Bipolar DisorderNCT02210390
Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan
A study testing Psycho education in people with Bipolar Disorder, run by Pakistan Institute of Living and Learning at 1 site in Pakistan.
Trial summary
Aim: To assess the Feasibility RCT of the efficacy of a culturally adapted psychological intervention for Bipolar disorder in Pakistan Design: Randomized Control Trial Setting: Psychiatric Departments of different Hospitals in Karachi. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Psycho education
- 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
- Jun 2012to May 2015
- 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
- Diagnosis of DSM IV Bipolar disorder
- Currently stable (YMRS <8, BDI<12)
- Age 18 to 65 years.
- Participants engaged with the mental health services since last 6 months.
- Able to give written informed consent.
- Resident of trial catchments area
- Ability to speak Urdu /Punjabi
Who cannot join
- Substance or alcohol dependent (i.e., those who fulfill the criteria for dependence according to DSM IV criteria)
- Inability to engage fully in the psychotherapy (due to cognitive impairment)
- Actively suicidal
- Any major psychiatric illness other than bipolar disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility RCT of the Efficacy of a Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan
Aim:
To assess the Feasibility RCT of the efficacy of a culturally adapted psychological intervention for Bipolar disorder in Pakistan
Design:
Randomized Control Trial
Setting:
Psychiatric Departments of different Hospitals in Karachi.
Participants:
A total of 36 Bipolar disorder patients will be randomized to psychological Intervention and treatment as usual arm.
Intervention:
Culturally Adapted psychological intervention for bipolar disorder
Outcome measure:
- Acceptance of intervention in terms of attending session and dropouts
- Knowledge and attitudes towards bipolar disorder
Read the detailed description
The purpose of the study is to test Feasibility RCT of the efficacy of a culturally adapted psychological intervention for Bipolar disorder in Pakistan
Primary Objectives :
- To determine effectiveness of educational intervention in terms of patient Satisfaction with overall care, knowledge and attitudes to bipolar disorder and medication adherence.
- To assess feasibility in terms of
- Recruitment
- Using instruments that will be used to assess recurrence rate in the main study (BDI, YMRS and obtaining prospective hospitalisation and medication data)
- acceptability of a culturally adapted bipolar group education package
- To allow 'fine tuning' of culturally adapted bipolar group education package (this will partly be achieved by using the SEMI at study entry)
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 twelve sessions of psychoeducation will be provided by trained research clinician during the period of three months. Patients in the treatment as usual (TAU) group will be given details of intervention at the end of the study and interested patients will be offered psychoeducation.
- Conditions
- Bipolar Disorder
- Being tested
- Psycho education
- Keywords
- Psycho-education, Bipolar , cultural adaptation, Pakistan
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycho educationBehavioural
Psycho-education Sessions will be offered weekly basis
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Psycho-education Sessions will be offered weekly basis Receives: Behavioral: Psycho education |
| Control | No intervention | 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.
Young Mania Rating Scale(YMRS)
The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms
Measured: three months
Knowledge and attitudes
Knowledge and attitudes towards bipolar disorder measured by using a standard questionnaire
Measured: three months
Beck's Depression Inventory Scale (BDI)
The BDI is a measure of depression severity and has been used in several previous studies in Pakistan and is validated for use in Urdu.
Measured: three months
Secondary outcomes (3)
Medication adherence
Self-reported Measure of Medication adherence
Measured: three months
Visual Analogue Scale
Patient satisfaction with overall care
Measured: three months
Short Explanatory Model Interview
used to elicit beliefs of mental illness
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2014 (estimated)
- Study startJun 2012
- Primary completionMay 2015
- Study completionMay 2015
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 Bipolar DisorderStudies 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
- Treatment
- 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 HospitalMuhammad I Husain, MRCPsych, Principal investigator, Camden and Islington NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210390
- Sponsor's protocol ID
- PSY-BPD-03
- Status last verified
- Dec 2016
- First submitted
- 5 Aug 2014
- Last updated
- 23 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Husain MI, Chaudhry IB, Rahman RR, Hamirani MM, Mehmood N, Haddad PM, Hodsoll J, Young AH, Naeem F, Husain N. Pilot study of a culturally adapted psychoeducation (CaPE) intervention for bipolar disorder in Pakistan. Int J Bipolar Disord. 2017 Dec;5(1):3. doi: 10.1186/s40345-017-0074-8. Epub 2017 Feb 11.
PubMed 28155203
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility RCT of the Efficacy of a Culturally Adapted Psychological Intervention for Bipolar Disorder in Pakistan
- ClinicalTrials.gov ID
- NCT02210390
- Acronym / sponsor ID
- PSY-BPD-03
- Conditions
- Bipolar Disorder
- Keywords
- Psycho-education, Bipolar , 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
- Jun 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 6 Aug 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 RCT of the efficacy of a culturally adapted psychological intervention for Bipolar disorder in Pakistan
Design:
Randomized Control Trial
Setting:
Psychiatric Departments of different Hospitals in Karachi.
Participants:
A total of 36 Bipolar disorder patients will be randomized to psychological Intervention and treatment as usual arm.
Intervention:
Culturally Adapted psychological intervention for bipolar disorder
Outcome measure:
- Acceptance of intervention in terms of attending session and dropouts
- Knowledge and attitudes towards bipolar disorder
Detailed description
The purpose of the study is to test Feasibility RCT of the efficacy of a culturally adapted psychological intervention for Bipolar disorder in Pakistan
Primary Objectives :
- To determine effectiveness of educational intervention in terms of patient Satisfaction with overall care, knowledge and attitudes to bipolar disorder and medication adherence.
- To assess feasibility in terms of
- Recruitment
- Using instruments that will be used to assess recurrence rate in the main study (BDI, YMRS and obtaining prospective hospitalisation and medication data)
- acceptability of a culturally adapted bipolar group education package
- To allow 'fine tuning' of culturally adapted bipolar group education package (this will partly be achieved by using the SEMI at study entry)
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 twelve sessions of psychoeducation will be provided by trained research clinician during the period of three months. Patients in the treatment as usual (TAU) group will be given details of intervention at the end of the study and interested patients will be offered psychoeducation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Psycho educationPsycho-education Sessions will be offered weekly basis |
| Control | No intervention | –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 (7 listed)
- Diagnosis of DSM IV Bipolar disorder
- Currently stable (YMRS <8, BDI<12)
- Age 18 to 65 years.
- Participants engaged with the mental health services since last 6 months.
- Able to give written informed consent.
Key exclusion criteria (4 listed)
- Substance or alcohol dependent (i.e., those who fulfill the criteria for dependence according to DSM IV criteria)
- Inability to engage fully in the psychotherapy (due to cognitive impairment)
- Actively suicidal
- Any major psychiatric illness other than bipolar disorder
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 |
|---|---|---|
| Psycho educationPsycho-education Sessions will be offered weekly basis | Behavioural | Intervention |
Primary outcome
Young Mania Rating Scale(YMRS)
Time frame: three months
The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms
Knowledge and attitudes
Time frame: three months
Knowledge and attitudes towards bipolar disorder measured by using a standard questionnaire
Beck's Depression Inventory Scale (BDI)
Time frame: three months
The BDI is a measure of depression severity and has been used in several previous studies in Pakistan and is validated for use in Urdu.
3 secondary outcomes
Medication adherence
Time frame: three months
Visual Analogue Scale
Time frame: three months
Short Explanatory Model Interview
Time frame: three 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 23 Dec 2016.
- Derived from this study: PubMed 28155203Husain MI, Chaudhry IB, Rahman RR, Hamirani MM, Mehmood N, Haddad PM, Hodsoll J, Young AH, Naeem F, Husain N. Pilot study of a culturally adapted psychoeducation (CaPE) intervention for bipolar disorder in Pakistan. Int J Bipolar Disord. 2017 Dec;5(1):3. doi: 10.1186/s40345-017-0074-8. Epub 2017 Feb 11.
Related trials for Bipolar Disorder
Recruiting
Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
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 Psycho education in people with Bipolar Disorder, 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 7 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 23 Dec 2016. 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?
Young Mania Rating Scale(YMRS) (time frame: three 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 NCT02210390, 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 23 Dec 2016.