Effects of Visual and Auditory Hallucinations on Cognitive and Emotional Functioning across with and without Schizophrenia individuals: A Placebo Intervention Study

Last registered on May 13, 2024

Pre-Trial

Trial Information

General Information

Title
Effects of Visual and Auditory Hallucinations on Cognitive and Emotional Functioning across with and without Schizophrenia individuals: A Placebo Intervention Study
RCT ID
AEARCTR-0013543
Initial registration date
May 02, 2024

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
May 13, 2024, 11:56 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Region

Primary Investigator

Affiliation
Foundation university Islamabad

Other Primary Investigator(s)

PI Affiliation
Foundation University School of Science and Technology

Additional Trial Information

Status
On going
Start date
2023-11-03
End date
2024-05-22
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Schizophrenia is a complex psychiatric disorder that typically presents with symptoms during late adolescence or early adulthood. This disorder is characterized by disruptions in cognitive processes, perceptions, and emotional responsiveness (American Psychiatric Association, DSM-5 Task Force, 2013). Auditory hallucinations are the sensory perceptions of hearing noises without an external stimulus and are most prevalent in patients who have psychosis (Gupta,V & Thakur, T. 2020). 60–80% of individuals with schizophrenia spectrum disorder report having auditory hallucinations (Lim, et al., 2016).According to a review of six studies (N = 42,519), 7.3% of people in general report having visual hallucinations (Waters et al, 2014).Excluding visual hallucinations resulting from physical sickness or drug/chemical usage lowers the prevalence to 6% (Ohayon, 2000).The aim of the study to examine the effect of visual and auditory hallucinations on cognitive functioning (episodic memory and amnesia) and emotional functioning (anxiety and schizophrenia) individual with and without Schizophrenia. However to investigate the potential effectiveness of a placebo intervention in individuals with and without Schizophrenia and to compare visual and auditory hallucination induction in individual with and without Schizophrenia. Moreover, the role of placebo intervention in improving the cognitive and emotional functioning will be investigated in the study. The study will be a temporal, double-blinded, simple randomized block design experiment will be conducted. The sample of 60 participants (diagnosed Schizophrenia n= 30; without Schizophrenia n=30) age of 18 and above will be recruit from different public and private hospitals and universities of Rawalpindi and Islamabad. Five scales are Positive and negative syndrome scale for schizophrenia (PANSS), Launay–Slade Hallucination Scale, Rey's auditory verbal learning test (RAVLT) , Mini mental state examination, Beck anxiety inventory alongside a detailed demographic sheet and consent form will be used. Subsequently, the participants will be induce visual and auditory hallucination and will examine effect on cognitive and emotional functioning. They will also be administered a placebo intervention to reduce the cognitive and emotional consequence induced hallucinations. Data will be collected using Psychopy software composed 10 blocks and analyzed by SPSS software. Paired sample t test, One way ANOVA and multivariate analysis will be used to analyze assumptions of the study. This study will open up new avenues for researchers and policy makers to conduct further studies to explore the role of visual and auditory hallucination across with and without Schizophrenia individuals. The study will guide the development of more effective interventions, such as psychotherapy and medication, that specifically target and address the cognitive (Episodic memory and Amnesia) and emotional (Anxiety and Schizophrenia) challenges associated with hallucination. Placebo as intervention help create better mental health treatments in clinical settings to manage symptoms using psychosocial methods.
External Link(s)

Registration Citation

Citation
Aqeel, Muhammad and Noureen bibi. 2024. "Effects of Visual and Auditory Hallucinations on Cognitive and Emotional Functioning across with and without Schizophrenia individuals: A Placebo Intervention Study." AEA RCT Registry. May 13. https://doi.org/10.1257/rct.13543-1.0
Experimental Details

Interventions

Intervention(s)
Intervention Start Date
2024-01-17
Intervention End Date
2024-03-05

Primary Outcomes

Primary Outcomes (end points)
primary outcome of my study is how induced hallucination effect the patient with and without schizophrenia
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
experiment is randomized block factorial design
Experimental Design Details
Randomization Method
done by computer
Randomization Unit
experimental sessions
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
With Schizophrenia ( n=30) without Schizophrenia (n=30)
Sample size: planned number of observations
60 individuals
Sample size (or number of clusters) by treatment arms
60 sample size
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
Centre for Cognitive and Neuroscience
IRB Approval Date
2023-12-30
IRB Approval Number
IRB-CCN-002-56789

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials