Effect of Visual and Auditory Hallucinations on Cognitive and Emotional Functioning: A Placebo Intervention Study with and without dementia patients

Last registered on April 26, 2024

Pre-Trial

Trial Information

General Information

Title
Effect of Visual and Auditory Hallucinations on Cognitive and Emotional Functioning: A Placebo Intervention Study with and without dementia patients
RCT ID
AEARCTR-0013284
Initial registration date
April 25, 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
April 26, 2024, 12:44 PM EDT

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

Locations

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Primary Investigator

Affiliation
Foundation university school of science and technology

Other Primary Investigator(s)

PI Affiliation
Foundation University Islamabad

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
Hallucination is a sensory experience in which a person can see, hear, smell, taste, or feel something that is not actually present in the environment. Visual and auditory hallucinations have drastic effects on cognitions and emotions which leaves long term residues on dementia patients and normal individuals functionality. There is evidence that hallucinations may lead to effect the semantic memory and emotional problem like distress and depression. The effect of visual and auditory hallucination can be extremely distressing for mostly dementia patients rather than healthy individuals. However, there is very little evidence that hallucination leads towards dementia and distress or depression. There is also very little empirical data available regarding the direct impact of visual and auditory on cognitive and emotional functioning of dementia patients and normal individuals thus the current study will examine this phenomenon in detail by investigating the effect of visual and auditory hallucinations on memory and emotional responses of dementia and normal individuals. Moreover, the role of placebo intervention will also be investigated in this study. A temporal, double-blinded, randomized block design experiment will be conducted on a sample of 40 individuals between ages 40 to 65 years, 20 dementia patients and 20 normal individuals. Dementia Rating Scale, Picture Sequence Memory Test, Launay–Slade Hallucination Scale, Mini mental state examination, Beck Depression Inventory alongside a detailed demographic sheet and consent form will be administered. Subsequently, the participants will be presented with a series of visual and auditory Hallucinations, to assess the effect on their cognitive and emotional functioning. They will also be administered a placebo intervention to reduce the emotional consequence of the stimulation. Data will be collected and analyzed using Psychopy. This study will open up new avenues for researchers and policy makers to conduct further studies to improve cognitive and psychological problems which is triggered by auditory and verbal hallucinations in both normal and dementia individuals. Current experiment will help helpful in clinical settings for researchers to conduct further studies and develop new interventions to improve cognitive and psychological functioning and establish mental health centers in education to improve psychological and cognitive problems. This study will also provide a deeper understanding of the aspects of visual and auditory hallucinations as a reference for creating awareness and effective intervention strategies in the future.
External Link(s)

Registration Citation

Citation
Akhtar, Rabia and Muhammad Aqeel. 2024. "Effect of Visual and Auditory Hallucinations on Cognitive and Emotional Functioning: A Placebo Intervention Study with and without dementia patients." AEA RCT Registry. April 26. https://doi.org/10.1257/rct.13284-1.0
Experimental Details

Interventions

Intervention(s)
Intervention Start Date
2024-01-04
Intervention End Date
2024-04-30

Primary Outcomes

Primary Outcomes (end points)
hallucination is the key component by inducing hallucination we will check the outcome that is effect on semantic memory and depression
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
block randomized factorial design
Experimental Design Details
Not available
Randomization Method
randomization done by a computer
Randomization Unit
experimental sessions
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
hospitals of rawalpindi and islamabad
Sample size: planned number of observations
sample of 60
Sample size (or number of clusters) by treatment arms
60 individual, 30 dementia patients and 30 normal individuals
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
2024-01-02
IRB Approval Number
IRB01