Integrated Metacognitive Therapy in First Episode Psychosis (IMT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02131116
Recruitment Status : Completed
First Posted : May 6, 2014
Last Update Posted : March 29, 2018
Information provided by (Responsible Party):
Jenifer Vohs, Indiana University

Brief Summary:
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 or disease Intervention/treatment Phase
Schizophrenia Schizophreniform Disorder Schizoaffective Disorder Behavioral: Integrated Metacognitive Therapy Behavioral: Treatment as Usual Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Integrated Metacognitive Approach to Improve Insight and Outcomes in Early Psychosis
Actual Study Start Date : May 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

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

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

  3. Insight [ Time Frame: 24 weeks ]
    Beck Cognitive Insight Scale

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

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

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

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

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

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

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

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

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02131116

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

Additional Information:
Responsible Party: Jenifer Vohs, Clinical Psychologist, Indiana University Identifier: NCT02131116     History of Changes
Other Study ID Numbers: 1401410369
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018

Keywords provided by Jenifer Vohs, Indiana University:
schizophreniform disorder
schizoaffective disorder
first episode psychosis

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