Condition category
Mental and Behavioural Disorders
Date applied
13/05/2019
Date assigned
04/06/2019
Last edited
07/06/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Schizophrenia is a severe long-term mental health condition. It causes a range of different psychological symptoms including hallucinations (hearing or seeing things that don't exist), delusions (unusual beliefs not based on reality), muddled thoughts based on hallucinations or delusions and changes in behaviour. Schizophrenia is a common cause of long-term disability in the 15-49-year-old group and whilst effective treatments are available, in developing countries around two-thirds of patients receive no treatment.

This lack of treatment, commonly known as the 'treatment gap' arises due to factors including poor treatment adherence, a lack of primary care involvement and poor access treatments. We have previously reported a new approach (Supervised Treatment in Out-Patients for Schizophrenia (STOPS)) that resulted in improved treatment adherence and functioning in a resource-poor setting in Khyber Pakhtunkhwa (KP), Pakistan. In this study we trained and supported relatives and family members to monitor medication taking, building on the success of a similar approach used for patients with tuberculosis.

We now aim to implement and evaluate a 'scaled-up' version of STOPS (STOPS+) which is based on the World Health Organisation mental health guidelines and maintain treatment adherence with the help of family members and text message reminders. We will work with primary care physicians and multipurpose primary are technicians to task shift care, under the supervision of mental health experts.

Who can participate?
Participants aged between 17-45 with a diagnosis of schizophrenia or schizoaffective disorder who are living within the catchment area of one of the participating Primary Healthcare Centres (PHCs).

What does the study involve?
24 PHCs in Peshawar, KP will be randomised to deliver either STOPS+ or Enhanced Treatment As Usual (ETAU). We will recruit 526 patients (263 in each arm) suffering from Schizophrenia or schizoaffective disorder. Potential participants will be identified from PHCs and hospitals. Potentially eligible patients will be informed about the trial and consent taken for a screening assessment. Eligible patients will be provided with additional information about the trial.

Once informed consent has been taken the baseline assessment will be completed. At the intervention PHCs the family member will also be provided with information about the trial, consent taken and will receive training in how to supervise their family members’ medication and will receive text message reminders for the first 3 months of participation.

Participants will be invited for a follow-up assessment at 6 and 12 months.

What are the possible benefits and risks of participating?
Those who take part may not receive any direct benefit, however the information we get from this study will help to improve access to medication and mental health treatment in primary care for people with schizophrenia.

Participants taking part in STOPS+ will continue to receive medication as they would have done otherwise and all medication provided follows current clinical guidelines. We are not investigating or testing any new medications. Medications provided at the Primary Healthcare Centre will be based on current guidelines.

For the intervention arm participants will be informed that the risk of disagreement can rarely cause a problem in relationships with supervising relative. Relatives will be trained for supervision so the risk will be minimised.

Participants will be informed that if there is any problem throughout participation the trained mental health professionals will be available for help. Participants will be informed of their right to withdraw from the study at any time if they find the supervision of treatment or any other part of the study is causing a problem.

Where is the study run from?
24 Primary Healthcare Centres in district Peshawar, Khyber Pakhtunkwa (KP).

When is the study starting and how long is it expected to run for?
The study is due to start in August 2019 and will recruit for 12 months with a 12 month treatment and follow-up period for participants.

Who is funding the study?
Keele University has been awarded the funding for this study by the Medical Research Council UK, as part of its Global Alliance for Chronic Disease programme.

Who is the main contact?
Mrs Michelle Robinson
m.e.robinson@keele.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Mrs Michelle Robinson

ORCID ID

http://orcid.org/0000-0002-2266-8250

Contact details

Research Institute for Primary Care and Health Sciences
Keele University
Staffordshire
ST5 5BG
United Kingdom
01782 734853
m.e.robinson@keele.ac.uk

Type

Scientific

Additional contact

Prof Ziaul Haq

ORCID ID

Contact details

Dean institute of Public Health and Social Sciences
Khyber Medical University
Phase V
Hayatabad
Peshawar
Khyber Pakhtunkhwa
25100
United Kingdom
+92 91 9217703, 9217696
drzia@kmu.edu.pk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

PID-180207

Study information

Scientific title

Supervised Treatment in Out-Patients for Schizophrenia: a community-based intervention to improve treatment adherence and reduce the treatment gap in schizophrenia (STOPS+).

Acronym

STOPS+

Study hypothesis

To evaluate the effectiveness of STOPS+ compared to Enhanced Treatment as Usual (ETAU) in improving the following in patients suffering from schizophrenia:
1. Functioning
2. Medication adherence

Ethics approval

1. Approved 30/04/2019, Keele University Faculty of Medicine and Health Sciences Research Ethics Committee (Keele University, Staffordshire, ST5 5BG; health.ethics@keele.ac.uk; 01782 732000), ref: MH-190017.
2. Approval pending, Khyber Medical University Ethics Board (Phase - V, Hayatabad, Khyber Pakhtunkhwa, Peshawar, Pakistan; reb@kmu.edu.pk; 091 9217258).

Study design

Cluster randomized parallel assignment single masking study

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

Schizophrenia and schizoaffective disorders

Intervention

ETAU Control arm
In Pakistan, the usual treatment for patients suffering from psychosis consists of accessing hospital-based psychiatric services with little involvement of primary care and limited provision of medication from the hospital pharmacy. Most patients buy medicines from the local chemists. This will be enhanced with the training in MhGAP for PHC physicians and regular and reliable provision of psychotropic drugs at PHC centres in both arms. ETAU provided in the control clusters will include prescribing evidence-based pharmacological treatments, outpatient attendance in the psychiatry department of the local hospital (as deemed appropriate by the consultant), and brief counselling about the treatment and outcome of the disorder. If required, patients may be admitted to an inpatient unit at the hospital. The patients will be informed that the antipsychotic medication is available in the PHC centre and they can assess the centre for the supply of medication. The PHC physician will have the option to liaise with the treating psychiatrist, as provided in the mhGAP guidelines.

The treatment and follow-up duration is for 12 months in total.

STOPS+ Intervention Arm
The intervention arm will consist of ETAU plus supervision by a trained family member for dispensing and administering medication. The family member will dispense and observe that the patient has taken the required medication and will record this information in a simple sheet of paper provided for this purpose. The treatment supervision will be reinforced by sending automated text message reminders to the person supervising the treatment at least once to confirm whether the medication has been administered.

The treatment and follow-up duration is 12 months in total.

Randomisation
Randomisation will occur at the PHC level and will be allocated using a 1:1 ratio to either intervention arm (STOPS+) or Enhanced Treatment as Usual (ETAU) and stratified by urban/rural setting.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Global Assessment of Functioning Scale (GAF, American Psychiatric Association, 2000) and Medication adherence are measured using a 5-point Likert scale (where 1 always takes medication and 5 is never), adapted from Herz et al. (2000) at baseline, 6 and 12 months.

Secondary outcome measures

1. Mental state and psychiatric symptoms are measured using the Brief Psychiatric Rating Scale (BPRS)(Overall et al, 1962) at screening, baseline, 6 and 12 months.
2. Substance abuse is measured using the Mini-International Neuropsychiatric Interview (M.I.N.I.) section on substance abuse (Sheehan et al, 1998) at screening, baseline, 6 and 12 months.
3. Caregivers’ burden is measured using the Family Burden Scale (Pai & Kapur, 1981) at baseline, 6 and 12 months.
4. Physical health assessments are measured using the Body Mass Index (BMI) Blood Pressure, waist circumference, PHC health record at baseline, 6 and 12 months.
5. Perceived stigma is measured using the internalized Stigma of Mental Illness (Lysaker et al, 2007) at baseline, 6 and 12 months.
6. Cost of care is measured using the Client Service Receipt Inventory SRI (Chisholm et al, 2000) at baseline, 6 and 12 months.
7. Quality-adjusted life year (QALY) and general Health status are measured using the EuroQoL (EQ5D) (Whynes et al, 2008) which is a standardized instrument for measuring generic health status will be used for computing quality-adjusted life year (QALY) at baseline, 6 and 12 months.
8. Side effects of antipsychotic medication are measured using the Glasgow Antipsychotic Side‐effect Scale (GASS) at baseline, 6 and 12 months.

Overall trial start date

01/05/2019

Overall trial end date

01/08/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Have a diagnosis of schizophrenia or schizoaffective disorder based on the International Classification of Disease 10 (ICD-10) criteria assessed using the Mini-International Neuropsychiatric Interview (MINI, Sheehan et al., 1998).
2. Aged between 17-45 years.
3. Do not meet the criteria for remission as defined by the Remission in Schizophrenia Working Group (Andreasen et al., 2005).
4. Have capacity and are able to give informed consent.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

526

Participant exclusion criteria

1. Have a serious or unstable medical illness.
2. Have a learning disability.
3. Have a severe drug dependence requiring treatment and/or detoxification.
4. Pregnant, trying to get pregnant or breastfeeding.

Recruitment start date

01/08/2019

Recruitment end date

31/08/2020

Locations

Countries of recruitment

Pakistan

Trial participating centre

Lady Reading Hospital
Soekarno Rd, Pipal Mandi, Peshawar,
Khyber Pakhtunkhwa
25000
United Kingdom

Trial participating centre

Khyber Medical University
Phase V Hayatabad, Peshawar,
Khyber Pakhtunkhwa
25100
United Kingdom

Sponsor information

Organisation

Khyber Medical University

Sponsor details

Khyber Medical University
Phase V
Hayatabad
Peshawar
Khyber Pakhtunkhwa
25100
United Kingdom
+92 91 9217703, 9217696
drzia@kmu.edu.pk

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

A report based on results and key policy implication will be published for district and national health authorities in English, and in Urdu for local key stakeholders. In scientific media, we expect the following major outputs: 1) a paper describing the study protocol 2) a study describing the results of the cluster RCT in a leading international peer-reviewed journal 3) a publication based on the cost-effectiveness analysis of STOP+ in an international peer-reviewed journal and 4) a paper describing the qualitative assessment and 5) a paper describing the implementation process outcomes. We will design a study specific website and also disseminate findings through social media (Facebook page and Twitter accounts).

IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/08/2022

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

07/06/2019: Internal review. 23/05/2019: Trial's existence confirmed by the Keele University FMHS Faculty Research Ethics Committee.