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Table 5 PREMIUM outcome assessments

From: 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

Instrument

Trial

Description

Outcome

Contextual validity

Beck Depression Inventory-II

HAP

21-item questionnaire assessment of depressive symptoms assessed on a scale of 0 to 3.

Mean total score

Widely used measure for evaluating depression in trials, including in India [57, 58].

Time Line Follow Back

CAP

Calendar tool supplemented by memory aids to obtain retrospective estimates of daily drinking over a specified time period.

Alcohol consumed in past two weeks (g)

Validated instrument [59] used in India [60].

AUDIT

CAP

10-item questionnaire with three questions on the amount and frequency of drinking, three questions on alcohol dependence and four on problems caused by alcohol.

Mean AUDIT score

Validated with primary health care patients in six countries [28] and used in study setting [61].

   

Remission (AUDIT score < 8)

 

Short Inventory of Problems

CAP

15-item questionnaire which assesses physical, social, intrapersonal, impulsive and interpersonal consequences of alcohol consumption.

Adverse consequences of alcohol consumption

Validated instrument [62] and used in India [63]. Translated into Konkani using standardized procedure followed by piloting.

PHQ-9

HAP CAP

Nine-item questionnaire assessment of depressive symptoms assessed on a scale of 0 to 3.

Prevalence of moderate-severe depression; mean total score.

Validated in primary care and Konkani version validated in Goa [25].

WHO Disability Assessment Schedule

HAP CAP

12-item questionnaire for measuring functional impairment over the previous 30 days. In addition, two items assess number of days the person was unable to work in the previous 30 days.

Total disability score; quality adjusted life years; number of days out of work.

Validated for international use [64] and used in previous trials in Goa [6, 65].

Client Service Receipt Inventory

HAP CAP

Questionnaire to collect data on the utilization and costs of health care and lost productivity (including that of care-givers).

Costs of illness (direct and indirect)

Previously used in trials in the study setting [66, 67] and elsewhere in India [65, 21].

Violence and suicidal behaviour

HAP CAP

Item 9 of the PHQ-9 with additional questions on suicide attempts and IPV.

Suicide plans and attempts

Based on interviews used in earlier studies in Goa [68].

   

Experience of IPV (for HAP trial only)

 
   

Perpetration of IPV (for CAP trial only)

 

Abbreviated Behavioural Activation for Depression Scale - short form

HAP

Adapted version of the Behavioural Activation for Depression Scale - short form [69].

Indicators of behavioural activation

Translated into Konkani using standardized procedure followed by piloting.

  1. AUDIT, Alcohol Use Disorders Identification Test; CAP, Counselling for Alcohol Problems; HAP, Healthy Activity Program; IPV, intimate partner violence, PHQ-9, Patient Health Questionnaire-9.