Table 3. Schedule of outcomes and measures.
Screening/baseline | 3 months | 6 months | 9 months | 12 months | 15 months | 18 months | ||
Primary outcome and measure | ||||||||
Relapse of MDD (SCID-5-RV: depression module) | x | x | x | x | x | x | x | |
Secondary outcomes and measures | ||||||||
Depressive symptoms (QIDS-SR) | Monthly | |||||||
Time to relapse (SCID-5-RV: depression module) | x | x | x | x | x | x | x | |
Time to remission (SCID-5-RV: depression module) | x | x | x | x | x | x | x | |
Rate of remission (SCID-5-RV: depression module) | x | x | x | x | x | x | x | |
Time in remission (SCID-5-RV: depression module) | x | x | x | x | x | x | x | |
Anxiety (GAD-7) | x | x | x | x | ||||
Vocational status (RUQ) | x | x | x | x | ||||
Cost-effectiveness (RUQ) | x | x | x | x | ||||
Therapeutic mechanisms and measures | ||||||||
Mindfulness skills (FMI) | x | x | x | x | ||||
Self-compassion (SCS-SF) | x | x | x | x | ||||
Social support (SPS) | x | x | x | x | ||||
Rumination (RRS-SF) | x | x | x | x | ||||
Exploratory outcomes and measures | ||||||||
Stress (PSS) | x | x | x | x | ||||
Social anxiety (LSAS) | x | x | x | x | ||||
Loneliness (UCLA Loneliness Scale) | x | x | x | x | ||||
Self-efficacy (Self-Efficacy Scale) | x | x | x | x | ||||
Self-esteem (Rosenberg SES) | x | x | x | x | ||||
Social and general functioning (SOFAS) | x | x | x | x | ||||
Suicidal ideation and attempts in past 6 months (CSSRS) | x | x | x | x | ||||
Deliberate self-harm (Risk Taking and Self-Harm Inventory†) | x | x | x | x | ||||
Psychological well-being (BPNSS) | x | x | x | x | ||||
Quality of life (AQoL-8D) | x | x | x | x | ||||
Behavioural activation (BADS-SF) | x | x | x | x | ||||
Sleep quality (PSQI) | x | x | x | x | ||||
Strengths use (SUS) | x | x | x | x | ||||
Medication adherence (RUQ)* | x | x | x | x | ||||
Substance use (ASSIST)* | x | x | x | x | ||||
Digital phenotype (AWARE-Light) | Continuous | |||||||
Affective and cognitive reactivity and social support (SEMA3 application) | Daily | |||||||
Intervention group-only outcomes and measures | ||||||||
Intervention acceptability (qualitative evaluation via semistructured interview) | x | |||||||
Therapeutic alliance (WAI-C, WAI-T) | x | x | x | x | ||||
Intervention use (ie, frequency, duration, pattern) | Continuous |
Potential covariates.
Risk Taking and Self-Harm Inventory for Adolescents.
AQoL-8DAssessment of Quality of Life - 8 DimensionsASSISTAlcohol, Smoking and Substance Involvement Screening Test BADS-SFBehavioural Activation for Depression Scale-short formBPNSSBasic Psychological Needs Satisfaction ScaleCSSRSColumbia-Suicide Severity Rating ScaleFMIFreiburg Mindfulness InventoryGAD-7Generalized Anxiety Disorder 7-item scaleLSASLiebowitz Social Anxiety ScaleMDDmajor depressive disorderPSQIPittsburgh Sleep Quality IndexPSSPerceived Stress ScaleQIDS-SRQuick Inventory of Depressive Symptomatology-Self-ReportRRS-SFRuminative Responses Scale - short formRUQResource Use QuestionnaireSCID-5-RVStructured Clinical Interview for DSM-5 Disorders, Research VersionSCS-SFSelf-Compassion Scale Short FormSEMA3Smartphone Ecological Momentary AssessmentSESSelf-Esteem ScaleSOFASSocial and Occupational Functioning Assessment ScaleSPSSocial Provisions ScaleSUSStrengths Use ScaleUCLAUCLA Loneliness Scale (Version 3)WAI-CWorking Alliance Inventory client versionWAI-TWorking Alliance Inventory therapist version