Integrated Metacognitive Therapy in First Episode Psychosis

NCT02131116 | Completed

• 1 other identifier: 1401410369
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenia; Schizophreniform Disorder; Schizoaffective Disorder

Keywords

schizophrenia; schizophreniform disorder; schizoaffective disorder; cognition; metacognition; insight; first episode psychosis; psychosis

Outcome Measures

Primary Outcomes (7)

• Insight

  improved insight as measured by the Scale of Unawareness of Illness

  24 weeks

• Insight

  Insight item on the Positive and Negative Syndrome Scale

  24 weeks

• Insight

  Beck Cognitive Insight Scale

  24 weeks

• metacognition

  Bell Lysaker Emotion Recognition Test

  24 weeks

• metacognition

  scores on the the Eyes Test

  24 weeks

• metacognition

  scores on the Hinting Test

  24 weeks

• metacognition

  Indiana Psychiatric Illness Interview and Metacognitive Assessment Scale),

  24 weeks

Secondary Outcomes (7)

• overall symptomatology

  24 weeks

• overall symptomatology

  24 weeks

• neurocognition

  24 weeks

• neurocognition

  24 weeks

• social functioning

  24 weeks

Study Arms (2)

IMT

EXPERIMENTAL

Integrated Metacognitive Therapy

Behavioral: Integrated Metacognitive Therapy; Behavioral: Treatment as Usual

TAU

NO INTERVENTION

No intervention group/Treatment as Usual

Interventions

Integrated Metacognitive Therapy BEHAVIORAL

Integrated Metacognitive Therapy

IMT

Treatment as Usual BEHAVIORAL

Treatment as Usual

Also known as: No intervention/Treatment as Usual

IMT

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (2)

Prevention and Recovery Center for Early Psychosis

Indianapolis, Indiana, 46202, United States

Location

Psychosocial Rehabilitation and Recovery Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Study Record Dates

• First Submitted: May 2, 2014
• First Posted: May 6, 2014
• Study Start: May 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

US (2)