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Integrated Metacognitive Therapy in First Episode Psychosis (IMT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jenifer Vohs, Indiana University
ClinicalTrials.gov Identifier:
NCT02131116
First received: May 2, 2014
Last updated: February 2, 2017
Last verified: February 2017
  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
Intervention Model: Parallel Assignment
Masking: No masking
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 Jenifer Vohs, Indiana University:

Primary Outcome Measures:
  • Insight [ Time Frame: 24 weeks ]
    improved insight as measured by the Scale of Unawareness of Illness

  • Insight [ Time Frame: 24 weeks ]
    Insight item on the Positive and Negative Syndrome Scale

  • Insight [ Time Frame: 24 weeks ]
    Beck Cognitive Insight Scale

  • metacognition [ Time Frame: 24 weeks ]
    Bell Lysaker Emotion Recognition Test

  • metacognition [ Time Frame: 24 weeks ]
    scores on the the Eyes Test

  • metacognition [ Time Frame: 24 weeks ]
    scores on the Hinting Test

  • metacognition [ Time Frame: 24 weeks ]
    Indiana Psychiatric Illness Interview and Metacognitive Assessment Scale),


Secondary Outcome Measures:
  • overall symptomatology [ Time Frame: 24 weeks ]
    Positive and Negative Syndrome Scale

  • overall symptomatology [ Time Frame: 24 weeks ]
    Liebowitz Social Anxiety Scale

  • neurocognition [ Time Frame: 24 weeks ]
    Brief Assessment for Cognition in Schizophrenia total score

  • neurocognition [ Time Frame: 24 weeks ]
    Trail Making Test, Part B

  • social functioning [ Time Frame: 24 weeks ]
    Quality of Life Scale

  • social functioning [ Time Frame: 24 weeks ]
    Social Functioning Scale

  • social functioning [ Time Frame: 24 weeks ]
    Marlow-Crowne Social Desirability Scale


Estimated Enrollment: 20
Actual Study Start Date: May 2014
Estimated Study Completion Date: June 2017
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
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   (Adult)
Sexes Eligible for Study:   All
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
Indianapolis, Indiana, United States, 46202
Psychosocial Rehabilitation and Recovery Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
  More Information

Additional Information:
Responsible Party: Jenifer Vohs, Clinical Psychologist, Indiana University
ClinicalTrials.gov Identifier: NCT02131116     History of Changes
Other Study ID Numbers: 1401410369
Study First Received: May 2, 2014
Last Updated: February 2, 2017

Keywords provided by Jenifer Vohs, Indiana University:
schizophrenia
schizophreniform disorder
schizoaffective disorder
cognition
metacognition
insight
first episode psychosis
psychosis

Additional relevant MeSH terms:
Disease
Schizophrenia
Psychotic Disorders
Mental Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders

ClinicalTrials.gov processed this record on May 25, 2017