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Integrated Metacognitive Therapy in First Episode Psychosis (IMT)

Primary Purpose

Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrated Metacognitive Therapy
Treatment as Usual
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring schizophrenia, schizophreniform disorder, schizoaffective disorder, cognition, metacognition, insight, first episode psychosis, psychosis

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prevention and Recovery Center for Early Psychosis
  • Psychosocial Rehabilitation and Recovery Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IMT

TAU

Arm Description

Integrated Metacognitive Therapy

No intervention group/Treatment as Usual

Outcomes

Primary Outcome Measures

Insight
improved insight as measured by the Scale of Unawareness of Illness
Insight
Insight item on the Positive and Negative Syndrome Scale
Insight
Beck Cognitive Insight Scale
metacognition
Bell Lysaker Emotion Recognition Test
metacognition
scores on the the Eyes Test
metacognition
scores on the Hinting Test
metacognition
Indiana Psychiatric Illness Interview and Metacognitive Assessment Scale),

Secondary Outcome Measures

overall symptomatology
Positive and Negative Syndrome Scale
overall symptomatology
Liebowitz Social Anxiety Scale
neurocognition
Brief Assessment for Cognition in Schizophrenia total score
neurocognition
Trail Making Test, Part B
social functioning
Quality of Life Scale
social functioning
Social Functioning Scale
social functioning
Marlow-Crowne Social Desirability Scale

Full Information

First Posted
May 2, 2014
Last Updated
March 27, 2018
Sponsor
Indiana University
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1. Study Identification

Unique Protocol Identification Number
NCT02131116
Brief Title
Integrated Metacognitive Therapy in First Episode Psychosis
Acronym
IMT
Official Title
An Integrated Metacognitive Approach to Improve Insight and Outcomes in Early Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The National Advisory Mental Health Council recently called for the development of non-pharmacological treatments that identify and target specific disease processes for clinical improvement in schizophrenia and other psychotic illnesses. One such illness process, vital for positive outcomes, is impaired awareness of illness or insight. Insight is often thought of as factual knowledge and acknowledgement of one's illness. More specifically, insight in psychosis has been conceptualized as a multi-dimensional construct, with several independent but overlapping dimensions, such as the ability to appropriately label aberrant mental events (e.g. hallucinations and delusions), recognition of illness, and willingness to engage in treatment. Relative to individuals with other mental illnesses, those with psychotic illness have the most impaired insight, presenting a number of challenges, including: poor treatment engagement and adherence, more frequent hospitalizations, greater positive and negative symptoms, and poor psychosocial functioning. This problem is particularly relevant in early phases of psychotic illness, where there remains a paucity of data. Data that is available has shown decreased insight is associated with increased symptoms and poorer cognitive functioning, both of which have the potential to impact illness course. Two reasons account for a lack of attention to the development of treatments for insight: i) the lack of an adequate model of the forces which cause and sustain poor insight and ii) a failure to consider an integrated treatment. Without an idea of the processes which sustain poor insight, interventions have been able to offer education about the nature of illness but have not been equipped to respond to the underlying processes that block the emergence of insight in treatment. While earlier literature framed insight as a failure to grasp a specific fact, more recent efforts suggest poor insight is primarily the result of a failure to create a coherent account of the complex events and personal experiences related to a psychiatric illness. These difficulties becoming aware of one's illness may be multi-determined and result from factors including deficits in metacognition, neurocognition, and symptoms. The development of insight is complex and highly dependent upon metacognitive processes, which have a unique, potentially moderating role. Metacognition involves a range of faculties that allow an individual to form representations of mental states of self and others, which then leads to the formation and revision of thoughts, beliefs, feelings, behaviors, and even individual aspirations. Therapies targeting metacognitive or mentalizing deficits have been successfully implemented for personality disorders, depression and anxiety. In psychotic disorders, decreased metacognitive capacity is thought to result in difficulties identifying the source of one's experiences, such as illness and its consequences. This leads to an inability to perceive the self as an active agent in the world and problems in understanding and acting upon the social cues (emotions and intentions) of others. A recently proposed Integrated Metacognitive therapeutic approach argues that insight will improve as an individual utilizes a constructed narrative to make sense of his or her experiences. In other words, illness and its consequences are understood in an individualized, personally relevant and acceptable way. Importantly, this approach addresses many obstacles to gaining insight not addressed by other approaches, including learning to deal with related emotional pain and depression, loss, and internalized stigma. This view is also consistent with intervention research showing that establishment of personal meaning is important for recovery, and promotes improved function and reduced symptoms. Case studies from our group and others have provided evidence that therapy targeting metacognitive processes is feasible in psychotic disorders and can indeed improve insight and function in persons with chronic schizophrenia. However, this approach has not been tailored to target insight, evaluated or tested in patients in the early phase of psychosis. In addition to metacognitive deficits, neurocognitive deficits have also been commonly observed in schizophrenia and involve decrements in capacities for attention/vigilance, verbal memory and executive function. Deficits in executive function have been found to predict concurrent and prospective assessments of poorer insight, spurring hypotheses that impairments in executive function leave persons unable to synthesize illness related experiences into a coherent and adequate story about how and why they are ill. Deficits in attention and memory may additionally obscure how historical events are connected to each other. As a whole, neurocognitive deficits may cause difficulties piecing together the individual's experience of illness into a coherent whole resulting in poor insight. Therefore, development of personal narratives using an integrated therapy would allow subjects the opportunity to better understand their illness experience, hence improving insight. The research presented above suggests that improving insight early in the psychotic disease process would likely result in improved treatment participation, ultimately leading to better outcomes. Motivated by a clear and pressing need to better address illness insight in early psychotic illness and recent positive findings related to doing so, the present investigation serves to test a novel Integrated Metacognitive Therapy (IMT) which targets insight and other important domains in early psychosis. Assuming IMT is successful, ongoing qualitative analysis of IMT sessions will allow for manual development, future randomized control trials, and ultimately treatment dissemination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder
Keywords
schizophrenia, schizophreniform disorder, schizoaffective disorder, cognition, metacognition, insight, first episode psychosis, psychosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IMT
Arm Type
Experimental
Arm Description
Integrated Metacognitive Therapy
Arm Title
TAU
Arm Type
No Intervention
Arm Description
No intervention group/Treatment as Usual
Intervention Type
Behavioral
Intervention Name(s)
Integrated Metacognitive Therapy
Intervention Description
Integrated Metacognitive Therapy
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual
Other Intervention Name(s)
No intervention/Treatment as Usual
Intervention Description
Treatment as Usual
Primary Outcome Measure Information:
Title
Insight
Description
improved insight as measured by the Scale of Unawareness of Illness
Time Frame
24 weeks
Title
Insight
Description
Insight item on the Positive and Negative Syndrome Scale
Time Frame
24 weeks
Title
Insight
Description
Beck Cognitive Insight Scale
Time Frame
24 weeks
Title
metacognition
Description
Bell Lysaker Emotion Recognition Test
Time Frame
24 weeks
Title
metacognition
Description
scores on the the Eyes Test
Time Frame
24 weeks
Title
metacognition
Description
scores on the Hinting Test
Time Frame
24 weeks
Title
metacognition
Description
Indiana Psychiatric Illness Interview and Metacognitive Assessment Scale),
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
overall symptomatology
Description
Positive and Negative Syndrome Scale
Time Frame
24 weeks
Title
overall symptomatology
Description
Liebowitz Social Anxiety Scale
Time Frame
24 weeks
Title
neurocognition
Description
Brief Assessment for Cognition in Schizophrenia total score
Time Frame
24 weeks
Title
neurocognition
Description
Trail Making Test, Part B
Time Frame
24 weeks
Title
social functioning
Description
Quality of Life Scale
Time Frame
24 weeks
Title
social functioning
Description
Social Functioning Scale
Time Frame
24 weeks
Title
social functioning
Description
Marlow-Crowne Social Desirability Scale
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Prevention and Recovery Center for Early Psychosis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Psychosocial Rehabilitation and Recovery Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Links:
URL
http://psychiatry.medicine.iu.edu/iupdp
Description
Related Info

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Integrated Metacognitive Therapy in First Episode Psychosis

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