Cbt for Psychosis and Affect on Psychosis Symptoms

NCT02653729 | Completed Phase 2 DMC

• 1 other identifier: abdulsattar
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psychosis

Keywords

cognitive behaviour therapy; first episode

Outcome Measures

Primary Outcomes (3)

• 50 participant with schizophrenia assessed by PANSS

  30 item question ask from participant

  2 hours

• 50 participant with schizophrenia assessed by SAI

  three question each have two parts

  30 mintus

• 50 participant with schizophrenia assessed by PSRS

  6 item on delusion and 11 item on auditory hallucination

  1 hour

Study Arms (2)

Espidone, Olepra, Donu & C.B.T

EXPERIMENTAL

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

Behavioral: cognitive behaviour therapy; Drug: Espidone; Drug: Olepra; Drug: Donu

Espidone, Olepra & Donu

ACTIVE COMPARATOR

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

Drug: Espidone; Drug: Olepra; Drug: Donu

Interventions

cognitive behaviour therapy BEHAVIORAL

Also known as: talk therapy, conversation therapy

Espidone, Olepra, Donu & C.B.T

Espidone DRUG

Also known as: risp

Espidone, Olepra & Donu; Espidone, Olepra, Donu & C.B.T

Olepra DRUG

Also known as: olan

Espidone, Olepra & Donu; Espidone, Olepra, Donu & C.B.T

Donu DRUG

Also known as: zanzia

Espidone, Olepra & Donu; Espidone, Olepra, Donu & C.B.T

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aisha Andleeb: lead

Related Publications (2)

• 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.

  PMID: 16946354 BACKGROUND

• 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.

  PMID: 25757714 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Cognitive Behavioral Therapy; Psychotherapy; Rieske iron-sulfur protein; 24,25-oxidolanosterol; 2-((((2-chloroethyl)-nitrosoamino)carbonyl)amino)-1,3-cyclohexanediol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.phil Scholars Department of Applied Psychology

Study Record Dates

• First Submitted: January 7, 2016
• First Posted: January 12, 2016
• Study Start: September 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 13, 2016

Record last verified: 2016-01