Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a NA study that has completed, run by Indiana University. The registered enrollment target is 20 participants.
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
Interventions
- BEHAVIORAL Treatment as Usual
- BEHAVIORAL Integrated Metacognitive Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-05 |
| Est. Completion | 2017-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02131116
The ClinicalTrials.gov registry entry for NCT02131116 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Treatment as Usual is the first listed.
NCT02131116 reports 0 study locations.
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.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.