INVERSIONES FINANCIERAS PERMANENTES 250 Inversiones financieras permanentes en capital.

Delivered by:OPHR

• Title/name of NSHW/OPHR and number:2 CBT counsellor (1 male; 1 female)

• Selection:Knowledge of English and Kswahili; essays and role plays to assess empathy, emotional perceptiveness; good communication skills and analytical abilities; met certification criteria for CBT training (adherence and competence)

• Educational background:High-school

• Training (contents, duration and by whom):Trained by study personnel; 175 hours of training; classes, role plays, videotaped feedback with medical students as simulated patients; assessment of adherence and competency using the YACS

• Supervision:300 hours of supervision prior to trial; during the trial, all CBT group sessions were videotaped and monitored weekly by 1 experienced CBT supervisor. Supervision was conducted via telephone during the latter stages of trial. 50% of sessions with men and women, respectively (18 sessions) were selected randomly, translated into English, with random back-translation verification, and rated by 2 highly experienced YACS raters from the Yale Psychotherapy Development Center

• Incentives/remuneration:Not stated Intervention details:

• Duration/frequency:6 weekly, gender stratified 90-minute group CBT sessions; 7 participants per group delivered by same-sex CBT counsellor

• Content of intervention:Manual-based CBT. Abstinence from alcohol was set as goal and a quit date was decided during the second session; behavioural analysis; risky behaviours and alcohol refusal skills reinforced

CONTROL:Routine medical care provided by the clinic (33 people) CO-INTERVENTIONS:Not reported

Outcomes Patient:Percentage of drinking days*; mean drinks per drinking days; abstinence at

longest follow-up §; adherence to CBT sessions § Carer:Not applicable

Process/health worker outcomes:Adherence and competence to CBT Economic outcomes:Not reported

(*: primary outcomes of the study; §: outcomes that we have not reported in this review) Time points:30 days; 60 days; 90 days post treatment

Notes Source of funding: National Institute on Alcohol Abuse and Alcoholism-funded

grant (R21AA016884) USAID-AMPATH Partnership from the United States Agency for International Development (President’s Emergency Plan for AIDS Relief and P50DA09241)

Notes on validation of instruments (screening and outcomes):Validated outcome tools

Additional information (e.g. provide by authors, existence of a published study protocol):Not applicable

Handling the data:As per footnotes in data and analysis

Prospective trial registration number:Clinicaltrials.gov identifier: NCT00792519 153 Non-specialist health worker interventions for the care of mental, neurological and substance-abuse disorders in low- and middle-

Papas 2011 RCT Kenya (Continued)

Risk of bias

Bias Authors’ judgement Support for judgement

Random sequence generation (selection bias)

Low risk Quote:“A stratified simple randomization

procedure was used to form gender-strati- fied cohorts. Within gender-based cohorts, participants were assigned randomly until a minimum was achieved of seven CBT and five usual care participants, thereby creat- ing some waiting time. A group of seven was required for CBT to enhance participa- tion, while fewer were required for the in- dividual usual care condition to minimize waiting time before treatment initiation”

Allocation concealment (selection bias) Low risk Quote: “Each participant was randomized

after she or he drew from a jar a paper with the name of the condition. The papers were prepared by study administrators to con- ceal the name of the condition during the drawing, which was supervised by staff ” Comment: Allocation was possibly con- cealed

Blinding of participants and personnel (performance bias)

All outcomes

Low risk Comment:not blinded but also was not

possible. No likely effect on outcomes

Blinding of outcome assessment (detection bias)

objective outcomes

Low risk Comment:Three alcohol saliva tests came

back positive during treatment phase. This showed concordance with patient’s self re- ported or scored outcomes

Blinding of outcome assessment (detection bias)

subjective outcomes

Unclear risk Quote: “Non-blinded research assistants

both recruited and interviewed partici- pants; none delivered study interventions” Comment: Unlikely that if they did not de- liver the intervention that there was much bias

Baseline outcome measurements similar Low risk Comment: All similar

Baseline characteristics similar? Low risk Comment: All similar

Incomplete outcome data (attrition bias) Efficacy data

Low risk Comment: 36/42 completed intervention;

32/33 stayed in control (completers), i.e. less than 20% drop outs

Papas 2011 RCT Kenya (Continued)

Incomplete outcome data (attrition bias) Safety data (e.g. adverse events)

Unclear risk Comment: Not reported

Protection against contamination Low risk Comment: RCT occurring just in one

clinic. The lessons from CBT therapy could therefore have been shared within the pop- ulation between controls and those in CBT intervention. However a large number of people were enrolled at the clinic suggest- ing its geographical remit is very wide

Reliable primary outcome measures Low risk Quote 1: “An initial sample of six tapes

was rated by two independent raters and indicated a high level of inter-rater reli- ability (mean intraclass correlation coeffi- cients) across both adherence (mean = 0. 98) and competence (mean = 0.95)” Quote 2:“Overall level of drinking was low in the trial, i.e. at the 90-day follow- up 69% of CBT participants reported ab- stinence and PDD was 5%. There were six positive saliva tests, three in CBT and three in usual care; five occurred during the treat- ment phase”

Comment: This latter statement suggests good correlation between physical objec- tive findings (saliva tests) and the scored outcomes

Selective reporting (reporting bias) Low risk Comment: All outcomes mentioned in

methods section were reported. The trial was prospectively registered and primary outcomes were identical: quantity and fre- quency of alcohol use

Other bias Low risk Comment:None detected

Paranthaman2010CBAMalaysi

Methods Study design:CBA study

Duration of study:Not specified which years of recruitment and intervention. Inter- vention length: 6 months

Participants Country:Malaysia

Income classification:Middle Geographical scope:Urban/semi-urban

Healthcare setting:Community psychiatric free-standing clinic Mental health condition:Schizophrenia

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