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.
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
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- 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
- 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
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Espidone; Drug: Olepra; Drug: Donu |
What is being measured
The primary outcome is the main question the study is designed to answer.
50 participant with schizophrenia assessed by PANSS
30 item question ask from participant
Measured: 2 hours
50 participant with schizophrenia assessed by SAI
three question each have two parts
Measured: 30 mintus
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.
- First posted12 Jan 2016 (estimated)
- Study startSep 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Aisha Andleeb
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aisha Andleeb, Bahauddin Zakariya University
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 16946354Naeem 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behaviour Therapy for Psychosis in First Episode Patient and the Outcome of Cognitive Behaviour Therapy on Psychotic Symptoms
- ClinicalTrials.gov ID
- NCT02653729
- Acronym / sponsor ID
- cbtpaps / abdulsattar
- Conditions
- Psychosis
- Keywords
- cognitive behaviour therapy, first episode
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aisha AndleebUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Espidone, Olepra, Donu & C.B.T | Experimental | Behavioral: cognitive behaviour therapy, Drug: Espidone, Drug: Olepra, Drug: DonuEspidone 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, Olepra & Donu | Active comparator | Drug: Espidone, Drug: Olepra, Drug: DonuEspidone tablet 2 mg and Donu 10 mg by mouth twice a day Olepra tablet 5 mg by mouth at night |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive behaviour therapyAlso: talk therapy, conversation therapy | Behavioural | Espidone, Olepra, Donu & C.B.T |
| EspidoneAlso: risp | Drug | Espidone, Olepra & Donu, Espidone, Olepra, Donu & C.B.T |
| OlepraAlso: olan | Drug | Espidone, Olepra & Donu, Espidone, Olepra, Donu & C.B.T |
| DonuAlso: zanzia | Drug | Espidone, Olepra & Donu, Espidone, Olepra, Donu & C.B.T |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
- Background: PubMed 16946354Aleman 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.
- Background: PubMed 25757714Naeem 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.