Wait-list Control Group Research Articles

Cultural Adaptation of RUBI Intervention with Korean Families(K-RUBI): A Mixed Method Study.

Challenging behaviors of young autistic children remain a major parenting challenge for many of their family members, including caregivers. Caregivers from underrepresented cultural or linguistic backgrounds may experience exacerbated difficulties related to challenging behaviors due to limited access to culturally sustaining and responsive interventions. Evidence-based behavior parent training programs, such as RUBI, are highly effective in increasing caregivers' capacity in preventing and responding to these behaviors in naturalistic settings using behavior analytic principles. Therefore, the purpose of this study was to examine the effectiveness, acceptability, and feasibility of the culturally adapted RUBI program with underserved families. We conduct a convergent mixed-methods study using a pilot randomized controlled trial with a waitlist control group and focus group interviews with 31 Korean families of young children with or suspected of autism. The Korean RUBI underwent rigorous cultural adaptation using the Cultural Adaptation Checklist, including the use of multiple community advisory boards to inform cultural adaptation. Both quantitative and qualitative findings revealed significant improvements in parents' confidence and knowledge in behavioral principles and decrease in severity of challenging behaviors, which suggest clinical utility of RUBI in an underrepresented, low-resourced community. A culturally adapted intervention for a different population can be perceived as a newly constructed intervention. This study provides insight on the systematic process of cultural adaptation of an established autism intervention and effectiveness, feasibility, and acceptability of RUBI.

Impact of School Gardens on Nutrition Education Among Limited-Income Communities in Alabama.

We sought to determine the impact of school gardens and nutrition education on student fruit and vegetable consumption from limited-income communities in Alabama. Third grade students at 99 Alabama schools with and without gardens on-site were randomized to receive either nutrition education or to a wait-list control group. Multi-level models were used to assess the effects of treatment and control with and without school gardens. Students attending schools with gardens demonstrated highest consumption of fruits and vegetables prior to treatment. Nutrition education alone translated into significant dietary improvements. Both gardens and education translated into greatest dietary improvements. Devising financially accessible, practical, and culturally relevant ways to improve student health through garden and nutrition education may help improve student diet. Forming comprehensive Extension, SNAP-Ed, and school collaboration to support gardens, nutrition education, and healthy school policies and systems can be a way to support and sustain healthy student learning environments. Combined gardening and nutrition education is associated with increases in fruit and vegetable consumption among majority rural, Southern students from limited-resource communities.

Cost-effectiveness analysis of mindfulness-based cognitive therapy in patients with anxiety disorders in secondary mental health care settings alongside a randomized controlled trial.

Anxiety disorder is one of the most prevalent mental disorders. Mindfulness-based cognitive therapy (MBCT) is effective for treating anxiety disorders. However, no studies have investigated the cost-effectiveness of MBCT for anxiety disorders. We aimed to conduct a cost-effectiveness analysis alongside a randomized controlled trial (RCT) to clarify the cost-effectiveness of MBCT for anxiety disorders. A cost-effectiveness analysis alongside an RCT was conducted for 8 weeks in 40 patients with anxiety disorders at a university hospital. Patients (1) aged 20-75 years; (2) who were diagnosed with panic disorder/agoraphobia or social anxiety disorder based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, criteria; and (3) who provided written consent were analyzed. The participants were allocated randomly (1:1 ratio) to the augmented MBCT group (i.e., MBCT plus treatment as usual [TAU]) or TAU (waitlist control) group. The cost-effectiveness was assessed using the incremental cost-effectiveness ratio (ICER), which is the ratio of the incremental costs divided by the incremental state-trait anxiety inventory- state (STAI-S), state-trait anxiety inventory- trait (STAI-T), and quality-adjusted life years (QALYs). The QALYs were estimated using The Japanese version of EuroQoL five-dimensional 3-level questionnaire. The unit cost data were derived from the government-regulated fees. This study was conducted from a public healthcare insurance perspective. No discount rates were considered. A total of 38 participants with complete data were included in the analysis. The MBCT was JPY 13,885 more than the cost of TAU and was associated with a STAI-S, STAI-T, and QALY increase of 10.13, 12.00, 0.009 respectively. The ICER were JPY 1,371 (USD13) per STAI-S, JPY 1,157 (USD 11) per STAI-T, and JPY 1,566,357 (USD 14,940) per QALY respectively. MBCT had an 77.5% probability of being cost-effective at a willingness to pay threshold in Japan (JPY 5,000,000 per QALY). The results of the four one-way sensitivity analyses supported the robustness of the base-case analysis findings. Augmented MBCT for anxiety disorders is cost-effective compared with TAU post-treatment from a public healthcare insurance perspective. Future studies should include long-term observations, and analysis from a societal perspective.

Effects of Breathing-Relaxation Training Plus Autonomous Sensory Meridian Response on Mood and Depressive Symptoms in Patients With Mild Depression.

To date, the feasibility of autonomous sensory meridian response (ASMR) as a complement to traditional treatments for patients with depression remains unclear. The main objective of this study was to investigate the effects of breathing-relaxation training plus ASMR on mood and depressive symptoms in patients with mild depression. A quasi-experimental pre- and post-test design with a non-equivalent control group was used. Forty patients with mild depression were assigned to the experimental group that received breathing-relaxation training plus ASMR or the wait-list control group for a total of 8 training sessions. To assess mood and depressive symptoms, the Korean version of the Profile of Mood State-Brief and the Patient Health Questionnaire-9 were performed. There was no significant difference in baseline demographic characteristics between both groups. After the 8 training sessions, the experimental group achieved a significantly greater improvement in mood and depressive symptoms with more ASMR experiences compared to the control group. These findings illustrated the feasibility of ASMR as a complementary tool and breathing-relaxation training plus ASMR might be clinically beneficial to alleviate negative mood and depressive symptoms in patients with mild depression.

Results of a randomized waitlist-controlled trial of online cognitive behavioral sex therapy and online mindfulness-based sex therapy for hypoactive sexual desire dysfunction in women.

This study aimed to investigate the efficacy of two internet-delivered psychological treatments for hypoactive sexual desire dysfunction (HSDD) in women: internet-based cognitive behavioral sex therapy (iCBST) and internet-based mindfulness-based sex therapy (iMBST). Women with HSDD were randomly assigned to one of three groups: iCBST, iMBST, or a waitlist control group. The interventions consisted of eight modules delivered via an e-health platform with e-coach support to enhance adherence. Sexual desire and sexual distress were assessed at baseline and at 3-, 6-, and 12-month follow-ups (active conditions only). Per protocol, of the 266 consenting women, 106 were randomized to iCBST (Mage = 36.1, SD = 10.3), 106 to iMBST (Mage = 36.4, SD = 0.2), and 54 to the control condition (Mage = 36.7, SD = 11.0). Primary analyses utilized an intention-to-treat approach with linear mixed models. Clinical significance, assessed with clinical cutoffs and the reliable change index, was examined for active conditions. Compared to the control condition, both iCBST and iMBST demonstrated significant improvements in sexual desire and sexual distress at 3-month (d = 0.89-1.14) and 6-month follow-up (d = 0.74-1.18). Results were sustained at 12-month follow-up, with 35 and 41% demonstrating reliable improvements and additional 20 and 24% achieving clinically significant improvements in sexual desire after iCBST and iMBST. Regarding sexual distress, 49 and 42% exhibited reliable change, with an additional 37%-42% achieving clinically significant improvements. Results provide support for the overall long-term efficacy of psychological therapies in treating HSDD in women. However, fewer than one in four women showed improvements in sexual desire that met the threshold for clinically significant change. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Effects of a mindfulness-based health promotion program on mindfulness, psychological capital, compassion fatigue, and affect in healthcare workers.

This study aimed to examine the effects of the Mindfulness-Based Health Promotion program on mindfulness, psychological capital, compassion fatigue, and affect in a sample of healthcare workers at a hospital in Colombia. Randomized controlled study with pre-test and post-test measures, in which 33 workers participated (Mage = 35.01, SD = 10.0), assigned to the experimental group (EG, n = 16, Mage = 34.00, SD = 9.59) and the wait-list control group (CG, n = 17, Mage = 36.03, SD = 10.56). The contrast of the program effects was carried out through a mixed factorial ANOVA. We found significant effects on observing, non-reacting and mindfulness as a function of the group factor. We concluded the Mindfulness-Based Health Promotion program showed positive effects on mindfulness, this was tested with a novel program designed for the Latin population. This study is pioneering in using this mindfulness program in Colombia. These findings offer valuable insights for leaders of healthcare institutions when developing intervention programs that promote the mental health in the workplace. Future studies with larger samples and mixed-methods are necessary to confirm our results and to identify factors that can predict these findings.

Second Wave Positive Psychology in the Prevention and Reduction of Parental Burnout: The CARE Intervention

Positive psychology interventions aim to enhance individuals’ resilience, mental health, and well-being. This study ( N = 34) aimed to assess whether the CARE (Coherence, Attention, Relationship, Engagement) intervention tailored to enhance parental strengths and resources may contribute to the prevention and reduction of parental burnout. We tested the hypothesis that, compared to a waiting-list control group, parents attending the intervention would present lower scores of parental burnout postintervention (T2). The results of the study showed that compared to the control group the CARE program contributed to the significant reduction of parental burnout within the intervention group, with a large effect size ( F(1, 32) = 7.74 , p = .01, η2p = 0.20). Within the CARE group, the severity of parental burnout significantly decreased ( t(32) = 3.87, Mdiff = 16.71, SEdiff = 4.32, p = .01), whereas there was no statistically significant difference in parental burnout symptoms between T1 and T2 among the participants from the control group ( t(32) = −0.07, Mdiff = −0.29, SEdiff = 4.32, p = 1.00). In conclusion, the findings of the present study suggest that the CARE intervention may significantly contribute to the reduction of parental burnout.

Process evaluation findings from Strong Hearts, Healthy Communities 2.0: a cardiovascular disease prevention intervention for rural women

BackgroundStrong Hearts, Healthy Communities 2.0 (SHHC-2.0) was a 24-week cardiovascular disease prevention program that was effective in improving physical activity and nutrition behaviors and clinical outcomes among women in 11 rural New York, USA towns. This study evaluated the delivery of SHHC-2.0 to prepare the intervention for further dissemination.MethodsThis process evaluation was guided by the Medical Research Council recommendations and engaged program leaders and participants (i.e., women over age 40) using quantitative and qualitative methods. The quantitative evaluation included examination of enrollment and retention data, a participant survey, and a fidelity checklist completed after classes. Descriptive and comparative statistics were used to assess implementation measures: program reach, participant attendance, dose delivered, program length, perceived effectiveness, fidelity, and participant satisfaction. The qualitative evaluation included focus groups (n = 13) and interviews (n = 4) using semi-structured guides; audio was recorded and transcripts were deductively coded and analyzed using directed content analysis and iterative categorization approaches. Comparisons across towns and between intervention and waitlist control groups were explored.ResultsAverage reach within towns was 7.5% of the eligible population (range 0.7-15.7%). Average attendance was 59.8% of sessions (range 42.0-77.4%). Average dose delivered by leaders was 86.4% of curriculum components (range 73.5-95.2%). Average session length was 51.8 ± 4.8 min across 48 sessions. Leaders’ perceived effectiveness rating averaged 4.1 ± 0.3 out of 5. Fidelity to curricular components was 81.8% (range 67.4-93.2%). Participants reported being “more than satisfied” with the overall program (88.8%) and the health benefits they obtained (72.9%). Qualitative analysis revealed that participants: (1) gained new knowledge and enjoyable experiences; (2) perceived improvements in their physical activity, nutrition, and/or health; (3) continued to face some barriers to physical activity and healthy eating, with those relating to social support being reduced; and (4) rated leaders and the group structure highly, with mixed opinions on the research elements.ConclusionsSHHC-2.0 had broad reach, was largely delivered as intended, and participants expressed high levels of satisfaction with the program and its health benefits. Our findings expand on best practices for implementing cardiovascular disease prevention programs in rural communities.Clinical trials Registrationwww.clinicaltrials.gov #NCT03059472.

Effectiveness of Ellis's Rational-Emotional Approach on Criminal Thinking and Law-Evasion in Male Prisoners.

This study aimed to investigate the effectiveness of Ellis's rational-emotional approach on criminal thinking and law-evasion in male prisoners. A quasi-experimental design utilizing pretest, post-test, and follow-up test and waiting-list control groups was conducted. Thirty male prisoners were selected by purposeful sampling and randomized into experimental and waiting list control groups. Participants of experimental group received 12 sessions of Ellis's rational-emotional approach intervention; and all participants answered to PICTS-L-SF and ABAWS as dependent variables at 3 time points (pretest, post-test, and 1 month follow-up). A repeated measures analysis of variance was used to analyze the data. Results showed criminal thinking and law-evasion in experimental group, as compared to control, at post-test phase was significantly decreased (p < .05); and improvement of dependent variables in the follow-up phase has also been continued (p < .05). Therefore, REBT can be beneficial for reducing criminal and illegal thoughts and behaviors among prisoners.

Diet Quality Changes in a 12-Week Web-Based Physical Activity Intervention without Explicit Dietary Guidance

Lifestyle habits seem interconnected and extant studies suggest that a lifestyle-related modification can impact other related behaviors. For instance, interventions targeting physical activity (PA) could potentially impact dietary patterns and quality. Therefore, we hypothesized that a web-based intervention to increase PA would lead to changes in diet quality without explicit dietary guidance. Our aim was to evaluate changes in diet quality, measured by the Healthy Eating Index 2020 (HEI-2020), following a 12-week web-based PA intervention in adults with obesity. The study consisted of secondary analysis of a 12-week pilot randomized controlled trial, wherein participants (N = 82) were randomized to the Physical Activity for The Heart (PATH) intervention group, which included workout videos and virtual coaching, or a wait-list control group. Diet quality was assessed at baseline and post-intervention using the HEI-2020 based on recalls collected through the Automated Self-Administered 24-h recall (ASA-24) system. Baseline characteristics were similar across groups. Both groups showed small improvements in HEI-2020 total scores after 12 wk (PATH: 65.11 vs. Control: 62.24). Stratification by moderate to vigorous physical activities increase (<60 min. vs. ≥60 min.) revealed greater improvements in specific HEI-2020 components in the ≥60 min group, though overall changes remained modest. The PA intervention led to small improvements in certain diet quality components, suggesting potential interconnectedness between PA and dietary habits. However, overall changes in HEI-2020 scores were modest. Future research with larger samples should explore the effects of PA intervention alone vs. combined with dietary guidance on diet quality in adults with obesity.

Internet-based cognitive behavioral intervention for adolescents with anxiety disorders: a study protocol for a parallel three armed randomized controlled trial

BackgroundAnxiety disorders are among the most prevalent mental health concerns affecting children and adolescents. Despite their high prevalence, statistics indicate that fewer than 25% of individuals in this demographic seek professional assistance for their condition. Consequently, there is a pressing need to develop innovative interventions aimed at improving treatment accessibility. ObjectivesThis study aims to assess the effectiveness of Internet-delivered Cognitive Behavioral Therapy (iCBT) for adolescents with anxiety, with a specific emphasis on involving parents in the treatment process.MethodsThe study is structured as a parallel three-armed randomized controlled trial, comparing Internet-delivered Cognitive Behavioral Therapy (iCBT) with planned feedback, iCBT with on-demand feedback, and a waitlist control group, each group including 56 participants. Participants in the two iCBT conditions will undergo a 14-week treatment regimen, while those in the waitlist control group will wait for 14 weeks before starting iCBT with planned feedback. Additionally, participants in the iCBT groups will be randomly assigned to receive a booster session or not. The study design is factorial including two factors: type of therapist feedback (factor 1) and booster or no booster (factor 2). The study population comprises adolescents aged between 12 and 17 years, residing in Denmark, diagnosed with an anxiety disorder according to DSM-5 criteria. The primary outcome measures are the Youth Online Diagnostic Assessment and the Spence Children’s Anxiety Scale. Assessments will occur at baseline, post-treatment, and at 3-, 6-, and 12-month follow-ups post-treatment.DiscussionThe findings of this study are anticipated to contribute to improving the accessibility of evidence-based treatments for adolescents with anxiety.Trial registrationThe study is registered at clinicalTrials.gov, under protocol ID 22/59602. The Initial release was the 16.10.2023, first posted due to technical problems 16.04.2024. https://clinicaltrials.gov/study/NCT06368557?locStr=Odense,%20Denmark&country=Denmark&city=Odense&page=2&rank=13.

Developing Self-Compassion in Healthcare Professionals Utilising a Brief Online Intervention: A Randomised Waitlist Control Trial.

(1) Background: The level of stress experienced by staff in the healthcare sector is highly prevalent and well documented. Self-compassion may support the health and wellbeing of individuals and enable them to stay well at work. This study aimed to understand whether a brief, online, self-guided, novel intervention improved the health and wellbeing of healthcare professionals. (2) Methods: In a parallel randomised controlled trial, a volunteer sample of healthcare professionals were assigned to an intervention group (n = 110) or a waitlist control group (n = 80). Measures of self-compassion, mental wellbeing, stress and burnout were collected by an online questionnaire at baseline, post-programme and, for the intervention group, at follow-up. (3) Results: This intervention appeared to be effective in increasing self-compassion and mental health and decreasing stress and burnout. Significant group effects and significant time × group interactions for overall self-compassion [F (2, 183) = 32.72, p < 0.001; effect size ηp2 = 0.226], mental wellbeing [F (2, 212) = 17.46, p < 0.001; effect size ηp2 = 0.135], perceived stress [F (2, 205) = 5.42, p = 0.006; effect size ηp2 = 0.46], personal burnout [F (2, 224) = 7.57, p = 0.001; effect size ηp2 = 0.063] and work burnout [F (2, 208) = 7.39, p = 0.001; effect size ηp2 = 0.062] were found. (4) Conclusions: This study shows promise that an affordable and scalable intervention can be effective for busy healthcare professionals operating in a significantly challenging environment.

Effectiveness of community-based Baduanjin exercise intervention for older adults with varying frailty status: a randomized controlled trial

BackgroundDue to poorer exercise tolerance, it may be challenging for frail older adults to engage in moderate- or vigorous-intensity exercise. While low-intensity exercise interventions may be more feasible, its effectiveness for such population group remains unclear. We examined the effectiveness and implementation of community-based Baduanjin Qigong, a low-intensity exercise program in older adults with varying frailty status.MethodsA two-arm, multicenter assessor-blind parallel group randomized controlled trial was conducted at three local senior activity centers. Fifty-six community-dwelling older adults with low handgrip strength were randomly allocated to either the intervention (IG) or wait-list control (CG) group. The IG underwent a supervised 16-week Baduanjin exercise program at a frequency of 2–3 × 60 min sessions/week. The CG was instructed to maintain their usual activity and received a monthly health education talk. The primary outcome measures were knee extension strength, vital exhaustion, and fear of falling. Secondary outcome measures include physiological falls risk, handgrip strength, gait speed, timed up and go test, 30-second sit-to-stand, quality of life, depression, and frailty. All outcome measures were assessed at baseline and 4-month follow-up.ResultsOverall, there were no statistically significant differences in all outcome measures between CG and IG at 4-month follow-up. However, in exploratory compliance analysis, a statistically significant group x time interaction was found for vital exhaustion (B = -3.65, 95% CI [-7.13, -0.16], p = .047) among participants with at least 75% attendance. In post-hoc within-group comparisons, IG showed improved vital exhaustion by 4.31 points (95% CI [1.41, 7.20], d = 0.60). The average participant attendance rate was 81.3%. No major adverse events occurred, and all participants reported positive experiences with the exercise intervention.ConclusionsOur study demonstrated that Baduanjin is a safe, feasible, and acceptable exercise program that can be successfully implemented in community settings for older adults with varying frailty status. With good adherence, Baduanjin exercise could potentially be effective in alleviating vital exhaustion. However, the effectiveness of Baduanjin on physical performance, psychological measures and frailty in community-dwelling older adults remains equivocal.Trial registrationClinicalTrials.gov NCT04549103. Registered September 16, 2020.

The impact of internet-based cognitive behavioral therapy on mental health outcomes and life in breast cancer patients: a systematic review and meta-analysis.

Internet-based cognitive behavioral therapy(ICBT) improves the impact of breast cancer through online platforms, modular learning, goal setting, relaxation exercises, and other techniques. Compared to traditional cognitive behavioral therapy (CBT), ICBT offers advantages such as the convenience of flexible time and location choices and reduced manpower requirements. In recent years, research exploring the impact of ICBT on breast cancer patients has been increasing, with conflicting results across different studies. Therefore, the purpose of this study was to comprehensively examine the impact of ICBT on the psychological health and quality of life of breast cancer patients through a systematic review and meta-analysis. We searched ten databases in both English and Chinese, with the search period extending from the inception of the databases to December 30, 2023. Literature screening, bias risk assessment, data extraction, and evidence level evaluation were independently conducted by two researchers. All the data were analyzed using RevMan 5.4 and Stata 17.0 software. A total of 2079 breast cancer patients were included in this study, of which 1171 patients received ICBT treatment. The results show that ICBT can reduce anxiety [SMD=-0.19, 95%CI (-0.37, -0.01), P=0.0008] and depression [SMD=-0.20, 95%CI (-0.37, -0.02), P=0.001], alleviate fatigue [SMD=-0.34, 95%CI (-0.67, -0.01), P=0.04], and improve quality of life [SMD=0.20, 95% CI (0.03, 0.38), P=0.02] in breast cancer patients. However, the intervention effects of ICBT on insomnia [SMD=-0.44, 95%CI (-0.93, 0.06), P=0.08] and sleep quality [SMD=-0.14, 95%CI (-0.30, 0.01), P=0.06] in breast cancer patients are not significant. The subgroup analysis showed that when the intervention period is longer than 8 weeks, the number of intervention modules exceeds 6, and a waitlist control group is included, there is a significant effect on reducing patients' anxiety and depression. However, the method of guidance and whether the intervention period exceeds 12 weeks are not related. ICBT can alleviate anxiety and depression in breast cancer patients, with the intervention effects being independent of the guidance method. Significant results were obtained when the intervention period was >8 weeks and the number of modules was >6. ICBT can reduce fatigue and improve quality of life in breast cancer patients, but its impact on sleep quality was not significant. More high-quality research is needed in the future. PROSPERO, identifier CRD42024494744.

Improving water competency among children on the autism spectrum: the AquOTic randomized controlled trial.

There is a critical need for evidence-based and manualized interventions targeting water competency including swim and water safety skills tailored to meet the needs of children on the autism spectrum, a group that is at a high risk of drowning. This study examined the efficacy of AquOTic-a 10-week occupational therapy-based aquatic intervention to improve water competency among children on the autism spectrum. A total of 37 children on the autism spectrum (ages 5-9 years) were randomized to a waitlist control group (n = 24) or AquOTic intervention group (n = 37; 28 males). Blinded assessors administered the standardized Water Orientation Test-Alyn (WOTA) 1 and 2 and a Swim Skills Checklist to all participants pre- and post-AquOTic/control. Repeated measures mixed effects models were used to examine intervention effects. Average WOTA 1 scores increased significantly after participants received AquOTic (Δ = 5.7; 95% CI: 3.7-7.8; p < 0.001), and average WOTA 2 scores increased significantly after participants received AquOTic (Δ = 9.0; 95% CI: 5.7-12.3; p < 0.001). Average swim skills increased significantly after participants received AquOTic (Δ = 7.6; 95% CI: 5.3, 10.0; p < 0.001). Our results highlight the efficacy of AquOTic to improve water competency among children on the autism spectrum. Further research is needed to examine long-term effects, dosage requirements to achieve water competency, and the impact of aquatic therapy on other health outcomes. clinicaltrials.gov, NCT05524753.

12424 A Feasibility Trial Of A Co-created Digital Self-management Programme For Adults With Polycystic Ovary Syndrome (Hope PCOS)

Abstract Disclosure: C.A. Percy: None. A. Turner: None. L. Aphramor: None. D. Broom: None. C. Clark: None. F. Martin: None. P. Wark: None. Introduction: Polycystic ovary syndrome (PCOS) has significant impact on depression, anxiety, psychological wellbeing and health-related quality of life. We co-created a theory-led, evidence-based, 6-week, digital self-management and positive wellbeing intervention (Hope PCOS), delivered to UK adults. We tested the intervention’s potential to improve mental health and wellbeing outcomes and its acceptability and usability for adults living with PCOS. Methods: This was a mixed methods feasibility randomised controlled trial conducted online, with a pre-post, waitlist-controlled design. Primary outcomes were recruitment, completion (≥ 3 intervention sessions) and follow-up rates. At baseline, participants reported demographic information, PCOS symptoms, depression (Patient Health Questionnaire (PHQ-9)), anxiety ((Generalised Anxiety Disorder Assessment (GAD-7)), polycystic ovary syndrome health-related quality of life (PCOSQ-50), psychological wellbeing (Warwick-Edinburgh Mental Wellbeing Scale, WEMWBS) and self-efficacy (Self-Efficacy to Manage Chronic Disease Scale (SEMCD6)) before randomisation to an intervention group (IG) receiving the intervention immediately or a waitlist control group (CG) receiving the intervention 12 weeks later. PHQ-9, GAD-7, PCOSQ-50, WEMWBS and SEMDC6 were reassessed at 6 and 12 weeks. IG participants reported the usability of the digital intervention (system usability scale (SUS)) and acceptability via qualitative exit interviews. Results: Of 131 eligible, consented participants, 83% (N=109, age M=37.1, SD=8.6 years) completed baseline measures and were randomised to the IG (n=54) or the CG (n=55). Baseline clinical caseness was high for depression (n=77, 70.6%) and anxiety (n=78, 71.6 %). Twenty-one participants (39%) in the IG completed ≥3 intervention sessions. At 6-week follow-up, completion of secondary outcomes was n=32 (59%) for IG and n= 38 (69%) for CG; at 12 weeks, n=31 (57%) for IG and n= 38 (69%) for CG. Twelve IG participants took part in the exit interviews. Exploratory descriptive statistics suggest there were greater improvements in depression, anxiety, psychological wellbeing, self-efficacy and quality of life for the intervention group completers compared to the waitlist control group. SUS data and thematic analysis suggest the intervention was usable, acceptable, relevant and interesting. Participants reported experiences including feeling seen and valued, having the difficulties of lifestyle change acknowledged, and learning valuable lessons, particularly how to monitor and manage emotions, prioritise self-care and complete personal goals. Conclusions: This novel intervention was rated as usable and acceptable, with potential for improving mental health and wellbeing outcomes. More research is needed to identify for whom the intervention is beneficial and on implementation in practice. Presentation: 6/1/2024

Personality change through mindfulness-based interventions: A preregistered systematic review and meta-analysis

Mindfulness-based interventions (MBIs) lead to improvements in mental health, and also increase trait mindfulness. Yet, trait mindfulness shows definitional and empirical overlaps with the personality dimension of neuroticism which is linked to mental health and is malleable through interventions as well. This meta-analysis examined whether previously reported associations between increases in self-reported trait mindfulness and mental health in MBIs, as well as in non-MBIs and treatment-as-usual (TAU) and waitlist controls, are mediated through concomitant changes in neuroticism on the between-study level. Data of 45 intervention studies (39 randomized controlled trials; total N = 2913) were investigated with three-level meta-analysis and the causal steps approach. Change in neuroticism mediated change in trait mindfulness and fully accounted for its mediational effects on mental health. Similar associative patterns were found for the active and TAU and waitlist control groups as well. Accounting for small-study effects did not alter this pattern of results. The findings highlight the relevance of neuroticism for intervention research and may explain previously observed apparent effects of trait mindfulness in non-MBIs and TAU and waitlist controls on mental health. The construct of trait mindfulness may need conceptual reconsideration and resharpening, and the investigation of personality change should be intensified in intervention research.

Efficacy of an online gatekeeper program for relatives of men at risk of suicide – a randomized controlled trial

BackgroundMen at risk for suicide are a challenging population group to reach with suicide prevention strategies. Gatekeepers hold a pivotal role in the prevention of male suicide, yet effective intervention requires them to have a level of knowledge and strategies to provide support.AimThis study aimed to examine the efficacy of an online gatekeeper program for gatekeepers in male suicide prevention, assessing knowledge, perceived preparedness, self-efficacy, and psychopathological symptoms of gatekeepers.MethodsEighty-four participants were randomized to either the intervention (n = 43) or the waitlist control group (n = 41). The intervention comprised four modules providing knowledge and strategies for addressing men in suicidal crises. Outcomes included depression (PHQ-9), distress (PSS-10), burden (BAS), involvement (IEQ), as well as gatekeeper outcomes and knowledge.ResultsCompleter analyses revealed significant improvement of depressive symptoms (d = 0.39) and an increase in gatekeeper outcomes (d = 0.58 to d = 0.84) and knowledge (d = 0.62) from baseline to post-assessment. The effects were maintained for 3 months. No significant effects could be found for burden, distress, and involvement.ConclusionsThe findings indicate that a brief gatekeeper program can serve as a valuable resource. Future research should focus on examining the mental health of gatekeepers themselves and its long-term effects on intervention behavior.Trial registrationGerman Clinical Trials Register, DRKS00030758, registered on 05.12.2022.

Effect of the i2TransHealth e-health intervention on psychological distress among transgender and gender diverse adults from remote areas in Germany: a randomised controlled trial

Transgender and gender diverse (TGD) people in remote areas face challenges accessing health-care services, including mental health care and gender-affirming medical treatment, which can be associated with psychological distress. In this study, we aimed to evaluate the effectiveness of a 4-month TGD-informed e-health intervention to improve psychological distress among TGD people from remote areas in northern Germany. In a randomised controlled trial done at a single centre in Germany, adults (aged ≥18 years) who met criteria for gender incongruence or gender dysphoria and who lived at least 50 km outside of Hamburg in one of the northern German federal states were recruited and randomly assigned (1:1) to i2TransHealth intervention or a wait list control group. Randomisation was performed with the use of a computer-based code. Due to the nature of the intervention, study participants and clinical staff were aware of treatment allocation, but researchers responsible for data analysis were masked to allocation groups. Study participants in the intervention group (service users) started the i2TransHealth intervention immediately after completing the baseline survey after enrolment. Participants assigned to the control group waited 4 months before they were able to access i2TransHealth services or regular care. The primary outcome was difference in the Brief Symptom Inventory (BSI)-18 summary score between baseline and 4 months, assessed using a linear model analysis. The primary outcome was assessed in the intention-to-treat (ITT) population, which included all randomly assigned participants. The trial was registered with ClinicalTrials.gov, NCT04290286. Between May 12, 2020, and May 2, 2022, 177 TGD people were assessed for eligibility, of whom 174 were included in the ITT population (n=90 in the intervention group, n=84 in the control group). Six participants did not provide data for the primary outcome at 4 months, and thus 168 people were included in the analysis population (88 participants in the intervention group and 80 participants in the control group). At 4 months, in the intervention group, the adjusted mean change in BSI-18 from baseline was -0·65 (95% CI -2·25 to 0·96; p=0·43) compared with 2·34 (0·65 to 4·02; p=0·0069) in the control group. Linear model analysis identified a significant difference at 4 months between the groups with regard to change in BSI-18 summary scores from baseline (between-group difference -2·98 [95% CI -5·31 to -0·65]; p=0·012). Adverse events were rare: there were two suicide attempts and one participant was admitted to hospital in the intervention group, and in the control group, there was one case of self-harm and one case of self-harm followed by hospital admission. The intervention was clinically significant in averting worsening psychological distress in service users, outperforming the wait list control group. These findings support the effectiveness of e-health services in TGD health care, specifically for people from remote areas. Innovation Committee at the Federal Joint Committee. For the German translation of the abstract see Supplementary Materials section.

Narrative exposure therapy for the treatment of trauma-related symptoms among adolescent survivors of sex trafficking: A pilot study

Background: India is home to 14 million survivors of human trafficking, with most being trafficked for sexual exploitation. Trafficking constitutes crimes that violate the rights of survivors, and despite its psychological consequences, there is little evidence-based guidance to meet the needs of these individuals. Aim: The current study aimed to examine the outcome of narrative exposure therapy (KIDNET) among adolescent survivors of sex trafficking in improving trauma-related symptoms, along with psychological distress, dissociation, depression, and anxiety. Methods: A pre-post study design was used with 20 adolescent female survivors of trafficking aged 13 to 17 years, with ten participants in the KIDNET group and ten participants in a waitlist control group. Trafficking Victim Identification Tool and Standard Progressive Matrices were administered as screening measures. The Clinician-Administered PTSD Scale for Children and Adolescents, Kessler’s Psychological Distress Scale, Shutdown Dissociation Scale, Patient Health Questionnaire, and Beck Anxiety Inventory were administered as outcome measures. Fourteen sessions of KIDNET were conducted for the clinical group, while sessions were conducted for the control group post delivery of intervention for the clinical group. Results: Findings suggest an overall improvement in the severity of trauma-related symptoms in the KIDNET group, with significant improvement in psychological distress, depression, and anxiety. Conclusion: Results indicate that KIDNET may be a promising and acceptable treatment for adolescent survivors of sex trafficking, and this intervention module may be safely delivered in further randomised controlled trials to ensure that the holistic needs of this vulnerable group are appropriately addressed.