Trial record 5 of 8 for:    breier

Integrated Metacognitive Therapy in First Episode Psychosis (IMT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Indiana University
Sponsor:
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT02131116
First received: May 2, 2014
Last updated: NA
Last verified: May 2014
History: No changes posted
  Purpose

Insight, or lack of illness awareness, is a prominent and pressing clinical concern in the treatment and recovery of patients with psychotic disorders. Impaired insight results in poor treatment engagement and adherence, more frequent hospitalizations, greater positive and negative symptoms, and poor psychosocial functioning. Addressing these complications early in the disease process may lead to altered illness course with better outcomes. To date, only a small number of nonpharmacological interventions have been developed, none of which adequately address poor insight during the first few years of psychotic illness. Further, presently available therapeutic interventions do not attend to difficulties associated with improved insight, such as depression. The purpose of this investigation is to implement a novel intervention designed to improve insight, metacognition, neurocognition, symptoms, and ultimately overall functioning in persons with early psychosis. The novel intervention will integrate a number of previously established therapeutic approaches, such as metacognitive, narrative, cognitive behavioral and motivational interviewing, and hence be labeled Integrated Metacognitive Therapy (IMT). In order to measure the efficacy of IMT, all subjects will undergo a battery of assessments in each of these domains prior to and following either a novel intervention (N = 10) or treatment as usual (N = 10) for a period of approximately six months. Throughout the study, each IMT session (N = 10, 24 sessions each) will be audio recorded, transcribed, and de-identified to allow for careful ongoing qualitative analyses of potential active and inert ingredients of the approach and ultimately the development of an IMT manual which can then be tested in a larger, more rigorous randomized control trial. This investigation will play an important role in advancing current knowledge about treating insight in early psychosis. Further, it will serve to expand upon the intervention tools available by producing a much needed treatment manual designed specifically to target insight during an illness phase crucial for positive long term outcomes in psychosis.


Condition Intervention
Schizophrenia
Schizophreniform Disorder
Schizoaffective Disorder
Behavioral: Integrated Metacognitive Therapy
Behavioral: Treatment as Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Integrated Metacognitive Approach to Improve Insight and Outcomes in Early Psychosis

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Insight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    improved insight as measured by the Scale of Unawareness of Illness

  • Insight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Insight item on the Positive and Negative Syndrome Scale

  • Insight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Beck Cognitive Insight Scale

  • metacognition [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Bell Lysaker Emotion Recognition Test

  • metacognition [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    scores on the the Eyes Test

  • metacognition [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    scores on the Hinting Test

  • metacognition [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Indiana Psychiatric Illness Interview and Metacognitive Assessment Scale),


Secondary Outcome Measures:
  • overall symptomatology [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Positive and Negative Syndrome Scale

  • overall symptomatology [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Liebowitz Social Anxiety Scale

  • neurocognition [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Brief Assessment for Cognition in Schizophrenia total score

  • neurocognition [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Trail Making Test, Part B

  • social functioning [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Quality of Life Scale

  • social functioning [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Social Functioning Scale

  • social functioning [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Marlow-Crowne Social Desirability Scale


Estimated Enrollment: 20
Study Start Date: May 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IMT
Integrated Metacognitive Therapy
Behavioral: Integrated Metacognitive Therapy
Integrated Metacognitive Therapy
Other Name: Integrated Metacognitive Therapy
Behavioral: Treatment as Usual
Treatment as Usual
Other Name: No intervention/Treatment as Usual
No Intervention: TAU
No intervention group/Treatment as Usual

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-35 years of age at study entry
  • Male or female
  • DSM IV-TR Diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder as confirmed by Structured Clinical Interview for DSM-IV-TR (SCID)
  • Onset of schizophreniform disorder, schizophrenia, or schizoaffective disorder within the past five years as defined by first medical records documentation of these conditions
  • Score of 4 or higher (moderate impairment) on the Positive and Negative Syndrome Scale (PANSS) insight item

Exclusion Criteria:

  • History of significant neurological illness or head trauma
  • Known IQ < 70 based on medical history
  • Current alcohol or drug dependence (excluding nicotine or caffeine) based on the SCID interview.
  • Subjects considered a high risk for suicidal acts - active suicidal ideation as determined by clinical interview OR any suicide attempt in 90 days prior to screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02131116

Locations
United States, Indiana
Prevention and Recovery Center for Early Psychosis Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Nikki Mehdiyoun, MA    317-880-8495    rsparc@iupui.edu   
Principal Investigator: Jenifer Vohs, PhD         
Sub-Investigator: Alan Breier, MD         
Sub-Investigator: Emily Liffick, MD         
Sub-Investigator: Michael Francis, MD         
Sub-Investigator: Kyle Minor, PhD         
Sub-Investigator: Nikki Mehdiyoun, MA         
Sub-Investigator: Teresa Kulig, MA         
Sub-Investigator: Natalie Case, MS         
Sub-Investigator: Megan Gaunnac, BA         
Sub-Investigator: Steven Lindgren, BA         
Sub-Investigator: Allison James         
Sub-Investigator: Bethany Leonart         
Sub-Investigator: Fred Malloy, MS         
Sub-Investigator: Joan Showalter, MA         
Sub-Investigator: David Spradley, RN         
Sub-Investigator: Emmalee Metzler, BA         
Sub-Investigator: Dominique White         
Psychosocial Rehabilitation and Recovery Center Active, not recruiting
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
  More Information

Additional Information:
No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT02131116     History of Changes
Other Study ID Numbers: 1401410369
Study First Received: May 2, 2014
Last Updated: May 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
schizophrenia
schizophreniform disorder
schizoaffective disorder
cognition
metacognition
insight
first epsisode psychosis
psychosis

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 11, 2014