NCT02653729: cbtpaps

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

Completed Phase 2 Last updated 12 January 2016

What this trial tests

Phase 2 trial testing cognitive behaviour therapy in Psychosis in 50 participants. Completed in 1 January 2016.

Timeline

1 September 2015

Primary endpoint
1 January 2016

1 January 2016

Quick facts

Lead sponsor	Aisha Andleeb
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	50
Start date	1 September 2015
Primary completion	1 January 2016
Estimated completion	1 January 2016

Drugs / interventions tested

• cognitive behaviour therapy
• Espidone — full drug profile →
• Olepra — full drug profile →
• Donu — full drug profile →

Conditions studied

• Psychosis — all drugs for Psychosis →

Sponsor

Aisha Andleeb — full company profile →

Who can join

Adults 18 to 35, any sex, with Psychosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 50 participant with schizophrenia assessed by PANSS
  Time frame: 2 hours
  30 item question ask from participant
• 50 participant with schizophrenia assessed by SAI
  Time frame: 30 mintus
  three question each have two parts
• 50 participant with schizophrenia assessed by PSRS
  Time frame: 1 hour
  6 item on delusion and 11 item on auditory hallucination

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cognitive behavioural therapy plus standard care versus standard care for people with schizophrenia.
   Jones C, Hacker D, Xia J, Meaden A, et al · · 2018 · cited 26× · PMID 30572373 · DOI 10.1002/14651858.cd007964.pub2
2. Cognitive behavioural therapy added to standard care for first-episode and recent-onset psychosis.
   Mayer SF, Corcoran C, Kennedy L, Leucht S, et al · · 2024 · cited 4× · PMID 38470162 · DOI 10.1002/14651858.cd015331.pub2