Integrated Metacognitive Therapy in First Episode Psychosis

Completed · Not applicable

Conditions studied: Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder

In brief

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.

Key facts

Study ID

NCT02131116

Run by

Indiana University

People needed

20

Starts

2014-05-01

Expected to finish

2017-12-01

Last updated by the study team

2018-03-29

Who can join

Age: 18 and older, up to 35. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Prevention and Recovery Center for Early Psychosis — Indianapolis, Indiana, United States
• Psychosocial Rehabilitation and Recovery Center — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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