Assessing the Efficacy and Safety of a Digital Therapeutic for Symptoms of Depression in Adolescents: Protocol for a Randomized Controlled Trial.

BACKGROUND: Depression is a serious, prevalent, recurrent, and undertreated disorder in adolescents. Low levels of treatment seeking and treatment adherence in this age group, combined with a growing national crisis in access to mental health care, have increased efforts to identify effective treatment alternatives for this demographic. Digital health interventions for mental illness can provide cost-effective, engaging, and accessible means of delivering psychotherapy to adolescents. OBJECTIVE: This protocol describes a virtual randomized controlled trial designed to evaluate the efficacy and safety of a self-guided, mobile app-based implementation of behavioral activation therapy, SparkRx, for the adjunct treatment of symptoms of depression in adolescents. METHODS: Participants are recruited directly through web-based and print advertisements. Following eligibility screening and consenting, participants are randomly assigned to a treatment arm (SparkRx) or a control arm (assessment-enhanced usual care) for 5 weeks. The primary efficacy outcome, total score on the 8-item Patient Health Questionnaire (PHQ-8), is assessed at the end of the 5-week intervention period. Additional participant-reported outcomes are assessed at baseline, the postintervention time point, and 1-month follow-up. The safety of the intervention is assessed by participant report (and legal guardian report, if the participant is younger than 18 years) and by patterns of symptom deterioration on the PHQ-8, as part of a larger clinical safety monitoring protocol. The primary efficacy outcome, total PHQ-8 score at the postintervention time point, will be compared between SparkRx and enhanced usual care arms using mixed effect modeling, with baseline PHQ-8 and current antidepressant medication status included as covariates. Secondary efficacy outcomes, including the proportion of participants exhibiting treatment response, remission, and minimal clinically significant improvement (all derived from total PHQ-8 scores), will be compared between groups using chi-square tests. Symptom severity at 1-month follow-up will also be compared between arms. Planned subgroup analyses will examine the robustness of treatment effects to differences in baseline symptom severity (PHQ-8 score <15 or ≥ 15) and age (younger than 18 years and older than 18 years). The primary safety outcome, the number of psychiatric serious adverse events, will be compared between trial arms using the Fisher exact test. All other adverse events will be presented descriptively. RESULTS: As of May 2023, enrollment into the study has concluded; 223 participants were randomized. The analysis of the efficacy and safety data is expected to be completed by Fall 2023. CONCLUSIONS: We hypothesize that the results of this trial will support the efficacy and safety of SparkRx in attenuating symptoms of depression in adolescents. Positive results would more broadly support the prospect of using accessible, scientifically validated, digital therapeutics in the adjunct treatment of mental health disorders in this age range. TRIAL REGISTRATION: ClinicalTrials.gov NCT05462652; https://clinicaltrials.gov/study/NCT05462652. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48740.

Trajectories of Treatment Response and Nonresponse in Youth at High Risk for Suicide.

OBJECTIVE: To examine trajectories of treatment response in suicidal youth who participated in a randomized controlled trial comparing dialectical behavior therapy (DBT) and individual and group supportive therapy. METHOD: Using latent class analysis across both treatment conditions, secondary analyses were conducted of data from a multisite randomized controlled trial comprising 173 youths ages 12-18 with repetitive self-harm (SH) (including ≥1 lifetime suicide attempts) and elevated suicidal ideation (SI). The sample was 95% female, 56.4% White, and 27.49% Latina. Participants received 6 months of DBT or individual and group supportive therapy and 6 months of follow-up. Primary outcomes were SH and SI. RESULTS: Of the sample, 63% and 74% were members of latent classes that showed improvement in SI and SH, respectively; 13% were total nonresponders, with no improvement in SI or SH. SH nonresponse emerged at the midpoint of treatment (3 months), with nonresponders showing a sharp increase in SH over the remainder of treatment and follow-up. Youth receiving DBT were significantly more likely to be an SH responder vs nonresponder than youths in individual and group supportive therapy (ꭓ21 = 6.53, p = .01). An optimal threshold cut point using multivariate predictors of total nonresponse (White, externalizing symptoms, total SH, and SI) predicted total nonresponders to DBT with 100% accuracy. CONCLUSION: This is the first study to identify trajectories of both SI and SH response to treatment in a sample of adolescents at risk of suicide. Results may inform personalized treatment approaches. CLINICAL TRIAL REGISTRATION INFORMATION: Collaborative Adolescent Research on Emotions and Suicide (CARES); https://www. CLINICALTRIALS: gov/; NCT01528020.

Dialectical Behavior Therapy for Suicidal Self-Harming Youth: Emotion Regulation, Mechanisms, and Mediators.

OBJECTIVE: This study evaluated mechanisms, mediation, and secondary/exploratory outcomes in our randomized controlled trial evaluating dialectical behavior therapy (DBT) compared to individual and group supportive therapy (IGST). We expand on previously reported results indicating a DBT advantage at posttreatment on planned suicide/self-harm outcomes, and greater self-harm remission (absence of self-harm, post hoc exploratory outcome) during active-treatment and follow-up periods. METHOD: This was a multi-site randomized trial of 173 adolescents with prior suicide attempts, self-harm, and suicidal ideation. Randomization was to 6 months of DBT or IGST, with outcomes monitored through 12 months. Youth emotion regulation was the primary mechanistic outcome. RESULTS: Compared to IGST, greater improvements in youth emotion regulation were found in DBT through the treatment-period [t(498) = 2.36, p = .019] and 12-month study period (t(498) = 2.93, p = .004). Their parents reported using more DBT skills: posttreatment t(497) = 4.12, p < .001); 12-month follow-up t(497) = 3.71, p < .001). Mediation analyses predicted to self-harm remission during the 6- to 12-month follow-up, the prespecified outcome and only suicidality/self-harm variable with a significant DBT effect at follow-up (DBT 49.3%; IGST 29.7%, p = .013). Improvements in youth emotion regulation during treatment mediated the association between DBT and self-harm remission during follow-up (months 6-12, estimate 1.71, CI 1.01-2.87, p = .045). Youths in DBT reported lower substance misuse, externalizing behavior, and total problems at posttreatment/6 months, and externalizing behavior throughout follow-up/12 months. CONCLUSION: Results support the significance of emotion regulation as a treatment target for reducing self-harm, and indicate a DBT advantage on substance misuse, externalizing behavior, and self-harm-remission, with 49.3% of youths in DBT achieving self-harm remission during follow-up. CLINICAL TRIAL REGISTRATION INFORMATION: Collaborative Adolescent Research on Emotions and Suicide; https://www.clinicaltrials.gov/; NCT01528020.

Implementation of Dialectical Behavior Therapy with Suicidal and Self-Harming Adolescents in a Community Clinic.

The object of this research was to examine the feasibility and effectiveness of Dialectical Behavior Therapy (DBT) with suicidal and self-harming adolescents treated in a community clinic. A group of 24 adolescents at high risk for suicide were enrolled in 6 months of comprehensive DBT, provided by therapists and trainees at a county-run outpatient mental health clinic serving disadvantaged, ethnic minority clients. Results showed significant pre/post-treatment decreases in suicide attempts, non-suicidal self-injury behaviors (NSSI), and suicidal ideation. Results also showed significant decreases in other suicide risk factors, including emotion dysregulation, depression, impulsivity, BPD symptoms, psychopathology, PTSD symptoms, and substance use, as well as increases in family expressiveness and reasons for living. Treatment retention and satisfaction rates were high. As many youth at risk for suicide will be treated in community settings, findings showing that receiving DBT in a community clinic resulted in significant improvements across a range of suicide risk factors are an important contribution to the adolescent suicide prevention literature.

Predictors and moderators of recurring self-harm in adolescents participating in a comparative treatment trial of psychological interventions.

BACKGROUND: In primary analyses, dialectical behavior therapy (DBT) was associated with greater reduction in self-harm during treatment than individual/group supportive therapy (IGST). The objective of this paper was to examine predictors and moderators of treatment outcomes for suicidal adolescents who participated in a randomized controlled trial evaluating DBT and IGST. METHODS: Adolescents (N = 173) were included in the intent-to-treat sample and randomized to receive 6 months of DBT or IGST. Potential baseline predictors and moderators were identified within four categories: demographics, severity markers, parental psychopathology, and psychosocial variables. Primary outcomes were suicide attempts (SA) and nonsuicidal self-injury evaluated at baseline, midtreatment (3 months), and end of treatment (6 months) via the Suicide Attempt and Self-Injury Interview (Psychological Assessment, 18, 2006, 303). For each moderator or predictor, a generalized linear mixed model was conducted to examine main and interactive effects of treatment and the candidate variable on outcomes. RESULTS: Adolescents with higher family conflict, more extensive self-harm histories, and more externalizing problems produced on average more reduction on SH frequency from baseline to post-treatment. Adolescents meeting BPD diagnosis were more likely to have high SH frequency at post-treatment. Analyses indicated significant moderation effects for emotion dysregulation on NSSI and SH. DBT was associated with better rates of improvement compared to IGST for adolescents with higher baseline emotion dysregulation and those whose parents reported greater psychopathology and emotion dysregulation. A significant moderation effect for ethnicity on SA over the treatment period was observed, where DBT produced better rate of improvement compared to IGST for Hispanic/Latino individuals. CONCLUSIONS: These findings may help to inform salient treatment targets and guide treatment planning. Adolescents that have high levels of family conflict, externalizing problems, and increased level of severity markers demonstrated the most change in self-harm behaviors over the course of treatment and benefitted from both treatment interventions. Those with higher levels of emotion dysregulation and parent psychopathology may benefit more from the DBT.

Reducing Health Risk Behaviors and Improving Depression in Adolescents: A Randomized Controlled Trial in Primary Care Clinics.

Objective: Primary care (PC) is a major service delivery setting that can provide preventive behavioral health care to youths. To explore the hypothesis that reducing health risk behaviors (HRBs) would lower depressive symptoms, and that health risk and depression can be efficiently targeted together in PC, this study (1) evaluates an intervention designed to reduce HRBs among adolescent PC patients with depressive symptoms and (2) examines prospective links between HRBs and depressive symptoms. Method: A Randomized controlled trial was conducted comparing a behavioral health intervention with enhanced Usual PC (UC+). Participants were 187 adolescents (ages 13-18 years) with past-year depression, assessed at baseline, 6 months, and 12 months. Primary outcome was the Health Risk Behavior Index (HRBI), a composite score indexing smoking, substance use, unsafe sex, and obesity risk. Secondary/exploratory outcomes were an index of the first three most correlated behaviors (HRBI-S), each HRB, depressive symptoms, and satisfaction with mental health care. Results: Outcomes were similar at 6 and 12 months, with no significant between-group differences. HRBI, HRBI-S, and depressive symptoms decreased, and satisfaction with mental health care increased across time in both groups. HRBI, HRBI-S, and smoking predicted later severe depression. Conversely, severe depression predicted later HRBI-S and substance use. Conclusions: UC+ and the behavioral health intervention yielded similar benefits in reducing HRBs and depressive symptoms. Findings underscore the bidirectional links between depression and HRBs, supporting the importance of monitoring for HRBs and depression in PC to allow for effective intervention in both areas.

Efficacy of Dialectical Behavior Therapy for Adolescents at High Risk for Suicide: A Randomized Clinical Trial.

Importance: Suicide is a leading cause of death among 10- to 24-year-old individuals in the United States; evidence on effective treatment for adolescents who engage in suicidal and self-harm behaviors is limited. Objective: To evaluate the efficacy of dialectical behavior therapy (DBT) compared with individual and group supportive therapy (IGST) for reducing suicide attempts, nonsuicidal self-injury, and overall self-harm among high-risk youths. Design, Setting, and Participants: This randomized clinical trial was conducted from January 1, 2012, through August 31, 2014, at 4 academic medical centers. A total of 173 participants (pool of 195; 22 withdrew or were excluded) 12 to 18 years of age with a prior lifetime suicide attempt (≥3 prior self-harm episodes, suicidal ideation, or emotional dysregulation) were studied. Adaptive randomization balanced participants across conditions within sites based on age, number of prior suicide attempts, and psychotropic medication use. Participants were followed up for 1 year. Interventions: Study participants were randomly assigned to DBT or IGST. Treatment duration was 6 months. Both groups had weekly individual and group psychotherapy, therapist consultation meetings, and parent contact as needed. Main Outcomes and Measures: A priori planned outcomes were suicide attempts, nonsuicidal self-injury, and total self-harm assessed using the Suicide Attempt Self-Injury Interview. Results: A total of 173 adolescents (163 [94.8%] female and 97 [56.4%] white; mean [SD] age, 14.89 [1.47] years) were studied. Significant advantages were found for DBT on all primary outcomes after treatment: suicide attempts (65 [90.3%] of 72 receiving DBT vs 51 [78.9%] of 65 receiving IGST with no suicide attempts; odds ratio [OR], 0.30; 95% CI, 0.10-0.91), nonsuicidal self-injury (41 [56.9%] of 72 receiving DBT vs 26 [40.0%] of 65 receiving IGST with no self-injury; OR, 0.32; 95% CI, 0.13-0.70), and self-harm (39 [54.2%] of 72 receiving DBT vs 24 [36.9%] of 65 receiving IGST with no self-harm; OR, 0.33; 95% CI, 0.14-0.78). Rates of self-harm decreased through 1-year follow-up. The advantage of DBT decreased, with no statistically significant between-group differences from 6 to 12 months (OR, 0.65; 95% CI, 0.12-3.36; P = .61). Treatment completion rates were higher for DBT (75.6%) than for IGST (55.2%), but pattern-mixture models indicated that this difference did not informatively affect outcomes. Conclusions and Relevance: The results of this trial support the efficacy of DBT for reducing self-harm and suicide attempts in highly suicidal self-harming adolescents. On the basis of the criteria of 2 independent trials supporting efficacy, results support DBT as the first well-established, empirically supported treatment for decreasing repeated suicide attempts and self-harm in youths. Trial Registration: ClinicalTrials.gov Identifier: NCT01528020.

Depression and Health Risk Behaviors: Towards Optimizing Primary Care Service Strategies for Addressing Risk.

PURPOSE: Depression and health risk behaviors in adolescents are leading causes of preventable morbidity and mortality. Primary care visits provide prime opportunities to screen and provide preventive services addressing risk behaviors/conditions. This study evaluated the co-occurrence of depression and health risk behaviors (focusing on smoking, drug and alcohol misuse, risky sexual behavior, and obesity-risk) with the goal of informing preventive service strategies. METHODS: Consecutive primary care patients (n=217), ages 13 to 18 years, selected to over-sample for depression, completed a Health Risk Behavior Survey and the Diagnostic Interview Schedule for Children and Adolescents (DISC) depression module. RESULTS: Youths with DISC-defined past-year depression were significantly more likely to report risk across multiple risk-areas, Wald X2(1)=14.39, p<.001, and to have significantly higher rates of past-month smoking, X2(1)=5.86, p=.02, substance misuse, X2(1)=15.12, p<.001, risky sex, X2 (1) =5.04, p=.03, but not obesity-risk, X2 (1) =0.19, p=.66. Cross-sectional predictors of risk behaviors across risk areas were similar. Statistically significant predictors across all risk domains included: youths' expectancies about future risk behavior; attitudes regarding the risk behavior; and risk behaviors in peers/others in their environments. CONCLUSIONS: Depression in adolescents is associated with a cluster of health risk behaviors that likely contribute to the high morbidity and mortality associated with both depression and health risk behaviors. Consistent with the United States National Prevention Strategy (2011) and the focus on integrated behavioral and medical health care, results suggest the value of screening and preventive services using combination strategies that target depression and multiple areas of associated health risk.

Conducting Research on Adolescent Suicide Attempters: Dilemmas and Decisions.

Research on effective treatments for adolescent suicide attempters is urgently needed. However, there has been a lack of research in this area. This is likely a result of the multiple challenges faced by investigators working with individuals at high risk of suicide. Based on our experiences conducting a large, randomized clinical trial with adolescent suicide attempters, in this article, we review ways to address these challenges in order to facilitate needed research on suicide prevention in adolescents.

Sexual harassment and PTSD: is sexual harassment diagnosable trauma?

Sexual harassment has become a major social, legal, and mental health problem because of its high prevalence and its negative consequences for victims. These consequences can include decreased productivity, loss of job, decreased income, and impaired psychological and physical well-being. Despite evidence from empirical studies that victims often exhibit posttraumatic stress disorder (PTSD) symptoms, some have argued that sexual harassment does not constitute legitimate trauma. We argue that many forms of sexual harassment meet the diagnostic Criteria A1 and A2 of PTSD. Finally, the DSM-IV trauma criterion is explicated, and its relationship with sexual harassment and its effects are discussed.