Feasibility, Acceptability, and Preliminary Efficacy of a Smartphone App-Led Cognitive Behavioral Therapy for Depression Under Therapist Supervision: Open Trial.

Major depressive disorder affects approximately 1 in 5 adults during their lifetime and is the leading cause of disability worldwide. Yet, a minority receive adequate treatment due to person-level (eg, geographical distance to providers) and systems-level (eg, shortage of trained providers) barriers. Digital tools could improve this treatment gap by reducing the time and frequency of therapy sessions needed for effective treatment through the provision of flexible, automated support. This study aimed to examine the feasibility, acceptability, and preliminary clinical effect of Mindset for Depression, a deployment-ready 8-week smartphone-based cognitive behavioral therapy (CBT) supported by brief teletherapy appointments with a therapist. This 8-week, single-arm open trial tested the Mindset for Depression app when combined with 8 brief (16-25 minutes) video conferencing visits with a licensed doctoral-level CBT therapist (n=28 participants). The app offers flexible, accessible psychoeducation, CBT skills practice, and support to patients as well as clinician guidance to promote sustained engagement, monitor safety, and tailor treatment to individual patient needs. To increase accessibility and thus generalizability, all study procedures were conducted remotely. Feasibility and acceptability were assessed via attrition, patient expectations and feedback, and treatment utilization. The primary clinical outcome measure was the clinician-rated Hamilton Depression Rating Scale, administered at pretreatment, midpoint, and posttreatment. Secondary measures of functional impairment and quality of life as well as maintenance of gains (3-month follow-up) were also collected. Treatment credibility (week 4), expectancy (week 4), and satisfaction (week 8) were moderate to high, and attrition was low (n=2, 7%). Participants self-reported using the app or practicing (either on or off the app) the CBT skills taught in the app for a median of 50 (IQR 30-60; week 4) or 60 (IQR 30-90; week 8) minutes per week; participants accessed the app on an average 36.8 (SD 10.0) days and completed a median of 7 of 8 (IQR 6-8) steps by the week 8 assessment. The app was rated positively across domains of engagement, functionality, aesthetics, and information. Participants' depression severity scores decreased from an average Hamilton Depression Rating Scale score indicating moderate depression (mean 19.1, SD 5.0) at baseline to a week 8 mean score indicating mild depression (mean 10.8, SD 6.1; d=1.47; P<.001). Improvement was also observed for functional impairment and quality of life. Gains were maintained at 3-month follow-up. The results show that Mindset for Depression is a feasible and acceptable treatment option for individuals with major depressive disorder. This smartphone-led treatment holds promise to be an efficacious, scalable, and cost-effective treatment option. The next steps include testing Mindset for Depression in a fully powered randomized controlled trial and real-world clinical settings. ClinicalTrials.gov NCT05386329; https://clinicaltrials.gov/study/NCT05386329?term=NCT05386329.

Wilhelm S ，Bernstein EE ，Bentley KH ，Snorrason I ，Hoeppner SS ，Klare D ，Greenberg JL ，Weingarden H ，McCoy TH ，Harrison O ... -  《JMIR Mental Health》

A Personalized Approach Bias Modification Smartphone App ("SWiPE") to Reduce Alcohol Use: Open-Label Feasibility, Acceptability, and Preliminary Effectiveness Study.

Approach bias modification (ApBM), a computerized cognitive intervention that trains people to "avoid" alcohol-related images and "approach" nonalcohol images, reduces the likelihood of relapse when administered during residential alcohol treatment. However, most individuals experiencing alcohol problems do not require, do not seek, or have difficulty accessing residential treatment. Smartphone-delivered ApBM could offer an easily accessible intervention to reduce alcohol consumption that can be personalized (eg, allowing selection of personally relevant alcohol and positive nonalcohol training images) and gamified to optimize engagement. We examined the feasibility, acceptability, and preliminary effectiveness of "SWiPE," a gamified, personalized alcohol ApBM smartphone app, and explored alcohol consumption and craving outcomes in people drinking at hazardous levels or above (Alcohol Use Disorders Identification Test [AUDIT] score ≥8) who wanted to reduce their alcohol use. In this open-label trial, frequency and quantity of alcohol consumption, alcohol dependence severity, and craving were measured prior to participants downloading SWiPE. Participants (n=1309) were instructed to complete at least 2 sessions per week for 4 weeks. Recruitment and completion rates were indicators of feasibility. Functionality, aesthetics, and quality ratings were indicators of acceptability. Participants were prompted to report frequency and quantity of alcohol consumption weekly during training and 1 month after training. They completed measures of craving and dependence after 4 weeks of training. We recruited 1309 participants (mean age 47.0, SD 10.0 years; 758/1309, 57.9% female; mean AUDIT score 21.8, SD 6.5) over 6 months. Participants completed a median of 5 sessions (IQR 2-9); 31.2% (409/1309) completed ≥8 sessions; and 34.8% (455/1309) completed the posttraining survey. Mean Mobile Application Rating Scale scores indicated good acceptability for functionality and aesthetics and fair acceptability for subjective quality. Among those who completed the posttraining assessment, mean past-week drinking days reduced from 5.1 (SD 2.0) pre-training to 4.2 (SD 2.3) in week 4 (t454=7.87; P<.001), and mean past-week standard drinks reduced from 32.8 (SD 22.1) to 24.7 (SD 20.1; t454=8.58; P<.001). Mean Craving Experience Questionnaire frequency scores reduced from 4.5 (SD 2.0) to 2.8 (SD 1.8; t435=19.39; P<.001). Severity of Dependence scores reduced from 7.7 (SD 3.0) to 6.0 (SD 3.2; t435=12.44; P<.001). For the 19.4% (254/1309) of participants who completed a 1-month follow-up, mean past-week drinking days and standard drinks were 3.9 (SD 2.5) and 23.9 (SD 20.7), respectively, both significantly lower than at baseline (P<.001). The findings suggest SWiPE is feasible and acceptable and may be effective at reducing alcohol consumption and craving in a predominantly nontreatment-seeking sample of adult Australians drinking at hazardous levels. SWiPE's efficacy, relative to a control condition, now needs establishing in a randomized controlled trial. Smartphone-delivered personalized ApBM could be a highly scalable, widely accessible support tool for reducing alcohol use. Australian New Zealand Clinical Trials Registry ACTRN12620000638932; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12620000638932p. RR2-10.2196/21278.

Manning V ，Piercy H ，Garfield JBB ，Clark SG ，Andrabi MN ，Lubman DI ... -  《JMIR mHealth and uHealth》

Adolescent Health Promotion Interventions Using Well-Care Visits and a Smartphone Cognitive Behavioral Therapy App: Randomized Controlled Trial.

Adolescent health promotion is important in preventing risk behaviors and improving mental health. Health promotion during adolescence has been shown to contribute to the prevention of late onset of the mental health disease. However, scalable interventions have not been established yet. This study was designed to test the efficacy of two adolescent health promotion interventions: a well-care visit (WCV) with a risk assessment interview and counseling and self-monitoring with a smartphone cognitive behavioral therapy (CBT) app. Our hypothesis was that participants who had received both WCV and the CBT app would have better outcomes than those who had received only WCV or those who had not received any intervention. We conducted a prospective multi-institutional randomized controlled trial. Participants were 217 adolescents aged 13-18 years. They were randomly divided into two intervention groups (WCV group and WCV with CBT app group) and a nonintervention group. WCV comprised a standardized physical examination along with a structured interview and counseling for youth risk assessment, which was designed with reference to the Guideline for Health Supervision of Adolescents of Bright Futures. A smartphone-based CBT program was developed based on the CBT approach. The CBT app comprised a 1-week psychoeducation component and a 1-week self-monitoring component. During the CBT program, participants created several self-monitoring sheets based on the CBT model with five window panels: event, thoughts, feelings, body response, and actions. The primary outcome was the change in scores for depressive symptoms. Secondary outcomes included changes in scores for self-esteem, quality of life, self-monitoring, and an adolescent health promotion scale. These outcomes were evaluated at baseline and at 1, 2, and 4 months after baseline. The exploratory outcome was the presence of suicidal ideation during the observation period. Intervention effects were estimated using mixed effect models. In total, 94% (204/217) of the participants completed the 4-month evaluation. Both intervention groups showed a significant effect in the form of reduced scores for depressive symptoms at 1 month in high school students; however, these effects were not observed at 2 and 4 months. The intervention effect was significantly more predominant in those scoring above cutoff for depressive symptoms. There was significantly less suicidal ideation in the intervention groups. As for secondary outcomes, there was significant increase in health promotion scale scores at the 4-month follow-up among junior high school students in the WCV group. Moreover, the CBT app was significantly effective in terms of obtaining self-monitoring skills and reducing depressive symptoms. Although adolescent health promotion interventions may have short-term benefits, the frequency of WCV and further revision of the CBT app should be considered to evaluate long-term effectiveness. University Hospital Medical Information Network Clinical Trials Registry UMIN 000036343; https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000041246.

Nagamitsu S ，Kanie A ，Sakashita K ，Sakuta R ，Okada A ，Matsuura K ，Ito M ，Katayanagi A ，Katayama T ，Otani R ，Kitajima T ，Matsubara N ，Inoue T ，Tanaka C ，Fujii C ，Shigeyasu Y ，Ishii R ，Sakai S ，Matsuoka M ，Kakuma T ，Yamashita Y ，Horikoshi M ... -  《JMIR mHealth and uHealth》

Reducing depressive symptomatology with a smartphone app: study protocol for a randomized, placebo-controlled trial.

Giosan C ，Cobeanu O ，Mogoaşe C ，Szentagotai A ，Mureşan V ，Boian R ... -  《Trials》

Web-Based Cognitive Behavioral Therapy Blended With Face-to-Face Sessions for Major Depression: Randomized Controlled Trial.

Meta-analyses of several randomized controlled trials have shown that cognitive behavioral therapy (CBT) has comparable efficacy to antidepressant medication, but therapist availability and cost-effectiveness is a problem. This study aimed to evaluate the effectiveness of Web-based CBT blended with face-to-face sessions that reduce therapist time in patients with major depression who were unresponsive to antidepressant medications. A 12-week, assessor-masked, parallel-group, waiting- list controlled, randomized trial was conducted at 3 medical institutions in Tokyo. Outpatients aged 20-65 years with a primary diagnosis of major depression who were taking ≥1 antidepressant medications at an adequate dose for ≥6 weeks and had a 17-item GRID-Hamilton Depression Rating Scale (HAMD) score of ≥14 were randomly assigned (1:1) to blended CBT or waiting-list groups using a computer allocation system, stratified by the study site with the minimization method, to balance age and baseline GRID-HAMD score. The CBT intervention was given in a combined format, comprising a Web-based program and 12 45-minute face-to-face sessions. Thus, across 12 weeks, a participant could receive up to 540 minutes of contact with a therapist, which is approximately two-thirds of the therapist contact time provided in the conventional CBT protocol, which typically provides 16 50-minute sessions. The primary outcome was the alleviation of depressive symptoms, as measured by a change in the total GRID-HAMD score from baseline (at randomization) to posttreatment (at 12 weeks). Moreover, in an exploratory analysis, we investigated whether the expected positive effects of the intervention were sustained during follow-up, 3 months after the posttreatment assessment. Analyses were performed on an intention-to-treat basis, and the primary outcome was analyzed using a mixed-effects model for repeated measures. We randomized 40 participants to either blended CBT (n=20) or waiting-list (n=20) groups. All patients completed the 12-week treatment protocol and were included in the intention-to-treat analyses. Participants in the blended CBT group had significantly alleviated depressive symptoms at week 12, as shown by greater least squares mean changes in the GRID-HAMD score, than those in the waiting list group (-8.9 points vs -3.0 points; mean between-group difference=-5.95; 95% CI -9.53 to -2.37; P<.001). The follow-up effects within the blended CBT group, as measured by the GRID-HAMD score, were sustained at the 3-month follow-up (week 24) and posttreatment (week 12): posttreatment, 9.4 (SD 5.2), versus follow-up, 7.2 (SD 5.7); P=.009. Although our findings warrant confirmation in larger and longer term studies with active controls, these suggest that a combined form of CBT is effective in reducing depressive symptoms in patients with major depression who are unresponsive to antidepressant medications. University Hospital Medical Information Network Clinical Trials Registry: UMIN000009242; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010852 (Archived by WebCite at http://www.webcitation. org/729VkpyYL).

Nakao S ，Nakagawa A ，Oguchi Y ，Mitsuda D ，Kato N ，Nakagawa Y ，Tamura N ，Kudo Y ，Abe T ，Hiyama M ，Iwashita S ，Ono Y ，Mimura M ... -  《JOURNAL OF MEDICAL INTERNET RESEARCH》