PsychosisNCT02167347
Culturally Adapted Family Intervention For Psychosis
A study testing Family intervention in people with Psychosis, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
Trial summary
Aim: To assess the feasibility of culturally adapted Family Intervention for Psychosis. Design: Randomized Control Trial Setting: psychiatric department of different hospitals Participants: A total of 36 caregivers of Psychosis patients will be randomized to psychological Intervention and treatment as usual arm. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Family intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- Feb 2012to Dec 2014
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Living with or with at least 10 hours per week face to face contact with an individual with psychosis who has a caring role. Plus the individual with psychosis themselves.
- Individuals aged between 18-65.
- Resident of Karachi.
- Participant is able to give informed written consent.
Who cannot join
- Severe drug or alcohol problem (i.e., those who fulfill the criteria for dependence according to ICD10 RDC).
- Unstable residential arrangements such that the likelihood of being available for the duration of the trial is low.
- .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Culturaly Adapted Family Intervention for Psychosis
Aim:
To assess the feasibility of culturally adapted Family Intervention for Psychosis.
Design:
Randomized Control Trial
Setting:
psychiatric department of different hospitals
Participants:
A total of 36 caregivers of Psychosis patients will be randomized to psychological Intervention and treatment as usual arm.
Intervention:
Culturally Adapted Family Intervention for Psychosis
Outcome measure:
Positive and Negative syndrome scale (PANSS) Experience of care -giving inventory(ECI) Care Well-Being \& Support(CWS)
Read the detailed description
The purpose of the study is to test the feasibility of culturally adaptive family intervention for Psychosis
Primary Objective :
- To test whether Pakistani families caring for someone with psychosis will engage with a model of family intervention which has been culturally adapted to meet their needs.
- To evaluate the acceptability of the intervention to the families who receive it and to gather feedback regarding any changes that might improve the intervention.
- To gain an impression of whether the intervention has the potential to address unmet psychological and social needs of the families and how this affects their levels of stress the investigators will conduct a feasibility pilot study to test whether Pakistani families offered the intervention will want to receive it. The Participants will be recruited from psychiatric department of different hospitals. They will be randomly divided into two groups; intervention group and treatment-as-usual group. A total of thirty six participants will be recruited in the pilot study and divided equally into two arms. This will ensure that, even after loss to follow-up, we will have at least 12 subjects per group for analysis (FDA guidance http://www.fda.gov/cder/guidance/5356fnl.pdf).Randomization will be carried out by the on offsite statistician. This will provide a reliable geographically remote service. For intervention group ten sessions of family intervention will be provided by trained research clinician during the period of three months. Relatives of Patients in the treatment as usual (TAU) group will be given details of intervention at the end of the study and interested families will be offered family intervention
- Conditions
- Psychosis
- Being tested
- Family intervention
- Keywords
- CBT, Psychosis, cultural adaptation, Pakistan
- Medical subject headings
- Psychotic Disorders, Color Vision Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family interventionBehavioural
Also called Psychosocial intervention
This 10 session Multi-modal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component
| Study group | Role | What they receive |
|---|---|---|
| Family Intervention | Experimental | Culturally Adapted Family intervention for Psychosis Sessions will be offered weekly basis Receives: Behavioral: Family intervention |
| Control | No intervention | Caregiver ' s Patients who will be randomized to the "treatment as usual" arm will receive routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative syndrome scale (PANSS)
The PANSS is a structured clinical interview consisting of 30 items designed to assess severity of symptoms over the past week on a 7-point scale.
Measured: six months
Experience of Care-giving inventory(ECI)
Commonly apply to persons who care for relative or friends With a serious mental illness
Measured: six months
Carer Wel-Being & Support(CWS)
A questionnaire for carers of people with a mental Health problem
Measured: six months
Secondary outcomes (4)
Family Questionnaire(FQ)
Find out the problem of caregiver for relative or friends With a serious mental illness.
Measured: six months
Insight rating scale
Assesses Improvement in insight
Measured: six months
Calgary Depression Scale for Schizophrenia
This is a nine-item scale developed by Addington et al. to assess depression in schizophrenia
Measured: six months
Short Explanatory Model Interview
used to elicit beliefs of mental illness
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startFeb 2012
- Primary completionJul 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Living and Learning
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manchester, Dow University of Health Sciences, Abbasi Shaheed Hospital
- Responsible party
- Sponsor
- Investigators
- Nusrat Husain, MD, Principal investigator, Pakistan Institute of Learning and Living, University of ManchesterImran Chaudhry, MD, Principal investigator, University of ManchesterFarooq Naeem, MRCPsych, Principal investigator, Pakistan Institute of Learning and Living, University of SouthamptonRaza Ur Rehman, FCPS, Principal investigator, Dow University of Health SciencesAjmal kazm, Principal investigator, Pakistan Institute of Living and LearningMunir Hamirani, FCPS, Principal investigator, Abbasi Shaheed Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167347
- Sponsor's protocol ID
- FINT-PSY-02
- Status last verified
- Aug 2015
- First submitted
- 17 Jun 2014
- Last updated
- 25 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Husain MO, Khoso AB, Renwick L, Kiran T, Saeed S, Lane S, Naeem F, Chaudhry IB, Husain N. Culturally adapted family intervention for schizophrenia in Pakistan: a feasibility study. Int J Psychiatry Clin Pract. 2021 Sep;25(3):258-267. doi: 10.1080/13651501.2020.1819332. Epub 2020 Sep 15.
PubMed 32930011
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Culturaly Adapted Family Intervention for Psychosis
- ClinicalTrials.gov ID
- NCT02167347
- Acronym / sponsor ID
- FINT-PSY-02
- Conditions
- Psychosis
- Keywords
- CBT, Psychosis, cultural adaptation, Pakistan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Pakistan Institute of Living and LearningUniversity, hospital or other
- Collaborators
- University of Manchester, Dow University of Health Sciences, Abbasi Shaheed Hospital
- Study start
- Feb 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Jun 2014 (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.
Aim:
To assess the feasibility of culturally adapted Family Intervention for Psychosis.
Design:
Randomized Control Trial
Setting:
psychiatric department of different hospitals
Participants:
A total of 36 caregivers of Psychosis patients will be randomized to psychological Intervention and treatment as usual arm.
Intervention:
Culturally Adapted Family Intervention for Psychosis
Outcome measure:
Positive and Negative syndrome scale (PANSS) Experience of care -giving inventory(ECI) Care Well-Being \& Support(CWS)
Detailed description
The purpose of the study is to test the feasibility of culturally adaptive family intervention for Psychosis
Primary Objective :
- To test whether Pakistani families caring for someone with psychosis will engage with a model of family intervention which has been culturally adapted to meet their needs.
- To evaluate the acceptability of the intervention to the families who receive it and to gather feedback regarding any changes that might improve the intervention.
- To gain an impression of whether the intervention has the potential to address unmet psychological and social needs of the families and how this affects their levels of stress the investigators will conduct a feasibility pilot study to test whether Pakistani families offered the intervention will want to receive it. The Participants will be recruited from psychiatric department of different hospitals. They will be randomly divided into two groups; intervention group and treatment-as-usual group. A total of thirty six participants will be recruited in the pilot study and divided equally into two arms. This will ensure that, even after loss to follow-up, we will have at least 12 subjects per group for analysis (FDA guidance http://www.fda.gov/cder/guidance/5356fnl.pdf).Randomization will be carried out by the on offsite statistician. This will provide a reliable geographically remote service. For intervention group ten sessions of family intervention will be provided by trained research clinician during the period of three months. Relatives of Patients in the treatment as usual (TAU) group will be given details of intervention at the end of the study and interested families will be offered family intervention
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Intervention | Experimental | Behavioral: Family interventionCulturally Adapted Family intervention for Psychosis Sessions will be offered weekly basis |
| Control | No intervention | –Caregiver ' s Patients who will be randomized to the "treatment as usual" arm will receive routine care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Living with or with at least 10 hours per week face to face contact with an individual with psychosis who has a caring role. Plus the individual with psychosis themselves.
- Individuals aged between 18-65.
- Resident of Karachi.
- Participant is able to give informed written consent.
Key exclusion criteria (3 listed)
- Severe drug or alcohol problem (i.e., those who fulfill the criteria for dependence according to ICD10 RDC).
- Unstable residential arrangements such that the likelihood of being available for the duration of the trial is low.
- .
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 |
|---|---|---|
| Family interventionAlso: Psychosocial interventionThis 10 session Multi-modal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component | Behavioural | Family Intervention |
Primary outcome
Positive and Negative syndrome scale (PANSS)
Time frame: six months
The PANSS is a structured clinical interview consisting of 30 items designed to assess severity of symptoms over the past week on a 7-point scale.
Experience of Care-giving inventory(ECI)
Time frame: six months
Commonly apply to persons who care for relative or friends With a serious mental illness
Carer Wel-Being & Support(CWS)
Time frame: six months
A questionnaire for carers of people with a mental Health problem
4 secondary outcomes
Family Questionnaire(FQ)
Time frame: six months
Insight rating scale
Time frame: six months
Calgary Depression Scale for Schizophrenia
Time frame: six months
Short Explanatory Model Interview
Time frame: six months
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 25 Aug 2015.
- Derived from this study: PubMed 32930011Husain MO, Khoso AB, Renwick L, Kiran T, Saeed S, Lane S, Naeem F, Chaudhry IB, Husain N. Culturally adapted family intervention for schizophrenia in Pakistan: a feasibility study. Int J Psychiatry Clin Pract. 2021 Sep;25(3):258-267. doi: 10.1080/13651501.2020.1819332. Epub 2020 Sep 15.
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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.
Nusrat Husain, MD principal investigator
Pakistan Institute of Learning and Living, University of Manchester
Imran Chaudhry, MD principal investigator
University of Manchester
Farooq Naeem, MRCPsych principal investigator
Pakistan Institute of Learning and Living, University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family intervention in people with Psychosis, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
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 4 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 25 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. 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?
Positive and Negative syndrome scale (PANSS) (time frame: six months). 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 NCT02167347, which also lists 1 linked publication.
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 25 Aug 2015.