Evaluating the Efficacy of a Digital Therapeutic (CT-152) as an Adjunct to Antidepressant Treatment in Adults With Major Depressive Disorder: Protocol for the MIRAI Remote Study.

BACKGROUND: Major depressive disorder (MDD) is common worldwide and can be highly disabling. People with MDD face many barriers to treatment and may not experience full symptom relief even when treated. Therefore, new treatment modalities are needed for MDD. Digital therapeutics (DTx) may provide people with MDD an additional treatment option. OBJECTIVE: This study aimed to describe a phase 3 remote, multicenter, randomized, masked, sham-controlled trial evaluating the efficacy of a smartphone app-based DTx (CT-152) in adult participants diagnosed with MDD, used as an adjunct to antidepressant therapy (ADT). METHODS: Participants aged 22-64 years with a current primary diagnosis of MDD and an inadequate response to ADT were included. Participants were randomized 1:1 to CT-152 or a sham DTx. CT-152 is a smartphone app-based DTx that delivers a cognitive-emotional and behavioral therapeutic intervention. The core components of CT-152 are the Emotional Faces Memory Task exercises, brief lessons to learn and apply key therapeutic skills, and SMS text messaging to reinforce lessons and encourage engagement with the app. The sham DTx is a digital working memory exercise with emotionally neutral stimuli designed to match CT-152 for time and attention. Participants took part in the trial for up to 13 weeks. The trial included a screening period of up to 3 weeks, a treatment period of 6 weeks, and an extension period of 4 weeks to assess the durability of the effect. Sites and participants had the option of an in-person or remote screening visit; the remaining trial visits were remote. Efficacy was evaluated using the Montgomery-Åsberg Depression Rating Scale, the Generalized Anxiety Disorder-7, Clinical Global Impression-Severity scale, the Patient Health Questionnaire-9, and the World Health Organization Disability Assessment Schedule 2.0. The durability of the effect was evaluated with the Montgomery-Åsberg Depression Rating Scale and Generalized Anxiety Disorder-7 scale. Adverse events were also assessed. Satisfaction, measured by the Participant and Healthcare Professional Satisfaction Scales, and health status, measured by the EQ-5D-5L, were summarized using descriptive statistics. RESULTS: This study was initiated in February 2021 and had a primary completion date in October 2022. CONCLUSIONS: This represents the methodological design for the first evaluation of CT-152 as an adjunct to ADT. This study protocol is methodologically robust and incorporates many aspects of conventional pivotal pharmaceutical phase 3 trial design, such as randomization and safety end points. Novel considerations included the use of a sham comparator, masking considerations for visible app content, and outcome measures relevant to DTx. The rigor of this methodology will provide a more comprehensive understanding of the effectiveness of CT-152. TRIAL REGISTRATION: ClinicalTrials.gov NCT04770285; https://clinicaltrials.gov/study/NCT04770285. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/56960.

The effect of the emotion regulation training on the resilience of caregivers of patients with schizophrenia: a parallel randomized controlled trial.

BACKGROUND: Schizophrenia is the most severe mental chronic disabling disease that the majority of the patients need constant care in a variety of aspects. Regarding the role of family caregivers in taking care of these patients, caregivers need to be resilient, in addition to other psychological traits, to adapt to the circumstance. This study aimed to investigate the effect of the emotion regulation training on the resilience of caregivers of patients with schizophrenia in southeastern Iran. METHODS: The study was a parallel randomized controlled trial. Seventy caregivers of patients with schizophrenia were selected by convenience sampling method and randomly assigned to an emotion regulation training group and a control group. The intervention group received eight 90-min training sessions (one session weekly) about emotion regulation. The participants completed the Conner-Davidson resilience scale before and one month after the intervention. RESULTS: The mean scores of the resilience increased in the control and intervention groups at the end of the study. A significant difference was found between the two groups (p < 0.001). At the beginning of the study, the mean score of the resilience was 59.94 in the control group and 51.97 in the intervention group. However, the mean score of the resilience in the control group was 61.28 after the intervention, which was not significant, but it was 69.08 in the intervention group, which was significant. A significant difference was observed between two groups in the mean scores (p = 0.01). CONCLUSIONS: According to the results of this study, cognitive and metacognitive skills of emotion regulation can be suggested as one of the methods for increasing the psychological well-being of schizophrenia patients' caregivers. The increase of mental well-being and resilience of caregivers can help them better manage a patient with schizophrenia. Trial registration IRCT registration number: IRCT2017061733997N2, Registration date: 2017-08-16, 1396/05/25, Registration timing: prospective, https://en.irct.ir/trial/26116.