Dataset Information

A booklet self-help intervention to reduce depressive symptoms among people living with HIV in Botswana: study protocol for a randomized controlled trial.

ABSTRACT:

Background

The treatment of mental health issues among people living with HIV (PLH) in Botswana is yet to be addressed. A recent study revealed that depressive symptoms are highly prevalent in a sample of PLH in Botswana. Based on empirical findings of a study that investigated intervention targets for PLH in Botswana, a self-help program with coaching in booklet format in the Setswana and English languages was developed, composed of cognitive behavioral techniques, coping skills interventions, and goal adjustment training. We will investigate the program for effectiveness in the treatment of depressive symptoms among PLH. Additionally, we will investigate treatment moderators and mediators. This paper describes the study protocol.

Methods/design

A randomized controlled trial will be conducted to compare the booklet self-help program with coaching with an attention-only control condition, by including pre-test, post-test, and follow-up assessments. We aim to enroll 200 participants with mild to moderate depressive symptoms into the study. The self-help program contains the following main components: activation, relaxation, changing maladaptive cognitions, and the attainment of new personal goals. This content is covered over six lessons to be completed in a maximum of 8 weeks. It uses a combination of psycho-education, assignments, and exercises. The participants will work on the program 1-2?h every week for 6 weeks (maximum 8 weeks). Coaches will offer support and motivate the participants. For both groups, depressive symptoms and possible mediators will be measured three times during the intervention, and at pre-test, post-test, and follow-up.

Discussion

If the intervention is found to effectively treat depressive symptoms, it will be implemented and thus help improve the psychological health of PLH in Botswana.

Trial registration

Netherlands Trial Register, NTR7428 . Registered on 23 August 2018.

SUBMITTER: Vavani B

PROVIDER: S-EPMC6688259 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Publications

A booklet self-help intervention to reduce depressive symptoms among people living with HIV in Botswana: study protocol for a randomized controlled trial.

Vavani Boitumelo B Kraaij Vivian V Spinhoven Phillip P Garnefski Nadia N

Trials 20190809 1

<h4>Background</h4>The treatment of mental health issues among people living with HIV (PLH) in Botswana is yet to be addressed. A recent study revealed that depressive symptoms are highly prevalent in a sample of PLH in Botswana. Based on empirical findings of a study that investigated intervention targets for PLH in Botswana, a self-help program with coaching in booklet format in the Setswana and English languages was developed, composed of cognitive behavioral techniques, coping skills interve ...[more]

PMID: 31399138

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Project description:BACKGROUND:Cognitive behavioral therapy (CBT) is frequently used to treat depressive symptoms in people living with HIV. We developed an internet-based cognitive behavioral intervention for people with HIV and depressive symptoms, which was based on an effective self-help booklet. The Web-based intervention was previously found to be effective. OBJECTIVE:The objective of this study was to investigate potential mediators of the Web-based intervention. METHODS:This study was part of a randomized controlled trial, in which the intervention was compared with an attention-only waiting list control condition. Participants were 188 (97 in intervention group and 91 in control group) people with HIV and mild to moderate depressive symptoms recruited in HIV treatment centers in the Netherlands. A total of 22 participants (22/188, 11.7%) in the study were female and 166 (166/188, 88.3%) were male. The average age of the participants was 46.30 years (SD 10.63). The intervention comprised Web-based self-help CBT for 8 weeks, 1 to 2 hours a week, including minimal telephone support from a coach. The participants received Web-based questionnaires at pretest, 3 times during the intervention/or waiting period, and post intervention. The outcome was depressive symptoms. Factors tested as potential mediators were changes in behavioral activation, relaxation, the cognitive coping strategies catastrophizing and positive refocusing, goal re-engagement, and coping self-efficacy. RESULTS:Using multilevel structural equation modeling, changes in behavioral activation (P=.006) and goal re-engagement (P=.009) were found to be significant mediators of the intervention effect. The mediation effect seemed to occur between weeks 3 and 5 for behavioral activation and weeks 1 and 3 for goal re-engagement. Using (bivariate) autoregressive latent trajectory analysis, we found a return effect (from the dependent variable to the mediator) for goal re-engagement but not for behavioral activation, which suggested that the mediation effect of changes in behavioral activation was stronger than that in goal re-engagement. CONCLUSIONS:The results suggest that changes in behavioral activation and goal re-engagement may mediate the effect of the Web-based intervention for people with HIV and depressive symptoms. The results may lead to possible mechanisms of change of the intervention and improvement of therapy outcomes. TRIAL REGISTRATION:Netherlands Trial Register NTR5407; https://www.trialregister.nl/trial/5298.

Project description:BACKGROUND:Research suggests that depressive disorders exist on a continuum, with subthreshold symptoms causing considerable population burden and increasing individual risk of developing major depressive disorder. An alternative strategy to professional treatment of subthreshold depression is population promotion of effective self-help interventions that can be easily applied by an individual without professional guidance. The evidence for self-help interventions for depressive symptoms is reviewed in the present work, with the aim of identifying promising interventions that could inform future health promotion campaigns or stimulate further research. METHODS:A literature search for randomised controlled trials investigating self-help interventions for depressive disorders or depressive symptoms was performed using PubMed, PsycINFO and the Cochrane Database of Systematic Reviews. Reference lists and citations of included studies were also checked. Studies were grouped into those involving participants with depressive disorders or a high level of depressive symptoms, or non-clinically depressed participants not selected for depression. A number of exclusion criteria were applied, including trials with small sample sizes and where the intervention was adjunctive to antidepressants or psychotherapy. RESULTS:The majority of interventions searched had no relevant evidence to review. Of the 38 interventions reviewed, the ones with the best evidence of efficacy in depressive disorders were S-adenosylmethionine, St John's wort, bibliotherapy, computerised interventions, distraction, relaxation training, exercise, pleasant activities, sleep deprivation, and light therapy. A number of other interventions showed promise but had received less research attention. Research in non-clinical samples indicated immediate beneficial effects on depressed mood for distraction, exercise, humour, music, negative air ionisation, and singing; while potential for helpful longer-term effects was found for autogenic training, light therapy, omega 3 fatty acids, pets, and prayer. Many of the trials were poor quality and may not generalize to self-help without professional guidance. CONCLUSION:A number of self-help interventions have promising evidence for reducing subthreshold depressive symptoms. Other forms of evidence such as expert consensus may be more appropriate for interventions that are not feasible to evaluate in randomised controlled trials. There needs to be evaluation of whether promotion to the public of effective self-help strategies for subthreshold depressive symptoms could delay or prevent onset of depressive illness, reduce functional impairment, and prevent progression to other undesirable outcomes such as harmful use of substances.

Project description:BACKGROUND:People living with HIV (PLWH) have high rates of depressive symptoms. However, only a few effective mental health interventions exist for this vulnerable population. OBJECTIVE:The aim of this study was to assess the efficacy of a WeChat-based intervention, Run4Love, with a randomized controlled trial among 300 people living with HIV and depression (PLWHD) in China. METHODS:We recruited PLWH from the HIV outpatient clinic in South China. Participants were screened based on the Center for Epidemiologic Studies-Depression (CES-D) scale. Those who scored 16 or higher were eligible to participate. A total of 300 eligible patients were enrolled. After obtaining informed consent from the participants, completion of a baseline survey, and collection of participants' hair samples for measuring cortisol, the participants were randomly assigned to an intervention or a control group in a 1:1 ratio. The intervention group received the Run4Love program, delivered via the popular social media app WeChat. Cognitive behavioral stress management courses and weekly reminders of exercise were delivered in a multimedia format. Participants' progress was monitored with timely and tailored feedback. The control group received usual care and a brochure on nutrition for PLWH. Data were collected at 3, 6, and 9 months. The primary outcome was depression, which was measured by a validated instrument. RESULTS:Participants in the intervention and control groups were comparable at baseline; about 91.3% (139/150), 88.3% (132/150), and 86.7% (130/150) participants completed the 3-, 6-, and 9-month follow-ups, respectively. At the 3-month follow-up, a significant reduction in CES-D score was observed in the intervention group (from 23.9 to 17.7 vs from 24.3 to 23.8; mean difference=-5.77, 95% CI -7.82 to -3.71; P<.001; standard effect size d=0.66). The mean changes in CES-D score from baseline to the 6- and 9-month follow-ups between the two groups remained statistically significant. No adverse events were reported. CONCLUSIONS:The WeChat-based mobile health (mHealth) intervention Run4Love significantly reduced depressive symptoms among PLWHD, and the effect was sustained. An app-based mHealth intervention could provide a feasible therapeutic option for many PLWHD in resource-limited settings. Further research is needed to assess generalizability and cost-effectiveness of this intervention. TRIAL REGISTRATION:Chinese Clinical Trial Registry ChiCTR-IPR-17012606; http://www.chictr.org.cn/showproj.aspx?proj=21019 (Archived by WebCite at https://www.webcitation.org/78Bw2vouF).

Project description:BackgroundDepression is the most prevalent mental health problem. The need for effective treatments for depression far outstrips the availability of trained mental health professionals. Smartphones and other widely available technologies are increasingly being leveraged to deliver treatments for depression. Whether there are patient characteristics that affect the potency of smartphone interventions for depression is not well understood.ObjectiveThis study aimed to evaluate whether patient characteristics including clinical diagnosis, depression severity, psychosis status, and current use of antidepressant medications impact the effects of an evidence-based smartphone intervention on depressive symptoms.MethodsData were collected as part of a 2-arm randomized controlled trial comparing a multimodal smartphone intervention called FOCUS with a clinic-based intervention. Here, we report on 82 participants assigned to 12 weeks of FOCUS treatment. We conducted assessments of depressive symptoms using the Beck Depression Inventory-second edition (BDI-II) at baseline, postintervention (3 months), and follow-up (6 months). We tested for differences in the amount of improvement in BDI-II scores from baseline to posttreatment and 6-month follow-up between each of the following patient subgroups using 2 (group) × 2 (time) mixed effects models: diagnosis (ie, schizophrenia spectrum disorder vs bipolar disorder vs major depressive disorder), depression severity (ie, minimal-mild vs moderate-severe depression), psychosis status (ie, presence vs absence of psychotic symptoms), and antidepressant use (ie, taking antidepressants vs not taking antidepressants).ResultsThe majority of participants were male (60%, 49/82), African American (65%, 53/82), and middle-aged (mean age 49 years), with a high school education or lower (62%, 51/82). There were no differences in patient demographics across the variables that were used to stratify the analyses. There was a significant group × time interaction for baseline depression severity (F1,76.8=5.26, P=.02 [posttreatment] and F1,77.4=6.56, P=.01 [6-month follow-up]). Participants with moderate or severe depression had significant improvements (t42=3.20, P=.003 [posttreatment] and t42=4.20, P<.001 [6-month follow-up]), but participants with minimal or mild depression did not (t31=0.20, P=.84 [posttreatment] and t30=0.43, P=.67 [6-month follow-up]). There were no significant group × time interactions for diagnosis, psychosis status, or antidepressant medication use. Participants with minimal or mild depression had negligible nonsignificant improvements (<1 point on the BDI-II). Reduction in depression in all other groups was larger (range 1.7-6.5 points on the BDI-II).ConclusionsOur results suggest that FOCUS can be deployed to treat moderate to severe depressive symptoms among people with schizophrenia spectrum disorders, bipolar disorder, and major depressive disorder, in concert with antidepressant medications or without them, in both people with and without active psychotic symptoms. The study results are consistent with research on transdiagnostic models in psychotherapy and extend our knowledge about the potential of transdiagnostic mobile health.Trial registrationClinicalTrials.gov NCT02421965; http://clinicaltrials.gov/ct2/show/NCT02421965 (Archived by WebCite at http://www.webcitation.org/76pyDlvAS).

Dataset Information

A booklet self-help intervention to reduce depressive symptoms among people living with HIV in Botswana: study protocol for a randomized controlled trial.

Background

Methods/design

Discussion

Trial registration

Publications

A booklet self-help intervention to reduce depressive symptoms among people living with HIV in Botswana: study protocol for a randomized controlled trial.

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