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PsychosisPhase 2cbtpapsNCT02653729

Cbt for Psychosis and Affect on Psychosis Symptoms

A Phase 2 study testing cognitive behaviour therapy, Espidone and Olepra in people with Psychosis, run by Aisha Andleeb.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 35 years
Conditions the study is for
Psychosis
What is being tested?
cognitive behaviour therapy, Espidone and Olepra
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
Sep 2015to Jan 2016
Phase
Phase 2
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

  • 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.

Who cannot join

  • 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.

About this study

Official title: Cognitive Behaviour Therapy for Psychosis in First Episode Patient and the Outcome of Cognitive Behaviour Therapy on Psychotic Symptoms

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.

Read the 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

  1. To explore the effect of cognitive behavior therapy for psychosis in first episode patients.
  2. To develop a guide to conduct cognitive behavior therapy in early psychosis patients.
  3. To evaluate the major clinical outcomes in the treatment of psychotic symptoms.
  4. 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:

  1. The Psychotic Symptom Rating Scales.
  2. Positive and Negative Symptom Scale.
  3. Schedule for Assessment of Insight.

Procedure

  1. Authors of scales will be informed about usage of the scale in current research.
  2. Get permission to Dr.Farooq Naeem usage of the CBT manual of psychosis.
  3. SPSSv.20 for data analysis
Conditions
Psychosis
Being tested
cognitive behaviour therapy, Espidone, Olepra, Donu
Keywords
cognitive behaviour therapy, first episode
Medical subject headings
Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cognitive behaviour therapyBehavioural

    Also called talk therapy, conversation therapy

  • EspidoneDrug

    Also called risp

  • OlepraDrug

    Also called olan

  • DonuDrug

    Also called zanzia

Study groups in NCT02653729
Study groupRoleWhat they receive
Espidone, Olepra, Donu & C.B.TExperimentalEspidone 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
Receives: Behavioral: cognitive behaviour therapy; Drug: Espidone; Drug: Olepra; Drug: Donu
Espidone, Olepra & DonuActive comparatorEspidone tablet 2 mg and Donu 10 mg by mouth twice a day Olepra tablet 5 mg by mouth at night
Receives: Drug: Espidone; Drug: Olepra; Drug: Donu

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 50 participant with schizophrenia assessed by PANSS

    30 item question ask from participant

    Measured: 2 hours

  2. 50 participant with schizophrenia assessed by SAI

    three question each have two parts

    Measured: 30 mintus

  3. 50 participant with schizophrenia assessed by PSRS

    6 item on delusion and 11 item on auditory hallucination

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2016 (estimated)
  2. Study startSep 2015
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02653729
Sponsor's protocol ID
abdulsattar
Acronym
cbtpaps
Status last verified
Jan 2016
First submitted
7 Jan 2016
Last updated
13 Jan 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 16946354
  • 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.

    PubMed 25757714

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cognitive behaviour therapy, Espidone and Olepra in people with Psychosis, run by Aisha Andleeb.

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 6 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 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

50 participant with schizophrenia assessed by PANSS (time frame: 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02653729, which also lists 2 linked publications.

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 13 Jan 2016.

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