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NCT02131116 · ClinicalTrials.gov registry record · NA

Integrated Metacognitive Therapy in First Episode Psychosis

A NA study, sponsored by Indiana University.

Completed
Registry status
NA
Development phase
20
Enrollment target

NCT02131116: Completed NA study, sponsored by Indiana University.

NCT02131116 is a NA study that has completed, run by Indiana University. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02131116, a NA study, has completed, sponsored by Indiana University.

COMPLETED
Registry status
NA
Development phase
20 participants
Enrollment target

Study 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 t

Primary Outcome

improved insight as measured by the Scale of Unawareness of Illness

Interventions

  • BEHAVIORAL Treatment as Usual
  • BEHAVIORAL Integrated Metacognitive Therapy

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2014-05
Est. Completion 2017-12
Phase NA
Indiana University

890 total trials

What the finished NCT02131116 record still lists

NCT02131116 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Treatment as Usual is the first listed.

NCT02131116 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02131116 about?

NCT02131116 is a clinical study titled "Integrated Metacognitive Therapy in First Episode 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 poo...

What is the current status of trial NCT02131116?

This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2014-05. Estimated completion is 2017-12.

What interventions are being tested in trial NCT02131116?

The interventions under investigation include: Treatment as Usual (BEHAVIORAL), Integrated Metacognitive Therapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT02131116?

This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02131116's enrollment target sits among peer trials

20 1768th of 2000 higher than 140 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02131116, the US trial registry maintained by the National Library of Medicine. NCT02131116 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.