Although trauma‐focused cognitive behavior therapy (TF‐CBT) is the recommended treatment for post‐traumatic stress disorder (PTSD), up to one‐half of patients do not respond to this intervention. There is an urgent need to develop new strategies to improve treatment response. Training people to recall specific positive memories may augment treatment gains in TF‐CBT. We conducted a controlled trial in Australia with current or former first responders (including police, firefighters and paramedics) with PTSD, who were randomized on a 1:1 basis to 12 weekly 90‐min individual sessions of either TF‐CBT combined with memory specificity training (TF‐CBT/MT) or TF‐CBT alone. The primary outcome was change in PTSD severity independently assessed at baseline, post‐treatment, and six months after treatment (primary outcome timepoint). Secondary outcomes included measures of depression, trauma‐related cognitions, alcohol use, and quality of life. Between October 2021 and May 2023, fifty participants were randomized to TF‐CBT/MT, and fifty to TF‐CBT alone. Most participants were males (71.0%) and the mean age was 46.8±9.9 years. At the 6‐month assessment, participants receiving TF‐CBT/MT showed a greater reduction of PTSD severity than those randomized to TF‐CBT alone (mean difference: 9.2, 95% CI: 3.2‐15.1, p=0.003), indicating a large effect size (0.9, 95% CI: 0.1‐1.6). Participants receiving TF‐CBT/MT also had greater reductions in alcohol use (mean difference: 5.3, 95% CI: 1.5‐9.2, p=0.007; effect size: 0.8, 95% CI: 0.2‐1.4) and self‐blame cognitions (mean difference: 0.8, 95% CI: 0.2‐1.4, p=0.008; effect size: 0.5, 95% CI: 0.1‐0.9). These data suggest that memory specificity training adds significantly to the effect of standard TF‐CBT in reducing PTSD severity. This approach can offer a simple and easy to implement strategy to augment treatment for PTSD patients.

Importance:A large proportion of college students report experiencing psychological distress. Smartphone app-based interventions may alleviate distress, but their effectiveness across severity levels is unclear. Artificial intelligence (AI)-enhanced response-adaptive randomized clinical trials may offer an efficient method to evaluate competing interventions. Objective:To compare the effectiveness of 3 brief, 2-week self-guided smartphone application-based interventions (physical activity, mindfulness, sleep hygiene) or an active control (ecological momentary assessment [EMA]) for reducing psychological distress among college students with mild, moderate, or severe distress. Design, Setting, and Participants:This population-based AI-enhanced response-adaptive randomized clinical trial included 1282 participants with distress scores of 20 or more on the 10-item Kessler Psychological Distress Scale in 12 minitrials from November 9, 2021, with final follow-up on February 17, 2023. Participants' distress was categorized as mild, moderate, or severe based on their normalized 21-item Depression Anxiety Stress Scale (DASS-21) scores at screening. Interventions:After a 2-week onboarding period of daily EMA, participants were assigned by a contextual multi-armed bandit algorithm to 1 of 4 two-week self-guided app interventions: physical activity, mindfulness, sleep hygiene, or a control that continued EMA. Main Outcomes and Measures:The primary outcome was change in psychological distress (DASS-21 total score) from week 2 (before intervention) to week 4 (after intervention). The primary end point was after the intervention (4 weeks). Secondary outcomes included DASS-21 subscale scores, self-reported physical activity, mindfulness, sleep quality, and app engagement, usability, and satisfaction. Analysis was performed on an intention-to-treat basis. Results:A total of 1282 individuals (mean [SD] age, 23.5 [5.2] years; 950 women [74.1%]) participated: physical activity (n = 305), mindfulness (n = 453), sleep hygiene (n = 431), or a control that continued EMA (n = 93). Among 349 participants with severe distress, physical activity (n = 79) and mindfulness (n = 180) were significantly more effective than the EMA control (n = 29) in reducing DASS-21 total scores (physical activity vs control: standardized mean difference [SMD], 0.62 [95% CI, 0.23-1.02]; mindfulness vs control: SMD, 0.53 [95% CI, 0.19-0.87]) and sleep hygiene (n = 61) (physical activity vs sleep hygiene: SMD, 0.50 [95% CI, 0.16-0.84]; mindfulness vs sleep hygiene: SMD, 0.41 [95% CI, 0.13-0.69]). Among 494 participants with mild distress, physical activity (n = 161) and sleep hygiene (n = 224) were significantly more effective than control (n = 37) in reducing DASS-21 total scores (physical activity vs control: SMD, 0.58 [95% CI, 0.30-0.86]; sleep hygiene vs control: SMD, 0.47 [95% CI, 0.20-0.73]). No significant group differences were observed among participants with moderate distress (n = 439). Conclusions and Relevance:In this AI-enhanced response-adaptive randomized clinical trial among college students, physical activity and mindfulness were most effective for severe distress, while physical activity and sleep hygiene were most effective for mild distress. These findings can guide personalized mental health interventions for college students. This trial improved efficiency by minimizing control group allocation but had reduced power to detect significant group differences. Trial Registration:http://anzctr.org.au Identifier: ACTRN12621001223820.

QuestionWhich brief digital intervention most effectively reduces mild, moderate, and severe levels of psychological distress among college students?FindingsThis artificial intelligence-enhanced response-adaptive randomized clinical trial involving 1282 distressed college students found that smartphone-based physical activity and mindfulness were most effective for severe distress and that physical activity and sleep hygiene were most effective for mild distress; no significant differences were observed for moderate distress. The trial's novel methods improved efficiency by reducing control group allocation.MeaningThese findings support using brief smartphone-based physical activity for mild and severe distress, mindfulness for severe distress, and sleep hygiene for mild distress. ImportanceA large proportion of college students report experiencing psychological distress. Smartphone app-based interventions may alleviate distress, but their effectiveness across severity levels is unclear. Artificial intelligence (AI)-enhanced response-adaptive randomized clinical trials may offer an efficient method to evaluate competing interventions.ObjectiveTo compare the effectiveness of 3 brief, 2-week self-guided smartphone application-based interventions (physical activity, mindfulness, sleep hygiene) or an active control (ecological momentary assessment [EMA]) for reducing psychological distress among college students with mild, moderate, or severe distress.Design, Setting, and ParticipantsThis population-based AI-enhanced response-adaptive randomized clinical trial included 1282 participants with distress scores of 20 or more on the 10-item Kessler Psychological Distress Scale in 12 minitrials from November 9, 2021, with final follow-up on February 17, 2023. Participants' distress was categorized as mild, moderate, or severe based on their normalized 21-item Depression Anxiety Stress Scale (DASS-21) scores at screening.InterventionsAfter a 2-week onboarding period of daily EMA, participants were assigned by a contextual multi-armed bandit algorithm to 1 of 4 two-week self-guided app interventions: physical activity, mindfulness, sleep hygiene, or a control that continued EMA.Main Outcomes and MeasuresThe primary outcome was change in psychological distress (DASS-21 total score) from week 2 (before intervention) to week 4 (after intervention). The primary end point was after the intervention (4 weeks). Secondary outcomes included DASS-21 subscale scores, self-reported physical activity, mindfulness, sleep quality, and app engagement, usability, and satisfaction. Analysis was performed on an intention-to-treat basis.ResultsA total of 1282 individuals (mean [SD] age, 23.5 [5.2] years; 950 women [74.1%]) participated: physical activity (n = 305), mindfulness (n = 453), sleep hygiene (n = 431), or a control that continued EMA (n = 93). Among 349 participants with severe distress, physical activity (n = 79) and mindfulness (n = 180) were significantly more effective than the EMA control (n = 29) in reducing DASS-21 total scores (physical activity vs control: standardized mean difference [SMD], 0.62 [95% CI, 0.23-1.02]; mindfulness vs control: SMD, 0.53 [95% CI, 0.19-0.87]) and sleep hygiene (n = 61) (physical activity vs sleep hygiene: SMD, 0.50 [95% CI, 0.16-0.84]; mindfulness vs sleep hygiene: SMD, 0.41 [95% CI, 0.13-0.69]). Among 494 participants with mild distress, physical activity (n = 161) and sleep hygiene (n = 224) were significantly more effective than control (n = 37) in reducing DASS-21 total scores (physical activity vs control: SMD, 0.58 [95% CI, 0.30-0.86]; sleep hygiene vs control: SMD, 0.47 [95% CI, 0.20-0.73]). No significant group differences were observed among participants with moderate distress (n = 439).Conclusions and RelevanceIn this AI-enhanced response-adaptive randomized clinical trial among college students, physical activity and mindfulness were most effective for severe distress, while physical activity and sleep hygiene were most effective for mild distress. These findings can guide personalized mental health interventions for college students. This trial improved efficiency by minimizing control group allocation but had reduced power to detect significant group differences.Trial Registrationhttp://anzctr.org.au Identifier: ACTRN12621001223820 This randomized clinical trial compares the effectiveness of 3 brief smartphone app-based interventions (physical activity, mindfulness, and sleep hygiene) or an active control (ecological momentary assessment) for reducing mild, moderate, and severe psychological distress among college students.

BackgroundWith increasing adoption of remote clinical trials in digital mental health, identifying cost-effective and time-efficient recruitment methodologies is crucial for the success of such trials. Evidence on whether web-based recruitment methods are more effective than traditional methods such as newspapers, media, or flyers is inconsistent. Here we present insights from our experience recruiting tertiary education students for a digital mental health artificial intelligence–driven adaptive trial—Vibe Up. ObjectiveWe evaluated the effectiveness of recruitment via Facebook and Instagram compared to traditional methods for a treatment trial and compared different recruitment methods’ retention rates. With recruitment coinciding with COVID-19 lockdowns across Australia, we also compared the cost-effectiveness of social media recruitment during and after lockdowns. MethodsRecruitment was completed for 2 pilot trials and 6 minitrials from June 2021 to May 2022. To recruit participants, paid social media advertising on Facebook and Instagram was used, alongside mailing lists of university networks and student organizations or services, media releases, announcements during classes and events, study posters or flyers on university campuses, and health professional networks. Recruitment data, including engagement metrics collected by Meta (Facebook and Instagram), advertising costs, and Qualtrics data on recruitment methods and survey completion rates, were analyzed using RStudio with R (version 3.6.3; R Foundation for Statistical Computing). ResultsIn total, 1314 eligible participants (aged 22.79, SD 4.71 years; 1079, 82.1% female) were recruited to 2 pilot trials and 6 minitrials. The vast majority were recruited via Facebook and Instagram advertising (n=1203; 92%). Pairwise comparisons revealed that the lead institution’s website was more effective in recruiting eligible participants than Facebook (z=3.47; P=.003) and Instagram (z=4.23; P<.001). No differences were found between recruitment methods in retaining participants at baseline, at midpoint, and at study completion. Wilcoxon tests found significant differences between lockdown (pilot 1 and pilot 2) and postlockdown (minitrials 1-6) on costs incurred per link click (lockdown: median Aus $0.35 [US $0.22], IQR Aus $0.27-$0.47 [US $0.17-$0.29]; postlockdown: median Aus $1.00 [US $0.62], IQR Aus $0.70-$1.47 [US $0.44-$0.92]; W=9087; P<.001) and the amount spent per hour to reach the target sample size (lockdown: median Aus $4.75 [US $2.95], IQR Aus $1.94-6.34 [US $1.22-$3.97]; postlockdown: median Aus $13.29 [US $8.26], IQR Aus $4.70-25.31 [US $2.95-$15.87]; W=16044; P<.001). ConclusionsSocial media advertising via Facebook and Instagram was the most successful strategy for recruiting distressed tertiary students into this artificial intelligence–driven adaptive trial, providing evidence for the use of this recruitment method for this type of trial in digital mental health research. No recruitment method stood out in terms of participant retention. Perhaps a reflection of the added distress experienced by young people, social media recruitment during the COVID-19 lockdown period was more cost-effective. Trial RegistrationAustralian New Zealand Clinical Trials Registry ACTRN12621001092886; https://tinyurl.com/39f2pdmd; Australian New Zealand Clinical Trials Registry ACTRN12621001223820; https://tinyurl.com/bdhkvucv

Objective Treatment of posttraumatic stress disorder (PTSD) is hindered by limited uptake, early drop-out and non-response. This pilot study aimed to explore the feasibility, acceptability, and usability of a mobile app as part of a blended approach to treating frontline workers experiencing PTSD.Method A single-group pre-post study was conducted with 10 adult frontline workers (firefighters, police, correctional workers) receiving trauma-focused cognitive-behavioural therapy for PTSD. Participants used an app (Support Base) designed to consolidate session content and encourage independent skills practice. At post-treatment, feasibility was assessed via app usage data and participant feedback, usability via the mHealth App Usability Questionnaire, and acceptability via items from the Mobile Application Rating Scale: user version.Results Usability ratings were above average and the app received an overall mean rating of 3.4/5. Despite generally positive attitudes towards using technology in therapy, participants had low levels of confidence/experience with wellbeing apps and almost half preferred using the standard treatment workbook. Clinicians highlighted a range of client barriers to app use, including difficulties in clinician/client collaboration. Overall, there was significant pre- to post-treatment improvement in clinical measures of PTSD and depression, but this change cannot be tied to app use.Conclusions Although Support Base was viewed by participants as usable and acceptable, there were feasibility issues which must be further considered in delivering this form of care. Due to the uncontrolled study design, any additive effects of the app beyond standard clinical treatment could not be assessed. The development of a more integrated blended care model is a potential avenue for future research.

BACKGROUND:Rumination and worry, forms of repetitive negative thinking (RNT), are implicated in the onset, maintenance, severity, and relapse risk of depression and anxiety disorders. This randomised controlled trial evaluated an internet intervention targeting both rumination and worry in adults compared to treatment-as-usual (TAU) and compared treatment effects and adherence when delivered with and without clinician guidance. METHODS:Adults (N = 137) with elevated RNT were randomly allocated to a 3-lesson clinician guided (n = 45) or self-help (n = 47) online program delivered over 6 weeks, or a TAU control group which waited 18 weeks to receive the program (n = 45). The clinician guided group received semi-structured phone support after each lesson. All three groups continued any pre-trial TAU. RNT, anxiety, depression, and psychological distress were assessed at baseline, post-treatment (week 7), and 3-month follow-up. RESULTS:Intention-to-treat linear mixed models showed that participants in the self-help and clinician guided groups had significantly lower RNT, anxiety, depression, and distress at post-treatment and 3-month follow-up compared to TAU. Treatment effects were significantly larger in the clinician guided group compared to self-help (between-group gs = 0.41-0.97). No significant between-group differences were found in adherence/program completion (guided: 76%; self-guided: 79%) or treatment satisfaction (1-5 scale: guided: M = 4.17, SD = 1.20; self-guided: M = 3.89, SD = 0.93). Total time spent on clinician guidance was M = 48.64 min (SD = 21.28). CONCLUSION:This brief online intervention for RNT is acceptable and efficacious in reducing RNT, anxiety, depression, and distress in both clinician guided and self-help formats. The program appeared most effective when delivered with clinician guidance. Larger definitive trials comparing guided and self-guided programs are needed. Australian and New Zealand Clinical Trials Registration number: ACTRN12620000959976.

Introduction Meta-analytical evidence confirms a range of interventions, including mindfulness, physical activity and sleep hygiene, can reduce psychological distress in university students. However, it is unclear which intervention is most effective. Artificial intelligence (AI)-driven adaptive trials may be an efficient method to determine what works best and for whom. The primary purpose of the study is to rank the effectiveness of mindfulness, physical activity, sleep hygiene and an active control on reducing distress, using a multiarm contextual bandit-based AI-adaptive trial method. Furthermore, the study will explore which interventions have the largest effect for students with different levels of baseline distress severity. Methods and analysis The Vibe Up study is a pragmatically oriented, decentralised AI-adaptive group sequential randomised controlled trial comparing the effectiveness of one of three brief, 2-week digital self-guided interventions (mindfulness, physical activity or sleep hygiene) or active control (ecological momentary assessment) in reducing self-reported psychological distress in Australian university students. The adaptive trial methodology involves up to 12 sequential mini-trials that allow for the optimisation of allocation ratios. The primary outcome is change in psychological distress (Depression, Anxiety and Stress Scale, 21-item version, DASS-21 total score) from preintervention to postintervention. Secondary outcomes include change in physical activity, sleep quality and mindfulness from preintervention to postintervention. Planned contrasts will compare the four groups (ie, the three intervention and control) using self-reported psychological distress at prespecified time points for interim analyses. The study aims to determine the best performing intervention, as well as ranking of other interventions. Ethics and dissemination Ethical approval was sought and obtained from the UNSW Sydney Human Research Ethics Committee (HREC A, HC200466). A trial protocol adhering to the requirements of the Guideline for Good Clinical Practice was prepared for and approved by the Sponsor, UNSW Sydney (Protocol number: HC200466_CTP). Trial registration number ACTRN12621001223820.

Accessible, affordable cognitive behavioral therapy (CBT) options for Social Anxiety Disorder (SAD) that allow for rapid symptom improvement are needed. The present study investigated the first intensive, 7-day internetbased CBT for SAD. An open pilot trial was conducted to test the acceptability, feasibility and preliminary outcomes of the program in a sample of 16 participants (9 females, M age = 40.34, SD = 10.55) with a DSM-5 diagnosis of SAD. Participants were enrolled into the 6-lesson online program, and completed the Social Phobia Scale [SPS], Social Interaction Anxiety Scale [SIAS], Patient Health Questionnaire-9 (PHQ-9), and Work and Social Adjustment Scale (WSAS) at baseline, post and one month follow-up. We found support for the feasibility and acceptability of the program; 15 participants (93.8%) completed the program, and all participants reported the program was satisfactory. Large, significant reductions in social anxiety severity on both the SPS and SIAS (Hedges' gs = 1.26-1.9) and functional impairment (WSAS; gs = 0.88-0.98) were found at post-treatment and follow-up. Medium, significant reductions in depressive symptom severity were also found (gs = 0.88-0.98 at post and follow-up, respectively). A third of participants scored below the clinical cut-off on both the SPS and SIAS at post-treatment and follow-up. A randomized controlled trial with longer follow-up is needed to evaluate the efficacy of this intensive internet-based treatment for SAD. Implications and future research directions are discussed.

Aim: To compare the efficacy and acceptability of internet-delivered exposure therapy for panic disorder, to multi-component internet-delivered cognitive behavioral therapy (iCBT) that included controlled breathing, cognitive restructuring and exposure. Methods: Participants with panic disorder, with or without agoraphobia, were randomized to internet-delivered exposure therapy (n = 35) or iCBT (n = 34). Both programs were clinician guided, with six lessons delivered over eight weeks. Outcomes included panic disorder and agoraphobia symptom severity, as well as depression symptom severity, functional impairment and days out of role. Results: Participants in both conditions displayed a large reduction in panic disorder symptom severity (ds >1.30) from pre- to post-treatment. Participants in both conditions displayed medium to large reduction in agoraphobia and depression symptom severity, functional impairment and days out of role. Effects were maintained at threeand six-month follow-up. There was no significant difference between the interventions in clinical outcomes, adherence or treatment satisfaction. Conclusions: Internet-delivered exposure therapy appeared to be as acceptable and efficacious as more established iCBT, despite including less strategies. However, a fully powered replication is now needed to compare the two approaches.

OBJECTIVE:Cognitive-behavioural models suggest that vicarious illness experiences precipitate health anxiety; however, this assumption is largely untested. This study aimed to (a) compare the severity of health anxiety and rates of clinical health anxiety, Illness Anxiety Disorder (IAD), and Somatic Symptom Disorder (SSD) in participants with and without a loved one with cancer, and (b) determine the predictors of health anxiety severity in participants with vicarious cancer experiences.METHODS:Participants with (n = 142) and without (n = 65) vicarious cancer experiences completed an online battery of questionnaires assessing the severity and cognitive, physiological, and behavioural components of health anxiety. Participants reporting clinical levels of health anxiety completed a diagnostic telephone interview to assess for IAD and SSD.RESULTS:Severity and rates of clinical health anxiety, IAD, and SSD did not differ between groups. Participants with a vicarious experience of cancer reported elevated fear of cancer recurrence regarding their loved one's illness, however only 15.8% reported clinically significant health anxiety. Hierarchical regression revealed that in participants with vicarious cancer experiences, less relationship closeness and greater perceived risk of cancer, severity of somatic symptoms, bodily hypervigilance, and catastrophic interpretation of symptoms predicted health anxiety. Being a caregiver for or genetically related to the person with cancer, the expectedness of the cancer diagnosis, and whether the loved one died from cancer were not significant predictors.CONCLUSIONS:These results suggest that people reporting vicarious cancer experiences do not have elevated rates of health anxiety. However, how these individuals interpret their experiences influences health anxiety severity.

The current systematic review and meta-analysis examined the efficacy and effectiveness of internet-delivered cognitive behavioral therapy (iCBT) on panic disorder and agoraphobia symptom severity. Twenty-seven studies were identified. Results from nine randomised controlled trials (RCTs) showed that iCBT outperformed waiting list and information controls for panic (g = 1.22) and agoraphobia (g = .91) symptoms, but the quality of RCTs varied and heterogeneity was high. Results from three RCTs suggested iCBT may have similar outcomes to face-to-face CBT in reducing panic and agoraphobia symptoms. Within-group effect sizes between baseline and post-treatment were large for panic (n = 29, g = 1.16) and medium for agoraphobia symptom severity (n = 18, g = .73). Subgroup analyses of within-group pre/post treatment effect sizes showed larger within-group effect sizes for efficacy studies (n = 15) compared to effectiveness studies (n = 14) for panic severity (g = 1.38 vs. g = .98) but not agoraphobia severity. There was no impact of program length, inclusion or arousal reduction techniques, or degree of clinician support. Within-group effects of iCBT suggest the reduction in panic and agoraphobia symptom severity is maintained at 3-6 month follow-up (n = 12).

Cognitive models of obsessive-compulsive disorder propose that beliefs about the importance of and need to control thoughts (ICT) are central to the maintenance of the disorder. Cognitive Bias Modification for Interpretation (CBM-I) can be used to experimentally test this theory and may also have clinical utility as an adjunct therapeutic tool. The current study extended previous research to investigate whether two CBM-I sessions (one within and one outside the laboratory) would augment effects on obsessive-compulsive beliefs and behavior. We randomly allocated undergraduate participants high in ICT beliefs to a Positive (n = 30) or Control (n = 36) CBM-I condition and conducted multi-modal assessments immediately following the first training and at one-week follow-up. As predicted, participants in the Positive condition reported a reduction in obsessive-compulsive beliefs from baseline to follow-up (partial η 2 = .42), whereas those in the Control condition did not. Participants responded more adaptively to the ICT relevant stressor task at follow-up compared to post-intervention, but there was no significant difference between conditions. Likewise, participants reported a reduction in obsessive symptoms over time that did not differ between conditions. The findings are considered in light of cognitive models of OCD, and clinical implications are discussed.

This is the first pilot study to explore the feasibility, acceptability and preliminary efficacy of intensive cognitive behavioral therapy (CBT) for panic disorder and/or agoraphobia delivered via the internet. Ten participants who met DSM-5 criteria for panic disorder and/or agoraphobia (6 males; mean age = 43.40, SD = 15.25) completed The Intensive Panic Program: a six-lesson exposure-based CBT program, delivered online over seven days. Clinician support was provided via phone and email. All 10 participants completed the program (100% adherence) and high levels of satisfaction were reported. We found large and significant reductions in panic symptom severity at post-treatment (d = 1.40), which were maintained at two-month follow-up. We also found large reductions in agoraphobic avoidance (d = 0.92) and functional impairment (d = 1.04) at follow-up, and days out of role were halved. On average, 132 min (SD = 42, range: 47–183) of clinician time was spent per participant during the treatment week. The results provide promising preliminary evidence for the feasibility and acceptability of internet-delivered intensive CBT for panic disorder and/or agoraphobia. A larger, randomized control trial is now needed to evaluate the efficacy of this program compared to a control group and to explore long-term outcomes.Clinical trial registration numberACTRN12618001501235