PREMIUM twelve-month follow-up trial: Clinical Outcomes and Cost-effectiveness dataset from the Healthy Activity Program (HAP) RCT – Data Codebook

Persistent identifier

10.17037/DATA.205

Description

The Program for Effective Mental Health Interventions in Under-Resourced Health Systems (PREMIUM) sought to develop and assess scalable psychological treatments that are culturally appropriate, affordable, and feasible for delivery by non-specialist health workers and apply these treatments to the two leading mental health disorders: moderately severe to severe depression (the Healthy Activity Program [HAP]) and harmful drinking (Counselling for Alcohol Problems [CAP]).

This data collection contains records of adult male/female Primary Health Centres (PHC) attenders (one patient per row) recruited in the trials site between October 28th 2013 and July 30th 2015, and followed-up for outcome assessments until September 30th 2016. It encompasses enrolment, treatment process (including therapy quality), cost-effectiveness, and clinical/other outcome data. Only variables relevant for the analysis of our twelve-month follow-up are presented.

Data access conditions

The HAP dataset is made available through controlled access, in accordance with the study’s ethical approvals. Researchers interested in the data should complete the application form, outlining the research that they are performed and data in which they are interested. If access is approved, they will subsequently be asked to sign a data transfer agreement to protect participant confidentiality.

Data Codebook

The submission is comprised of three datasets outlined below:

PREMIUM_HAP_Econ_dataset_3_and_12_months_dataset
PREMIUM_main_12month_followup_effectiveness_wide
PREMIUM_Repeated_Measures_Mediation_Long

Please contact the relevant authors for questions related to the dataset content.

PREMIUM_HAP_Econ_dataset_3_and_12_months_dataset

Variable Name	Variable Label	Answer Label	Answer Code	Variable Type
no	Patient ID	Open ended		Numeric
B_Patient_Age	Patient age	Open ended		Numeric
B_Patient_Gender	Patient gender			Numeric
		Female	1
		Male	2
B_Expect_cat1	How useful do you think this treatment will be for you to recover from your health problems?	Open ended		Numeric
B_Patient_Marital_Status	Marital status of patient at baseline			Numeric
		Married	1
		Never married	2
		Widowed	3
		Divorced or separated	4
		Living with someone as a couple	5
B_Patient_Occupation	Patient occupation at baseline			Numeric
		Student	1
		Unemployed	2
		Housewife(does not work outside home)	3
		labourer/domestic worker/farmer	4
		Trader, Food seller	5
		Seamstress, Hairdresser, Driver	6
b_PHQ_cat	PHQ Category	Open ended		Numeric
oe3_bdi_total_calculated	oe3 BDI Total calculated	Open ended		Numeric
remit3	PHQ remission at 3 months			Numeric
		non-remit	0
		remit	1
c3_pub_cost_PHC	C3 Public cost - PHC	Open ended		Numeric
c3_pub_cost_HDoc	c3 pub cost HDoc	Open ended		Numeric
c3_pub_cost_hospital	c3 pub cost hospital	Open ended		Numeric
c3_tot_pub_lab_costs	c3 total pub lab costs	Open ended		Numeric
c3_tot_public_med_costs	c3 total public med costs	Open ended		Numeric
c3_Overall_intervention_cost	c3 Overall intervention cost	Open ended		Numeric
c3_total_public_purse_cost	c3 total public purse cost	Open ended		Numeric
c3_total_oop_costs	c3 total oop costs	Open ended		Numeric
c3_total_all_pub_prod_narrow	c3 total all pub prod narrow	Open ended		Numeric
c3_total_all_pub_prod_nw_das1516	c3 total all pub prod nw das1516	Open ended		Numeric
c12_pub_cost_PHC	c12 pub cost PHC	Open ended		Numeric
c12_pub_cost_HDoc	c12 pub cost HDoc	Open ended		long
c12_pub_cost_hospital	c12 pub cost hospital	Open ended		Numeric
c12_tot_pub_lab_costs	c12 total pub lab costs	Open ended		Numeric
c12_tot_public_med_costs	c12 total public med costs	Open ended		Numeric
N_c12_Overall_intervention_cost	N c12 Overall intervention cost	Open ended		Numeric
N_c12_total_public_costs	N c12 total public costs	Open ended		long
N_c12_total_oop_costs	N c12 total oop costs	Open ended		long
N_c12_total_all_pub_prod_narrow	N c12 total all pub prod narrow	Open ended		long
N_c12_total_all_pub_prod_nw_das1	N c12 total all pub prod nw das1	Open ended		long
Yr_pub_cost_PHC	Year pub cost PHC	Open ended		Numeric
Yr_pub_cost_Hdoc	Year pub cost Hdoc	Open ended		long
Yr_pub_cost_hospital	Year pub cost hospital	Open ended		Numeric
Yr_tot_pub_lab_costs	Year total pub lab costs	Open ended		Numeric
Yr_tot_public_med_costs	Year total public med costs	Open ended		Numeric
Yr_total_public_costs	Year total public costs	Open ended		long
Yr_total_prod_costs_narrow	Year total prod costs narrow	Open ended		Numeric
Yr_cost_who_das_15and16	Year cost who das 15 and 16	Open ended		long
Yr_total_public_purse_cost	Year total public purse cost	Open ended		long
Yr_tot_all_pub_prod_narrow_das15	Year total all pub prod narrow das15	Open ended		long
pub_cost_PHC_	pub cost PHC	Open ended		Numeric
pub_cost_Hdoc_	pub cost Hdoc	Open ended		Numeric
pub_cost_hospital_	pub cost hospital	Open ended		Numeric
tot_pub_lab_costs_	tot pub lab costs	Open ended		Numeric
tot_public_med_costs_	tot public med costs	Open ended		Numeric
total_public_costs_	total public costs	Open ended		Numeric
Overall_intervention_cost_	Overall intervention cost	Open ended		Numeric
total_prod_costs_narrow_	total prod costs narrow	Open ended		Numeric
cost_who_das_15and16_	cost who das 15 and 16	Open ended		Numeric
total_public_purse_cost_	total public purse cost	Open ended		Numeric
tot_all_pub_prod_narrow_das1516_	Total all pub prod narrow das1516	Open ended		Numeric
trial_arm				Numeric
		A	0
		B	1
QALY_3_MONTH	QALY values for last 30 days after 3 months	Open ended		Numeric
QALY_12_MONTH	QALY values for 30 days at 12 months	Open ended		Numeric
Total_QALY		Open ended		Numeric
remit12	PHQ remission at 12 months			Numeric
		non-remit	0
		remit	1
oe12_phq9_totscore	12 Months Outcome PHQ Total	Open ended		Numeric
remission	Remission status			Numeric
		non-remit	0
		remit	1
oe12_bditotal	12 Months Outcome BDI Total	Open ended		Numeric
newid	Patient ID	Open ended		Numeric

PREMIUM_main_12month_followup_effectiveness_wide

Variable Name	Variable Label	Answer Label	Answer Code	Variable Type
newid	Patient ID	Open ended		Numeric
trial_arm	Trial Arm			Numeric
		A	0
		B	1
		Group PT	2
B_PHC_Code	Kindly select your PHC			Numeric
		Bicholim-BI	1
		Candolim- CA	2
		Siolim - SI	3
		Sanquelim -SQ	4
		Valpoi - VA	5
		Pernem-PN	6
		Aldona- AL	7
		Casarvarnem - CM	8
		Betki	9
		Corlim / Divar	10
B_Consent_study	Has the patient consented for Study?			Numeric
		No	0
		Yes	1
B_Patient_Age	Patient's Age in completed years	Open ended		Numeric
agegrp	Patient age group in completed years			Numeric
		18-24	1
		25-34	2
		35-44	3
		45-54	4
		>=55	5
B_Patient_Marital_Status	Patient's Marital Status			Numeric
		Married	1
		Never Married	2
		Widowed	3
		Divorced or separated	4
		Living with someone as a couple	5
B_Patient_Gender	Patient's Gender			Numeric
		Female	1
		Male	2
B_PatientExpectations	You may be allocated to see a counsellor as part of your treatment for the health problems the questionnaire has shown that may be having			Numeric
		Not useful	1
		A little useful	2
		Somewhat useful	3
		Moderately useful	4
		Very Useful	5
B_Expect_cat1	How useful do you think this treatment will be for you to recover from your health problems?			Numeric
		<=somewhat	2
		Moderate	3
		Very	4
		Missing	9
B_Expect_cat_bin	How useful do you think this treatment will be for you to recover from your health problems? (Category)			Numeric
		<=somewhat	0
		Moderate or Very	1
		Missing	9
B_PHQ_Problems_began_bin	Time period that problems began			Numeric
		12 weeks or under	1
		Over 12 wks	2
oe3_int_status	Status of patient on visit			Numeric
		Present & Agreed for Interview	1
		Present, Refused	2
		Died	3
		Temporarily unable to respond to interview or Temporarily absent	4
		Could not locate address	5
		Interview not completed even after 5 visits	6
		Permanently Emigrated	7
oe12_bdi_total_calculated	oe12 Beck Depression Inventory (BDI) total calculated	Open ended		Numeric
oe12_phq9_totscore_calculated	oe12_phq9_totscore_calculated	Open ended		Numeric
b_PHQ_cat	PHQ category at baseline			Numeric
		Moderately severe	0
		Severe	1
response12m10cutoff	PHQ response at 12 months			Numeric
		non-response	0
		response	1
fullrelapsephq10	Full relapse PHQ-10			Numeric
		no full relapse	0
		full relapse	1
partrelapsephq10	Partial relapse PHQ-10			Numeric
		No partial relapse	0
		Partial relapse	1
ipv12_any	Intimate Partner Violence			Numeric
		ipv absent	0
		ipv present	1
		not currently married	998
oe12_das_tot	12 Months Outcome WHODAS Total	Open ended		Numeric
oe12_das15_act_unable	WHODAS_15. In the past 30 days, for how many days were you totally unable to carry out your usual activities or work because of any health condition?	Open ended		Numeric
oe12_suicide_attempt	IN THE PAST 3 MONTHS have you made an attempt to take your life, by taking an over			Numeric
		No	0
		Yes	1
oe12_bdi_total_2	oe12 Beck Depression Inventory (BDI) Total	Open ended		Numeric
recoveryat12m5cutoff				Numeric
		non-recovered	0
		recovered	1
suicide12_combined	suicide12_combined			Numeric
		non-recovered	0
		recovered	1
ipv12_phys	Physical intimate partner violence			Numeric
		ipv absent	0
		ipv present	1
		not currently married	998
ipv12_psych	Psychological or emotional intimate partner violence			Numeric
		No	0
		Yes	1
		Not applicable	998
changephq	Absolute change in PHQ score from baseline to 12 months	Open ended		Numeric
propreducphq	Relative change in PHQ score from baseline to 12 months	Open ended		Numeric
globratetension	Reported changes in Depression / Tension in last 12 Months			Numeric
		Worse	0
		No change	1
		Better	2
		Fully recovered	3
globratetension_bin	Ration of depression/tension			Numeric
		not better	0
		better/recovered	1
mcidabsolut_bin	MCID Absolute - binary			Numeric
		No MCID	0
		MCID	1
mcidrelative_bin	MCID relative - binary			Numeric
		No MCID	0
		MCID	1
anyresponse	Any response			Numeric
		non-response at either 3 or 12 months	0
		phq-9<10 at either 3 or 12 months	1
oe3_badsf_tot		Open ended		Numeric
oe3_attend	Attendance			Numeric
		Attended 3 months	1
		Did not attend 3 month	2
in_trt_stat	in_trt_stat			Numeric
		Dropout / Un-planned Discharge	0
		Planned Discharge	1
Refferal	Refferal	Open ended		Numeric
Tot_no_sessions	Total number of Sessions attended			Numeric
		No sessions done	0
Mean_session_dur	Average session duration	Open ended		Numeric
Tot_no_sessions_calc	Total number of Sessions attended (calculated - see notes)	Open ended		Numeric
Mean_session_dur_cal		Open ended		Numeric
oe12_ADT_use	Patient-level use of Anti-Depressants drugs			Numeric
		No	0
		Yes	1
oe12_mcidtension	2. Overall, thinking back since the time you entered this study one year ago, ho			Numeric
		Become worse	0
		About the same/no change	1
		Better	2
		Fully recovered	3
oe12_attend	oe12_attend			Numeric
	oe3_12_attend	Attended 12 months	1
		Did not attend 12 month	2
oe3_12_attend	oe3_12_attend			Numeric
		Attended both	1
		Neither 3 nor 12	2
		Either 3 or 12	3
any3_12_sae	any3_12_sae	Open ended		Numeric
tot12_sae	tot12_sae	Open ended		Numeric
any3_12_adt	any3_12_adt	Open ended		Numeric

PREMIUM_Repeated_Measures_Mediation_Long

Variable Name	Variable Label	Answer Label	Answer Code	Variable Type
newid	Patient ID	Open ended		Numeric
trial_arm	Trial Arm			Numeric
		A	0
		B	1
		Group PT	2
B_PHC_Code	Primary health Centre			Numeric
		Bicholim-BI	1
		Candolim- CA	2
		Siolim ? SI	3
		Sanquelim ? SQ	4
		Valpoi - VA	5
		Pernem-PN	6
		Aldona- AL	7
		Casarvarnem - CM	8
		Betki	9
		Corlim / Divar	10
B_Consent_study	Has the patient consented for Study?			Numeric
		No	0
		Yes	1
B_Patient_Age	Patient's Age in completed years	Open ended		Numeric
agegrp	Patient's age group in completed years			Numeric
		18-24	1
		25-34	2
		35-44	3
		45-54	4
		55 or over	5
B_Patient_Marital_Status	Patient's Marital Status			Numeric
		Married	1
		Never Married	2
		Widowed	3
		Divorced or separated	4
		Living with someone as a couple	5
B_Patient_Gender	Patient's gender			Numeric
		Female	1
		Male	2
B_PatientExpectations	You may be allocated to see a counsellor as part of your treatment for the health problems the questionnaire has shown that may be having			Numeric
		Not useful	1
		A little useful	2
		Somewhat useful	3
		Moderately useful	4
		Very Useful	5
B_Expect_cat1	How useful do you think this treatment will be for you to recover from your health problems?			Numeric
		<=somewhat	2
		Moderate	3
		Very	4
		Missing	9
B_Expect_cat_bin	How useful do you think this treatment will be for you to recover from your health problems? (Category)			Numeric
		<=somewhat	0
		Moderate or Very	1
		Missing	9
B_PHQ_Problems_began_bin	Time period that problems began			Numeric
		12 weeks or under	1
		More than 12 wks	2
oe3_int_status	Status of patient on visit			Numeric
		Present & Agreed for Interview	1
		Present, Refused	2
		Died	3
		Temporarily unable to respond to interview or temporarily absent	4
		Could not locate address	5
		Interview not completed even after 5 visits	6
		Permanently Emigrated	7
oe12_bdi_total_calculated	oe12 BDI Total calculated	Open ended		Numeric
oe12_phq9_totscore_calculated	oe12 phq9 Total score calculated	Open ended		Numeric
b_PHQ_cat	PHQ category			Numeric
		Moderately severe	0
		Severe	1
response_	Response			Numeric
		non-response	0
		response	1
fullrelapsephq10	Full relapse PHQ10			Numeric
		no full relapse	0
		full relapse	1
partrelapsephq10	Partial relapse PHQ10			Numeric
		no partial relapse	0
		partial relapse	1
ipv12_any	Intimate Partner Violence			Numeric
		ipv absent	0
		ipv present	1
		not currently married	998
oe12_das_tot	12 Months Outcome WHODAS Total	Open ended		Numeric
oe12_das15_act_unable	WHODAS_15. In the past 30 days, for how many days were you totally unable to carry out your usual activities or work because of any health condition?	Open ended		Numeric
oe12_suicide_attempt	IN THE PAST 3 MONTHS have you made an attempt to take your life, by taking an overdose			Numeric
		No	0
		Yes	1
oe12_bdi_total_2	oe12 BDI total	Open ended		Numeric
recoveryat12m5cutoff	Recovery at 12 months			Numeric
		non-recovered	0
		recovered	1
suicide12_combined	suicide12_combined			Numeric
		No	0
		Yes	1
suicide_thought12_bin	Suicidal thoughts (binary)			Numeric
		?
		?
ipv12_phys	Physical intimate partner violence (IPV)			Numeric
		ipv absent	0
		ipv present	1
		not currently married	998
ipv12_psych	Psychological or emotional intimate partner violence (IPV)	ipv absent	0	Numeric
		ipv present	1
		not currently married	998

changephq	Absolute change in PHQ score from baseline to 12 months	Open ended		Numeric
propreducphq	Relative change in PHQ score from baseline to 12 months	Open ended		Numeric
globratetension	Reported changes in depression/tension in last 12 Months			Numeric
		Worse	0
		No change	1
		Better	2
		Fully recovered	3
globratetension_bin	Reported changes in depression/tension in last 12 Months (category)			Numeric
		not better	0
		better/recovered	1
mcidabsolut_bin	MCID Absolute - binary			Numeric
		No MCID	0
		MCID	1
mcidrelative_bin	MCID Relative - binary			Numeric
		No MCID	0
		MCID	1
anyresponse	Any response			Numeric
		non-response at either 3 or 12 months	0
		phq-9<10 at either 3 or 12 months	1
oe3_badsf_tot	Behavioral activation score	Open ended		Numeric
oe3_attend	Attended in past 3 months			Numeric
		Attended 3 months	1
		Did not attend 3 month	2
in_trt_stat	in_trt_stat			Numeric
		Dropout / Un-planned Discharge	0
		Planned Discharge	1
Refferal	Referral	Open ended		Numeric
Tot_no_sessions	Total number of sessions attended			Numeric
		No sessions done	0
Mean_session_dur	Mean duration of session	Open ended		Numeric
Tot_no_sessions_calc	Total number of sessions attended (calculated - see notes)	Open ended		Numeric
Mean_session_dur_cal	Mean duration of session (calculated - see notes)	Open ended		Numeric
oe12_ADT_use	Patient-level use of Anti-Depressants drugs			Numeric
		No	0
		Yes	1
oe12_mcidtension	2. Overall, thinking back since the time you entered this study one year ago, ho			Numeric
		Become worse	0
		About the same/no change	1
		Better	2
		Fully recovered	3
oe12_attend	oe12_attend			Numeric
		Attended 12 months	1
		Did not attend 12 month	2
oe3_12_attend	oe3_12_attend			Numeric
		Attended both	1
		Neither 3 nor 12	2
		Either 3 or 12	3
any3_12_sae	Any serious adverse reaction in past 12 months			Numeric
		No	0
		Yes	1
tot12_sae	tot12_sae			Numeric
		No	0
		Yes	1
any3_12_adt	Any patient use of anti-depressants drugs in past 12 months			Numeric
		No	0
		Yes	1