Ignite Creation Date:
2024-05-06 @ 3:49 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02386605
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2015-01-23
Brief Title:
Motivational Negative Symptoms in Schizophrenia Intervention and Biomarkers
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Motivational Negative Symptoms in Schizophrenia Intervention and Biomarkers
Status:
COMPLETED
Status Verified Date:
2021-04
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:
Negative symptoms significantly interfere with daily functioning among individuals with schizophrenia They are strongly related to functional impairments 1 and contribute to the poor community outcomes of Veterans with schizophrenia Motivational negative symptoms interfere with obtaining and maintaining employment 2 forming social relationships3 and living independently 4 Developing treatments to effectively reduce negative symptoms is important to achieve improvements in daily functioning Recent empirical studies report that psychosocial interventions for negative symptoms can have a moderate to large effect size on community functioning and negative symptom severity However the treatments that have been utilized so far are either cognitive-behavioral therapy interventions that require over a year of weekly individual sessions and thus are very resource- and time-intensive or they are skills-training groups that do not address any of the cognitive and motivational aspects of negative symptoms Although group treatments are increasingly hailed as the gold standard for schizophrenia there is currently no group intervention explicitly for motivational negative symptoms and functional deficits Furthermore treatment development and clinical trials are increasingly reliant on neurophysiological measures of clinical severity and treatment response and so far there are not identified negative symptom biomarkers
The current CDA proposal will test a group-based treatment based on established motivational enhancement MI techniques augmented with cognitive-behavioral approaches compared to an active control group treatment for improving motivational negative symptoms in Veterans with schizophrenia I will assess the efficacy of MI with measures from two outcome domains 1 negative symptoms clinical ratings and 2 functional outcomes real-world improvements in social instrumental and independent living I will assess the relationship between these outcomes and neurophysiological biomarkers pupillometry and electroencephalography EEG Participants will be randomly assigned to the MI treatment or a control treatment for weekly 1-hour sessions for 12 weeks The assessment battery will be administered at baseline at completion of treatment and at 6-month follow-up The investigators will enroll 60 Veterans with schizophrenia that are low functioning and have high negative symptoms across the 4 years of the study
This proposal is designed to examine group-based MI for reducing negative symptoms and improving functioning in key domains ie interpersonal instrumental and independent living skills Moreover it will thoroughly investigate biomarkers of negative symptoms with pupillometry and EEG The development and evaluation of this recovery- oriented group MI treatment for Veterans with disabling negative symptoms will yield results that can inform larger treatment trials and neurophysiological measurement of negative symptoms in Veterans with schizophrenia
The current CDA proposal will test a group-based treatment based on established motivational enhancement MI techniques augmented with cognitive-behavioral approaches compared to an active control group treatment for improving motivational negative symptoms in Veterans with schizophrenia I will assess the efficacy of MI with measures from two outcome domains 1 negative symptoms clinical ratings and 2 functional outcomes real-world improvements in social instrumental and independent living I will assess the relationship between these outcomes and neurophysiological biomarkers pupillometry and electroencephalography EEG Participants will be randomly assigned to the MI treatment or a control treatment for weekly 1-hour sessions for 12 weeks The assessment battery will be administered at baseline at completion of treatment and at 6-month follow-up The investigators will enroll 60 Veterans with schizophrenia that are low functioning and have high negative symptoms across the 4 years of the study
This proposal is designed to examine group-based MI for reducing negative symptoms and improving functioning in key domains ie interpersonal instrumental and independent living skills Moreover it will thoroughly investigate biomarkers of negative symptoms with pupillometry and EEG The development and evaluation of this recovery- oriented group MI treatment for Veterans with disabling negative symptoms will yield results that can inform larger treatment trials and neurophysiological measurement of negative symptoms in Veterans with schizophrenia
Detailed Description:
Despite significant advances in pharmacological treatments for schizophrenia SCZ the rate of disability among Veterans diagnosed with SCZ remains high Functional disability among Veterans with SCZ creates a huge and costly burden on the national VA healthcare system and interferes with community integration and quality of life In particular SCZ is associated with low rates of employment few social relationships and poor independent living skills The negative symptoms of SCZ ie avolition anhedonia asociality are primary determinants of functional impairments and they have no validated treatments Extensive work has been devoted to treating positive symptoms and cognitive deficits but much less has been done to develop pharmacological and psychosocial treatments for negative symptoms Developing such interventions is a critical public health goal as it would benefit one of the largest groups of disabled Veterans
The recently-emerging recovery-oriented approach to serious mental illness reflects a fundamental shift from a focus on symptom reduction to a focus on patients goals and community functioning Developing treatments for negative symptoms to augment community functioning is a strong reflection of this shift Importantly preliminary research suggests that motivational negative symptoms respond to novel evidence-based psychosocial interventions The primary goal of this proposal is to adapt and implement a recovery-oriented evidence-based intervention Motivational Interviewing MI for the treatment of motivational negative symptoms in Veterans with SCZ MI originally developed for substance use disorders is effective to increase commitment to new behaviors in a range of areas including treatment adherence exercise gambling and depression Importantly it has been shown to be applicable to Veterans with psychosis but it is not known if MI can reduce functional deficits that are attributable to motivational negative symptoms
More specifically the scientific goals of this proposal are to 1 evaluate the efficacy of a group-based MI intervention on motivational negative symptoms for Veterans with SCZ and 2 to examine potential biomarkers of negative symptoms and treatment response I will assess the efficacy of MI with measures from two outcome domains 1 negative symptoms clinical ratings and 2 functional outcomes real-world improvements in social instrumental and independent living I will assess the relationship between these outcomes and neurophysiological biomarkers pupillometry and electroencephalography EEG To address these questions 60 Veterans with SCZ who have at least moderate levels of motivational negative symptoms will be randomly assigned in a 11 ratio to MI or a standard treatment relaxation skills training Both treatments will consist of weekly 60-min group sessions for twelve weeks The assessment will be administered at baseline at completion of treatment and at 6-month follow-up
Specific Aim 1 To adapt the existing MI approach for group-based MI treatment for Veterans with SCZ
Specific Aim 2 To examine the treatment effects of MI compared to the control procedure on motivational negative symptoms and functional outcomes
Hypothesis 2a Individuals who receive MI will have significant improvements in motivational negative symptoms compared to those who receive the control
Hypothesis 2b Individuals who receive MI will have significant improvements in aspects of functioning including social instrumental and independent living domains compared to those who receive the control
Specific Aim 3 To examine neurophysiological biomarkers ie EEG and pupillometry of motivational negative symptom severity and treatment response
Hypothesis 3a At baseline subjects with more negative symptoms at baseline will have more aberrant EEG and pupillary measures
Hypothesis 3b For subjects in the treatment group change in the biomarkers toward normalization over study duration will correlate with treatment related improvement in motivational negative symptoms
Exploratory Aim To explore a causal model by examining whether MI improves defeatist beliefs compared to a control procedure
Although MI is a well-established intervention for a range of clinical populations and conditions the proposed project will be the first examination of MI in a group format for motivational negative symptoms in SCZ If validated it could be disseminated throughout the VA for other patient populations with motivational and functional deficits eg traumatic brain injury post-traumatic stress disorder Therefore this CDA application will facilitate my research independence and provide me with a unique combination of skills that will equip me to be a local professional resource and long-term VA researcher
The recently-emerging recovery-oriented approach to serious mental illness reflects a fundamental shift from a focus on symptom reduction to a focus on patients goals and community functioning Developing treatments for negative symptoms to augment community functioning is a strong reflection of this shift Importantly preliminary research suggests that motivational negative symptoms respond to novel evidence-based psychosocial interventions The primary goal of this proposal is to adapt and implement a recovery-oriented evidence-based intervention Motivational Interviewing MI for the treatment of motivational negative symptoms in Veterans with SCZ MI originally developed for substance use disorders is effective to increase commitment to new behaviors in a range of areas including treatment adherence exercise gambling and depression Importantly it has been shown to be applicable to Veterans with psychosis but it is not known if MI can reduce functional deficits that are attributable to motivational negative symptoms
More specifically the scientific goals of this proposal are to 1 evaluate the efficacy of a group-based MI intervention on motivational negative symptoms for Veterans with SCZ and 2 to examine potential biomarkers of negative symptoms and treatment response I will assess the efficacy of MI with measures from two outcome domains 1 negative symptoms clinical ratings and 2 functional outcomes real-world improvements in social instrumental and independent living I will assess the relationship between these outcomes and neurophysiological biomarkers pupillometry and electroencephalography EEG To address these questions 60 Veterans with SCZ who have at least moderate levels of motivational negative symptoms will be randomly assigned in a 11 ratio to MI or a standard treatment relaxation skills training Both treatments will consist of weekly 60-min group sessions for twelve weeks The assessment will be administered at baseline at completion of treatment and at 6-month follow-up
Specific Aim 1 To adapt the existing MI approach for group-based MI treatment for Veterans with SCZ
Specific Aim 2 To examine the treatment effects of MI compared to the control procedure on motivational negative symptoms and functional outcomes
Hypothesis 2a Individuals who receive MI will have significant improvements in motivational negative symptoms compared to those who receive the control
Hypothesis 2b Individuals who receive MI will have significant improvements in aspects of functioning including social instrumental and independent living domains compared to those who receive the control
Specific Aim 3 To examine neurophysiological biomarkers ie EEG and pupillometry of motivational negative symptom severity and treatment response
Hypothesis 3a At baseline subjects with more negative symptoms at baseline will have more aberrant EEG and pupillary measures
Hypothesis 3b For subjects in the treatment group change in the biomarkers toward normalization over study duration will correlate with treatment related improvement in motivational negative symptoms
Exploratory Aim To explore a causal model by examining whether MI improves defeatist beliefs compared to a control procedure
Although MI is a well-established intervention for a range of clinical populations and conditions the proposed project will be the first examination of MI in a group format for motivational negative symptoms in SCZ If validated it could be disseminated throughout the VA for other patient populations with motivational and functional deficits eg traumatic brain injury post-traumatic stress disorder Therefore this CDA application will facilitate my research independence and provide me with a unique combination of skills that will equip me to be a local professional resource and long-term VA researcher
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?:
False
Is an FDA AA801 Violation?:
None