Enhanced Treatment As Usual Research Articles

A Pilot Randomized Control Trial of the Striving Towards EmPowerment and Medication Adherence (STEP-AD) Intervention for Black Women Living with HIV

Black women living with HIV (BWLWH) face adversities associated with lower HIV medication adherence, viral non-suppression, and mental health symptoms (e.g., post-traumatic stress disorder) such as trauma/violence, racism, HIV-related discrimination/stigma, and gender-related stressors. We developed the first intervention based in cognitive behavioral therapy and culturally congruent coping for BWLWH to increase medication adherence and decrease PTSD symptoms by enhancing resilience, self-care, engagement in care, and coping for trauma, racism, HIV-related discrimination/stigma, and gender-related stressors. A pilot randomized control trial was conducted with BWLWH and histories of trauma who were at risk for their HIV viral load remaining or becoming detectable (i.e., below 80% medication adherence, detectable viral load in the past year, and/or missed HIV-related appointments). 119 BWLWH were assessed at baseline and 70 met inclusion criteria, completed one session of Life-Steps adherence counseling, and were randomized to either nine sessions of STEP-AD (Striving Towards EmPowerment and Medication Adherence) or ETAU (enhanced treatment as usual consisting of biweekly check-ins). Women completed a post intervention follow up assessment (3 months post baseline) and 3-month post intervention follow-up (6 months post baseline). Via STATA the difference-in-difference methodology with mixed models compared STEP-AD to ETAU on changes in outcomes over time. BWLWH in STEP-AD compared to E-TAU had significantly higher ART adherence (estimate = 9.36 p = 0.045) and lower likelihood of being clinically diagnosed with PTSD (OR = .07, estimate = − 2.66, p = 0.03) as well as borderline significance on higher CD4 count (estimate = 161.26, p = 0.05). Our findings suggest preliminary efficacy of STEP-AD in improving ART adherence, mental health, and immune function.

Assessing the impact of jail-initiated medication for opioid use disorder: A multisite analysis of the SOMATICS collaborative.

The objective of this study was to estimate the associations of jail-initiated medication for opioid use disorder (MOUD) and patient navigation (PN) with opioid use disorder (OUD) at 6 months post-release. Three randomized trials (combined N = 330) were combined to assess whether MOUD (extended-release naltrexone or interim methadone) initiated prior to release from jail with or without PN would reduce the likelihood of a DSM-5 diagnosis of OUD 6 months post-release relative to enhanced treatment-as-usual (ETAU). Across the three studies, assignment to MOUD compared to ETAU was not associated with an OUD diagnosis at 6 months post-release (69% vs. 75%, respectively, OR = 0.67, 95% CI: 0.42 to 1.20). Similarly, PN compared to MOUD without PN was not associated with an OUD diagnosis (63% vs 77%, respectively, OR = 0.61, 95% CI: 0.27 to 1.53). Results underscore the need to further optimize the effectiveness of MOUD for patients initiating treatment in jail, beginning with an emphasis on post-release treatment adherence.

Cognitive therapy for depression in tuberculosis treatment: protocol for multicentre pragmatic parallel arm randomised control trial with an internal pilot

Introduction and objectivesThere is an unmet need to develop high-quality evidence addressing tuberculosis (TB)-related mental health comorbidity, particularly in the context of lower-middle-income countries. This study aims to examine the...

Neurophysiological brain function predicts response to cognitive rehabilitation and mindfulness in multiple sclerosis: a randomized trial

BackgroundCognitive treatment response varies highly in people with multiple sclerosis (PwMS). Identification of mechanisms is essential for predicting response.ObjectivesThis study aimed to investigate whether brain network function predicts response to cognitive rehabilitation therapy (CRT) and mindfulness-based cognitive therapy (MBCT).MethodsPwMS with cognitive complaints completed CRT, MBCT, or enhanced treatment as usual (ETAU) and performed three measurements (baseline, post-treatment, 6-month follow-up). Baseline magnetoencephalography (MEG) measures were used to predict treatment effects on cognitive complaints, personalized cognitive goals, and information processing speed (IPS) using mixed models (secondary analysis REMIND-MS study).ResultsWe included 105 PwMS (96 included in prediction analyses; 32 CRT, 31 MBCT, 33 ETAU), and 56 healthy controls with baseline MEG. MEG did not predict reductions in complaints. Higher connectivity predicted better goal achievement after MBCT (p = 0.010) and CRT (p = 0.018). Lower gamma power (p = 0.006) and higher connectivity (p = 0.020) predicted larger IPS benefits after MBCT. These MEG predictors indicated worse brain function compared to healthy controls (p < 0.05).ConclusionsBrain network function predicted better cognitive goal achievement after MBCT and CRT, and IPS improvements after MBCT. PwMS with neuronal slowing and hyperconnectivity were most prone to show treatment response, making network function a promising tool for personalized treatment recommendations.Trial registrationThe REMIND-MS study was prospectively registered in the Dutch Trial registry (NL6285; https://trialsearch.who.int/Trial2.aspx?TrialID=NTR6459).

1 Cognitive Rehabilitation and Mindfulness Reduce Cognitive Complaints in Multiple Sclerosis (REMIND-MS): a Randomized Controlled Trial

Objective:Cognitive problems, both complaints and objective impairments, are frequent and disabling in patients with multiple sclerosis (MS) and profoundly affect daily living. However, intervention studies that focus on cognitive problems that patients experience in their daily lives are limited. This study therefore aimed to investigate the effectiveness of cognitive rehabilitation therapy (CRT) and mindfulness-based cognitive therapy (MBCT) on patient-reported cognitive complaints in MS.Participants and Methods:In this randomized-controlled trial, MS patients with cognitive complaints completed questionnaires and underwent neuropsychological assessments at baseline, post-treatment and 6-month follow-up. Patient-reported cognitive complaints were primarily investigated. Secondary outcomes included personalized cognitive goals and objective cognitive function. CRT and MBCT were compared to enhanced treatment as usual (ETAU) using linear mixed models.Results:Patients were randomized into CRT (n=37), MBCT (n=36) or ETAU (n=37), of whom 100 completed the study. Both CRT and MBCT positively affected patient-reported cognitive complaints compared to ETAU at post-treatment (p&lt;.05), but not 6 months later. At 6-month follow-up, CRT had a positive effect on personalized cognitive goals (p=.028) and MBCT on processing speed (p=.027). Patients with less cognitive complaints at baseline benefited more from CRT on the Cognitive Failures Questionnaire (i.e. primary outcome measuring cognitive complaints) at post-treatment (p=.012-.040), and those with better processing speed at baseline benefited more from MBCT (p=.016).Conclusions:Both CRT and MBCT alleviated cognitive complaints in MS patients immediately after treatment completion, but these benefits did not persist. In the long term, CRT showed benefits on personalized cognitive goals and MBCT on processing speed. These results thereby provide insight in the specific contributions of available cognitive treatments for MS patients.

Evaluation of the Early Adolescent Skills for Emotions (EASE) intervention in Lebanon: A randomized controlled trial

BackgroundThere is a need for scalable evidence-based psychological interventions for young adolescents experiencing high levels of psychological distress in humanitarian settings and low- and middle-income countries. Poor mental health during adolescence presents a serious public health concern as it is a known predictor of persistent mental disorders in adulthood. This study evaluates the effectiveness of a new group-based intervention developed by the World Health Organization (Early Adolescent Skills for Emotions; EASE), implemented by non-specialists, to reduce young adolescents' psychological distress among mostly Syrian refugees in Lebanon. MethodsWe conducted a two-arm, single-blind, individually randomized group treatment trial. Adolescents aged 10 to 14 years who screened positive for psychological distress using the Pediatric Symptom Checklist (PSC) were randomly allocated to EASE or enhanced treatment as usual (ETAU) (1:1.6). ETAU consisted of a single scripted psycho-education home-visit session with the adolescent and their caregivers. EASE consists of seven group sessions with adolescents and three sessions with caregivers. The primary outcome was adolescent-reported psychological distress as measured with the PSC (internalizing, externalizing, and attentional symptoms). Secondary outcomes included depression, posttraumatic stress, well-being, functioning, and caregivers' parenting and distress. All outcomes were assessed at baseline, endline, and 3 months (primary time point) and 12 months follow-up. ResultsDue to the COVID-19 pandemic and other adversities in Lebanon at the time of this research, the study was prematurely terminated, resulting in an under-powered trial sample (n = 198 enrolled compared to n = 445 targeted). We screened 604 children for eligibility. The 198 enrolled adolescents were assigned to EASE (n = 80) and ETAU (n = 118), with retention rates between 76.1 and 88.4% across all timepoints. Intent-to-treat analyses demonstrated no between-group differences on any of the outcome measures between the EASE and ETAU. We did observe a significant improvement on the primary outcome equally in the EASE and ETAU groups (−0.90, 95% CI: −3.6, 1.8; p = .52), − a trend that was sustained at three months follow-up. Sub-group analyses, for those with higher depression symptoms at baseline, showed ETAU outperformed EASE on reducing depression symptoms (difference in mean change = 2.7, 95% CI: 0.1, 5.3; p = .04; d = 0.59) and internalizing problems (difference in mean change 1.0, 95% CI: 0.08, 1.9; p = .03; d = 0.56) . ConclusionNo conclusions can be drawn about the comparative effectiveness of the intervention given that the sample was underpowered as a result of early termination. Both EASE and single session psycho-education home visits resulted in meaningful improvements in reducing psychological distress. We did not identify any indications in the data suggesting that EASE was more effective than a single session family intervention in the context of the COVID-19 pandemic and other crises in Lebanon. Fully powered research is needed to evaluate the effectiveness of EASE.

A culturally adapted manual-assisted problem-solving intervention (CMAP) for adults with a history of self-harm: a multi-centre randomised controlled trial

BackgroundSelf-harm is an important predictor of a suicide death. Culturally appropriate strategies for the prevention of self-harm and suicide are needed but the evidence is very limited from low- and middle-income countries (LMICs). This study aims to investigate the effectiveness of a culturally adapted manual-assisted problem-solving intervention (CMAP) for patients presenting after self-harm.MethodsThis was a rater-blind, multicenter randomised controlled trial. The study sites were all participating emergency departments, medical wards of general hospitals and primary care centres in Karachi, Lahore, Rawalpindi, Peshawar, and Quetta, Pakistan. Patients presenting after a self-harm episode (n = 901) to participating recruitment sites were assessed and randomised (1:1) to one of the two arms; CMAP with enhanced treatment as usual (E-TAU) or E-TAU. The intervention (CMAP) is a manual-assisted, cognitive behaviour therapy (CBT)-informed problem-focused therapy, comprising six one-to-one sessions delivered over three months. Repetition of self-harm at 12-month post-randomisation was the primary outcome and secondary outcomes included suicidal ideation, hopelessness, depression, health-related quality of life (QoL), coping resources, and level of satisfaction with service received, assessed at baseline, 3-, 6-, 9-, and 12-month post-randomisation. The trial is registered on ClinicalTrials.gov. NCT02742922 (April 2016).ResultsWe screened 3786 patients for eligibility and 901 eligible, consented patients were randomly assigned to the CMAP plus E-TAU arm (n = 440) and E-TAU arm (N = 461). The number of self-harm repetitions for CMAP plus E-TAU was lower (n = 17) compared to the E-TAU arm (n = 23) at 12-month post-randomisation, but the difference was not statistically significant (p = 0.407). There was a statistically and clinically significant reduction in other outcomes including suicidal ideation (− 3.6 (− 4.9, − 2.4)), depression (− 7.1 (− 8.7, − 5.4)), hopelessness (− 2.6 (− 3.4, − 1.8), and improvement in health-related QoL and coping resources after completion of the intervention in the CMAP plus E-TAU arm compared to the E-TAU arm. The effect was sustained at 12-month follow-up for all the outcomes except for suicidal ideation and hopelessness. On suicidal ideation and hopelessness, participants in the intervention arm scored lower compared to the E-TAU arm but the difference was not statistically significant, though the participants in both arms were in low-risk category at 12-month follow-up. The improvement in both arms is explained by the established role of enhanced care in suicide prevention.ConclusionsSuicidal ideation is considered an important target for the prevention of suicide, therefore, CMAP intervention should be considered for inclusion in the self-harm and suicide prevention guidelines. Given the improvement in the E-TAU arm, the potential use of brief interventions such as regular contact requires further exploration.

The Clinical Impact and Cost-Effectiveness of Clinic-Based Cognitive Behavioral Therapy for People With HIV, Depression, and Virologic Failure in South Africa.

Depression affects 25%-30% of people with HIV (PWH) in the Republic of South Africa (RSA) and is associated with both antiretroviral therapy (ART) nonadherence and increased mortality. We evaluated the cost-effectiveness of task-shifted, cognitive behavioral therapy (CBT) for PWH with diagnosed depression and virologic failure from a randomized trial in RSA. RSA. Using the Cost-Effectiveness of Preventing AIDS Complications model, we simulated both trial strategies: enhanced treatment as usual (ETAU) and ETAU plus CBT for ART adherence and depression (CBT-AD; 8 sessions plus 2 follow-ups). In the trial, viral suppression at 1 year was 20% with ETAU and 32% with CBT-AD. Model inputs included mean initial age (39 years) and CD4 count (214/μL), ART costs ($7.5-22/mo), and CBT costs ($29/session). We projected 5- and 10-year viral suppression, quality-adjusted life-years (QALYs), lifetime costs, and incremental cost-effectiveness ratios (ICERs: $/QALY [discounted 3%/yr]; cost-effectiveness threshold: ≤$2545/QALY [0.5× per capita GDP]). In sensitivity analyses, we determined how input parameter variation affected cost-effectiveness. Model-projected 5- and 10-year viral suppression were 18.9% and 8.7% with ETAU and 21.2% and 9.7% with CBT-AD, respectively. Compared with ETAU, CBT-AD would increase discounted life expectancy from 4.12 to 4.68 QALYs and costs from $6210/person to $6670/person (incremental cost-effectiveness ratio: $840/QALY). CBT-AD would remain cost-effective unless CBT-AD cost >$70/session and simultaneously improved 1-year viral suppression by ≤4% compared with ETAU. CBT for PWH with depression and virologic failure in RSA could improve life expectancy and be cost-effective. Such targeted mental health interventions should be integrated into HIV care.

The Collaborative Assessment and Management of Suicidality compared to enhanced treatment as usual for inpatients who are suicidal: A randomized controlled trial.

Although use of inpatient crisis hospital intervention for suicide risk is common, the evidence for inpatient treatments that reduce suicidal thoughts and behaviors is remarkably limited. To address this need, this novel feasibility pilot randomized controlled trial compared the use of the Collaborative Assessment and Management of Suicidality (CAMS) to enhanced treatment as usual (E-TAU) within a standard acute inpatient mental health care setting. We hypothesized that CAMS would be more effective than E-TAU in reducing suicidal thoughts and behaviors. As secondary outcomes we also investigated depressive symptoms, general symptom burden, reasons for living, and quality of the therapeutic relationship. All patients were admitted due to acute suicidal thoughts or behaviors. They were randomly assigned to CAMS (n = 43) or E-TAU (n = 45) and assessed at four time points (admission, discharge, 1 month and 5 months after discharge). We used mixed-effects models, effect sizes, and reliable change analyses to compare improvements across and between treatment groups over time. Intent-to-treat analyses of 88 participants [mean age 32.1, SD = 13.5; n = 47 (53%) females] showed that both groups improved over time across all outcome measures with no significant between-group differences in terms of change in suicidal ideation, depression, reasons for living, and distress. However, CAMS showed larger effect sizes across all measures; for treatment completers CAMS patients showed significant improvement in suicidal ideation (p = 0.01) in comparison to control patients. CAMS patients rated the therapeutic relationship significantly better (p = 0.02) than E-TAU patients and were less likely to attempt suicide within 4 weeks after discharge (p = 0.05). CAMS and E-TAU were both effective in reducing suicidal thoughts and symptom distress. Within this feasibility RCT the pattern of results was generally supportive of CAMS suggesting that inpatient use of CAMS is both feasible and promising. However, our preliminary results need further replication within well-powered multi-site randomized controlled trials. DRKS-ID/ICTRP-ID: DRKS00013727. The trial was retrospectively registered in the German Clinical Trials Register, registration code/ DRKS-ID: DRKS00013727 on 12.01.2018 and also in the International Clinical Trials Registry Platform of the World Health Organization (identical registration code).

Feasibility randomised controlled trial of the Early Adolescent Skills for Emotions psychological intervention with young adolescents in Lebanon

BackgroundGlobally, there is a vast mental health treatment gap, whereby the majority of adolescents living in low- and middle-income countries requiring mental health services, do not have access to adequate care. To improve access, the World Health Organization (WHO) developed a range of interventions, designed to be low-cost and delivered by non-specialists. We conducted a two-arm, individually randomised group treatment feasibility trial of a new WHO group intervention for young adolescents with emotional distress (‘Early Adolescent Skills for Emotions’; EASE) in Lebanon.MethodThe aim of this study was to determine the feasibility of the intervention and study procedures. Adolescents aged 10 to 14 years were eligible to take part if they scored above a validated cut-off on the Child Psychosocial Distress Screener. Participants were randomized to EASE or enhanced treatment as usual (ETAU) control using a 1:1 ratio. EASE consisted of seven group sessions with adolescents and three sessions with caregivers. ETAU consisted of a single brief psychoeducation home visit. Child and caregiver outcomes were measured by blind assessors at baseline, endline (8 weeks post-randomisation), and three month follow-up (20 weeks post-randomisation), with the primary outcome measure being child psychological symptoms on the Pediatric Symptom Checklist. Qualitative interviews were conducted with adolescents (n = 13), caregivers (n = 17), facilitators (n = 6), trainers (n = 3), and outreach staff (n = 1) at endline to assess barriers and facilitators related to the feasibility and delivery of EASE and study procedures.ResultsOf 154 adolescents screened, 67 (43%) were eligible, completed baseline, and were randomized. Sixty adolescents (90%) completed endline assessments (31 EASE, 29 ETAU), and fifty-nine (88%) completed three-month assessments (29 EASE, 30 ETAU). Qualitatively, participants provided overall positive feedback about the intervention. Several challenges and suggestions for improvement were raised around logistics, intervention content, and acceptability of assessment measures. Implementation data highlighted challenges with intervention uptake and attendance. Outcome measures generally had strong psychometric properties (range: α = 0.77 to α = 87), however did not demonstrate change over time in either group.ConclusionsThe EASE intervention and study procedures are acceptable and feasible for implementation with vulnerable adolescents in Lebanon, however several improvements are necessary prior to full-scale evaluation.Trial registration#ISRCTN60799626, retrospectively registered on 04/10/2022.

Gender Moderates Results of a Randomized Clinical Trial for the Khanya Intervention for Substance Use and ART Adherence in HIV Care in South Africa

Little is known about gender effects of alcohol and drug use (AOD) among people living with HIV (PLWH) in resource-limited settings. Using multilevel models, we tested whether gender moderated the effect of Khanya, a cognitive-behavioral therapy-based intervention addressing antiretroviral (ART) adherence and AOD reduction. We enrolled 61 participants from HIV care and examined outcomes at 3- and 6-months compared to enhanced treatment as usual (ETAU). Gender significantly moderated the effect of Khanya on ART adherence (measured using electronically-monitored and biomarker-confirmed adherence), such that women in Khanya had significantly lower ART adherence compared to men in Khanya; no gender differences were found for AOD outcomes. Exploratory trajectory analyses showed men in Khanya and both genders in ETAU had significant reductions in at least one AOD outcome; women in Khanya did not. More research is needed to understand whether a gender lens can support behavioral interventions for PLWH with AOD.Trial registry ClinicalTrials.gov identifier: NCT03529409. Trial registered on May 18, 2018.

Addressing chronic pain with Focused Acceptance and Commitment Therapy in integrated primary care: findings from a mixed methods pilot randomized controlled trial

BackgroundOver 100 million Americans have chronic pain and most obtain their treatment in primary care clinics. However, evidence-based behavioral treatments targeting pain-related disability are not typically provided in these settings. Therefore, this study sought to: 1) evaluate implementation of a brief evidence-based treatment, Focused Acceptance and Commitment Therapy (FACT-CP), delivered by an integrated behavioral health consultant (BHC) in primary care; and 2) preliminarily explore primary (self-reported physical disability) and secondary treatment outcomes (chronic pain acceptance and engagement in valued activities).MethodsThis mixed-methods pilot randomized controlled trial included twenty-six participants with non-cancer chronic pain being treated in primary care (54% women; 46% Hispanic/Latino). Active participants completed a 30-min individual FACT-CP visit followed by 3 weekly 60-min group visits and a booster visit 2 months later. An enhanced treatment as usual (ETAU) control group received 4 handouts about pain management based in cognitive-behavioral science. Follow-up research visits occurred during and after treatment, at 12 weeks (booster visit), and at 6 months. Semi-structured interviews were conducted to collect qualitative data after the last research visit. General linear mixed regression models with repeated measures explored primary and secondary outcomes.ResultsThe study design and FACT-CP intervention were feasible and acceptable. Quantitative analyses indicate at 6-month follow-up, self-reported physical disability significantly improved pre-post within the FACT-CP arm (d = 0.64); engagement in valued activities significantly improved within both the FACT-CP (d = 0.70) and ETAU arms (d = 0.51); and chronic pain acceptance was the only outcome significantly different between arms (d = 1.04), increased in the FACT-CP arm and decreased in the ETAU arm. Qualitative data analyses reflected that FACT-CP participants reported acquiring skills for learning to live with pain, consistent with increased chronic pain acceptance.ConclusionFindings support that FACT-CP was acceptable for patients with chronic pain and feasible for delivery in a primary care setting by a BHC. Results provide preliminary evidence for improved physical functioning after FACT-CP treatment. A larger pragmatic trial is warranted, with a design based on data gathered in this pilot.Trial registrationclinicaltrials.gov, NCT04978961 (27/07/2021).

Adaptive Treatment for Youth With Substance Use and Depression: Early Depression Response and Short-term Outcomes.

To investigate prevalence and predictors of early depression response (EDR) in adolescents with substance use and depression receiving cognitive-behavioral therapy (CBT) for substance use and to test the efficacy of supplemental CBT targeting depression (CBT-D) for non-EDR adolescents in an adaptive treatment approach. At 2 sites, 95 youths (ages 14-21, mean [SD]= 17.4 [1.8]) with alcohol or cannabis use and depressive symptoms received up to 12 sessions of CBT for substance use over 14 weeks. Assessments were at baseline and weeks 4, 9, and 14. The Children's Depression Rating Scale-Revised was the primary depression measure, with a reduction of 50% or more on this scale at week 4 defining EDR. The primary substance use outcomes of alcohol use, heavy alcohol use, and cannabis use frequency were assessed via interview report on the Alcohol Consumption Questionnaire and the Drug Checklist. Urinalysis provided a secondary measure of cannabis use. Non-EDR adolescents were randomly assigned to supplemental CBT-D or enhanced treatment as usual (ETAU). Thirty-five adolescents (37%; 95% CI, 27%-47%) demonstrated EDR. Fewer days of cannabis use (odds ratio 0.977; 95% CI, 0.961-0.992) and absence of conduct disorder (odds ratio 0.149; 95% CI, 0.031-0.716) predicted EDR. Frequency of drinking (F1,82= 11.09, η2= 0.119, p= .001), heavy drinking (F1,82= 19.91, η2= 0.195, p< .0001), and cannabis use (F1,220= 35.01, η2= 0.137, p< .001) decreased over time for EDR, CBT-D, and ETAU adolescents, with EDR adolescents evidencing earlier lower cannabis use (F2,220= 4.16, η2= 0.036, p= .0169). Negative (clean) urine screens increased over time (F1,219= 5.10, η2= 0.023, p= .0249). Comparison of CBT-D and ETAU indicated that depression significantly decreased over time in both groups (F1,48= 64.20, η2= 0.572, p< .001), with no advantage for CBT-D. Approximately one-third of adolescents with substance use and depression attain EDR during substance use treatment. Less frequent cannabis use facilitates depression response. The relatively small sample may have precluded identification of additional EDR predictors. Treatment for Teens With Alcohol Abuse and Depression; https://clinicaltrials.gov/; NCT02227589.

Costs, benefits, and cost-benefit of Collaborative Assessment and Management of Suicidality versus enhanced treatment as usual.

Suicide rates have been steadily increasing in both the U.S. general population and military, with significant psychological and economic consequences. The purpose of the current study was to examine the economic costs and cost-benefit of the suicide-focused Collaborative Assessment and Management of Suicidality (CAMS) intervention versus enhanced treatment as usual (ETAU) in an active duty military sample using data from a recent randomized controlled trial of CAMS versus ETAU. The full intent-to-treat sample included 148 participants (mean age 26.8 years ± 5.9 SD years, 80% male, 53% White). Using a micro-costing approach, the cost of each condition was calculated at the individual level from a healthcare system perspective. Benefits were estimated at the individual level as cost savings in past-year healthcare expenditures based on direct care reimbursement rates. Cost-benefit was examined in the form of cost-benefit ratios and net benefit. Total costs, benefits, cost-benefit ratios, and net benefit were calculated and analyzed using general linear mixed modeling on multiply imputed datasets. Results indicated that treatment costs did not differ significantly between conditions; however, CAMS was found to produce significantly greater benefit in the form of decreased healthcare expenditures at 6-month follow-up. CAMS also demonstrated significantly greater cost-benefit ratios (i.e., benefit per dollar spent on treatment) and net-benefit (i.e., total benefit less the cost of treatment) at 12-month follow-up. The current study suggests that beyond its clinical effectiveness, CAMS may also convey potential economic advantages over usual care for the treatment of suicidal active duty service members. Our findings demonstrate cost savings in the form of reduced healthcare expenditures, which theoretically represent resources that can be reallocated toward other healthcare system needs, and thus lend support toward the overall value of CAMS.

Feasibility and acceptability of Problem Management Plus (PM+) among Syrian refugees and asylum seekers in Switzerland: a mixed-method pilot randomized controlled trial

ABSTRACT Background Syrian refugees in Switzerland face several barriers in accessing mental health care. Cost-effective psychological interventions are urgently needed to meet the mental health needs of refugees. Problem Management Plus (PM+) is an evidence-based, psychological intervention delivered by trained non-specialist ‘helpers’. Objective To assess the feasibility and acceptability of PM+ among Syrian refugees in Switzerland. Methods We conducted a single-blind pilot randomized controlled trial (RCT) with Syrian refugees impaired by psychological distress (K10 > 15 and WHODAS 2.0 > 16). Participants were randomized to PM+ or Enhanced Treatment As Usual (ETAU). Participants were assessed at baseline, and 1 week and 3 months after the intervention, and completed measures indexing mental health problems and health care usage. Semi-structured interviews were conducted with different stakeholders. Results N = 59 individuals were randomized into PM+ (n = 31) or ETAU (n = 28). N = 18 stakeholders were interviewed about facilitators and barriers for the implementation of PM+. Retention rates in the trial (67.8%) and mean intervention attendance (M = 3.94 sessions, SD = 1.97) were high. No severe events related to the study were reported. These findings indicate that the trial procedures and PM+ were feasible, acceptable and safe. Conclusions The findings support the conduct of a definitive RCT and show that PM+ might have the potential to be scaled-up in Switzerland. The importance, as well as the challenges, of implementing and scaling-up PM+ in high-income countries, such as Switzerland, are discussed.

Long-term effectiveness of Self-Help Plus in refugees and asylum seekers resettled in Western Europe: 12-month outcomes of a randomised controlled trial.

As refugees and asylum seekers are at high risk of developing mental disorders, we assessed the effectiveness of Self-Help Plus (SH + ), a psychological intervention developed by the World Health Organization, in reducing the risk of developing any mental disorders at 12-month follow-up in refugees and asylum seekers resettled in Western Europe. Refugees and asylum seekers with psychological distress (General Health Questionnaire-12 ⩾ 3) but without a mental disorder according to the Mini International Neuropsychiatric Interview (M.I.N.I.) were randomised to either SH + or enhanced treatment as usual (ETAU). The frequency of mental disorders at 12 months was measured with the M.I.N.I., while secondary outcomes included self-identified problems, psychological symptoms and other outcomes. Of 459 participants randomly assigned to SH + or ETAU, 246 accepted to be interviewed at 12 months. No difference in the frequency of any mental disorders was found (relative risk [RR] = 0.841; 95% confidence interval [CI] 0.389-1.819; p-value = 0.659). In the per protocol (PP) population, that is in participants attending at least three group-based sessions, SH + almost halved the frequency of mental disorders at 12 months compared to ETAU, however so few participants and events contributed to this analysis that it yielded a non-significant result (RR = 0.528; 95% CI 0.180-1.544; p-value = 0.230). SH + was associated with improvements at 12 months in psychological distress (p-value = 0.004), depressive symptoms (p-value = 0.011) and wellbeing (p-value = 0.001). The present study failed to show any long-term preventative effect of SH + in refugees and asylum seekers resettled in Western European countries. Analysis of the PP population and of secondary outcomes provided signals of a potential effect of SH + in the long-term, which would suggest the value of exploring the effects of booster sessions and strategies to increase SH + adherence.

Residual posttraumatic stress disorder symptoms after provision of brief behavioral intervention in low- and middle-income countries: An individual-patient data meta-analysis.

BackgroundTo address shortages of mental health specialists in low‐ and middle‐income countries, task‐shifting approaches have been employed to train nonspecialists to deliver evidence‐based scalable psychosocial interventions. Problem Management Plus (PM+) is a brief transdiagnostic nontrauma focused intervention for people affected by adversity. This study reports on the capacity of PM+ to address specific symptoms of posttraumatic stress disorder (PTSD).MethodsIndividual patient data from three randomised controlled trials were combined and analysed to observe the impacts of PM+ (n = 738) or enhanced treatment as usual (ETAU) (n = 742) interventions on specific PTSD symptoms at posttreatment and 3‐month follow‐up. The PTSD‐Checklist for DSM‐5 (PCL‐5) was used to index PTSD symptoms, and presence of each symptom was defined as moderate severity (score ≥ 2 on individual items).ResultsThe average PCL‐5 score at baseline was 26.1 (SD: 16.8) with 463 (31.3%) scoring above 33, indicative of a diagnosis of PTSD. Following intervention, 12.5% and 5.8% of participants retained a score greater than 33 at postassessment and follow‐up, respectively. There was greater symptom reduction for PM+ than for ETAU for most symptoms. Hyperarousal symptoms were the most common residual symptoms after PM+, with more than 30% of participants reporting persistent sleep disturbance, concentration difficulties, and anger.ConclusionPM+ led to greater reduction in symptoms relating to re‐experiencing and avoidance. The evidence indicates that strategies focusing on hyperarousal symptoms including sleep, concentration, and anger difficulties, could be strengthened in this brief intervention.

Treating depression and improving adherence in HIV care with task-shared cognitive behavioural therapy in Khayelitsha, South Africa: a randomized controlled trial.

IntroductionMajor depressive disorder, highly prevalent among people with HIV (PWH) globally, including South Africa, is associated with suboptimal adherence to antiretroviral therapy. Globally, there are insufficient numbers of mental health providers and tested depression treatments. This study's aim was to test task‐shared cognitive‐behavioural therapy for adherence and depression (CBT‐AD) in HIV, delivered by clinic nurses in South Africa.MethodsThis was a two‐arm randomized controlled effectiveness trial (recruitment: 14 July 2016 to 4 June 2019, last follow 9 June 2020). One‐hundred‐sixty‐one participants with clinical depression and virally uncontrolled HIV were recruited from primary care clinics providing HIV care, in Khayelitsha, South Africa. Arm 1 was task‐shared, nurse‐delivered CBT‐AD; and arm 2 was enhanced treatment as usual (ETAU). Primary outcomes (baseline to 4 months) were blinded Hamilton Depression Rating Scale (HAM‐D) scores, and weekly adherence via real‐time monitoring (Wisepill). Secondary outcomes were adherence and depression over 4‐, 8‐ and 12‐month follow‐ups, proportion of participants with undetectable viremia and continuous CD4 cell counts at 12 months. Additional analyses involved viral load and CD4 over time.ResultsAt 4 months, the HAMD scores in the CBT‐AD condition improved by an estimated 4.88 points more (CI: –7.86, –1.87, p = 0.0016), and for weekly adherence, 1.61 percentage points more per week (CI: 0.64, 2.58, p = 0.001) than ETAU. Over follow‐ups, CBT‐AD had an estimated 5.63 lower HAMD scores (CI: –7.90, –3.36, p < 0.001) and 23.56 percentage points higher adherence (CI: 10.51, 34.21, p < 0.001) than ETAU. At 12 months, adjusted models indicated that the odds of having an undetectable viremia was 2.51 greater at 12 months (CI: 1.01, 6.66, p = 0.047), and 3.54 greater over all of the follow‐ups (aOR = 3.54, CI: 1.59, 20.50; p = 0.038) for those assigned CBT‐AD. CD4 was not significantly different between groups at 12 months or over time.ConclusionsTask‐shared, nurse‐delivered, CBT‐AD is effective in improving clinical depression, ART adherence and viral load for virally unsuppressed PWH. The strategy of reducing depression to allow patients with self‐care components of medical illness to benefit from adherence interventions is one to extend. Implementation science trials and analyses of cost‐effectiveness are needed to translate findings into clinical practice.Trial RegistrationClinicalTrials.gov Identifier: NCT02696824 https://clinicaltrials.gov/ct2/show/NCT02696824

Effectiveness of Self-Help Plus in Preventing Mental Disorders in Refugees and Asylum Seekers in Western Europe: A Multinational Randomized Controlled Trial

Introduction: Self-Help Plus (SH+) is a group-based psychological intervention developed by the World Health Organization for managing stress. Objective: To assess the effectiveness of SH+ in preventing mental disorders in refugees and asylum seekers in Western Europe. Methods: We conducted a randomized controlled trial in 5 European countries. Refugees and asylum seekers with psychological distress (General Health Questionnaire score ≥3), but without a Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) or ICD/10 diagnosis of mental disorder, as assessed with the Mini International Neuropsychiatric Interview (MINI), were randomized to SH+ or enhanced treatment as usual (ETAU). The primary outcome was the frequency of mental disorders with the MINI at 6 months. Secondary outcomes included the frequency of mental disorders at postintervention, self-identified problems, psychological symptoms, and other outcomes. Results: Four hundred fifty-nine individuals were randomly assigned to SH+ or ETAU. For the primary outcome, we found no difference in the frequency of mental disorders at 6 months (Cramer V = 0.007, p = 0.90, RR = 0.96; 95% CI 0.52–1.78), while the difference significantly favored SH+ at after the intervention (secondary outcome, measured within 2 weeks from the last session; Cramer V = 0.13, p = 0.01, RR = 0.50; 95% CI 0.29–0.87). Conclusions: This is the first randomized indicated prevention study with the aim of preventing the onset of mental disorders in asylum seekers and refugees in Western Europe. As a prevention effect of SH+ was not observed at 6 months, but rather after the intervention only, modalities to maintain its beneficial effect in the long term need to be identified.

Project Khanya: results from a pilot randomized type 1 hybrid effectiveness-implementation trial of a peer-delivered behavioural intervention for ART adherence and substance use in HIV care in South Africa.

IntroductionSouth Africa (SA) has the highest number of people living with HIV (PLWH) globally, and a significant burden of alcohol and other drug use (AOD). Although integrating AOD treatment into HIV care may improve antiretroviral therapy (ART) adherence, this is not typically routine practice in SA or other low‐resource settings. Identifying interventions that are feasible and acceptable for implementation is critical to improve HIV and AOD outcomes.MethodsA pilot randomized hybrid type 1 effectiveness‐implementation trial (N = 61) was conducted to evaluate the feasibility and acceptability of Khanya, a task‐shared, peer‐delivered behavioral intervention to improve ART adherence and reduce AOD in HIV care in SA. Khanya was compared to enhanced treatment as usual (ETAU), a facilitated referral to on‐site AOD treatment. Implementation outcomes, defined by Proctor’s model, included feasibility, acceptability, appropriateness and fidelity. Primary pilot effectiveness outcomes were ART adherence at post‐treatment (three months) measured via real‐time electronic adherence monitoring, and AOD measured using biomarker and self‐report assessments over six months. Data collection was conducted from August 2018 to April 2020.Results and discussionNinety‐one percent of participants (n = 56) were retained at six months. The intervention was highly feasible, acceptable, appropriate and delivered with fidelity (>90% of components delivered as intended by the peer). There was a significant treatment‐by‐time interaction for ART adherence (estimate = −0.287 [95% CI = −0.507, −0.066]), revealing a 6.4 percentage point increase in ART adherence in Khanya, and a 22.3 percentage point decline in ETAU. Both groups evidenced significant reductions in alcohol use measured using phosphatidylethanol (PEth) (F(2,101) = 4.16, p = 0.01), significantly decreased likelihood of self‐reported moderate or severe AOD (F(2,104) = 7.02, p = 0.001), and significant declines in alcohol use quantity on the timeline follow‐back (F(2,102) = 21.53, p < 0.001). Among individuals using drugs and alcohol, there was a greater reduction in alcohol use quantity in Khanya compared to ETAU over six months (F(2,31) = 3.28, p = 0.05).ConclusionsResults of this pilot trial provide initial evidence of the feasibility and acceptability of the Khanya intervention for improving adherence in an underserved group at high risk for ongoing ART non‐adherence and HIV transmission. Implementation results suggest that peers may be a potential strategy to extend task‐sharing models for behavioral health in resource‐limited, global settings.