description:
Neuromyelitis optica spectrum disorder NMOSD also known as Devic disease is an inflammatory disorder of the central nervous system The primary symptom of NMOSD is attacks of inflammation and damage in the optic nerves and spinal cord Such attacks may cause rapid onset of eye pain or blindness limb weakness numbness or partial paralysis shooting pain or tingling in the neck back or abdomen loss of bowel and bladder control and prolonged nausea vomiting or hiccups These attacks may have periods of remission and relapse with relapses most commonly occurring years to months apart Monophasic NMO is a less common variant of NMOSD and is characterized by a single severe attack that may last days or weeks When a patient is first diagnosed with NMOSD it is unclear whether or not they will have relapses The psychological burden of NMOSD is documented in the empirical literature with a focus on experience of depression pain sexual dysfunction sleep issues stigma and impact on partners
Between 30 and 50 of individuals with NMOSD have been found to endorse clinically significant depressive symptoms on the Beck Depression Inventory Compared with patients with Multiple Sclerosis MS NMOSD patients are twice as likely to receive a formal diagnosis of Recurrent Major Depressive Disorder
Pain bowel and bladder dysfunction visual impairment reduced sexual function and inability to work were found to most negatively impact emotional well-being and quality of life among people with NMOSD It is estimated that chronic pain affects over 80 of NMOSD patients including patients without recent relapse still commonly reporting moderate or severe pain Pain severity is the strongest negative predictor of quality of life and the most common symptom of concern voiced by patients to their physician
Sexual dysfunction specifically reduced libido decreased orgasm and erectile dysfunction have been reported by 75 of males and 75 of females living with NMOSD
Sleep disturbance is common in NMOSD with 64 of NMOSD patients identified as poor sleepers with correlations with anxiety depression pain disability and disease duration Similarly 714 of NMOSD patients endorsed fatigue with correlations with sleep disturbance depression pain and quality of life
Further contributing to the psychological burden of life with NMOSD 60 of patients reported being affected by NMOSD-related stigma Embarrassment due to physical limitations perceived exclusion avoidanceostracism and blame for their illness were deemed the most impactful targets of stigma
The psychological burden is also well-defined by patients with NMOSD and their loved ones in online forums blogs and social media In addition to the domains cited in the literature patients and loved ones often discuss anxiety delayed diagnosis physical disability and impact on relationships as hallmark characteristics of life with NMOSD Despite the many studies suggesting that life with NMOSD is marred by many psychological stressors including increased depression there does not appear to be any psychosocial intervention to date to help patients and loved ones cope with this burden Furthermore narratives from patients across media describe profound psychological burdens that go untreated
Given the prevalence of depression stress stigma and physical impediments associated with NMOSD it makes sense that patients and their loved ones would resort to avoidance-based coping distraction with television avoiding talking about illness avoiding reminders of illness to manage these issues Compared with patients with multiple sclerosis and with healthy controls patients with NMOSD were more likely to use mental disengagement strategies while both NMOSD and MS patients were more likely to use acceptance and behavioral disengagement strategies compared with healthy controls However while avoidance-based coping may provide an effective short-term escape from the psychological burden of NMOSD it is considered a maladaptive coping strategy in the longer term as avoidance can be associated with medication nonadherence missing clinic visits failure to inform medical providers about symptoms and can be associated with a paradoxical increase in depression and anxiety
While the economic burden of NMOSD including financial cost of treatments loss of income due to disability and associated financial pressure on caregiverloved ones is well known the psychological impact of NMOSD on caregivers and loved ones remains under-studied to date Based on PHQ-9 score 211 of loved ones of NMOSD patients were found to be experiencing mild moderate or moderately severe depressive symptoms However partners did not endorse clinically significant burden anxiety or depression Rather partners endorsed pressure to take on new roles both inside and outside of the home during NMOSD relapses with both male and female partners identifying challenges related to gender role shift
Partners endorsed limiting hobbies and activities to prioritize the patients health particularly during a relapse along with frustration about accommodating NMOSD symptoms in public spaces helplessness that they cannot fix their partners problems isolation due to lack of support and anxiety about their partners well-being and about their own health Male partners reported hardly expressing thoughts and feelings about NMOSD and reported that prior to study participation they had never been asked how they feel about NMOSD Lack of caregiver support and avoidance-based coping are associated with caregiver strain and burnout Given the physical impediments associated with NMOSD caregivers are often responsible for managing the patients medication regimen and transporting patients to their infusion appointments Caregiver burnout can understandably negatively impact patient treatment engagement
Therefore the investigators propose a caregiver-assisted NMOSD-specific mental health intervention Given physical limitations associated with NMOSD and increased comfort with telehealth over the past few years the investigators propose a telehealth-delivered intervention will be most accessible and effective 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 ones 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
Between 30 and 50 of individuals with NMOSD have been found to endorse clinically significant depressive symptoms on the Beck Depression Inventory Compared with patients with Multiple Sclerosis MS NMOSD patients are twice as likely to receive a formal diagnosis of Recurrent Major Depressive Disorder
Pain bowel and bladder dysfunction visual impairment reduced sexual function and inability to work were found to most negatively impact emotional well-being and quality of life among people with NMOSD It is estimated that chronic pain affects over 80 of NMOSD patients including patients without recent relapse still commonly reporting moderate or severe pain Pain severity is the strongest negative predictor of quality of life and the most common symptom of concern voiced by patients to their physician
Sexual dysfunction specifically reduced libido decreased orgasm and erectile dysfunction have been reported by 75 of males and 75 of females living with NMOSD
Sleep disturbance is common in NMOSD with 64 of NMOSD patients identified as poor sleepers with correlations with anxiety depression pain disability and disease duration Similarly 714 of NMOSD patients endorsed fatigue with correlations with sleep disturbance depression pain and quality of life
Further contributing to the psychological burden of life with NMOSD 60 of patients reported being affected by NMOSD-related stigma Embarrassment due to physical limitations perceived exclusion avoidanceostracism and blame for their illness were deemed the most impactful targets of stigma
The psychological burden is also well-defined by patients with NMOSD and their loved ones in online forums blogs and social media In addition to the domains cited in the literature patients and loved ones often discuss anxiety delayed diagnosis physical disability and impact on relationships as hallmark characteristics of life with NMOSD Despite the many studies suggesting that life with NMOSD is marred by many psychological stressors including increased depression there does not appear to be any psychosocial intervention to date to help patients and loved ones cope with this burden Furthermore narratives from patients across media describe profound psychological burdens that go untreated
Given the prevalence of depression stress stigma and physical impediments associated with NMOSD it makes sense that patients and their loved ones would resort to avoidance-based coping distraction with television avoiding talking about illness avoiding reminders of illness to manage these issues Compared with patients with multiple sclerosis and with healthy controls patients with NMOSD were more likely to use mental disengagement strategies while both NMOSD and MS patients were more likely to use acceptance and behavioral disengagement strategies compared with healthy controls However while avoidance-based coping may provide an effective short-term escape from the psychological burden of NMOSD it is considered a maladaptive coping strategy in the longer term as avoidance can be associated with medication nonadherence missing clinic visits failure to inform medical providers about symptoms and can be associated with a paradoxical increase in depression and anxiety
While the economic burden of NMOSD including financial cost of treatments loss of income due to disability and associated financial pressure on caregiverloved ones is well known the psychological impact of NMOSD on caregivers and loved ones remains under-studied to date Based on PHQ-9 score 211 of loved ones of NMOSD patients were found to be experiencing mild moderate or moderately severe depressive symptoms However partners did not endorse clinically significant burden anxiety or depression Rather partners endorsed pressure to take on new roles both inside and outside of the home during NMOSD relapses with both male and female partners identifying challenges related to gender role shift
Partners endorsed limiting hobbies and activities to prioritize the patients health particularly during a relapse along with frustration about accommodating NMOSD symptoms in public spaces helplessness that they cannot fix their partners problems isolation due to lack of support and anxiety about their partners well-being and about their own health Male partners reported hardly expressing thoughts and feelings about NMOSD and reported that prior to study participation they had never been asked how they feel about NMOSD Lack of caregiver support and avoidance-based coping are associated with caregiver strain and burnout Given the physical impediments associated with NMOSD caregivers are often responsible for managing the patients medication regimen and transporting patients to their infusion appointments Caregiver burnout can understandably negatively impact patient treatment engagement
Therefore the investigators propose a caregiver-assisted NMOSD-specific mental health intervention Given physical limitations associated with NMOSD and increased comfort with telehealth over the past few years the investigators propose a telehealth-delivered intervention will be most accessible and effective 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 ones 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None