Clinical Research Directory

Narrative Therapy Among Young People With Moderate Level of Mental Distress in Hong Kong

This cluster randomized controlled trial (cRCT) aims to evaluate the effectiveness of a narrative therapy (NT) intervention in (i) reducing mental distress, depressive symptoms, and anxiety, as well as (ii) enhancing perceived control and fostering a stronger sense of self among at-risk youth in Hong Kong. Participants are youths with moderate mental health concerns, indicated by K6 scores ranging from 11 to 14. The study involves seven clusters, each based on community hubs, which will be randomly assigned to either the intervention group or a wait-list control group. Clusters assigned to the intervention group will receive six face-to-face sessions led by trained youth workers. Control clusters will receive the same intervention after the initial follow-up period. Participants will be evaluated at baseline, post-intervention, and one-month follow-up. An interim analysis is built for the sake of evaluation of the collected data from the ongoing trial, in which the primary research question is addressed, and which has the potential for modifying the conduct of the study. Furthermore, a qualitative follow-up will be conducted after the trial, involving both participants and the workers delivering the NT intervention. This qualitative component aims to gather feedback on participants' experiences, and inform potential revisions to enhance future implementation. It is hypothesized that youths receiving the NT intervention will show significantly greater improvements in perceived control and sense of self, along with reductions in mental distress, as well as depressive and anxiety symptoms, compared to those in the wait-list control group.

The Effect of Digital Markers in the Self-management of Depressive Symptoms

The purpose of the MENTINA trial is to investigate the effect of using the smartphone-based MENTINA app for self-monitoring of depressive symptoms and rule-based feedback in individuals with current or previous depression, psychological vulnerability, and increased risk of depression in a randomized controlled trial (RCT) over a 12-month trial period. The aim is to potentially offer the MENTINA app as a self-management tool for individuals with psychological vulnerability and/or depressive symptoms or episodes. Method and Design: International, multicenter (three centers), parallel-group, RCT. The active group is assigned the smartphone-based MENTINA app including rule-based data feedback. The control group uses the MENTINA app for questionnaire-based data collection (outcomes) and collection of sensor-based data. Study Procedures: The trial will be open-label and unblinded. The trial uses the self-reported Patient Health Questionnaire-9 score (PHQ-9) as the primary outcome measure. Scoring will take place every 14 days over the 12-month trial period. Depressive symptoms during the first 6 months of app use will also be evaluated as secondary outcomes. Participants, Including Inclusion and Exclusion Criteria A total of 220 individuals will be included from each center (Denmark, Germany, and Spain) with psychological vulnerability (depressive symptoms and possibly previous depressive episodes). A total sample size of 660 participants will be included. Inclusion criteria: * Age 18 years or older * Depressive symptoms, assessed by PHQ-9 \> 8, AND/OR * Current or previous depressive episode(s) (ICD-10 F32, F33) * Owns and uses a smartphone * Signed informed consent to participate Exclusion criteria: * ICD-10 diagnosis of dementia, schizophrenia, mania, or bipolar disorder, as well as ongoing substance abuse * Current psychotic depression * Current suicide risk * Acute somatic illness requiring treatment (intensive care) * Insufficient language skills in Danish, German or Spanish (depending on site) Side Effects, Risks, and Disadvantages Side effects and risks: We do not expect any serious side effects from using the MENTINA app. Possible side effects could include increased focus on one's own illness, potentially worsening depressive symptoms and suicidal thoughts. Recruitment of Participants The study population will consist of adults vulnerable to mental health issues, defined by a PHQ-9 score \> 8 or previous depressive symptoms at the time of inclusion. Each study site will be responsible for local recruitment and follow-up.

Cognitive Behavioural Therapy for Insomnia Among Young People With Moderate Level of Mental Distress in Hong Kong

This cluster randomized controlled trial (cRCT) aims to evaluate the effectiveness of a Cognitive Behavioral Therapy for Insomnia (CBTi) intervention in enhancing sleep quality, overall quality of life, functional ability, and reducing mental distress among at-risk youths in Hong Kong. Participants are youths with moderate mental health concerns, indicated by K6 scores ranging from 11 to 14. The study involves seven clusters, each based on community hubs, which will be randomly assigned to either the intervention group or a wait-list control group. Clusters assigned to the intervention group will receive six weekly face-to-face sessions led by trained youth workers. Control clusters will receive the same intervention after the initial follow-up period. Participants will be evaluated at baseline, post-intervention, and one-month follow-up. An interim analysis is built for the sake of evaluation of the collected data from the ongoing trial, in which the primary research question is addressed, and which has the potential for modifying the conduct of the study. Furthermore, a qualitative follow-up will be conducted after the trial, involving both participants and the workers delivering the CBTi intervention. This qualitative component aims to gather feedback on participants' experiences, and inform potential revisions to enhance future implementation. It is hypothesized that youths receiving the CBTi intervention will show significantly greater improvements in sleep quality, quality of life, and functioning, along with reductions in mental distress, as well as depressive and anxiety symptoms, compared to those in the wait-list control group.

Digital Care Programs for Mental Health

The purpose of this study is to create a research repository, composed of data collected over the course of digital care programs for mental health distress delivered by Sword Mind to individuals. This will allow the investigators to observe the acceptance, engagement, and outcomes of programs using this approach in the treatment of multiple mental health concerns.