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The effectiveness and cost-effectiveness of lay counsellor-delivered psychological treatments for harmful and dependent drinking and moderate to severe depression in primary care in India: PREMIUM study protocol for randomized controlled trials.

Patel V, Weobong B, Nadkarni A, Weiss HA, Anand A, Naik S, Bhat B, Pereira J, Araya R, Dimidjian S, Hollon SD, King M, McCambridge J, McDaid D, Murthy P, Velleman R, Fairburn CG, Kirkwood B - Trials (2014)

Bottom Line: A major hurdle to the implementation of evidence-based psychological treatments in primary care in developing countries is the non-availability of skilled human resources.The enhanced usual care comprises providing primary health centre doctors with contextualized World Health Organization guidelines and screening results.Psychological treatments will be delivered by lay counsellors, over a maximum period of three months.

View Article: PubMed Central - HTML - PubMed

Affiliation: Sangath Centre, Alto-Porvorim, 403521 Goa, India. vikram.patel@lshtm.ac.uk.

ABSTRACT

Background: The leading mental health causes of the global burden of disease are depression in women and alcohol use disorders in men. A major hurdle to the implementation of evidence-based psychological treatments in primary care in developing countries is the non-availability of skilled human resources. The aim of these trials is to evaluate the effectiveness and cost-effectiveness of two psychological treatments developed for the treatment of depression and alcohol use disorders in primary care in India.

Methods/design: This study protocol is for parallel group, randomized controlled trials (Healthy Activity Program for moderate to severe depression, Counselling for Alcohol Problems for harmful and dependent drinking) in eight primary health centres in Goa, India. Adult primary care attendees will be screened with the Patient Health Questionnaire for depression and, in men only, the Alcohol Use Disorders Identification Test for drinking problems. Screen-positive attendees will be invited to participate; men who screen positive for both disorders will be invited to participate in the Counselling for Alcohol Problems trial. Those who consent will be allocated in a 1:1 ratio to receive either the respective psychological treatment plus enhanced usual care or enhanced usual care only using a computer generated allocation sequence, stratified by primary health centre and, for depression, by sex. The enhanced usual care comprises providing primary health centre doctors with contextualized World Health Organization guidelines and screening results. Psychological treatments will be delivered by lay counsellors, over a maximum period of three months. Primary outcomes are severity of disorder and remission rates at three months post-enrolment and, for the Counselling for Alcohol Problems trial, drinking and the impact of drinking on daily lives. Secondary outcomes include severity of disorder and remission rates at 12 months, disability scores, suicidal behaviour and economic impact, and cost-effectiveness at three and 12 months. 500 participants with depression and 400 participants with harmful drinking will be recruited. Primary analyses will be intention-to-treat.

Discussion: These trials may offer a new approach for the treatment of moderate-severe depression and drinking problems in primary care that is potentially scalable as it relies on delivery by a single pool of lay counsellors.

Trial registration: Both trials are registered with the International Society for the Registration of Clinical Trials (Healthy Activity Programme registration number ISRCTN95149997; Counselling for Alcohol Problems registration number ISRCTN76465238).

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Related in: MedlinePlus

PREMIUM trials flow chart. AUDIT, Alcohol Use Disorders Identification Test; Counselling for Alcohol Problems; HAP, Healthy Activity Program; PHQ-9, Patient Health Questionnaire-9; PHC, Primary Health Clinic; FU, Follow Up.
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Figure 1: PREMIUM trials flow chart. AUDIT, Alcohol Use Disorders Identification Test; Counselling for Alcohol Problems; HAP, Healthy Activity Program; PHQ-9, Patient Health Questionnaire-9; PHC, Primary Health Clinic; FU, Follow Up.

Mentions: The flow chart (Figure 1) shows the process of recruitment and follow-up of participants in the trials. The HAP trial will include participants of both genders, and the CAP trial will only include male participants because HD and AD are rare in women in India [24]. Eligible patients will be invited to participate in either the HAP or CAP trial as appropriate by the health assistant after the patient’s consultation session with the PHC doctor. After provision of written and verbal information, consent will be sought. A record of the age, educational attainment, marital status, gender, screening questionnaire score and reason for refusal will be maintained for those who do not consent. Eligible patients who are willing to participate in the trial but are unable to complete the informed consent procedure due to time constraints will be invited to return on another occasion, or followed-up by the health assistant at their homes or a convenient location to complete the procedure. Such patients will be allowed a period of two weeks to confirm their participation in the trials. Recruitment will be censored to a maximum of the first two to three eligible participants per day (irrespective of the type of disorder) to ensure uniform staggering across all PHCs (which vary in size of patient attendance) and to avoid over-loading of counsellors.


The effectiveness and cost-effectiveness of lay counsellor-delivered psychological treatments for harmful and dependent drinking and moderate to severe depression in primary care in India: PREMIUM study protocol for randomized controlled trials.

Patel V, Weobong B, Nadkarni A, Weiss HA, Anand A, Naik S, Bhat B, Pereira J, Araya R, Dimidjian S, Hollon SD, King M, McCambridge J, McDaid D, Murthy P, Velleman R, Fairburn CG, Kirkwood B - Trials (2014)

PREMIUM trials flow chart. AUDIT, Alcohol Use Disorders Identification Test; Counselling for Alcohol Problems; HAP, Healthy Activity Program; PHQ-9, Patient Health Questionnaire-9; PHC, Primary Health Clinic; FU, Follow Up.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4230277&req=5

Figure 1: PREMIUM trials flow chart. AUDIT, Alcohol Use Disorders Identification Test; Counselling for Alcohol Problems; HAP, Healthy Activity Program; PHQ-9, Patient Health Questionnaire-9; PHC, Primary Health Clinic; FU, Follow Up.
Mentions: The flow chart (Figure 1) shows the process of recruitment and follow-up of participants in the trials. The HAP trial will include participants of both genders, and the CAP trial will only include male participants because HD and AD are rare in women in India [24]. Eligible patients will be invited to participate in either the HAP or CAP trial as appropriate by the health assistant after the patient’s consultation session with the PHC doctor. After provision of written and verbal information, consent will be sought. A record of the age, educational attainment, marital status, gender, screening questionnaire score and reason for refusal will be maintained for those who do not consent. Eligible patients who are willing to participate in the trial but are unable to complete the informed consent procedure due to time constraints will be invited to return on another occasion, or followed-up by the health assistant at their homes or a convenient location to complete the procedure. Such patients will be allowed a period of two weeks to confirm their participation in the trials. Recruitment will be censored to a maximum of the first two to three eligible participants per day (irrespective of the type of disorder) to ensure uniform staggering across all PHCs (which vary in size of patient attendance) and to avoid over-loading of counsellors.

Bottom Line: A major hurdle to the implementation of evidence-based psychological treatments in primary care in developing countries is the non-availability of skilled human resources.The enhanced usual care comprises providing primary health centre doctors with contextualized World Health Organization guidelines and screening results.Psychological treatments will be delivered by lay counsellors, over a maximum period of three months.

View Article: PubMed Central - HTML - PubMed

Affiliation: Sangath Centre, Alto-Porvorim, 403521 Goa, India. vikram.patel@lshtm.ac.uk.

ABSTRACT

Background: The leading mental health causes of the global burden of disease are depression in women and alcohol use disorders in men. A major hurdle to the implementation of evidence-based psychological treatments in primary care in developing countries is the non-availability of skilled human resources. The aim of these trials is to evaluate the effectiveness and cost-effectiveness of two psychological treatments developed for the treatment of depression and alcohol use disorders in primary care in India.

Methods/design: This study protocol is for parallel group, randomized controlled trials (Healthy Activity Program for moderate to severe depression, Counselling for Alcohol Problems for harmful and dependent drinking) in eight primary health centres in Goa, India. Adult primary care attendees will be screened with the Patient Health Questionnaire for depression and, in men only, the Alcohol Use Disorders Identification Test for drinking problems. Screen-positive attendees will be invited to participate; men who screen positive for both disorders will be invited to participate in the Counselling for Alcohol Problems trial. Those who consent will be allocated in a 1:1 ratio to receive either the respective psychological treatment plus enhanced usual care or enhanced usual care only using a computer generated allocation sequence, stratified by primary health centre and, for depression, by sex. The enhanced usual care comprises providing primary health centre doctors with contextualized World Health Organization guidelines and screening results. Psychological treatments will be delivered by lay counsellors, over a maximum period of three months. Primary outcomes are severity of disorder and remission rates at three months post-enrolment and, for the Counselling for Alcohol Problems trial, drinking and the impact of drinking on daily lives. Secondary outcomes include severity of disorder and remission rates at 12 months, disability scores, suicidal behaviour and economic impact, and cost-effectiveness at three and 12 months. 500 participants with depression and 400 participants with harmful drinking will be recruited. Primary analyses will be intention-to-treat.

Discussion: These trials may offer a new approach for the treatment of moderate-severe depression and drinking problems in primary care that is potentially scalable as it relies on delivery by a single pool of lay counsellors.

Trial registration: Both trials are registered with the International Society for the Registration of Clinical Trials (Healthy Activity Programme registration number ISRCTN95149997; Counselling for Alcohol Problems registration number ISRCTN76465238).

Show MeSH
Related in: MedlinePlus