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Dataset of cognitive behavioral intervention for persons living with HIV in China: A randomized pilot trial.

ABSTRACT: Globally, persons living with HIV (PLWH) are vulnerable to depressive and anxious symptoms [1]. Cognitive behavioural therapy (CBT) is one of the first-line mental health treatment strategies for PLWH [2-3]. However, structured and systematic cognitive behavioural intervention (CBI) is rare for PLWH in China. This data article presents the raw data of a parallel two-arm randomized controlled trial investigating the preliminary effects of CBI on depression, anxiety, medication adherence, quality of life, and CD4 lymphocyte counts for PLWH in China. Twenty PLWH who aged ?18, were undergoing antiretroviral therapy (ART), and scored the Patient Health Questionnaire-4 (PHQ-4) ?2 were recruited face-to-face and randomly assigned to groups based on computerized random number generation. Intervention participants received a tailored group-based 10-week-long CBI. Control participants only took laboratory tests and received free ART medication. The data includes demographic variables, exposure variables and outcomes. The outcomes were repeated-measured at baseline (T0), after the intervention (T1), and after 6 months of follow-up (T2). We assessed depression and anxiety via the Hospital Anxiety and Depression Scale (HADS), quality of life via the WHOQOL-HIV BREF, medication adherence via self-report adherence, the visual analog scale (VAS) and the medication possession ratio (MPR). CD4 lymphocyte counts were available on participants' medical records. The main manuscript of this dataset is "cognitive behavioral intervention for persons living with HIV in China: a randomized pilot trial" (Han et al., submitted for publication) [4].

SUBMITTER: Han S

PROVIDER: S-EPMC7153287 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Dataset of cognitive behavioral intervention for persons living with HIV in China: A randomized pilot trial.

Han Shuyu S Hu Yan Y Zhu Zheng Z Wu Bei B

Data in brief 20200331

Globally, persons living with HIV (PLWH) are vulnerable to depressive and anxious symptoms [1]. Cognitive behavioural therapy (CBT) is one of the first-line mental health treatment strategies for PLWH [2-3]. However, structured and systematic cognitive behavioural intervention (CBI) is rare for PLWH in China. This data article presents the raw data of a parallel two-arm randomized controlled trial investigating the preliminary effects of CBI on depression, anxiety, medication adherence, quality ...[more]

PMID: 32300622

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Project description:IntroductionSustained HIV viral suppression is the ultimate goal of HIV treatment. African American/Black and Latino persons with HIV (PWH) in the United States are less likely than their White peers to achieve and sustain viral suppression. To address these disparities, we developed a "low-touch" behavioral intervention drawing on motivational interviewing and behavioral economics. The intervention had three main components: (1) a motivational interviewing counseling session, (2) 16 weeks of automated text messages and quiz questions about HIV management, where participants earned points by answering quiz questions, and 3) a lottery prize, based on viral suppression status, number of points earned, and chance (max. $275).Materials and methodsThe intervention was tested in a pre-test/post-test design. The present pilot study used mixed methods to explore the intervention's feasibility, acceptability, impact, and ways it could be improved. Participants engaged in a baseline assessment, qualitative interview, and two structured follow-up assessments over an 8-month period, and provided laboratory reports to document HIV viral load. We carried out descriptive quantitative analyses. Qualitative data were analyzed using a directed content analysis approach. Data integration was carried out using the joint display method.FindingsParticipants (N = 40) were 50 years old, on average (SD = 11), and approximately half (58%) were male. Close to two-thirds (68%) were African American/Black and 32% were Latino. Participants were diagnosed with HIV 22 years ago on average (SD = 8). The intervention was feasible (e.g., mean number of quiz questions answered = 13/16) and highly acceptable. While not powered to assess efficacy, the proportion with suppressed HIV viral load increased from baseline to follow-up (46% participants at the first, 52% participants at the second follow-up evidenced HIV viral suppression). In qualitative analyses, perspectives included that overall, the intervention was acceptable and useful, it was distinct from other programs, lottery prizes were interesting and appreciated but not sufficient to motivate behavior change, and the structure of lottery prizes was not sufficiently clear. Regarding data integration, qualitative data shed light on and extended quantitative results, and added richness and context.ConclusionThis low-touch intervention approach is sufficiently promising to warrant refinement and study in future research.

Project description:ObjectiveThe United States is amidst an opioid epidemic, including synthetic opioids that may result in rapid death, leaving minimal opportunity for bystander rescue. We pilot tested a behavioral intervention to reduce the occurrence of opioid overdose among opioid dependent persons at high-risk for subsequent overdose.Materials and methodsWe conducted a single-blinded randomized-controlled trial of a repeated dose motivational interviewing intervention (REBOOT) to reduce overdose versus treatment as usual, defined as information and referrals, over 16 months at the San Francisco Department of Public Health from 2014-2016. Participants were 18-65 years of age, had opioid use disorder by Structured Clinical Interview, active opioid use, opioid overdose within 5 years, and prior receipt of naloxone kits. The intervention was administered at months 0, 4, 8, and 12, preceded by the assessment which was also administered at month 16. Dual primary outcomes were any overdose event and number of events, collected by computer-assisted personal interview, as well as any fatal overdose events per vital records.ResultsA total of 78 persons were screened and 63 enrolled. Mean age was 43 years, 67% were born male, 65% White, 17% African-American, and 14% Latino. Ninety-two percent of visits and 93% of counseling sessions were completed. At baseline, 33.3% of participants had experienced an overdose in the past four months, with a similar mean number of overdoses in both arms (p = 0.95); 29% overdosed during follow-up. By intention-to-treat, participants assigned to REBOOT were less likely to experience any overdose (incidence rate ratio [IRR] 0.62 [95%CI 0.41-0.92, p = 0.019) and experienced fewer overdose events (IRR 0.46, 95%CI 0.24-0.90, p = 0.023), findings that were robust to sensitivity analyses. There were no differences between arms in days of opioid use, substance use treatment, or naloxone carriage.ConclusionsREBOOT reduced the occurrence of any opioid overdose and the number of overdoses.Trial registrationclinicaltrials.gov NCT02093559.

Project description:ImportanceDigital cognitive behavioral therapy for insomnia (DCBT-I) requires adaptation to different sociocultural contexts. Moreover, studies comparing DCBT-I and sleep education in the same operating interface are lacking.ObjectiveTo investigate the efficacy of a smartphone-based Chinese culture-adapted DCBT-I application (app) for insomnia compared with sleep education using the same app.Design, setting, and participantsThis was a single-blinded, randomized clinical trial conducted from March 2021 to January 2022. Screening and randomization were conducted at Peking University First Hospital. Follow-up visits were performed online or in the same hospital. After assessing for eligibility, eligible participants were enrolled and allocated (1:1) to DCBT-I or sleep education groups. Data were analyzed from January to February 2022.InterventionsA Chinese smartphone-based app with the same interface was used in both DCBT-I and sleep education groups over 6 weeks, with 1-, 3-, and 6-month follow-ups.Main outcomes and measuresThe primary outcome was Insomnia Severity Index (ISI) scores with the intention-to-treat principle. Secondary and exploratory outcomes included sleep diary measures; self-reported scales assessing dysfunctional beliefs about sleep, mental health, and quality of life; and smart bracelet measures.ResultsOf 82 participants (mean [SD] age, 49.67 [14.49] years; 61 [74.4%] females), with 41 randomized to sleep education and 41 randomized to DCBT-I; 77 participants completed the 6-week intervention (39 participants in the sleep education group and 38 participants in the DCBT-I group; full analysis data set) and 73 completed the 6-month follow-up (per protocol data set). Mean (SD) ISI scores in the DCBT-I group were significantly lower than those in the sleep education group after the 6-week intervention (12.7 [4.8] points vs 14.9 [5.0] points; Cohen d = 0.458; P = .048) and at the 3-month follow-up (12.1 [5.4] points vs 14.8 [5.5] points; Cohen d = 0.489; P = .04). There were significant improvements from before to after the intervention for both the sleep education and DCBT-I groups, with large effect sizes(sleep education: d = 1.13; DCBT-I: d = 1.71). Some of the sleep diary measures and self-reported scales showed more improvements in the DCBT-I group than sleep education group, such as total sleep time (mean [SD]: 3 months, 403.9 [57.6] minutes vs 363.2 [72.3] minutes; 6 months, 420.3 [58.0] minutes vs 389.7 [59.4] minutes) and sleep efficiency (mean [SD]: 3 months, 87.4% [8.3%] vs 76.7% [12.1%]; 6 months, 87.5% [8.2%] vs 78.1% [10.9%]).Conclusions and relevanceIn this randomized clinical trial, the smartphone-based Chinese culture-adapted DCBT-I improved insomnia severity compared with sleep education. Future multicenter clinical trials with large sample sizes are needed to validate its effectiveness in the Chinese population.Trial registrationClinicalTrials.gov Identifier: NCT04779372.

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Dataset of cognitive behavioral intervention for persons living with HIV in China: A randomized pilot trial.

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Dataset of cognitive behavioral intervention for persons living with HIV in China: A randomized pilot trial.

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