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A group-based mental health intervention for young people living with HIV in Tanzania: results of a pilot individually randomized group treatment trial.

ABSTRACT: BACKGROUND:Increasing numbers of young people living with HIV (YPLWH) have unaddressed mental health challenges. Such challenges are associated with poor antiretroviral therapy (ART) adherence and high mortality. Few evidence-based mental health interventions exist to improve HIV outcomes among YPLWH. METHODS:This pilot group treatment trial individually randomized YPLWH from two clinical sites in Tanzania, evaluated acceptability, feasibility, and preliminary effectiveness of a mental health intervention, Sauti ya Vijana (SYV; The Voice of Youth), was compared to the local standard-of-care (SOC) for improving ART adherence and virologic suppression. Enrolled YPLWH were 12-24?years of age and responded to mental health and stigma questionnaires, self-reported adherence, objective adherence measures (ART concentration in hair), and HIV RNA at baseline and 6-months (post-intervention). Feasibility and acceptability were evaluated, and potential effectiveness was assessed by comparing outcomes between arms using mixed effects modeling. RESULTS:Between June 2016 and July 2017, 128 YPLWH enrolled; 105 were randomized and 93 (55 in SYV) followed-up at 6-months and were thereby included in this analysis. Mean age was 18.1?years; 51% were female; and 84% were HIV-infected perinatally. Attendance to intervention sessions was 86%; 6-month follow-up was 88%, and fidelity to the protocol approached 100%. Exploratory analyses of effectiveness demonstrated self-reported adherence improved by 7.3 percentage points (95% CI: 2.2, 12.3); and the pooled standard deviation for all ART concentration values increased by 0.17?units (95% CI: -?0.52, 0.85) in the SYV arm compared to SOC. Virologic suppression rates (HIV RNA

SUBMITTER: Dow DE

PROVIDER: S-EPMC7487650 | biostudies-literature | 2020 Sep

REPOSITORIES: biostudies-literature

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A group-based mental health intervention for young people living with HIV in Tanzania: results of a pilot individually randomized group treatment trial.

Dow Dorothy E DE Mmbaga Blandina T BT Gallis John A JA Turner Elizabeth L EL Gandhi Monica M Cunningham Coleen K CK O'Donnell Karen E KE

BMC public health 20200904 1

<h4>Background</h4>Increasing numbers of young people living with HIV (YPLWH) have unaddressed mental health challenges. Such challenges are associated with poor antiretroviral therapy (ART) adherence and high mortality. Few evidence-based mental health interventions exist to improve HIV outcomes among YPLWH.<h4>Methods</h4>This pilot group treatment trial individually randomized YPLWH from two clinical sites in Tanzania, evaluated acceptability, feasibility, and preliminary effectiveness of a m ...[more]

PMID: 32887558

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Project description:ObjectivesPilot feasibility randomised controlled trial (RCT) for the singing groups for people with aphasia (SPA) intervention to assess: (1) the acceptability and feasibility of participant recruitment, randomisation and allocation concealment; (2) retention rates; (3) variance of continuous outcome measures; (4) outcome measure completion and participant burden; (5) fidelity of intervention delivery; (6) SPA intervention costs; (7) acceptability and feasibility of trial and intervention to participants and others involved.DesignA two-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed methods process evaluation and economic evaluation.SettingThree community-based cohorts in the South-West of England.ParticipantsEligible participants with post-stroke aphasia were randomised 1:1 to SPA or control.InterventionThe manualised SPA intervention was delivered over 10 weekly singing group sessions, led by a music facilitator and assisted by an individual with post-stroke aphasia. The intervention was developed using the Information-Motivation-Behavioural skills model of behaviour change and targeted psychosocial outcomes. Control and intervention participants all received an aphasia information resource pack.Outcome measuresCollected at baseline, 3 and 6 months post-randomisation, candidate primary outcomes were measured (well-being, quality of life and social participation) as well as additional clinical outcomes. Feasibility, acceptability and process outcomes included recruitment and retention rates, and measurement burden; and trial experiences were explored in qualitative interviews.ResultsOf 87 individuals screened, 42 participants were recruited and 41 randomised (SPA=20, control=21); 36 participants (SPA=17, control=19) completed 3-month follow-up, 34 (SPA=18, control=16) completed 6-month follow-up. Recruitment and retention (83%) were acceptable for a definitive RCT, and participants did not find the study requirements burdensome. High fidelity of the intervention delivery was shown by high attendance rates and facilitator adherence to the manual, and participants found SPA acceptable. Sample size estimates for a definitive RCT and primary/secondary outcomes were identified.ConclusionsThe SPA pilot RCT fulfilled its objectives, and demonstrated that a definitive RCT of the intervention would be both feasible and acceptable.Trial registration numberNCT03076736.

Project description:BackgroundYouth homelessness is a substantial issue, and many youths experiencing homelessness have mental health issues as both a cause and consequence of homelessness. These youths face many barriers to receiving traditional mental health services, and as a result, only a few youths experiencing homelessness receive any form of mental health care.ObjectiveThis project aimed to develop and determine the feasibility and acceptability of engaging young adults (ie, individuals aged 18-24 years) experiencing homelessness in a remotely delivered mental health intervention. This intervention provided brief emotional support and coping skills, drawing from cognitive behavioral principles as an introduction into psychosocial support. The intervention was piloted in a homeless shelter network.MethodsA total of 35 young adults experiencing homelessness participated in a single-arm feasibility pilot trial. Participants received a mobile phone, a service and data plan, and 1 month of support from a coach consisting of up to 3 brief phone sessions, text messaging, and mobile mental health apps. We evaluated feasibility by looking at completion of sessions as well as the overall program and acceptability with satisfaction ratings. We also collected clinical symptoms at baseline and the end of the 1-month support period. We used validity items to identify participants who might be responding inappropriately and thus only report satisfaction ratings and clinical outcomes from valid responses.ResultsMost participants (20/35, 57%) completed all 3 of their phone sessions, with an average of 2.09 sessions (SD 1.22) completed by each participant. Participants sent an average of 15.06 text messages (SD 12.62) and received an average of 19.34 messages (SD 12.70). We found higher rates of satisfaction among the participants with valid responses, with 100% (23/23) of such participants indicating that they would recommend participation to someone else and 52% (12/23) reporting that they were very or extremely satisfied with their participation. We found very little change from pre- to posttreatment on measures of depression (d=0.27), post-traumatic stress disorder (d=0.17), and emotion regulation (d=0.10).ConclusionsThis study demonstrated that it was feasible to engage homeless young adults in mental health services in this technology-based intervention with high rates of satisfaction. We did not find changes in clinical outcomes; however, we had a small sample size and a brief intervention. Technology might be an important avenue to reach young adults experiencing homelessness, but additional work could explore proper interventions to deliver with such a platform.Trial registrationClinicalTrials.gov NCT03620682; https://clinicaltrials.gov/ct2/show/NCT03620682.

Project description:BackgroundLongitudinal studies examining the life trajectories of young people after they have exited homelessness have identified concerns with persistent social and economic exclusion, struggles to shake off identities of homelessness, and housing instability. This pilot study sought to explore the feasibility of improving socioeconomic inclusion outcomes by bolstering identity capital (sense of purpose and control, self-efficacy and self-esteem) among young people who had experienced homelessness.MethodsNineteen individuals (aged 18-26) who had transitioned out of homelessness within the past three years participated in a six-week, six-session program focused on building identity capital. The study employed a mixed method prospective cohort hybrid design with an intervention group (Group One) and a delayed intervention comparison group (Group Two). Participants were interviewed every three months until nine months post-intervention.ResultsNone of the youth who began the intervention dropped out of the program, with the exception of one participant who moved across the country and was unable to continue. Immediately after participating in the intervention, Group One had statistically significant improvements (p < .05) and large to very large effect sizes in self-esteem (d = 1.16) and physical community integration (d = 1.79) compared to changes in Group Two over the same period, which had not yet begun the intervention. In the pooled analysis, small to moderate effect sizes in hopelessness, physical community integration, and self-esteem were observed at all post-intervention time points. Notably, at six- and nine-months post-intervention, statistically significant improvements (p < .05) and moderate effect sizes in hopelessness (d = -0.73 and d = -0.60 respectively) and self-esteem (d = 0.71 and d = 0.53 respectively) were observed. Youth shared they appreciated the normalizing (vs. pathologizing) of strategies they needed to learn and spoke of the importance of framing new skills as something one needs "to have a better life" vs. "to get better."ConclusionsThese early findings signal that targeting identity capital is feasible and may be a promising approach to incorporate into a more complex intervention that includes housing, education, and employment supports to help youth transition out of homelessness. Future research could build on these findings through a sufficiently powered randomized controlled trial.

Project description:BackgroundOver the last decade, researchers have sought for alternative interventions that have better treatment effects than Cognitive Behavioral Therapy (CBT) when treating psychotic symptoms. Mindfulness-based interventions have been a proposed alternative to CBT, yet research regarding its feasibility, acceptance and effectiveness is lacking when treating individuals with early psychosis in inpatient settings.ObjectiveBefore conducting a large-scale randomized-controlled trial (RCT), this pilot study evaluated the feasibility and the potential efficacy of a mindfulness-based inpatient group intervention that targets emotion regulation in patients with early psychosis, and thus indirectly improving psychotic symptoms.MethodsA pre-post study was performed. Thirty-six patients with early psychosis treated at the specialized inpatient treatment "Frühinterventions- und Therapiezentrum; FRITZ" (early intervention and therapy center) received eight group therapy sessions. Assessments were performed at baseline, after 8 weeks post treatment and at follow-up after 16 weeks.ResultsRates of patients who participated in the study suggests that a mindfulness-based group therapy is highly accepted and feasible for patients with early psychosis being treated in an inpatient ward. Friedman analyses revealed significant changes in the primary outcomes of emotional goal attainment (Goal 1: W = 0.79; Goal 2: W = 0.71) and psychotic symptoms (PANSS-T: W = 0.74). Significant, albeit small, effect sizes were found in patients' self-perception of emotion regulation skills (ERSQ: W = 0.23).DiscussionWe found favorable findings regarding the feasibility and acceptance of the Feel-Good mindfulness-based intervention. Results of the study provide a basis for an estimation of an adequate sample size for a fully powered RCT that needs to be conducted to test whether Feel-Good is effective in the inpatient treatment of psychotic symptoms for individuals with early psychosis.Clinical trial registration[https://clinicaltrials.gov/ct2/show/NCT04592042], identifier [NCT04592042].

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A group-based mental health intervention for young people living with HIV in Tanzania: results of a pilot individually randomized group treatment trial.

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A group-based mental health intervention for young people living with HIV in Tanzania: results of a pilot individually randomized group treatment trial.

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