Motivational Negative Symptoms in Schizophrenia: Intervention and Biomarkers

NCT02386605 | Completed Results

• 1 other identifier: D1851-W
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

recovery; rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  2 weeks

Study Arms (2)

Treatment

EXPERIMENTAL

Motivational Interviewing Treatment group

Behavioral: Motivational Interviewing and Cognitive Behavioral Therapy

Control

ACTIVE COMPARATOR

Relaxation Skills Training group

Behavioral: Relaxation Skills

Interventions

Motivational Interviewing and Cognitive Behavioral Therapy BEHAVIORAL

group-based recovery-oriented Motivational Interviewing combined with cognitive-behavioral therapy to target the negative symptoms of schizophrenia

Treatment

Relaxation Skills BEHAVIORAL

Relaxation and mindfulness skills training group for comparison condition for negative symptoms of schizophrenia

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

Related Publications (1)

• 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.

  PMID: 36891649 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Motivational Interviewing; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Behavior Therapy; Psychotherapy

Results Point of Contact

• Title: Dr. Felice Reddy
• Organization: Greater Los Angeles VA Healthcare System

felice.reddy@gmail.com

3104783711

Study Officials

• Lena F Reddy

  VA Greater Los Angeles Healthcare System, West Los Angeles, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: March 12, 2015
• Study Start: March 28, 2016
• Primary Completion: December 31, 2019
• Study Completion: June 30, 2020
• Last Updated: April 8, 2021
• Results First Posted: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)