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Nurse-Delivered Cognitive Behavioral Therapy for Adherence and Depression Among People Living With HIV (the Ziphamandla Study): Protocol for a Randomized Controlled Trial.

ABSTRACT: BACKGROUND:There is an unmet need to develop effective, feasible, and scalable interventions for poor adherence and depression in persons living with HIV in low- and middle-income countries (LMIC). OBJECTIVE:This study aims to investigate the effectiveness of a nurse-delivered cognitive behavioral therapy (CBT) intervention for adherence and depression (CBT-AD) among persons living with HIV who are failing first-line antiretroviral therapy (ART) in Cape Town, South Africa. METHODS:This study is a 2-arm randomized controlled trial of CBT-AD integrated into the HIV primary care setting in South Africa. A total of 160 participants who did not achieve viral suppression from their first-line ART and have a unipolar depressive mood disorder will be randomized to receive either 8 sessions of CBT-AD or enhanced treatment as usual. Participants will be assessed for major depressive disorder using the Mini International Neuropsychiatric Interview at baseline and 4, 8, and 12 months. The primary outcomes are depression on the Hamilton Depression Scale (HAM-D; as assessed by a blinded assessor) at the 4-month assessment and changes in ART adherence (assessed via real-time, electronic monitoring with Wisepill) between baseline and the 4-month assessment. Secondary outcomes are HIV viral load and CD4 cell count at the 12-month assessment as well as ART adherence (Wisepill) and depression (HAM-D) over follow-up (4-, 8-, and 12-month assessments). RESULTS:The trial commenced in August 2015 and recruitment began in July 2016. Enrollment was completed in June 2019. CONCLUSIONS:Results of this study will inform whether an existing intervention (CBT-AD) can be effectively administered in LMIC by nurses with training and ongoing supervision. This will present unique opportunities to further explore the scale-up of a behavioral intervention to enhance ART adherence among persons living with HIV with major depression in a high-prevalence setting, to move toward achieving The Joint United Nations Programme on HIV/AIDS 90-90-90 goals. TRIAL REGISTRATION:ClincialTrials.gov NCT02696824; https://clinicaltrials.gov/ct2/show/NCT02696824. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/14200.

SUBMITTER: Joska JA

PROVIDER: S-EPMC7055790 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

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Nurse-Delivered Cognitive Behavioral Therapy for Adherence and Depression Among People Living With HIV (the Ziphamandla Study): Protocol for a Randomized Controlled Trial.

Joska John A JA Andersen Lena S LS Smith-Alvarez Rosana R Magidson Jessica J Lee Jasper S JS O'Cleirigh Conall C Safren Steven A SA

JMIR research protocols 20200203 2

<h4>Background</h4>There is an unmet need to develop effective, feasible, and scalable interventions for poor adherence and depression in persons living with HIV in low- and middle-income countries (LMIC).<h4>Objective</h4>This study aims to investigate the effectiveness of a nurse-delivered cognitive behavioral therapy (CBT) intervention for adherence and depression (CBT-AD) among persons living with HIV who are failing first-line antiretroviral therapy (ART) in Cape Town, South Africa.<h4>Meth ...[more]

PMID: 32012114

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Project description:BackgroundCognitive behavioral therapy for adherence and depression (CBT-AD) performed by clinical psychologists is an effective treatment for improving the depression in people living with HIV (PLWH). However, because access to clinical psychologists is limited in most clinics, CBT-AD is rarely performed for PLWH in Korea. This pilot study evaluates whether CBT-AD can be effectively performed by a nurse trained and supervised by a clinical psychologist, with a view to the wider provision of CBT-AD.Materials and methodsOne clinical psychologist developed manuals, educated and supervised one nurse. PLWH with depression or adherence to self-reported antiretroviral therapy <90% were enrolled, and CBT-AD was conducted once weekly for 12 sessions. PLWH were assessed for adherence by visual analog scale, Beck depression inventory (BDI) for depression, PozQoL for quality of life, and Berger's 40-item stigma scale for stigma at baseline, after the 6th, 12th session, at 4-, and 8-months after CBT-AD. Acceptability for PLWH and feasibility for providers were evaluated through surveys.ResultsFive male PLWH have completed the study protocols (mean age 29.2 years). All study participants showed improving depression (mean BDI at baseline 33.0 ± 7.0, and after the 12th session 13.4 ± 3.5), and the effect was maintained at the 8-month follow-up (BDI 15.4 ± 6.4). Quality of life showed a tendency to improve (mean PozQoL at baseline 28.0 ± 7.7, after 12th session 36.8 ± 4.4, and at the 8-month follow-up 38.2 ± 7.9), but stigma did not show clear improvement (Berger's 40-item stigma scale at baseline 121.0 ± 3.9, after 12th session 107.6 ± 8.8. and at the 8-month follow-up 107.6 ± 5.0). All study participants received great help from CBT-AD and expressed their desire to continue. All providers agreed that nurse-delivered CBT-AD could be implemented in routine clinical practice.ConclusionOur findings suggest that a nurse-delivered CBT-AD could be feasible and acceptable for PLWH through structured interventions. It has been shown to have the potential to help PLWH, especially for their depression and quality of life.Trial registrationClinicalTrials.gov Identifier: NCT03823261.

Project description:ObjectivesWe investigated whether differences in cognitive performance between people living with HIV (PLWH) and comparable HIV-negative people were mediated or moderated by depressive symptoms and lifestyle factors.MethodsA cross-sectional study of 637 'older' PLWH aged ≥ 50 years, 340 'younger' PLWH aged < 50 years and 276 demographically matched HIV-negative controls aged ≥ 50 years enrolled in the Pharmacokinetic and Clinical Observations in People over Fifty (POPPY) study was performed. Cognitive function was assessed using a computerized battery (CogState). Scores were standardized into Z-scores [mean = 0; standard deviation (SD) = 1] and averaged to obtain a global Z-score. Depressive symptoms were evaluated via the Patient Health Questionnaire (PHQ-9). Differences between the three groups and the effects of depression, sociodemographic factors and lifestyle factors on cognitive performance were evaluated using median regression. All analyses accounted for age, gender, ethnicity and level of education.ResultsAfter adjustment for sociodemographic factors, older and younger PLWH had poorer overall cognitive scores than older HIV-negative controls (P < 0.001 and P = 0.006, respectively). Moderate or severe depressive symptoms were more prevalent in both older (27%; P < 0.001) and younger (21%; P < 0.001) PLWH compared with controls (8%). Depressive symptoms (P < 0.001) and use of hashish (P = 0.01) were associated with lower cognitive function; alcohol consumption (P = 0.02) was associated with better cognitive scores. After further adjustment for these factors, the difference between older PLWH and HIV-negative controls was no longer significant (P = 0.08), while that between younger PLWH and older HIV-negative controls remained significant (P = 0.01).ConclusionsPoorer cognitive performances in PLWH compared with HIV-negative individuals were, in part, mediated by the greater prevalence of depressive symptoms and recreational drug use reported by PLWH.

Project description:ObjectivesTo examine the effectiveness of group cognitive behavioural therapy (CBT) for postpartum depression (PPD) delivered by public health nurses with little to no previous psychiatric training at improving depression, worry, social support and the mother-infant relationship.MethodsMothers (n = 141) living in Ontario, Canada with Edinburgh Postnatal Depression Scale Scores ≥10 and an infant <12 months of age were randomized to receive nine weekly 2-h sessions of in-person group CBT for PPD delivered by two public health nurses plus treatment as usual (TAU; experimental group) or TAU alone (control group). Primary outcomes were change in EPDS score and current major depressive disorder (Mini International Neuropsychiatric Interview) assessed immediately post-treatment (T2). Secondary outcomes included maternal worry, social support, and quality of the mother-infant relationship. All outcomes were assessed again six months post-treatment (T3).ResultsParticipants in the experimental group had statistically significantly greater reductions in PPD symptoms immediately post-treatment (T2) (B = -5.35, p < 0.01), were more likely to manifest a clinically significant improvement in EPDS scores (≥4 points; OR = 3.44, 95%CI: 1.49-7.94), and no longer have symptoms consistent with current MDD (OR = 5.31, 95% CI: 1.78-15.83). Six months post-treatment (T3), experimental group participants had higher odds of clinically significant PPD improvement (OR = 5.10, 95%CI: 1.89-13.78), while 25% of the experimental group and 70% of remaining control group participants reported current MDD (p < 0.01). Statistically significant improvements in worry and the mother-infant relationship were also observed, decreases maintained at six months post-treatment.ConclusionsPublic health nurses with little to no previous psychiatric training can be trained to deliver effective group CBT for PPD to improve depression, worry, and the mother-infant relationship. Task shifting PPD treatment with group CBT to public health nurses could improve treatment uptake and lead to better outcomes for mothers, families, and the healthcare system.(Trial Registration NCT03039530).

Project description:BackgroundDepression in older adults has serious biological, psychological, and social consequences. Homebound older adults experience a high burden of depression and significant barriers to accessing mental health treatments. Few interventions to address their specific needs have been developed. Existing treatment modalities can be challenging to scale up, are not tailored to unique population concerns, and require significant staffing support. Technology-assisted, layperson-facilitated psychotherapy has the potential to overcome these challenges.ObjectiveThe aim of this study is to assess the efficacy of a layperson-facilitated internet-delivered cognitive behavioral therapy program tailored for homebound older adults. The novel intervention, Empower@Home, was developed based on user-centered design principles and partnerships between researchers, social service agencies, care recipients, and other stakeholders serving low-income homebound older adults.MethodsThis 2-arm, 20-week pilot randomized controlled trial (RCT) with a waitlist control crossover design aims to enroll 70 community-dwelling older adults with elevated depressive symptoms. The treatment group will receive the 10-week intervention immediately, whereas the waitlist control group will cross over and receive the intervention after 10 weeks. This pilot is part of a multiphase project involving a single-group feasibility study (completed in December 2022). This project consists of a pilot RCT (described in this protocol) and an implementation feasibility study running in parallel with the pilot RCT. The primary clinical outcome of the pilot is the change in depressive symptoms after the intervention and at the 20-week postrandomization follow-up. Additional outcomes include acceptability, adherence, and changes in anxiety, social isolation, and quality of life.ResultsInstitutional review board approval was obtained for the proposed trial in April 2022. Recruitment for the pilot RCT began in January 2023 and is anticipated to end in September 2023. On completion of the pilot trial, we will examine the preliminary efficacy of the intervention on depression symptoms and other secondary clinical outcomes in an intention-to-treat analysis.ConclusionsAlthough web-based cognitive behavioral therapy programs are available, most programs have low adherence and very few are tailored for older adults. Our intervention addresses this gap. Older adults, particularly those with mobility difficulties and multiple chronic health conditions, could benefit from internet-based psychotherapy. This approach can serve a pressing need in society while being cost-effective, scalable, and convenient. This pilot RCT builds on a completed single-group feasibility study by determining the preliminary effects of the intervention compared with a control condition. The findings will provide a foundation for a future fully-powered randomized controlled efficacy trial. If our intervention is found to be effective, implications extend to other digital mental health interventions and populations with physical disabilities and access restrictions who face persistent disparities in mental health.Trial registrationClinicalTrials.gov NCT05593276; https://clinicaltrials.gov/ct2/show/NCT05593276.International registered report identifier (irrid)PRR1-10.2196/44210.

Project description:The incidence of depression is higher in PLWH (people living with HIV) than in the general population. It is of clinical significance to explore effective measures to improve depression in patients. But the available evidence is still quite limited. CBT (cognitive behavioral therapy) is considered to be one of the effective methods to improve depression, medication adherence and quality of life in PLWH. Therefore, this study aimed to systematically evaluate the effect of cognitive behavioral therapy on improving depressive symptoms and increasing adherence to antiretroviral therapy (ART) in people living with HIV (Human Immunodeficiency Virus). The Cochrane Library, Embase, PubMed, and Web of Science databases were searched by computer to collect randomized controlled trials on the effects of cognitive behavioral therapy on improving depression and increasing ART medication adherence in PLWH, and the retrieval time was from the inception of each database to January 10, 2022. Meta-analysis was performed by two researchers using Stata 15.0 software after screening the literature, extracting data and evaluating quality according to inclusion and exclusion criteria. A total of 16 studies with 1,998 patients were included. Meta-analysis results showed that CBT improved depressive symptoms in PLWH (SMD = −0.09, 95% CI [−0.13 to −0.04], P < 0.001) with better long-term (<6 months) depression improvement (SMD = −0.09, 95% CI [−0.15 to −0.02], P = 0.006) than short-term (0–6 months); the difference in improved ART medication adherence in the CBT group compared to the control group was not statistically significant (SMD = 0.04, 95% CI [−0.06 to 0.13], P = 0.490). There may be publication bias due to incomplete inclusion of literature as only published literature was searched. Cognitive behavioral therapy is effective in improving depressive symptoms in people living with HIV, with better long-term (>6 months) results than short-term (0–6 months).

Dataset Information

Nurse-Delivered Cognitive Behavioral Therapy for Adherence and Depression Among People Living With HIV (the Ziphamandla Study): Protocol for a Randomized Controlled Trial.

Publications

Nurse-Delivered Cognitive Behavioral Therapy for Adherence and Depression Among People Living With HIV (the Ziphamandla Study): Protocol for a Randomized Controlled Trial.

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