QUALITY ASSURANCE PLAN. The researchers will review and report the process during the
trial covering participant enrolment, consent and eligibility to protect participants,
including reporting of harm and completeness, accuracy and timeliness of data collection.
STANDARD OPERATING PROCEDURES. Participants will be identified from community mental
health services who meet all the study eligibility criteria (listed in section
Eligibility). Participants will be recruited over a period of 20 months by mental health
professionals (clinical psychology residents). Community sample for validation will be
recruited by social media. Participants will not receive financial reimbursement for
taking part in this trial.
DATA DICTIONARY. All variables collected in this study are listed and described in an
electronic case report form, with associated guidelines, to ensure consistency in all
gathered data. The following data will be collected in this trial:
Sociodemographical data. Anxiety symptoms: Generalized Anxiety Disorder 7-item scale
(GAD-7) Depressice symptoms: Patient Health Questionnaire-9 (PHQ-9) Epistemic Trust: The
Epistemic Trust Questionnaire (QET) Epistemic Trust, Mistrust and Credulity: The
Epistemic Trust, Mistrust and Credulity Questionnaire (ETMCQ).
Reflective functioning: The Reflective Functioning Questionnaire (RFQ-8) Functional
impact: The Work and Social Adjustment Scale (WSAS) Satisfaction with therapy: The
Consumer Reports Effectiveness Score (CRES-4)
SAMPLE SIZE ASSESSMENT. The study has sensitivity to detect effect sizes that are
considered clinically significant (Cohen's d =0.50) for a power of 0.8, an Alpha of 0.05
and an estimated sample of 100 participants. The calculation was performed with the
GPower 3.1.9.2 program for a mean difference with a t-test for two independent groups.
For the validation of the QET, taking into account the subject-item ratio of at least 5:
1 (24 items), and considering the minimum number of recommended subjects to perform an
Exploratory Factor Analysis, the minimum number of participants must be 150.Thus,
estimating losses of 20%, the total number of participants estimated for the validation
is n = 180 .
STATISTICS ANALYSIS PLAN. The analysis will be made following an intention-to-treat
procedure. The change of means in the primary outcome variable between the two study
groups will be analyzed with the Student's t-test for independent samples if the criteria
for its application are met. If the criteria for its application are not met,
nonparametric tests will be used. For continuous secondary variables, this test will also
be used. A multivariate analysis of variance (ANCOVA) will also be considered to
introduce any possible covariate that differs between the two comparison groups in the
first evaluation. Potential confounding variables will include gender, age, previous
level of depression and anxiety, and diagnosis. A 95% confidence level will be used for
all comparisons. The R program will be used for all statistical analyses.
PLAN FOR MISSING DATA. Each researcher is responsible for ensuring that any missing data
will be reported as missing in the study database. Procedures can sometimes be considered
when using statistical methods that fail in the presence of any missing values, or when
in the case of multiple-predictor statistical models all the data for an individual would
be omitted because of a missing value in one of the predictors. For analyses involving
multiple regression analysis, a multiple imputation approach will be considered and used
if statistically sound, depending on the proportion and pattern of missing values.
METHODS TO ENSURE VALIDITY AND QUALITY OF DATA. Accurate and reliable data collection
will be assured by verification and cross-check of the case report form (CRF) against the
researcher´s records (source document verification). Source document verification will be
conducted for 5% of data in subjects. Discrepancies and queries will be generated
accordingly in the CRF for online resolution by the researcher at the site. In addition,
the CRF data will be reviewed on an ongoing basis for medical and scientific
plausibility.