Treatment of emotional disorders: depression and anxiety disorders Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients: 1. Over 18 years of age 2. Meet the diagnostic criteria for an anxiety or depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) 3. Understand and read Spanish or Catalan 4. Have access to the Internet and an email address 5. Give informed consent Mental Health Professionals: 1. They work at centers participating in the study 2. They agree to participate in the study 3. They sign an informed consent form
Exclusion criteria
Exclusion criteria: Patients: 1. Diagnosis of schizophrenia, bipolar disorder, or alcohol or substance dependence 2. High risk of suicide 3. Presence of a medical condition that prevents psychological treatment 4. Receiving other psychological treatment (other than TAU or the online program) during the study 5. For participants in the online treatment condition with pharmacological treatment, this must be stabilized (doses cannot be changed or increased during the study, only reduced)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Depression severity and impairment is measured using the Spanish version of the Overall Depression Severity and Impairment Scale (ODSIS) at baseline, end of intervention, and follow-up at 3, 6, 9, and 12 months 2. Anxiety severity and impairment is measured using the Spanish version of the Overall Anxiety Severity and Impairment Scale (OASIS) at baseline, end of intervention, and follow-up at 3, 6, 9, and 12 months 3. Positive and negative affect is measured using the Spanish version of the Positive and Negative Affect Scale (PANAS) at baseline, end of intervention, and follow-up at 3, 6, 9, and 12 months 4. Health-related quality of life is measured using the Spanish version of the EuroQol-5D-5L at baseline, end of intervention, and follow-up at 3, 6, 9, and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Implementation outcomes: 1. Feasibility is measured using the Feasibility of Intervention Measure (FIM) and passive platform data including module completion, dropout, and frequency of use at baseline, end of intervention, and follow-up at 3, 6, 9, and 12 months 2. Acceptability is measured using the System Usability Scale (SUS), Acceptability of Intervention Measure (AIM), and the Client Satisfaction Questionnaire adapted to Internet-Based interventions (CSQ-I) at baseline, end of intervention, and follow-up at 3, 6, 9, and 12 months 3. Appropriateness is measured using the Intervention Appropriateness Measure (IAM) at baseline, end of intervention, and follow-up at 3, 6, 9, and 12 months 4. Adoption is measured using the Evidence-Based Practice Attitude Scale (EBPAS-50) and the Attitudes towards Psychological Online Intervention (APOI) at baseline, end of intervention, and follow-up at 3, 6, 9, and 12 months 5. Barriers and facilitators are measured quantitatively using the Pragmatic Context Assessment Tool (pCAT) and qualitatively using semi-structured interviews and focus groups following Consensual Qualitative Research (CQR) guidelines at end of intervention and follow-up at 3, 6, 9, and 12 months Cost-effectiveness: 6. Direct healthcare and social service costs are measured using the TiC-P Adults questionnaire at end of intervention and follow-up at 3, 6, 9, and 12 months 7. Indirect costs due to lost work productivity are measured using the Productivity Costs Questionnaire (iPCQ) at end of intervention and follow-up at 3, 6, 9, and 12 months | — |
Countries
Spain