SchizophreniaNCT02386605
Motivational Negative Symptoms in Schizophrenia: Intervention and Biomarkers
A study testing Motivational Interviewing and Cognitive Behavioral Therapy and Relaxation Skills in people with Schizophrenia and Schizoaffective Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Motivational Interviewing and Cognitive Behavioral Therapy and Relaxation Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2016to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of schizophrenia or schizoaffective disorder
- No medication changes in the past six weeks
- No psychiatric hospitalization in the past three months
- No changes in housing in the past two months
Who cannot join
- Neurological disorder
- seizures
- history of serious head injury
- substance dependence in the past 6 months or abuse in the past month
- being insufficiently fluent in English
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
West Los Angeles, California, 90073
About this study
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 relationships[3] 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 (i.e., 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.
Read the 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 (i.e. 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 1:1 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 (i.e., 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 (e.g., 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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Motivational Interviewing and Cognitive Behavioral Therapy, Relaxation Skills
- Keywords
- recovery, rehabilitation
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing and Cognitive Behavioral TherapyBehavioural
group-based recovery-oriented Motivational Interviewing combined with cognitive-behavioral therapy to target the negative symptoms of schizophrenia
Relaxation SkillsBehavioural
Relaxation and mindfulness skills training group for comparison condition for negative symptoms of schizophrenia
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Motivational Interviewing Treatment group Receives: Behavioral: Motivational Interviewing and Cognitive Behavioral Therapy |
| Control | Active comparator | Relaxation Skills Training group Receives: Behavioral: Relaxation Skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strauss-Carpenter Level of Function Scale
This scale is a 43-item report of a patient's behavior and functioning across the following domains: physical functioning (e.g., vision, hearing), personal care skills (e.g., eating, grooming), interpersonal skills (e.g., initiating, accepting, and maintaining social contacts; effectively communicating), social acceptability (e.g., absence of verbal and physical abuse, absence of repetitive behaviors), community activities (e.g., shopping, using the telephone, paying bills, use of leisure time, use of public transportation), and work skills (e.g., employable skills, level of supervision, punctuality). Each item is rated on a 5 point likert scale. A functional skill composite is created by summing the interpersonal relationships, activities, and work skills domains. The range for the summary score was 64 - 120, with higher scores indicating better functioning.
Measured: 3 months
Clinical Assessment Interview for Negative Symptoms
The CAINS is a 13-item instrument that yields two subscales which measure the two primary negative symptom factors: Motivation and Pleasure (MAP) which measures experiential negative symptoms and Expression which measures the expressive negative symptoms. The MAP was used as a primary dependent variable, it includes 9 items rated 0-4 and yields a mean subscale (0-4). Higher scores reflect greater impairment.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study start28 Mar 2016
- Primary completion31 Dec 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lena F Reddy, Principal investigator, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386605
- Sponsor's protocol ID
- D1851-W
- Status last verified
- Apr 2021
- First submitted
- 23 Jan 2015
- Last updated
- 8 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reddy LF, Glynn SM, McGovern JE, Sugar CA, Reavis EA, Green MF. A Novel Psychosocial Intervention for Motivational Negative Symptoms in Schizophrenia: Combined Motivational Interviewing and CBT. Am J Psychiatry. 2023 May 1;180(5):367-376. doi: 10.1176/appi.ajp.20220243. Epub 2023 Mar 9.
PubMed 36891649
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Negative Symptoms in Schizophrenia: Intervention and Biomarkers
- ClinicalTrials.gov ID
- NCT02386605
- Acronym / sponsor ID
- D1851-W
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- recovery, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 28 Mar 2016 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 12 Mar 2015 (estimated)
- Results
- Posted 8 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 relationships[3] 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 (i.e., 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 (i.e. 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 1:1 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 (i.e., 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 (e.g., 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Behavioral: Motivational Interviewing and Cognitive Behavioral TherapyMotivational Interviewing Treatment group |
| Control | Active comparator | Behavioral: Relaxation SkillsRelaxation Skills Training group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of schizophrenia or schizoaffective disorder
- No medication changes in the past six weeks
- No psychiatric hospitalization in the past three months
- No changes in housing in the past two months
Key exclusion criteria (5 listed)
- Neurological disorder
- seizures
- history of serious head injury
- substance dependence in the past 6 months or abuse in the past month
- being insufficiently fluent in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing and Cognitive Behavioral Therapygroup-based recovery-oriented Motivational Interviewing combined with cognitive-behavioral therapy to target the negative symptoms of schizophrenia | Behavioural | Treatment |
| Relaxation SkillsRelaxation and mindfulness skills training group for comparison condition for negative symptoms of schizophrenia | Behavioural | Control |
Primary outcome
Strauss-Carpenter Level of Function Scale
Time frame: 3 months
This scale is a 43-item report of a patient's behavior and functioning across the following domains: physical functioning (e.g., vision, hearing), personal care skills (e.g., eating, grooming), interpersonal skills (e.g., initiating, accepting, and maintaining social contacts; effectively communicating), social acceptability (e.g., absence of verbal and physical abuse, absence of repetitive behaviors), community activities (e.g., shopping, using the telephone, paying bills, use of leisure time, use of public transportation), and work skills (e.g., employable skills, level of supervision, punctuality). Each item is rated on a 5 point likert scale. A functional skill composite is created by summing the interpersonal relationships, activities, and work skills domains. The range for the summary score was 64 - 120, with higher scores indicating better functioning.
Clinical Assessment Interview for Negative Symptoms
Time frame: 2 weeks
The CAINS is a 13-item instrument that yields two subscales which measure the two primary negative symptom factors: Motivation and Pleasure (MAP) which measures experiential negative symptoms and Expression which measures the expressive negative symptoms. The MAP was used as a primary dependent variable, it includes 9 items rated 0-4 and yields a mean subscale (0-4). Higher scores reflect greater impairment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36891649Reddy LF, Glynn SM, McGovern JE, Sugar CA, Reavis EA, Green MF. A Novel Psychosocial Intervention for Motivational Negative Symptoms in Schizophrenia: Combined Motivational Interviewing and CBT. Am J Psychiatry. 2023 May 1;180(5):367-376. doi: 10.1176/appi.ajp.20220243. Epub 2023 Mar 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena F Reddy principal investigator
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Cognitive Behavioral Therapy and Relaxation Skills in people with Schizophrenia and Schizoaffective Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strauss-Carpenter Level of Function Scale (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02386605, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.