Mental disorders (broad) Mental disorders (broad)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Participants (patients and their loved ones) are at least 18 years old - Participants are able to speak and read Dutch - Participating patients have obtained a referral for a treatment in Dutch general of specialized mental healthcare - Each participating patient has a loved one willing to participate in the study trial. If patients are randomized to the second arm (eHealth PPI for patients and loved ones), these patients and their loved ones can participate together in the eHealth PPI.
Exclusion criteria
Exclusion criteria: - Patients suffering from severe acute suicidality - Patients diagnosed with a psychotic disorder or complaints - Patients and loved ones without access to internet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Below, parameters (A1, A2, A3, A4, A5) for assessing (cost) effectiveness will be described. While preliminary effectiveness of the eHealth PPI will already be rated in the RSCD, (cost) effectiveness will be determined rigorously in the RCT.Please note, that although we see (cost) effectiveness as our primary study objective and parameters, only the first parameter (positive mental health) is the primary outcome variable (baseline to 1 year follow-up post outpatient psychological treatment). The sample size calculation is based on this primary outcome variable. A1. Positive mental health In order to examine the primary objective, the frequency of positive mental health symptoms will be defined as the main study parameter. This parameter will be measured, using the Mental Health Continuum Short Form (MHC-SF), which is a clinically validated instrument aimed at assessing positive mental health across a range of emotional, psychological and social domains (Lamers et al., 2011). A2. Self-reported psychological symptoms Self-reported psychological symptoms will be defined as the second parameter for examining the primary objective. This parameter will be operationalized, using the validated Brief Symptom Inventory (BSI), measuring the number of self-reported psychological symptoms across a range of domains that are clinically relevant in adults and adolescents (De Beurs & Zitman, 2005). A3. Patient dropout A parameter for patient dropout will be measured in all three treatment conditions, since patient dropout is an important clinical marker of treatment success (Arntz et al., 2023). A4. Quality of life First, general and objective quality of life is often considered an important parameter for health gains in the field of health economics. This parameter will be employed, using quality-adjusted Life Years (QALYs). In general, QALYs can be estimated, using utility scores from the EQ-5D-5L questionnaire (Feng et al., 2021; van Dongen et al., 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Below, parameters (B1, B2, B3, B4) will be described regarding the added clinical effects of including loved ones. Loved ones are included in both the RSCD and RCT. B1. Positive mental health B2. Self-reported psychological symptoms B3. Dropout B4. Loved ones assessing patient recovery Similar to the clinical parameters mentioned in (A), positive mental health, self-reported psychological symptoms and dropout (B1, B2, B3, B4) will be measured among patients and their loved ones in the second arm (eHealth PPI for patients and loved ones). While dropout will be measured statistically in this treatment arm, positive mental health and self-reported psychological symptoms will be measured, using the MHC-SF among loved ones. In this arm, loved ones will receive a different set of questionnaires to rate aspects of positive mental health in their own life (scenario 1) and to evaluate the psychological well-being of the patient they are related to (scenario 2). In the former scenario, loved ones will receive distinct questionnaires to rate their own beliefs regarding self-compassion, savouring and optimism. In light of this purpose, the Self Compassion Scale - Short Form (SCS-SF), Savouring Beliefs Inventory (SBI) and Life Orientation Test - Revised (LOT-R) will be used, respectively (Babenko & Guo, 2019; Ford et al., 2017; Hinz et al., 2017). In the latter scenario, loved ones will serve as a proxy for assessing a patient*s psychological well-being, which may be considered an important marker of treatment success. Loved ones will conduct this proxy rating for the patient they are related to, using the validated Patient Health Questionnaire (PHQ-9). Although the PHQ-9 is often used for self-administration, it can also be used as a proxy instrument to rate well-being and depressive symptoms in other people (Rooney et al., 2013). Patients and loved ones are allowed to interact while moving through the eHealth PPI, which may enhance protective resour | — |
Countries
Netherlands
Contacts
open universiteit