Enhanced Care As Usual Research Articles

Evaluation of a Guided Chatbot Intervention for Young People in Jordan: Feasibility Randomized Controlled Trial.

Depression and anxiety are a leading cause of disability worldwide and often start during adolescence and young adulthood. The majority of young people live in low- and middle-income countries where there is a lack of mental health services. The World Health Organization (WHO) developed a guided, nonartificial intelligence chatbot intervention called Scalable Technology for Adolescents and youth to Reduce Stress (STARS) to reduce symptoms of depression and anxiety among young people affected by adversity. The objective of this study was to evaluate the feasibility of the STARS intervention and study procedures among young people in Jordan. A 2-arm, single-blind, feasibility randomized controlled trial was conducted among 60 young people aged 18 years to 21 years living in Jordan with self-reported elevated levels of psychological distress. Immediately after baseline, participants were randomized 1:1 into the STARS intervention or enhanced care as usual (ECAU). STARS consisted of 10 lessons in which participants interacted with a chatbot and learned several cognitive behavioral therapy strategies, with optional guidance by a trained e-helper through 5 weekly phone calls. ECAU consisted of a static web page providing basic psychoeducation. Online questionnaires were administered at baseline (week 0) and postassessment (week 8) to assess depression (Hopkins Symptom Checklist-25 [HSCL-25]), anxiety (HSCL-25), functional impairment (WHO Disability Assessment Schedule [WHODAS] 2.0), psychological well-being (WHO-Five Well-Being Index [WHO-5]), and agency (State Hope Scale). Process evaluation interviews with stakeholders were conducted after the postassessment. Participants were recruited in December 2022 and January 2023. Of 700 screening website visits, 160 participants were eligible, and 60 participants (mean age 19.7, SD 1.16 years; 49/60, 82% female) continued to baseline and were randomized into STARS (n=30) or ECAU (n=30). Of those who received STARS, 37% (11/30) completed at least 8 chatbot lessons, and 13% (4/30) completed all 5 support calls. The research protocol functioned well in terms of balanced randomization, high retention at postassessment (48/60, 80%), and good psychometric properties of the online questionnaires. Process evaluation interviews with STARS participants, ECAU participants, e-helpers, and the clinical supervisor indicated the acceptability of the study procedures and the STARS and ECAU conditions and highlighted several aspects that could be improved, including the e-helper support and features of the STARS chatbot. This study demonstrated the feasibility and acceptability of the STARS intervention and research procedures. A fully powered, definitive randomized controlled trial will be conducted to evaluate the effectiveness of STARS. ISRCTN ISRCTN19217696; https://doi.org/10.1186/ISRCTN19217696.

Cost-Effectiveness of the Mindfulness-Based Childbirth and Parenting Program for Pregnant Women With Fear of Childbirth

ObjectiveTo examine the cost-effectiveness of the Mindfulness-Based Childbirth and Parenting (MBCP) program compared with enhanced care as usual (ECAU). DesignRandomized controlled trial. SettingMidwifery settings in the Netherlands, April 2014 to July 2017. ParticipantsSubset of pregnant women with high levels of fear of childbirth (N = 54: randomized to MBCP, n = 32, or to ECAU, n = 22) who were selected from the parent study because they completed all four cost questionnaires. MethodsWe measured self-reported health care and non-health care costs. A subset of participants from the parent study completed the questionnaires at all four assessment points. We used the Wijma Delivery Expectancy Questionnaire to measure fear of childbirth and used the EuroQol-5D to measure quality of life. We used these measures of effect together with societal costs in the primary cost-effectiveness analyses. In the secondary cost-effectiveness analyses, we used different estimates of effects and costs to test the robustness of the primary analyses. ResultsIn all but one scenario, MBCP was more effective and cost less than ECAU. As indicated by the acceptability curves, the likelihood of MBCP being cost-effective varied within a range of 70% to 98%. ConclusionOur findings indicate that MBCP is a cost-effective intervention to reduce fear of childbirth in pregnant women. Important next steps are to replicate the study in countries with different health care systems and to explore the potential for further integration of MBCP into midwifery care.

Self-Help Plus for refugees and asylum seekers: an individual participant data meta-analysis

QuestionRefugees and asylum seekers are at high risk of mental disorders due to various stressors before, during and after forceful displacement. The WHO Self-Help Plus (SH+) intervention was developed to...

Community based sociotherapy for depressive symptomatology of Congolese refugees in Rwanda and Uganda (CoSTAR): a protocol for a cluster randomised controlled trial

ABSTRACT Background: Conflict in the Democratic Republic of Congo has led to large numbers of refugees fleeing to Uganda and Rwanda. Refugees experience elevated levels of adverse events and daily stressors, which are associated with common mental health difficulties such as depression. The current cluster randomised controlled trial aims to investigate whether an adapted form of Community-based Sociotherapy (aCBS) is effective and cost-effective in reducing depressive symptomatology experienced by Congolese refugees in Uganda and Rwanda. Methods: A two-arm, single-blind cluster randomised controlled trial (cRCT) will be conducted in Kyangwali settlement, Uganda and Gihembe camp, Rwanda. Sixty-four clusters will be recruited and randomly assigned to either aCBS or Enhanced Care As Usual (ECAU). aCBS, a 15-session group-based intervention, will be facilitated by two people drawn from the refugee communities. The primary outcome measure will be self-reported levels of depressive symptomatology (PHQ-9) at 18-weeks post-randomisation. Secondary outcomes will include levels of mental health difficulties, subjective wellbeing, post-displacement stress, perceived social support, social capital, quality of life, and PTSD symptoms at 18-week and 32-week post-randomisation. Cost effectiveness of aCBS will be measured in terms of health care costs (cost per Disability Adjusted Life Year, DALY) compared to ECAU. A process evaluation will be undertaken to investigate the implementation of aCBS. Conclusion: This cRCT will be the first investigating aCBS for mental health difficulties experienced by refugees and will contribute to knowledge about the use of psychosocial interventions for refugees at a time when levels of forced migration are at a record high. Trial registration: ISRCTN.org identifier: ISRCTN20474555.

Mindfulness-based childbirth and parenting for pregnant women with high fear of childbirth and their partners: outcomes of a randomized controlled trial assessing short- and longer-term effects on psychological well-being, birth and pregnancy experience

ObjectivesMindfulness-Based Childbirth and Parenting (MBCP) reduces mothers’ anticipated fear of childbirth (FOC), nonurgent obstetric interventions during childbirth and may improve childbirth outcomes in women with high FOC (Veringa-Skiba et al, 2022). The aim of this study was to examine the short- and longer-term outcomes of MBCP on psychological well-being, pregnancy and birth experience, as compared to enhanced care-as-usual (ECAU), in pregnant women with high FOC and their partners. DesignParticipants were randomly assigned to MBCP or ECAU and completed questionnaires preintervention (T1), immediately after intervention (T2), two to four weeks after childbirth (T3) and 16-20 weeks after childbirth (T4). Both intention-to-treat and per-protocol analyses were conducted. SettingThe courses were provided by trained midwives. ParticipantsParticipants included 141 pregnant women and 120 partners. InterventionMBCP comprised a nine-weekly three-hour session mindfulness group course for pregnant couples; ECAU consisted of two 90-minute individual couple consultation sessions. MeasurementsMeasures of psychological well-being included measures like stress, depression, anxiety and fatigue. Measures of pregnancy and birth experience concerned experiencing uplifts during pregnancy, experienced fear of childbirth, labour pain and satisfaction with childbirth. FindingsNo differences between MBCP and ECAU in the total group of birthing women were found. However, women with (at least an onset of) labour that participated in MBCP reported a better birth experience compared to ECAU at T3. Concerning the total partner group only one difference between MBCP and ECAU was found at T4; MBCP partners reported an increase in fatigue. However, in the partner risk group (i.e., partners with lower psychological well-being before intervention) partners experienced better psychological well-being at T2 and T3 after MBCP than ECAU. Key conclusionsMBCP and ECAU demonstrate similar effects on psychological well-being, birth and pregnancy experience. However, MBCP appears superior to ECAU for labouring women in having a better childbirth experience and for partners at risk for psychological complaints in increasing their psychological well-being. Implications for practiceMBCP only positively affects the childbirth experience of those who experience (onset of) natural birth. It might be advisable to include partners at risk for psychological complaints in the MBCP.

Effects of a WHO-guided digital health intervention for depression in Syrian refugees in Lebanon: A randomized controlled trial.

BackgroundMost displaced people with mental disorders in low- and middle-income countries do not receive effective care, and their access to care has deteriorated during the Coronavirus Disease 2019 (COVID-19) pandemic. Digital mental health interventions are scalable when digital access is adequate, and they can be safely delivered during the COVID-19 pandemic. We examined whether a new WHO-guided digital mental health intervention, Step-by-Step, in which participants were supported by a nonspecialist helper, was effective in reducing depression among displaced people in Lebanon.Methods and findingsWe conducted a single-blind, 2-arm pragmatic randomized clinical trial, comparing guided Step-by-Step with enhanced care as usual (ECAU) among displaced Syrians suffering from depression and impaired functioning in Lebanon. Primary outcomes were depression (Patient Health Questionnaire, PHQ-9) and impaired functioning (WHO Disability Assessment Schedule-12, WHODAS) at posttreatment. Secondary outcomes included subjective well-being, anxiety, post-traumatic stress, and self-described problems. A total of 569 displaced people from Syria with depression (PHQ-9 ≥ 10) and impaired functioning (WHODAS > 16) were randomized to Step-by-Step (N = 283; lost to follow-up: N = 167) or ECAU (N = 286; lost to follow-up: 133). Participants were considered to be lost to follow-up when they did not fill in the outcome measures at posttest or follow-up. Recruitment started on December 9, 2019 and was completed on July 9, 2020. The last follow-up assessments were collected in December 2020. The study team had access to the online platform, where they could see treatment arm assignment for each participant. All questionnaires were completed by participants online. Intention-to-treat (ITT) analyses showed intervention effects on depression (standardized mean differences [SMDs]: 0.48; 95% CI: 0.26; 0.70; p < 0.001), impaired functioning (SMD: 0.35; 95% CI: 0.14; 0.56; p < 0.001), post-traumatic stress (SMD: 0.36; 95% CI: 0.16; 0.56; p < 0.001), anxiety (SMD: 0.46; 95% CI: 0.24; 0.68; p < 0.001), subjective well-being (SMD: 0.47; 95% CI: 0.26; 0.68; p < 0.001), and self-identified personal problems (SMD: 0.49; 95% CI 0.28; 0.70; p < 0.001). Significant effects on all outcomes were maintained at 3 months follow-up. During the trial, one serious adverse event occurred, unrelated to the intervention. The main limitation of the current trial is the high dropout rate.ConclusionsIn this study, we found that a guided, digital intervention was effective in reducing depression in displaced people in Lebanon. The guided WHO Step-by-Step intervention we examined should be made available to communities of displaced people that have digital access.Trial registrationClinicalTrials.gov NCT03720769.

Guided digital health intervention for depression in Lebanon: randomised trial

BackgroundMost people with mental disorders in communities exposed to adversity in low-income and middle-income countries (LMICs) do not receive effective care. Digital mental health interventions are scalable when digital access...

Mindful awareness as a mechanism of change for natural childbirth in pregnant women with high fear of childbirth: a randomised controlled trial

BackgroundMindfulness-Based Childbirth and Parenting (MBCP) is effective in increasing natural childbirth in pregnant women with high fear of childbirth (FOC) as compared to enhanced care as usual (ECAU). We aimed to examine through which pathway of action MBCP reaches this effect, based on a model of approaching or avoiding the challenges related to childbirth.MethodsOne hundred eleven pregnant women with high FOC were measured pre- and post-intervention on FOC (emotion pathway), catastrophic beliefs about labour pain (cognition pathway) and mindful awareness (attention pathway). A multiple mediation model was used to examine through which pathway the mechanism of change operated in relation to approach (i.e., natural childbirth) versus avoidance (i.e., self-requested caesarean section).ResultsIt was found that greater mindful awareness (18% R2 = 0.18, F[1107] = 22.77, p < 0.0001) was the only significant mechanism of change operating through the attentional pathway leading to natural childbirth. More specifically, nonreactivity to inner experience (a facet of mindful awareness) showed to be the strongest mechanism of change. More extensive meditation practice was positively associated with natural childbirth; however, the number of completed MBCP sessions was not associated with the outcome.ConclusionsAn increase in mindful awareness was the strongest mechanism of change for better adaptation to the challenges of childbirth. Decreases in neither FOC nor catastrophic beliefs about labour pain were identified as mechanisms of change. Additionally, the more one meditated, the more one was inclined towards a natural childbirth. MBCP enhances adaptation to the challenges of childbirth and less use of obstetric interventions in the presence of high FOC.Trial registrationThe Netherlands Trial Register (NTR; 4302).

Group problem management plus (PM+) to decrease psychological distress among Syrian refugees in Turkey: a pilot randomised controlled trial

BackgroundSyrian refugees resettled in Turkey show a high prevalence of symptoms of mental disorders. Problem Management Plus (PM+) is an effective psychological intervention delivered by non-specialist health care providers which has shown to decrease psychological distress among people exposed to adversity. In this single-blind pilot randomised controlled trial, we examined the methodological trial procedures of Group PM+ (gPM+) among Syrian refugees with psychological distress in Istanbul, Turkey, and assessed feasibility, acceptability, perceived impact and the potential cost-effectiveness of the intervention.MethodsRefugees with psychological distress (Kessler Psychological Distress Scale, K10 > 15) and impaired psychosocial functioning (World Health Organization Disability Assessment Schedule, WHODAS 2.0 > 16) were recruited from the community and randomised to either gPM+ and enhanced care as usual (E-CAU) (n = 24) or E-CAU only (n = 22). gPM+ comprised of five weekly group sessions with eight to ten participants per group. Acceptability and feasibility of the intervention were assessed through semi-structured interviews. The primary outcome at 3-month follow-up was symptoms of depression and anxiety (Hopkins Symptoms Checklist-25). Psychosocial functioning (WHODAS 2.0), symptoms of posttraumatic stress disorder and self-identified problems (Psychological Outcomes Profiles, PSYCHLOPS) were included as secondary outcomes. A modified version of the Client Service Receipt Inventory was used to document changes in the costs of health service utilisation as well as productivity losses.ResultsThere were no barriers experienced in recruiting study participants and in randomising them into the respective study arms. Retention in gPM+ was high (75%). Qualitative analyses of the interviews with the participants showed that Syrian refugees had a positive view on the content, implementation and format of gPM+. No adverse events were reported during the implementation. The study was not powered to detect an effect. No significant difference between gPM+ and E-CAU group on primary and secondary outcome measures, or in economic impacts were found.ConclusionsgPM+ delivered by non-specialist peer providers seemed to be an acceptable, feasible and safe intervention for Syrian refugees in Turkey with elevated levels of psychological distress. This pilot RCT sets the stage for a fully powered RCT.Trial registrationClinicalTrials.gov Identifier NCT03567083; date: 25/06/2018.

Recovering From Intimate Partner Violence Through Strengths and Empowerment: Findings From a Randomized Clinical Trial.

Objective: Recovering from Intimate Partner Violence through Strengths and Empowerment (RISE) is a brief, variable-length (1-6 sessions), modular, individualized psychosocial counseling intervention for women experiencing intimate partner violence (IPV). Pilot findings demonstrated the potential helpfulness, acceptability, and feasibility of RISE; however, a randomized clinical trial (RCT) is needed to support program effectiveness.Methods: This RCT enrolled 60 women who experienced IPV within the prior year. Participants were recruited from an urban Veterans Health Administration hospital (October 2018 to September 2020). Participants completed a pretreatment assessment that included measures of relevant outcomes (primary: empowerment, self-efficacy, patient activation, and valued living; secondary: depression symptoms, IPV, and satisfaction with the intervention) and were randomly assigned to RISE or an enhanced care as usual (ECAU) condition. RISE participants received 1 to 6 sessions. ECAU participants received a single session consisting of psychoeducation, safety planning, resources, and referrals. Participants were reassessed 10 and 14 weeks after enrollment.Results: Intent-to-treat analyses using unconditional growth models revealed significant time-by-condition effects: RISE participants demonstrated higher increases in empowerment (d = 3.46) and self-efficacy (d = 1.09). RISE participants also experienced significant improvements in valued living (d = 0.53), depression symptoms (d = 0.49), and IPV reduction (d = 1.07) over time; however, the lack of a significant difference by condition suggested similar effectiveness of the interventions on these outcomes. Satisfaction was significantly higher for RISE than ECAU (d = 1.23).Conclusions: Results indicate the effectiveness of RISE in enhancing psychosocial well-being, especially empowerment and self-efficacy, among women experiencing IPV, for whom accessible health care-based interventions are needed.Trial Registration: ClinicalTrials.gov identifier: NCT03261700.

QOLP-29. THE EFFECTS OF AN ONLINE, NURSE-LED NEEDS-BASED SUPPORT PROGRAM ON NEURO-ONCOLOGY FAMILY CAREGIVERS' DISTRESS: A RANDOMIZED CONTROLLED TRIAL

Abstract BACKGROUND Patients with primary malignant brain tumors have high symptom burden and commonly rely on family caregivers for practical and emotional support. This can lead to negative mental and physical consequences for caregivers. We investigated effectiveness of an 8-week nurse-led online needs-based support program (SmartCare©) with and without online self-guided cognitive behavioral therapy (CBT) for depression compared to enhanced care as usual (ECAU) on depressive symptoms, caregiving-specific distress, anxiety, mastery, and burden. METHODS Family caregivers with depressive symptoms were randomized to three groups: SmartCare© plus/minus self-guided CBT, or ECAU. Primary outcomes (depressive symptoms (CES-D); caregiving-specific distress (Caregiver Needs Screen)) and secondary outcomes (anxiety (POMS-A), caregiver mastery (Caregiver Mastery Scale), and caregiver burden (Caregiver Reactions Assessment)) were assessed online. Intention to treat analyses of covariance corrected for baseline scores were performed for outcomes at four months. RESULTS In total, 120 family caregivers participated. Accrual and CBT engagement were lower than expected, therefore intervention groups were combined (n=80) and compared to ECAU (n=40). For depressive symptoms, no statistically significant group differences were found. Caregiving-specific distress decreased in the intervention group compared with ECAU (p=0.01, partial ɳ 2=0.08). Among secondary outcomes, there was a trend towards improvement in mastery for the intervention group compared with ECAU (p=0.08, partial ɳ 2=0.04). CONCLUSION SmartCare©, with or without self-guided CBT, reduced caregiving-specific distress with a trend towards improving mastery. SmartCare© has the potential to improve the lives of families coping with a brain tumor diagnosis.

The effects of SmartCare© on neuro-oncology family caregivers' distress: a randomized controlled trial.

Patients with primary malignant brain tumors have high symptom burden and commonly rely on family caregivers for practical and emotional support. This can lead to negative mental and physical consequences for caregivers. We investigated effectiveness of an 8-week nurse-led online needs-based support program (SmartCare©) with and without online self-guided cognitive behavioral therapy (CBT) for depression compared to enhanced care as usual (ECAU) on depressive symptoms, caregiving-specific distress, anxiety, mastery, and burden. Family caregivers scoring ≥ 6 on a depressive symptoms inventory were randomized to three groups: ECAU plus self-guided CBT and SmartCare©; ECAU plus SmartCare©; ECAU only. Primary outcomes (depressive symptoms; caregiving-specific distress) and secondary outcomes (anxiety, caregiver mastery, and caregiver burden) were assessed online. Intention to treat (ITT) and per protocol (PP) analyses of covariance corrected for baseline scores were performed for outcomes at 4months. In total, 120 family caregivers participated. Accrual and CBT engagement were lower than expected, therefore intervention groups were combined (n = 80) and compared to ECAU (n = 40). For depressive symptoms, no statistically significant group differences were found. Caregiving-specific distress decreased in the intervention group compared with ECAU (ITT: p = 0.01, partial ɳ2 = 0.08; PP: p = 0.02, partial ɳ2 = 0.08). A trend towards improvement in mastery for the intervention group compared with ECAU was identified (ITT: p = 0.08, partial ɳ2 = 0.04; PP: p = 0.07, partial ɳ2 = 0.05). SmartCare©, with or without self-guided CBT, reduced caregiving-specific distress with a trend towards improving mastery. SmartCare© has the potential to improve the lives of families coping with a brain tumor diagnosis. NCT02058745; 10 February 2014.

OS10.4.A The effects of SmartCare on neuro-oncology family caregivers’ distress: a randomized controlled trial

Abstract BACKGROUND Patients with primary malignant brain tumors have high symptom burden and commonly rely on family caregivers for practical and emotional support. This can lead to negative mental and physical consequences for caregivers. We investigated effectiveness of an 8-week nurse-led online needs-based support program (SmartCare©) with and without online self-guided cognitive behavioral therapy (CBT) for depression compared to enhanced care as usual (ECAU) on depressive symptoms, caregiving-specific distress, anxiety, mastery, and burden. MATERIAL AND METHODS Family caregivers with depressive symptoms were randomized to three groups: SmartCare© plus/minus self-guided CBT, or ECAU. Primary outcomes (depressive symptoms (CES-D); caregiving-specific distress (Caregiver Needs Screen)) and secondary outcomes (anxiety (POMS-A), caregiver mastery (Caregiver Mastery Scale), and caregiver burden (Caregiver Reactions Assessment)) were assessed online. Intention to treat analyses of covariance corrected for baseline scores were performed for outcomes at four months. RESULTS In total, 120 family caregivers participated. Accrual and CBT engagement were lower than expected, therefore intervention groups were combined (n=80) and compared to ECAU (n=40). For depressive symptoms, no statistically significant group differences were found. Caregiving-specific distress decreased in the intervention group compared with ECAU (p=0.01, partial ɳ 2=0.08). Among secondary outcomes, there was a trend towards improvement in mastery for the intervention group compared with ECAU (p=0.08, partial ɳ 2=0.04). CONCLUSION SmartCare©, with or without self-guided CBT, reduced caregiving-specific distress with a trend towards improving mastery. SmartCare© has the potential to improve the lives of families coping with a brain tumor diagnosis.

Fear of childbirth, nonurgent obstetric interventions, and newborn outcomes: A randomized controlled trial comparing mindfulness-based childbirth and parenting with enhanced care as usual.

ObjectiveTo investigate whether mindfulness‐based childbirth and parenting (MBCP) or enhanced care as usual (ECAU) for expectant couples decreases fear of childbirth (FOC) and nonurgent obstetric interventions during labor and improves newborn outcomes.DesignRandomized controlled trial.SettingMidwifery settings, the Netherlands, April 2014‐July 2017.PopulationPregnant women with high FOC (n = 141) and partners.MethodsAllocation to MBCP or ECAU. Hierarchical multilevel and intention‐to‐treat (ITT) and per‐protocol (PP) analyses.Main outcome measuresPrimary: pre‐/postintervention FOC, labor anxiety disorder, labor pain (catastrophizing and acceptance), and preferences for nonurgent obstetric interventions. Secondary: rates of epidural analgesia (EA), self‐requested cesarean birth (sCB), unmedicated childbirth, and 1‐ and 5‐minute newborn's Apgar scores.ResultsMBCP was significantly superior to ECAU in decreasing FOC, catastrophizing of labor pain, preference for nonurgent obstetric interventions, and increasing acceptance of labor pain. MBCP participants were 36% less likely to undergo EA (RR 0.64, 95% CI [0.43‐0.96]), 51% less likely to undergo sCB (RR 0.49, 95% CI [0.36‐0.67]), and twice as likely to have unmedicated childbirth relative to ECAU (RR 2.00, 95% CI [1.23‐3.20]). Newborn's 1‐minute Apgar scores were higher in MBCP (DM −0.39, 95% CI [−0.74 to −0.03]). After correction for multiple testing, results remained significant in ITT and PP analyses, except EA in ITT analyses and 1‐minute Apgar.ConclusionsMBCP for pregnant couples reduces mothers’ fear of childbirth, nonurgent obstetric interventions during childbirth and may improve childbirth outcomes. MBCP adapted for pregnant women with high FOC and their partners appears an acceptable and effective intervention for midwifery care.

A digital mental health intervention to reduce depressive symptoms among overseas Filipino workers: protocol for a pilot hybrid type 1 effectiveness-implementation randomized controlled trial

BackgroundThe current pilot randomized controlled trial (RCT) protocol will comprehensively describe the implementation of a culturally adapted Filipino version of the World Health Organization Step-by-Step (SbS-F) program, unguided online psychological intervention for people with depression based on behavioral activation, among overseas Filipino workers (OFWs) in Macao (Special Administrative Region). The main objective of this pilot study is to explore the preliminary effectiveness of the SbS-F program to decrease participant-reported depressive symptoms compared to enhanced care as usual (ECAU); and the secondary objectives are to explore the preliminary effectiveness of the SbS-F to decrease participant-reported anxiety symptoms and improve wellbeing, and to evaluate the potential for SbS-F implementation in real-world settings.MethodsThis trial will follow an effectiveness-implementation hybrid type 1 trial design and utilize the Reach, Efficacy/Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to accelerate the translation of clinical research into more effective implementation strategies and policies. Participants will be randomized 1:1 to control and treatment groups. Control group participants will receive ECAU that consists of brief depression psychoeducation and referral to local community partners. Treatment group participants will receive a 5-session of digital intervention through a mobile phone application. The primary outcome (depression) and psychological secondary outcomes (anxiety symptoms and wellbeing) will be measured using validated instruments. To evaluate study implementation, an embedded mixed-methods design will be used to collect data from various stakeholders. Data then will be analyzed using intention to treat principle and reported following the Consolidated Standards of Reporting Trials (CONSORT) guideline.DiscussionThis study will provide important new knowledge about the preliminary effectiveness of SbS-F, a mobile application, as a digital mental health intervention and its scalability. If SbS-F shows positive results among OFWs in Macao, it has strong potential to be used by OFWs in other countries that may also experience depression and difficulty accessing mental health services.Trial registrationProspective registration, Chinese Clinical Trial Registry (ChiCTR2000034959) on 26/07/2020.

Assessing the Reliability of the CAMS Rating Scale Using aGeneralizability Study.

Background: An important consideration when conducting randomized controlled trials is treatment differentiation. Direct observation helps ensure that providers in different treatment groups are delivering distinct interventions. One direct observation method is the use of a measure to rate clinician performance when delivering an intervention. Aims: This generalizability study evaluated the reliability of the CAMS Rating Scale (CRS), a measure used to assess delivery of the Collaborative Assessment and Management of Suicidality (CAMS). Method: Digitally recorded tapes of clinicians delivering either CAMS or Enhanced Care-As-Usual (E-CAU) were coded using the CRS. Sessions (N=36) were each coded by two raters, and encompassed four clinicians, four time points, and 34 unique patients across two treatment groups. A reliability coefficient (i.e., G coefficient) and the percentages of variance contributed by each component of the measurement model were obtained. Results: The CRS reliably differentiates CAMS from E-CAU, minimizes measurement error relative to expected variance sources, and continues to demonstrate high inter-rater reliability. Limitations: The absence of blind raters, a formal training protocol for the rating team, and ratings from all clinician-patient dyads at all time points was a limitation. Conclusion: The CRS is a reliable treatment differentiation measure that can play an integral role in studies evaluating CAMS.

The psychometric properties of the Collaborative Assessment and Management of Suicidality rating scale.

The CAMS Rating Scale (CRS) is an adherence measure for the Collaborative Assessment and Management of Suicidality (CAMS), a suicide-specific clinical intervention. This study examined the ability of the CRS to assess adherence to CAMS. Video-recorded therapy sessions of clinicians delivering either CAMS or Enhanced Care-As-Usual (E-CAU) were rated with the CRS. These ratings (N = 98) were used to evaluate criterion validity, internal consistency, and factor structure. Criterion validity and factor analyses did not support the organization of the CRS into its current subscales. Furthermore, the identified factor model and item-level statistics revealed weak CRS items. Finally, internal consistency was higher among CAMS clinicians than among clinicians delivering E-CAU. These results establish the CRS as a measure that can effectively assess the adherence to CAMS in its current form. Potential revisions to future iterations of the CRS are discussed.

The collaborative assessment and management of suicidality (CAMS) versus enhanced care as usual (E-CAU) with suicidal soldiers: Moderator analyses from a randomized controlled trial

ABSTRACTGiven historically high rates of suicide among military personnel over the past decade the present study analyzed whether key demographic, military, and research-based variables moderated clinical treatment outcomes of 148 suicidal active duty US Army soldiers. This is a secondary analysis of data from a randomized controlled trial comparing the collaborative assessment and management of suicidality (CAMS) to enhanced care as usual (E-CAU; Jobes et al., 2017). Nine potential moderator variables were derived from the suicidology literature, military-specific considerations, and previous CAMS research; these were sex, age, marital status, race, lifetime suicide attempts, combat deployments, time in service, initial distress, and borderline personality disorder diagnosis. The clinical outcomes included six suicide- and mental health-related variables. Six of the eight significant moderator findings in this study showed CAMS outperforming E-CAU in certain subgroups with medium to large effect sizes ranging from 0.48 to 1.50. Collectively, the results suggest that CAMS was associated with the greatest improvement among lower complexity soldier patients, particularly those with lower initial distress and fewer deployments. Those who were married or older generally responded better to CAMS, although the results were not entirely consistent with respect to age. CAMS’s effectiveness for married soldiers and those with lower initial distress was a particularly robust finding that persisted when adjusting more stringently for multiple testing. This study sheds light on several factors associated with the success of CAMS among suicidal soldiers that can assist in matching the treatment to those that may benefit the most.

A Randomized Controlled Trial of the Collaborative Assessment and Management of Suicidality versus Enhanced Care as Usual With Suicidal Soldiers

Objective: This study describes a randomized controlled trial called “Operation Worth Living” (OWL) which compared the use of the Collaborative Assessment and Management of Suicidality (CAMS) to enhanced care as usual (E-CAU). We hypothesized that CAMS would be more effective than E-CAU for reducing suicidal ideation (SI) and suicide attempts (SA), along with secondary behavioral health and health care utilization markers for U.S. Army Soldier outpatients with significant SI (i.e., > 13 on Beck’s Scale for Suicide Ideation). Method: Study participants were 148 Soldiers who presented to a military outpatient behavioral health clinic. There were 73 Soldiers in the experimental arm of the trial who received adherent CAMS; 75 Soldiers received E-CAU. Nine a-priori treatment outcomes (SI, past year SA, suicide-related emergency department (ED) admits, behavioral health-related ED admits, suicide-related inpatient psychiatric unit (IPU) days, behavioral health-related IPU days, mental health, psychiatric distress, resiliency) were measured through assessments at Baseline and at 1, 3, 6, and 12 months post-Baseline (with a 78% retention of intent-to-treat participants at 12 months). Results: Soldiers in both arms of the trial responded to study treatments in terms of all primary and secondary outcomes (effect sizes ranged from 0.63 to 12.04). CAMS participants were significantly less likely to have any suicidal thoughts by 3 months in comparison to those in E-CAU (Cohen’s d = 0.93, p=.028). Conclusions: Soldiers receiving CAMS and E-CAU significantly improved post-treatment. Those who received CAMS were less likely to report SI at 3 months; further group differences were not otherwise seen.

Testing the effects of brief intervention in primary care for problem drug use in a randomized controlled trial: rationale, design, and methods

BackgroundA substantial body of research has established the effectiveness of brief interventions for problem alcohol use. Following these studies, national dissemination projects of screening, brief intervention (BI), and referral to treatment (SBIRT) for alcohol and drugs have been implemented on a widespread scale in multiple states despite little existing evidence for the impact of BI on drug use for non-treatment seekers. This article describes the design of a study testing the impact of SBIRT on individuals with drug problems, its contributions to the existing literature, and its potential to inform drug policy.Methods/designThe study is a randomized controlled trial of an SBIRT intervention carried out in a primary care setting within a safety net system of care. Approximately 1,000 individuals presenting for scheduled medical care at one of seven designated primary care clinics who endorse problematic drug use when screened are randomized in a 1:1 ratio to BI versus enhanced care as usual (ECAU). Individuals in both groups are reassessed at 3, 6, 9, and 12 months after baseline. Self-reported drug use and other psychosocial measures collected at each data point are supplemented by urine analysis and public health-related data from administrative databases.DiscussionThis study will contribute to the existing literature by providing evidence for the impact of BI on problem drug use based on a broad range of measures including self-reported drug use, urine analysis, admission to drug abuse treatment, and changes in utilization and costs of health care services, arrests, and death with the intent of informing policy and program planning for problem drug use at the local, state, and national levels.Trial registrationClinicalTrials.gov NCT00877331