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Cbt for Psychosis and Affect on Psychosis Symptoms (cbtpaps)

Primary Purpose

Psychosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
cognitive behaviour therapy
Espidone
Olepra
Donu
Sponsored by
Aisha Andleeb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis focused on measuring cognitive behaviour therapy, first episode

Eligibility Criteria

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

Inclusion Criteria:

  • Patients diagnosed with psychosis by psychiatrist of the recruiting unit.
  • Patients with duration of illness till 3 years.
  • Patients with the minimum of 5 years of education.
  • Patients within the age range of 18 to 35 years.
  • Competent and willing to give informed consent.
  • Patients living in the study catchment area.

Exclusion Criteria:

  • Patients with drug induced psychosis.
  • Patients with severe psychopathology, unable to give informed consent.
  • Patients suffering from organic or neurological disorder.
  • Patients suffering from chronic physical condition.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Espidone, Olepra, Donu & C.B.T

    Espidone, Olepra & Donu

    Arm Description

    Espidone tablet 2 mg and Donu 10 mg by mouth twice a day and Olepra tablet 5 mg by mouth at night and C.B.T 6 session program 45 minutes session after every 15 days

    Espidone tablet 2 mg and Donu 10 mg by mouth twice a day Olepra tablet 5 mg by mouth at night

    Outcomes

    Primary Outcome Measures

    50 participant with schizophrenia assessed by PANSS
    30 item question ask from participant
    50 participant with schizophrenia assessed by SAI
    three question each have two parts
    50 participant with schizophrenia assessed by PSRS
    6 item on delusion and 11 item on auditory hallucination

    Secondary Outcome Measures

    Full Information

    First Posted
    January 7, 2016
    Last Updated
    January 12, 2016
    Sponsor
    Aisha Andleeb
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02653729
    Brief Title
    Cbt for Psychosis and Affect on Psychosis Symptoms
    Acronym
    cbtpaps
    Official Title
    Cognitive Behaviour Therapy for Psychosis in First Episode Patient and the Outcome of Cognitive Behaviour Therapy on Psychotic Symptoms
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    January 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Aisha Andleeb

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study aims to examine the effectiveness of cognitive behavior therapy for psychosis in first episode patients and see the outcome of CBT on psychotic symptoms. Because cognitive behavior therapy mostly use in depressive patient to treat the negative thinking pattern Cognitive behavioral approaches in the treatment of psychosis have become more prevalent in recent years for a number of reasons. Evidence has been available for the past two or three decades regarding the success of these techniques with other forms of psychopathology such as depression, anxiety disorders, and medical problems. Anxiety, depression and low self-esteem have been cited as the most common consequences of psychotic disorders. The observation has also emerged that many patients develop their own coping strategies for reducing the frequency, severity, and disruptiveness of their symptoms. There has also been increasing evidence regarding the influence of social environmental factors on the course of psychosis and the development of stress-vulnerability models to explain these relationships. Research suggests that 20 to 50 percent of persons with psychosis who receive neuroleptics continue to experience difficulties related to their psychotic symptoms.
    Detailed Description
    This research aims to examine the effect of cognitive and behavior therapy for psychosis in first episode patients and see the outcome of CBT on psychotic symptoms. Cognitive and Behavior Therapy for Psychosis Cognitive behavioral therapy (CBT) is talking therapy that can help to manage problems by changing the way you think and behave. There are notable clinical successes in treating common emotional disorders using cognitive-behavioral approaches based on precise theoretical models. In anxiety disorders, the underlying fear beliefs are tested in behavioral experiments to substantially reduce symptoms; in depression, mood is lifted by reevaluating negative views of the self and limiting excessive rumination. With psychosis, similar psychological processes are active in the experience of delusions and hallucinations. For example, persecutory delusions are conceptualized as threat beliefs that are the patient's attempts to make sense of his or her personal experiences, while hallucinations are problematic when they are interpreted by the patient as representing powerful and destructive forces. Hence, in cognitive therapy for psychosis, fearful thoughts are carefully reevaluated; withdrawal from social contact and activity is gradually reversed; and feelings of hope, control, and self-worth are fostered. Patients with psychosis are given time to talk about their experiences and, importantly, strategies are developed from this collaborative discussion. In this one-on-one therapy, distressing experiences take center stage. The first generation of cognitive-behavioral therapy (CBT) for psychosis, when added to standard care, has demonstrated efficacy in treating patients with delusions and hallucinations. Psychosis Psychosis is a serious mental disorder characterized by thinking and emotions that are so impaired, that they indicate that the person experiencing them has lost contact with reality. People with psychosis are described as psychotic. People experiencing psychosis may exhibit some personality changes and thought disorder. Depending on its severity, this may be accompanied by unusual or bizarre behavior, as well as difficulty with social interaction and impairment in carrying out daily life activities. The term "psychosis" is very broad and can mean anything from relatively normal aberrant experiences through to the complex and catatonic expressions of schizophrenia and bipolar type 1 disorder. In properly diagnosed psychiatric disorders (where other causes have been excluded by extensive medical and biological laboratory tests), psychosis is a descriptive term for the hallucinations, delusions, sometimes violence, and impaired insight that may occur. Psychosis is generally the term given to noticeable deficits in normal behavior (negative signs) and more commonly to diverse types of hallucinations or delusional beliefs, especially as regards the relation between self and others as in grandiosity and paranoia. Objectives To explore the effect of cognitive behavior therapy for psychosis in first episode patients. To develop a guide to conduct cognitive behavior therapy in early psychosis patients. To evaluate the major clinical outcomes in the treatment of psychotic symptoms. To examine the feasibility of cognitive behavior therapy in psychotic patients. Rationale of the study This study aims to examine the effectiveness of cognitive behavior therapy for psychosis in first episode patients and see the outcome of CBT on psychotic symptoms. Because cognitive behavior therapy mostly use in depressive patient to treat the negative thinking pattern Cognitive behavioral approaches in the treatment of psychosis have become more prevalent in recent years for a number of reasons. Evidence has been available for the past two or three decades regarding the success of these techniques with other forms of psychopathology such as depression, anxiety disorders, and medical problems. Anxiety, depression and low self-esteem have been cited as the most common consequences of psychotic disorders. The observation has also emerged that many patients develop their own coping strategies for reducing the frequency, severity, and disruptiveness of their symptoms. There has also been increasing evidence regarding the influence of social environmental factors on the course of psychosis and the development of stress-vulnerability models to explain these relationships. Research suggests that 20 to 50 percent of persons with psychosis who receive neuroleptics continue to experience difficulties related to their psychotic symptoms. The therapeutic process consists of helping the patient become aware of his or her internal stream of thoughts when distressed, and to identify and modify the dysfunctional thoughts. Behavioral techniques are used to bring about functional changes in behavior, regulate emotion, and help the cognitive restructuring process. Modifying the patient's underlying dysfunctional beliefs leads to lasting improvements. In this structured therapy, the therapist and patient work collaboratively to use an approach that features reality testing and experimentation. Method Research Design The present study will be a feasibility rater blind randomized controlled trial study to test the efficacy of brief CBT for patients with suffering from first episode psychosis. Sample Total 50 patients meeting the inclusion criteria of the study will be recruited from psychiatry unit of a public hospital of Raheem yar khan, Pakistan. conducted by using 50 patient met the eligibility criteria. Instruments/Assessment Measures The following assessment measures will be used in the research: The Psychotic Symptom Rating Scales. Positive and Negative Symptom Scale. Schedule for Assessment of Insight. Procedure Authors of scales will be informed about usage of the scale in current research. Get permission to Dr.Farooq Naeem usage of the CBT manual of psychosis. SPSSv.20 for data analysis

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psychosis
    Keywords
    cognitive behaviour therapy, first episode

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Espidone, Olepra, Donu & C.B.T
    Arm Type
    Experimental
    Arm Description
    Espidone tablet 2 mg and Donu 10 mg by mouth twice a day and Olepra tablet 5 mg by mouth at night and C.B.T 6 session program 45 minutes session after every 15 days
    Arm Title
    Espidone, Olepra & Donu
    Arm Type
    Active Comparator
    Arm Description
    Espidone tablet 2 mg and Donu 10 mg by mouth twice a day Olepra tablet 5 mg by mouth at night
    Intervention Type
    Behavioral
    Intervention Name(s)
    cognitive behaviour therapy
    Other Intervention Name(s)
    talk therapy, conversation therapy
    Intervention Type
    Drug
    Intervention Name(s)
    Espidone
    Other Intervention Name(s)
    risp
    Intervention Type
    Drug
    Intervention Name(s)
    Olepra
    Other Intervention Name(s)
    olan
    Intervention Type
    Drug
    Intervention Name(s)
    Donu
    Other Intervention Name(s)
    zanzia
    Primary Outcome Measure Information:
    Title
    50 participant with schizophrenia assessed by PANSS
    Description
    30 item question ask from participant
    Time Frame
    2 hours
    Title
    50 participant with schizophrenia assessed by SAI
    Description
    three question each have two parts
    Time Frame
    30 mintus
    Title
    50 participant with schizophrenia assessed by PSRS
    Description
    6 item on delusion and 11 item on auditory hallucination
    Time Frame
    1 hour

    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: Patients diagnosed with psychosis by psychiatrist of the recruiting unit. Patients with duration of illness till 3 years. Patients with the minimum of 5 years of education. Patients within the age range of 18 to 35 years. Competent and willing to give informed consent. Patients living in the study catchment area. Exclusion Criteria: Patients with drug induced psychosis. Patients with severe psychopathology, unable to give informed consent. Patients suffering from organic or neurological disorder. Patients suffering from chronic physical condition.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16946354
    Citation
    Aleman A, Agrawal N, Morgan KD, David AS. Insight in psychosis and neuropsychological function: meta-analysis. Br J Psychiatry. 2006 Sep;189:204-12. doi: 10.1192/bjp.189.3.204.
    Results Reference
    background
    PubMed Identifier
    25757714
    Citation
    Naeem F, Saeed S, Irfan M, Kiran T, Mehmood N, Gul M, Munshi T, Ahmad S, Kazmi A, Husain N, Farooq S, Ayub M, Kingdon D. Brief culturally adapted CBT for psychosis (CaCBTp): A randomized controlled trial from a low income country. Schizophr Res. 2015 May;164(1-3):143-8. doi: 10.1016/j.schres.2015.02.015. Epub 2015 Mar 8.
    Results Reference
    background

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