SchizophreniaIMTNCT02131116
Integrated Metacognitive Therapy in First Episode Psychosis
A study testing Integrated Metacognitive Therapy and Treatment as Usual in people with Schizophrenia and Schizophreniform Disorder, run by Indiana University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder
- What is being tested?
- Integrated Metacognitive Therapy and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Prevention and Recovery Center for Early Psychosis
Indianapolis, Indiana, 46202
Psychosocial Rehabilitation and Recovery Center
Indianapolis, Indiana, 46202
About this study
Official title: An Integrated Metacognitive Approach to Improve Insight and Outcomes in Early Psychosis
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.
Read the 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.
- Being tested
- Integrated Metacognitive Therapy, Treatment as Usual
- Keywords
- schizophrenia, schizophreniform disorder, schizoaffective disorder, cognition, metacognition, insight, first episode psychosis, psychosis
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Metacognitive TherapyBehavioural
Integrated Metacognitive Therapy
Treatment as UsualBehavioural
Also called No intervention/Treatment as Usual
Treatment as Usual
| Study group | Role | What they receive |
|---|---|---|
| IMT | Experimental | Integrated Metacognitive Therapy Receives: Behavioral: Integrated Metacognitive Therapy; Behavioral: Treatment as Usual |
| TAU | No intervention | No intervention group/Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insight
improved insight as measured by the Scale of Unawareness of Illness
Measured: 24 weeks
Insight
Insight item on the Positive and Negative Syndrome Scale
Measured: 24 weeks
Insight
Beck Cognitive Insight Scale
Measured: 24 weeks
metacognition
Bell Lysaker Emotion Recognition Test
Measured: 24 weeks
metacognition
scores on the the Eyes Test
Measured: 24 weeks
metacognition
scores on the Hinting Test
Measured: 24 weeks
metacognition
Indiana Psychiatric Illness Interview and Metacognitive Assessment Scale),
Measured: 24 weeks
Secondary outcomes (7)
overall symptomatology
Positive and Negative Syndrome Scale
Measured: 24 weeks
overall symptomatology
Liebowitz Social Anxiety Scale
Measured: 24 weeks
neurocognition
Brief Assessment for Cognition in Schizophrenia total score
Measured: 24 weeks
neurocognition
Trail Making Test, Part B
Measured: 24 weeks
social functioning
Quality of Life Scale
Measured: 24 weeks
social functioning
Social Functioning Scale
Measured: 24 weeks
social functioning
Marlow-Crowne Social Desirability Scale
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenifer Vohs, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02131116
- Sponsor's protocol ID
- 1401410369
- Acronym
- IMT
- Status last verified
- Mar 2018
- First submitted
- 2 May 2014
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Metacognitive Approach to Improve Insight and Outcomes in Early Psychosis
- ClinicalTrials.gov ID
- NCT02131116
- Acronym / sponsor ID
- IMT / 1401410369
- Keywords
- schizophrenia, schizophreniform disorder, schizoaffective disorder, cognition, metacognition, insight, first episode psychosis, psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 6 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMT | Experimental | Behavioral: Integrated Metacognitive Therapy, Behavioral: Treatment as UsualIntegrated Metacognitive Therapy |
| TAU | No intervention | –No intervention group/Treatment as Usual |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Metacognitive TherapyIntegrated Metacognitive Therapy | Behavioural | IMT |
| Treatment as UsualAlso: No intervention/Treatment as UsualTreatment as Usual | Behavioural | IMT |
Primary outcome
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),
7 secondary outcomes
overall symptomatology
Time frame: 24 weeks
overall symptomatology
Time frame: 24 weeks
neurocognition
Time frame: 24 weeks
neurocognition
Time frame: 24 weeks
social functioning
Time frame: 24 weeks
social functioning
Time frame: 24 weeks
social functioning
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Metacognitive Therapy and Treatment as Usual in people with Schizophrenia and Schizophreniform Disorder, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insight (time frame: 24 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.