Condition category
Mental and Behavioural Disorders
Date applied
03/06/2019
Date assigned
05/06/2019
Last edited
14/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The Family Involvement intervention has been developed from existing approaches called Trialogue and psychoeducation. A key part of these approaches is bringing together several people living with mental health difficulties, their family members and mental health professionals into regular meetings. These different groups meet as equals to discuss topics that they have previously agreed on, share experiences and to learn from one another. This study aims to find whether Family Involvement can help to improve care for people living with common mental health conditions (mild-to-moderate depression and anxiety) in Pakistan. More specifically the aim is to find out how patients, family members/friends, and health professionals experience of Family Involvement improves outcomes like quality of life and symptoms for patients.

Who can participate?
Patients aged 18-65 years with mild-to-moderate depression and/or anxiety, who are enrolled in individual counselling on the Pursukoon Zindangi program

What does the study involve?
The patients receive the Family Involvement intervention at an agreed community location once per month over a 6-month period. One or two family members/ friends are recruited for each patient. These participants attend the monthly Family Involvement meetings with their relatives. Three counsellors are recruited to help facilitate the Family Involvement meetings. The Family Involvement intervention is based on principles of Trialogue and psychoeducation. It involves bringing together several patients, one or two of their family members/friends and one or two mental health professionals in monthly meetings, as equals, so that they may discuss pre-agreed topics, share experiences and mutual learning. Patients, family members/friends and clinicians are interviewed at the end of the study to see how they experienced the intervention.

What are the possible benefits and risks of participating?
Common mental health conditions including depression and anxiety cause distress to affected individuals. In countries such as Pakistan there is often a lack of human and financial resources for specialised mental health services in the community. This study will provide evidence on how to include effective and long-lasting local based interventions for community based mental health programs in the country. Overall, the study will build both mental health and research capacity within Pakistan. Additionally, for patients who will be involved in testing the intervention, this might lead to improved quality of life, social functioning and symptom reduction. Family members and friends might benefit from having space to share their experiences and learn from other patients and families, which might lead to an improved ability to provide care for their family member or friend with mental illness. No significant risks are expected from participating in this study, but it is possible that whilst completing the research assessments or interviews, the questions asked might trigger feelings of distress or anxiety. To minimise this risk, researchers with experience working with mental health disorders will be employed, research assessments can be stopped at any point, and further support can be provided to the participant if necessary. Participants might also experience anxiety trying new interventions. Throughout the intervention-testing period, patients will continue to receive their routine care, including any medication. The intervention can be stopped at any point.

Where is the study run from?
1. Interactive Research and Development (Pakistan)
2. The Indus Hospital (Pakistan)

When is the study starting and how long is it expected to run for?
May 2019 to July 2020

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
1. Ms Sana Sajun
s.sajun@qmul.ac.uk
2. Ms Erin Burn
e.burn@qmul.ac.uk
3. Ms Catherine Fung
c.fung@qmul.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Ms Sana Sajun

ORCID ID

Contact details

Unit for Social and Community Psychiatry
Newham Centre for Mental Health
London
E13 8SP
Ukraine
+44 (0)20 540 4380 Ext: 2312
s.sajun@qmul.ac.uk

Type

Scientific

Additional contact

Ms Erin Burn

ORCID ID

Contact details

Unit for Social and Community Psychiatry
Newham Centre for Mental Health
London
E13 8SP
United Kingdom
+44 (0)20 540 4380 Ext: 2344
e.burn@qmul.ac.uk

Type

Scientific

Additional contact

Ms Catherine Fung

ORCID ID

Contact details

Unit for Social and Community Psychiatry
Newham Centre for Mental Health
London
E13 8SP
United Kingdom
+44 (0)20 540 4380 Ext: 2312
c.fung@qmul.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

16/137/97

Study information

Scientific title

Testing the effectiveness, acceptability and feasibility of family involvement in common mental health conditions in Pakistan: a non-controlled trial

Acronym

Study hypothesis

To test the acceptability, feasibility and effectiveness of Family Involvement against usual treatment.
The specific research questions are:
1. How can Family Involvement be used to support community mental health care in Pakistan?
2. How is Family Involvement experienced by patients, family members/friends and professionals?
3. How do outcomes change when Family Involvement is used?

Ethics approval

1. Approved 28/02/2019, Interactive Research and Development Ethics Committee (Institutional Review Board (IRD-IRB), IRD Admin Office, 4th Floor, The Indus Hospital Research Center, Main Korangi crossing, Karachi, Pakistan; Tel: +92 (0)300 8272693; Email: irb@ird.global), ref: IRD_IRB_2019_02_005
2. Approved 16/05/2019, Queen Mary Ethics of Research Committee (Hazel Covill, Room W117, Finance Department, Queens' Building, Queen Mary University of London, Mile End Road, London, E1 4NS; Tel: +44 (0)20 7882 7915; Email: h.covill@qmul.ac.uk), ref: QMERC2019/21

Study design

Interventional single-centre non-controlled trial

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Community

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Common mental health conditions (including mild to moderate depression and anxiety)

Intervention

The Family Involvement Intervention will be tested in an open non-controlled trial with 30 patients. The patients will receive Family Involvement at an agreed location once per month over a 6 month period. 1-2 family members/friends will be recruited for each patient. These participants will attend the monthly Family Involvement meetings with their relatives. 3 counsellors will be recruited to help facilitate the Family Involvement meetings. The Family Involvement intervention is based on principles of Trialogue and psychoeducation. It involves bringing together several patients, 1-2 of their family members/friends, and 1-2 mental health professionals in monthly meetings, as equals, so that they may discuss pre-agreed topics, share experiences and mutual learning.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Quality of life measured using the Manchester Short Assessment of Quality of Life (MANSA) at baseline and 6 months

Secondary outcome measures

1. Objective social functioning, measured using Objective Social Outcome Index (SIX) at baseline and 6 months
2. Symptoms measured using Aga Khan University Anxiety and Depression Scale (AKUADs) at baseline and 6 months

Overall trial start date

20/05/2019

Overall trial end date

31/07/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Score of 20-60 on the AKUAD Scale for the symptoms of anxiety and depression
2. Aged 18-65 years old
3. Capacity to provide informed consent
4. Living within a 10 km radius of the clinic where recruitment will take place
5. Enrolled for individual counselling with Pursukoon Zindagi (Peaceful Life) Program
6. Scores 5 or below on the MANSA scale

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30 patients, 30-60 family members/friends, 3 counsellors

Participant exclusion criteria

1. Does not meet inclusion criteria
2. Primary diagnosis of substance-use disorder, organic psychosis and/or neurocognitive disorder
3. Participating in another interventional study by this or another research group

Recruitment start date

27/05/2019

Recruitment end date

30/09/2019

Locations

Countries of recruitment

Pakistan

Trial participating centre

Interactive Research and Development
4th Floor, Woodcraft Building Plot 3 & 3-A Sector 47 Korangi Creek Road
Karachi
75190
Pakistan

Trial participating centre

Indus Health Network: The Indus Hospital, Korangi
Plot C-76, Sector 31/5, Opposite، Crossing، Darussalam Society Sector 39 Korangi
Karachi
75190
Pakistan

Sponsor information

Organisation

Queen Mary University of London

Sponsor details

Mile End Road
London
E1 4NS
United Kingdom
+44 (0)20 7540 4380 Ext: 2312
s.sajun@qmul.ac.uk

Sponsor type

University/education

Website

https://www.qmul.ac.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The researchers intend to publish the quantitative and qualitative findings from this study by August 2020. Regarding dissemination, this study is part of a research group which also aims to build sustainable research capacity. The dissemination plan therefore aims to inform research, policy and practice. The researchers plan to disseminate findings across Pakistan. Dissemination will include publications, attending conferences, and using platforms like Twitter and the Group website.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. The combined sets of all data from all countries will be held at QMUL in anonymised form. Data sharing with external interests will be considered only after the publication of the finding that reflect the given data. The datasets will be available upon request from Stefan Priebe (s.priebe@qmul.ac.uk). The data collected will be both quantitative and qualitative. The duration of availability of data has not yet been decided. During the course of the study, data will be shared internally within the Group using an online data collection platform called REDCap, for basic descriptive and comparative analysis. The method for sharing the data externally (if required) will be decided in due course. Informed consent will be obtained from all participants involved in the study. All participants are assigned a patient ID at the point of enrolment and all subsequent data collected will be linked to this ID, without any link to identifiable data, following Good Clinical Practice.

Intention to publish date

31/10/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

14/06/2019: Uploaded protocol (not peer reviewed) 05/06/2019: Trial's existence confirmed by QMUL ethics committee.