AzTrials
AzTrials

First Episode PsychosisNCT03501160

Socially Inappropriate Behaviour in People With First Episode Psychosis: A Caregivers' Perspective

An observational study of First Episode Psychosis, run by Chinese University of Hong Kong at 2 sites in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Social impairment is one of the core symptoms in first episode psychosis (FEP). Despite negative symptoms and social cognition impairment found in patient suffering from FEP, clinicians occasionally identified socially inappropriate behaviours (SIB) after onset and stabilization of psychotic disorder. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
First Episode Psychosis
What is being tested?
Face-to face semi-structured in-depth interview
How many people
8 participants
Where
2 sitesHong Kong
Study dates
12 Jun 2018to 31 Oct 2019
Phase
Observational
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 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Social impairment is one of the core symptoms in first episode psychosis and a part of its diagnostic criteria. Social impairment not only affects families and working performance but also creates distress and disharmony in social interactions and relationships. Despite of negative symptoms and social cognitive impairment found in patient suffering from first episode psychosis, clinicians occasionally identified socially inappropriate affectionate behavior after onset of psychotic disorder. Socially inappropriate behavior was mainly observed as social inappropriate affectionate behavior, childish behavior and regressive behavior. Clinicians observed some patient became excessively dependent on family members and displayed intimate physical contact towards family members.

Who may be able to join

  • Active Chinese case in psychiatric specialist out-patient clinic
  • Suffering from schizophrenic spectrum disorder (ICD-10)
  • Showing socially inappropriate behavior after onset and stabilization of schizophrenic spectrum disorder

Who cannot join

  • Case of bipolar affective disorder, drug induced psychosis and intellectual disability
  • Case of active substance abuse
  • Case of presenting active psychotic symptoms

Trial locations and contacts

2 sites in 1 country.

Hong Kong2 sites
  • North District Hospital, Hospital Authority

    Sheung Shui

  • Alice Ho Miu Ling Nethersole Hospital, Hospital Authority, HKSAR

    Tai Po

Other trials in Hong Kong

About this study

Social impairment is one of the core symptoms in first episode psychosis (FEP). Despite negative symptoms and social cognition impairment found in patient suffering from FEP, clinicians occasionally identified socially inappropriate behaviours (SIB) after onset and stabilization of psychotic disorder. It is also uncommon that some caregivers often complain about their relatives with psychosis of embarrassing and immature behaviour. SIB mainly observed in form of excessive emotional expression, childish behaviour and regressive behaviour. There is limited research focusing on this inadequate behavioural pattern in patient with first episode psychosis recently. It was worth investigating this phenomenon and gain more understanding in other comorbidity symptoms and caregiving distress arisen from this. Psychometric tests and validated assessment tools are well-developed for measuring positive symptoms, negative symptoms, neurocognitive deficits and social cognition impairment in schizophrenic patients but none of them is useful specifically for assessing SIB, and not to mention, from carer's perspective. It could be an obstacle for clinicians to investigate the phenomena of the prevalence and the impact on family in real life without any validated assessment tools or questionnaires. This qualitative study aims to identify the SIB in patients with FEP and to explore the caregiving experience and distress. Hopefully, this study may help designing a questionnaire for future exploration on this topic.

Read the detailed description

Study Design

This study will be conducted in descriptive qualitative design. Descriptive qualitative design is an eclectic and pragmatic approach. It presents comprehensive summaries of a phenomenon or events in everyday language. It studies a phenomenon to discover patterns and themes about life events intensely. Meanings of the data provided by informants should be kept as much as possible in any interpretation of the researcher. It helps to in-depth understand the experiences of caring individuals with first episode psychosis in Hong Kong. It also allows them to express their observed socially inappropriate behaviors and perceived burdens and coping strategies in their own words. It allows researches to focus on discovering the experiences and gaining insights from informants regarding a poorly understood phenomenon and develop questionnaires or interventions.

Sampling

Purposive sampling will be employed in this study. Purposive sampling allows rich and in-depth data collection as researcher purposely selecting subjects who are judged to be suitable in the population or particularly knowledgeable about the issues under study. It is particular well suited to this study as it provides a systematic way of exploring the full picture of the observed phenomenon. Using homogeneous purposive sampling can ensure selecting samples for having a shared characteristic or set of characteristics and focusing on one specific subgroup in which all the sample members are similar in a particular level or hierarchy.

The subjects will be recruited from Alice Ho Miu Ling Nethersole Hospital (AHNH) and North District Hospital (NDH) psychiatric specialist out-patient clinic. The psychiatrists working in Early Assessment Services for Young People with psychosis (EASY) team will refer the suitable Chinese cases after granted the agreement from potential subjects. The Inclusion criteria framed all target subjects were Hong Kong primary caregivers whose offspring was primary diagnosed of schizophrenic spectrum disorder with social inappropriate behavior after onset of illness. The patient should be under active care by EASY team. The cases of bipolar affective disorder and drug induced psychosis should be excluded from the study. In addition, the cases of active substance abuse and presenting active psychotic symptoms were also not suitable for the study.

Study Population Description

Socially inappropriate behavior was occasionally identified by clinicians in patient with first episode psychosis. SIB was mainly observed as social inappropriate affectionate behavior, childish behavior and regressive behavior. Clinicians observed some patient became excessively dependent on family members and displayed intimate physical contact towards family members. Such socially inappropriate behaviors may explain by frontal lobe dysfunction or deficits in theory of mind.

Socially inappropriate behaviour, as well as social disinhibition, is defined as inappropriate behaviours in term of verbal, physical or sexual acts which reflect a loss of inhibition or an inability to conform to social or cultural behavioural norms. The broad definition of SIB is regarded as physical actions with intimate or sexual behaviours which acting impulsively in motor and verbal expression. Also, SIB is also descried as a behavioural syndrome characterized by immaturity and insensitivity towards others. Research study showed SIB could be assumed to result from deficits in theory of mind as patient failed to understanding of other's mind and perspective. Various psychiatric and neurologic disorders are notable for further developing of socially inappropriate behaviours. Frontal lobe dysfunction, frontal lobe lesions, traumatic brain injury, Tourette's syndrome and frontotemporal dementia were found correlated to the development of socially inappropriate behaviours. The affected patients are unable to correctly identify moral transgressions or having impairment in judgement in their actual behaviours, excessive emotionally based acts and sexual misbehaviours.

Research studies indicated evidence in frontal lobe dysfunction is one of the major causes of SIB in the pathogenesis of schizophrenic spectrum disorder. The schizophrenic patient who suffered from frontal lobe damage demonstrated dramatic personality change, cognitive impairment and negative symptoms. The frontal system damage induced specific impairment of deficits in various aspects especially causing impulsive acts, inappropriate activities, excessive emotional expressions and childish behaviours. It is commonly to find patient shown declining in cognitive functioning, social impairment, poor motivation, lack of responsibility and impaired judgement in related to frontal lobe dysfunction.

Data Collection

Face-to face semi-structured in-depth interview will be arranged in order to explore the inappropriate social behavior and caregiver stress from caregivers. The interview will be guided by a semi-structured interview guide which specially designed for exploring clinical picture of inappropriate social and affectionate behavior and caregiving distress. The interview guide mainly consisted of specific questions and open-ended questions that encourage the subjects to talk freely in relevant topics during interview. Demographic data was also collected in the beginning of interview. Each interview will be conducted around 60 minutes until data saturated. The interview will be audio-taped with informed consent from subjects. The interview will be audio-taped and being transcribed into verbatim in text material for data analysis.

Data analysis

Data collected in the interview was audio taped and being transcribed into verbatim in text material for data analysis. Content analysis is used for analyzing the content of the collected data. It is used for analyzing the numerous findings to identify prominent themes and patterns among all collected data. It is commonly known as breaking down collected data into smaller units and grouping the similar content and concept into a sub-group with specific coding and naming. Phases and key words identified in the content of collected data which shared the common ground and meaning were interpreted and divided into related themes in order to disseminate the findings in category scheme. It determines the trends and relationship of reality by systematic coding and categorizing approach. Verbatim and related narrative materials were reviewed repeatedly by principal investigator in order to identify the underlying themes accurately and precisely.

Ethical Consideration

The study was governed and monitored by NTEC-CUHK Joint CREC. Potential subjects were invited purposively to attend the interview with full disclosure of the study. Written informed consent must be obtained from the subjects before the interview. The consent form clearly stated the essential information of study and the rights of being a research subject in Chinese. Subjects had freedom to refuse joining the study and answering questions from researchers. Subjects had the right to withdraw from the study at any time. All data and information collected was regarded as confidential and strictly accessible by responding researchers only. All data collected will be encrypted with password (electronic documents) and placed in safety place with double lock (written documents). All data and information collected in the study including audio-tape recordings and the verbatim materials will be destroyed after the completion of the study. This study do not involve any treatment or procedure differ from current treatment practice to subjects.

Being tested
Face-to face semi-structured in-depth interview
Keywords
Regressive behaviors, Childish behaviors, Socially Inappropriate Behaviors, Qualitative study, Schizophrenic spectrum disorder, First episode psychosis, Caregiving experience, Caregiving distress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Face-to face semi-structured in-depth interviewOther

    Face-to face semi-structured in-depth interview will be arranged in order to explore the inappropriate social behavior and caregiver stress from caregivers. The interview will be guided by a semi-structured interview guide which specially designed for exploring clinical picture of inappropriate social and affectionate behavior and caregiving distress. The interview guide mainly consisted of specific questions and open-ended questions that encourage the subjects to talk freely in relevant topics during interview. Demographic data was also collected in the beginning of interview. Each interview will be conducted around 60 minutes until data saturated. The interview will be audio-taped with informed consent from subjects.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Socially inappropriate behavior in patients with first episode psychosis and its related prevailing caregiving stress and burdens.

    To identify and assess the clinical pictures of socially inappropriate behavior in first episode psychosis and its impact and related caregiving stress from caregivers' perspective by using face-to face semi-structured in-depth interview.

    This piece of study would explore the socially inappropriate behavior in patients with first episode psychosis. This study was expected to provide a descriptive summary and further understanding on the phenomenon interested. It would hope to arouse social attention and provide insight in future planning of social and healthcare resources in community regarding the prevailing burdens and caregiving stress perceived by caregivers of individuals who diagnosed first episode psychosis with socially inappropriate behavior in Hong Kong.

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2018
  2. Study start12 Jun 2018
  3. Primary completion31 Oct 2019
  4. Study completion31 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Family based
Time perspective
Retrospective
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03501160
Sponsor's protocol ID
Joint CUHK-NTEC CREC 2018.079
Status last verified
Jul 2021
First submitted
1 Apr 2018
Last updated
30 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Arciniegas DB, Wortzel HS. Emotional and behavioral dyscontrol after traumatic brain injury. Psychiatr Clin North Am. 2014 Mar;37(1):31-53. doi: 10.1016/j.psc.2013.12.001.

    PubMed 24529422
  • Bratlien U, Oie M, Lien L, Agartz I, Lie Romm K, Vaskinn A, Ueland T, Andreassen OA, Melle I. Social dysfunction in first-episode psychosis and relations to neurocognition, duration of untreated psychosis and clinical symptoms. Psychiatry Res. 2013 May 15;207(1-2):33-9. doi: 10.1016/j.psychres.2012.10.010. Epub 2012 Nov 13.

    PubMed 23153893
  • Breitborde NJ, Kleinlein P, Srihari VH. Self-determination and first-episode psychosis: associations with symptomatology, social and vocational functioning, and quality of life. Schizophr Res. 2012 May;137(1-3):132-6. doi: 10.1016/j.schres.2012.02.026. Epub 2012 Mar 22.

    PubMed 22445463
  • Breitborde NJ, Srihari VH, Woods SW. Review of the operational definition for first-episode psychosis. Early Interv Psychiatry. 2009 Nov;3(4):259-65. doi: 10.1111/j.1751-7893.2009.00148.x.

    PubMed 22642728
  • Chang WC, Lau CFC, Chan SSI, Hui CLM, Chan SKW, Lee EHM, Lin J, Chen EYH. Premorbid, clinical and cognitive correlates of primary negative symptoms in first-episode psychosis. Psychiatry Res. 2016 Aug 30;242:144-149. doi: 10.1016/j.psychres.2016.05.045. Epub 2016 Jun 1.

    PubMed 27280524
  • Chen ES, Chang WC, Hui CL, Chan SK, Lee EH, Chen EY. Self-stigma and affiliate stigma in first-episode psychosis patients and their caregivers. Soc Psychiatry Psychiatr Epidemiol. 2016 Sep;51(9):1225-31. doi: 10.1007/s00127-016-1221-8. Epub 2016 Apr 27.

    PubMed 27118543
  • Compton, M. T., & Broussard, B. (2009). The first episode of psychosis: A guide for patients and their families. Oxford: Oxford University Press

  • Cornblatt BA, Carrion RE, Addington J, Seidman L, Walker EF, Cannon TD, Cadenhead KS, McGlashan TH, Perkins DO, Tsuang MT, Woods SW, Heinssen R, Lencz T. Risk factors for psychosis: impaired social and role functioning. Schizophr Bull. 2012 Nov;38(6):1247-57. doi: 10.1093/schbul/sbr136. Epub 2011 Nov 10.

    PubMed 22080497
  • Corrigan, P. W., & Watson, A. C. (2002). The paradox of self-stigma and mental illness. Clinical Psychology: Science & Practice, 9, 35-53.

  • Cowen, P., Harrison, P., & Burns, T. (2012). Shorter Oxford textbook of psychiatry. Oxford: Oxford University Press.

  • Cressman VL, Schobel SA, Steinfeld S, Ben-David S, Thompson JL, Small SA, Moore H, Corcoran CM. Anhedonia in the psychosis risk syndrome: associations with social impairment and basal orbitofrontal cortical activity. NPJ Schizophr. 2015 Jul 15;1:15020. doi: 10.1038/npjschz.2015.20. eCollection 2015.

    PubMed 27336033
  • Cuesta MJ, Garcia de Jalon E, Campos MS, Ibanez B, Sanchez-Torres AM, Peralta V. Duration of untreated negative and positive symptoms of psychosis and cognitive impairment in first episode psychosis. Schizophr Res. 2012 Nov;141(2-3):222-7. doi: 10.1016/j.schres.2012.08.019. Epub 2012 Sep 16.

    PubMed 22989921
  • Dodell-Feder D, Tully LM, Hooker CI. Social impairment in schizophrenia: new approaches for treating a persistent problem. Curr Opin Psychiatry. 2015 May;28(3):236-42. doi: 10.1097/YCO.0000000000000154.

    PubMed 25768085
  • Eddy CM, Cavanna AE. On being your own worst enemy: an investigation of socially inappropriate symptoms in Tourette syndrome. J Psychiatr Res. 2013 Sep;47(9):1259-63. doi: 10.1016/j.jpsychires.2013.05.019. Epub 2013 Jun 13.

    PubMed 23768869
  • Elo S, Kyngas H. The qualitative content analysis process. J Adv Nurs. 2008 Apr;62(1):107-15. doi: 10.1111/j.1365-2648.2007.04569.x.

    PubMed 18352969

Questions about this trial

What is this clinical trial studying?

An observational study of First Episode Psychosis, run by Chinese University of Hong Kong at 2 sites in Hong Kong.

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 3 inclusion and 3 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 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

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?

Socially inappropriate behavior in patients with first episode psychosis and its related prevailing caregiving stress and burdens. (time frame: 12 Months). 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 NCT03501160, which also lists 56 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 30 Jul 2021.

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