The Brazilian and Peruvian versions of the BADS-SF were administered to participants as part of a randomized clinical trial (RCT) which evaluated the effectiveness of a BA intervention in the treatment of depressive symptoms through a mobile application. The study was developed and carried out by the LATIN-MH research hub (Latin America Treatment and Innovation Network), based at the city of São Paulo, Brazil, in the Medicine School of University of São Paulo (FMUSP) and Peruvian University Cayetano Heredia, in Lima, Peru. It was conducted between the years 2016 and 2018 with funding provided by the National Institutes of Health (NIH).
Ethics approvals were obtained in both universities’ review boards and all required government agencies.
This included all health services ethics boards in Peru.
RCT Project registration number in Brazil 2.636.669 and CAAEE: 54416516.7.0000.0065, which derived the present study under registration number 3.761.649 and CAAEE 26392719.6.0000.0065. [Trial registration NCT028406662 (Brazil), NCT03026426 (Peru)].
The author of the original version of the BADS-SF permitted its translation and adaptation for Brazilian Portuguese and Peruvian Spanish.
Participants in Brazil (n = 880) were recruited from 20 Family Health Units (FHU), cluster-randomized into 10 intervention-units and 10 control-units with equal number of participants per unit (n = 44).
In Peru, participants (n = 432) were recruited from three tertiary hospitals and four Primary Health Care Centers for the elderly (PHC) and individually randomized into a control group (n = 215) and an intervention group (n = 217).
All participants had diabetes and/or hypertension, were 21 years or older, literate, and had a score of 10 or more on the Patient Health Questionnaire 9 (PHQ-9).
Those who showed medium-high or high suicidal ideation in the PHQ-9 assessment were excluded from the study [15].
The process of cross-cultural adaptation of the original scale to Brazilian Portuguese was based on the procedures outlined by Beaton et. al. [16]. Two translators affiliated to the RCT, one psychologist and one nurse, both fluent in English, created two independent versions of the scale. Both versions were discussed by the translators and after resolving differences and ambiguities, were synthesized in a 3rd version. This version was back-translated into English by a third translator, native in English and fluent in Portuguese, not related to the study, to verify the translation accuracy. Finally, a committee composed of five health experts, Brazilian and fluent in English, were requested to, individually, compare the adapted version of the scale to the original one, make suggestions and comment on its appropriateness, and compute two separate grades in a Likert scale ranging from 1 to 5 (1 - very bad; 2 - bad; 3 - regular; 4 - good and 5 - very good), concerning its idiomatic and conceptual equivalence [17].
Regarding the Peruvian process, As the BAD-SF is composed of 7 items taken from the BADS and one additional item [18], translation was needed for this additional item. The other items underwent idiomatic adaptations to expressions used with the Peruvian vocabulary. Two psychologists conducted this process, and the result was submitted to six judges, experts in mental health, for the same idiomatic and conceptual equivalence analysis that occurred in the Brazilian adaptation.
Assessment of the Content Validity
After the process of cross-cultural adaptation, the content validity of both versions of the BADS-SF was measured using the Content Validity Index (CVI) calculation. This index measures the judges’ level of agreement on how similar the adapted version is regarding comprehensiveness and representativeness when compared to the original version [19, 20].
First, the proportion of 4 (good) or 5 (very good) in each item was calculated for both categories, idiomatic and conceptual equivalence, a total of 18 grades per expert. After that, the CVI was calculated by the mean of this proportion. The CVIs were considered acceptable if the values are superior to 0.80 [21].
Assessment of the construct validity
The construct validity of the scale was assessed by the Principal Component Analysis (PCA) method. This analysis allows us to confirm the factor analysis of the original scale or to propose a new model of factors for the Brazilian and Peruvian contexts. The Promax method was used for factor rotation.
Bartlett’s test of Sphericity and KMO (Kaiser-Meyer-Olkin) measure was extracted to confirm sampling adequacy.
Reliability assessment (Cronbach’s alpha)
Cronbach’s alpha coefficient was calculated to assess the internal consistency of the items for each version of the scale. Values from 0.60 were considered acceptable, as observed in the literature [22].
Quality supervision of the study
To ensure the quality of the study and data collection, the BADS-SF completion was facilitated by trained researchers. Participants completed the BAD-SF at the time of inclusion, after 3 months (1st follow-up assessment), and again at 6 months (2nd follow-up assessment).
The data were electronically collected and protected by encryption. Missing data were excluded using the pairwise deletion analysis approach [23].
Statistical analyses were performed using Stata, version 15 (StataCorp LLC, TX, USA) and SPSS Statistics version 20 (IBM, NY, USA) software.