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Effectiveness of psychological treatments for depression and alcohol use disorder delivered by community-based counsellors: two pragmatic randomised controlled trials within primary healthcare in Nepal.

ABSTRACT: BACKGROUND:Evidence shows benefits of psychological treatments in low-resource countries, yet few government health systems include psychological services.AimEvaluating the clinical value of adding psychological treatments, delivered by community-based counsellors, to primary care-based mental health services for depression and alcohol use disorder (AUD), as recommended by the Mental Health Gap Action Programme (mhGAP). METHOD:Two randomised controlled trials, separately for depression and AUD, were carried out. Participants were randomly allocated (1:1) to mental healthcare delivered by mhGAP-trained primary care workers (psychoeducation and psychotropic medicines when indicated), or the same services plus individual psychological treatments (Healthy Activity Program for depression and Counselling for Alcohol Problems). Primary outcomes were symptom severity, measured using the Patient Health Questionnaire - 9 item (PHQ-9) for depression and the Alcohol Use Disorder Identification Test for AUD, and functional impairment, measured using the World Health Organization Disability Assessment Schedule (WHODAS), at 12 months post-enrolment. RESULTS:Participants with depression in the intervention arm (n = 60) had greater reduction in PHQ-9 and WHODAS scores compared with participants in the control (n = 60) (PHQ-9: M = -5.90, 95% CI -7.55 to -4.25, ? = -3.68, 95% CI -5.68 to -1.67, P < 0.001, Cohen's d = 0.66; WHODAS: M = -12.21, 95% CI -19.58 to -4.84, ? = -10.74, 95% CI -19.96 to -1.53, P= 0.022, Cohen's d = 0.42). For the AUD trial, no significant effect was found when comparing control (n = 80) and intervention participants (n = 82). CONCLUSION:Adding a psychological treatment delivered by community-based counsellors increases treatment effects for depression compared with only mhGAP-based services by primary health workers 12 months post-treatment.Declaration of interestNone.

SUBMITTER: Jordans MJD

PROVIDER: S-EPMC6878117 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Effectiveness of psychological treatments for depression and alcohol use disorder delivered by community-based counsellors: two pragmatic randomised controlled trials within primary healthcare in Nepal.

Jordans Mark J D MJD Luitel Nagendra P NP Garman Emily E Kohrt Brandon A BA Rathod Sujit D SD Shrestha Pragya P Komproe Ivan H IH Lund Crick C Patel Vikram V

The British journal of psychiatry : the journal of mental science 20190125 2

<h4>Background</h4>Evidence shows benefits of psychological treatments in low-resource countries, yet few government health systems include psychological services.AimEvaluating the clinical value of adding psychological treatments, delivered by community-based counsellors, to primary care-based mental health services for depression and alcohol use disorder (AUD), as recommended by the Mental Health Gap Action Programme (mhGAP).<h4>Method</h4>Two randomised controlled trials, separately for depre ...[more]

PMID: 30678744

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Project description:BackgroundThe Healthy Activity Programme (HAP), a brief behavioural intervention delivered by lay counsellors, enhanced remission over 3 months among primary care attendees with depression in peri-urban and rural settings in India. We evaluated the sustainability of the effects after treatment termination, the cost-effectiveness of HAP over 12 months, and the effects of the hypothesized mediator of activation on clinical outcomes.Methods and findingsPrimary care attendees aged 18-65 years screened with moderately severe to severe depression on the Patient Health Questionnaire 9 (PHQ-9) were randomised to either HAP plus enhanced usual care (EUC) (n = 247) or EUC alone (n = 248), of whom 95% completed assessments at 3 months, and 91% at 12 months. Primary outcomes were severity on the Beck Depression Inventory-II (BDI-II) and remission on the PHQ-9. HAP participants maintained the gains they showed at the end of treatment through the 12-month follow-up (difference in mean BDI-II score between 3 and 12 months = -0.34; 95% CI -2.37, 1.69; p = 0.74), with lower symptom severity scores than participants who received EUC alone (adjusted mean difference in BDI-II score = -4.45; 95% CI -7.26, -1.63; p = 0.002) and higher rates of remission (adjusted prevalence ratio [aPR] = 1.36; 95% CI 1.15, 1.61; p < 0.009). They also fared better on most secondary outcomes, including recovery (aPR = 1.98; 95% CI 1.29, 3.03; p = 0.002), any response over time (aPR = 1.45; 95% CI 1.27, 1.66; p < 0.001), higher likelihood of reporting a minimal clinically important difference (aPR = 1.42; 95% CI 1.17, 1.71; p < 0.001), and lower likelihood of reporting suicidal behaviour (aPR = 0.71; 95% CI 0.51, 1.01; p = 0.06). HAP plus EUC also had a marginal effect on WHO Disability Assessment Schedule score at 12 months (aPR = -1.58; 95% CI -3.33, 0.17; p = 0.08); other outcomes (days unable to work, intimate partner violence toward females) did not statistically significantly differ between the two arms. Economic analyses indicated that HAP plus EUC was dominant over EUC alone, with lower costs and better outcomes; uncertainty analysis showed that from this health system perspective there was a 95% chance of HAP being cost-effective, given a willingness to pay threshold of Intl$16,060-equivalent to GDP per capita in Goa-per quality-adjusted life year gained. Patient-reported behavioural activation level at 3 months mediated the effect of the HAP intervention on the 12-month depression score (β = -2.62; 95% CI -3.28, -1.97; p < 0.001). Serious adverse events were infrequent, and prevalence was similar by arm. We were unable to assess possible episodes of remission and relapse that may have occurred between our outcome assessment time points of 3 and 12 months after randomisation. We did not account for or evaluate the effect of mediators other than behavioural activation.ConclusionsHAP's superiority over EUC at the end of treatment was largely stable over time and was mediated by patient activation. HAP provides better outcomes at lower costs from a perspective covering publicly funded healthcare services and productivity impacts on patients and their families.Trial registrationISRCTN registry ISRCTN95149997.

Project description:BackgroundCounselling for Alcohol Problems (CAP), a brief intervention delivered by lay counsellors, enhanced remission and abstinence over 3 months among male primary care attendees with harmful drinking in a setting in India. We evaluated the sustainability of the effects after treatment termination, the cost-effectiveness of CAP over 12 months, and the effects of the hypothesized mediator 'readiness to change' on clinical outcomes.Methods and findingsMale primary care attendees aged 18-65 years screening with harmful drinking on the Alcohol Use Disorders Identification Test (AUDIT) were randomised to either CAP plus enhanced usual care (EUC) (n = 188) or EUC alone (n = 189), of whom 89% completed assessments at 3 months, and 84% at 12 months. Primary outcomes were remission and mean standard ethanol consumed in the past 14 days, and the proposed mediating variable was readiness to change at 3 months. CAP participants maintained the gains they showed at the end of treatment through the 12-month follow-up, with the proportion with remission (AUDIT score < 8: 54.3% versus 31.9%; adjusted prevalence ratio [aPR] 1.71 [95% CI 1.32, 2.22]; p < 0.001) and abstinence in the past 14 days (45.1% versus 26.4%; adjusted odds ratio 1.92 [95% CI 1.19, 3.10]; p = 0.008) being significantly higher in the CAP plus EUC arm than in the EUC alone arm. CAP participants also fared better on secondary outcomes including recovery (AUDIT score < 8 at 3 and 12 months: 27.4% versus 15.1%; aPR 1.90 [95% CI 1.21, 3.00]; p = 0.006) and percent of days abstinent (mean percent [SD] 71.0% [38.2] versus 55.0% [39.8]; adjusted mean difference 16.1 [95% CI 7.1, 25.0]; p = 0.001). The intervention effect for remission was higher at 12 months than at 3 months (aPR 1.50 [95% CI 1.09, 2.07]). There was no evidence of an intervention effect on Patient Health Questionnaire 9 score, suicidal behaviour, percentage of days of heavy drinking, Short Inventory of Problems score, WHO Disability Assessment Schedule 2.0 score, days unable to work, or perpetration of intimate partner violence. Economic analyses indicated that CAP plus EUC was dominant over EUC alone, with lower costs and better outcomes; uncertainty analysis showed a 99% chance of CAP being cost-effective per remission achieved from a health system perspective, using a willingness to pay threshold equivalent to 1 month's wages for an unskilled manual worker in Goa. Readiness to change level at 3 months mediated the effect of CAP on mean standard ethanol consumption at 12 months (indirect effect -6.014 [95% CI -13.99, -0.046]). Serious adverse events were infrequent, and prevalence was similar by arm. The methodological limitations of this trial are the susceptibility of self-reported drinking to social desirability bias, the modest participation rates of eligible patients, and the examination of mediation effects of only 1 mediator and in only half of our sample.ConclusionsCAP's superiority over EUC at the end of treatment was largely stable over time and was mediated by readiness to change. CAP provides better outcomes at lower costs from a societal perspective.Trial registrationISRCTN registry ISRCTN76465238.

Project description:BackgroundExperiencing anxiety and depression is very common in people with dementia and mild cognitive impairment (MCI). Psychological interventions have been suggested as a potential treatment for these populations. Current research suggests that people with dementia and MCI have limited opportunities for psychological treatments aimed at improving their well-being. A systematic review of the evidence on their effectiveness is likely to be useful in terms of improving outcomes for patients and for future recommendations for practice.ObjectivesThe main objective of this review was to assess the effectiveness of psychological interventions in reducing anxiety and depression in people with dementia or mild cognitive impairment (MCI).Search methodsWe searched the Cochrane Dementia and Cognitive Improvement Group Specialized Register and additional sources for both published and unpublished data.Selection criteriaWe included randomised controlled trials (RCTs) comparing a psychological intervention with usual care or a placebo intervention (social contact control) in people with dementia or MCI.Data collection and analysisTwo review authors worked independently to select trials, extract data and assess studies for risk of bias, using a data extraction form. We contacted authors when further information was not available from the published articles.Main resultsSix RCTs involving 439 participants with dementia were included in the review, but no studies of participants with MCI were identified. The studies included people with dementia living in the community or in nursing home care and were carried out in several countries. Only one of the studies was classified as low risk of bias. Five studies were at unclear or high risk of bias due to uncertainties around randomisation, blinding and selective reporting of results. The studies used the different psychological approaches of cognitive behavioural therapy (CBT), interpersonal therapy and counselling. Two studies were of multimodal interventions including a specific psychological therapy. The comparison groups received either usual care, attention-control educational programs, diagnostic feedback or services slightly above usual care.Meta-analysis showed a positive effect of psychological treatments on depression (6 trials, 439 participants, standardised mean difference (SMD) -0.22; 95% confidence interval (CI) -0.41 to -0.03, moderate quality evidence) and on clinician-rated anxiety (2 trials, 65 participants, mean difference (MD) -4.57; 95% CI -7.81 to -1.32, low quality evidence), but not on self-rated anxiety (2 trials, SMD 0.05; 95% CI -0.44 to 0.54) or carer-rated anxiety (1 trial, MD -2.40; 95% CI -4.96 to 0.16). Results were compatible with both benefit and harm on the secondary outcomes of patient quality of life, activities of daily living (ADLs), neuropsychiatric symptoms and cognition, or on carers' self-rated depressive symptoms, but most of the studies did not measure these outcomes. There were no reports of adverse events.Authors' conclusionsWe found evidence that psychological interventions added to usual care can reduce symptoms of depression and clinician-rated anxiety for people with dementia. We conclude that psychological interventions have the potential to improve patient well-being. Further high quality studies are needed to investigate which treatments are most effective and to evaluate the effect of psychological interventions in people with MCI.

Project description:BackgroundGreater access to evidence-based psychological treatments is needed. This review aimed to evaluate whether internet-delivered psychological treatments for mood and anxiety disorders are efficacious, noninferior to established treatments, safe, and cost-effective for children, adolescents and adults.MethodsWe searched the literature for studies published until March 2013. Randomized controlled trials (RCTs) were considered for the assessment of short-term efficacy and safety and were pooled in meta-analyses. Other designs were also considered for long-term effect and cost-effectiveness. Comparisons against established treatments were evaluated for noninferiority. Two reviewers independently assessed the relevant studies for risk of bias. The quality of the evidence was graded using an international grading system.ResultsA total of 52 relevant RCTs were identified whereof 12 were excluded due to high risk of bias. Five cost-effectiveness studies were identified and three were excluded due to high risk of bias. The included trials mainly evaluated internet-delivered cognitive behavioral therapy (I-CBT) against a waiting list in adult volunteers and 88% were conducted in Sweden or Australia. One trial involved children. For adults, the quality of evidence was graded as moderate for the short-term efficacy of I-CBT vs. waiting list for mild/moderate depression (d = 0.83; 95% CI 0.59, 1.07) and social phobia (d = 0.85; 95% CI 0.66, 1.05), and moderate for no efficacy of internet-delivered attention bias modification vs. sham treatment for social phobia (d = -0.04; 95% CI -0.24, 0.35). The quality of evidence was graded as low/very low for other disorders, interventions, children/adolescents, noninferiority, adverse events, and cost-effectiveness.ConclusionsI-CBT is a viable treatment option for adults with depression and some anxiety disorders who request this treatment modality. Important questions remain before broad implementation can be supported. Future research would benefit from prioritizing adapting treatments to children/adolescents and using noninferiority designs with established forms of treatment.

Project description:PurposeIn this study, we investigated whether patients undergoing arthroscopic treatment of femoral acetabular impingement syndrome (FAIS) seek health care for treatment of comorbid depression and anxiety in the year following hip arthroscopy.MethodsUsing the Truven Health Marketscan database, FAIS patients who underwent hip arthroscopy between January 2009 and December 2016 were identified. Claims related to depression or anxiety filed during the year before surgery were required for inclusion. Using claims for pharmaceutical and psychological therapy treatments for mental health disorders, four groups of patients were analyzed on the basis of preoperative anxiety/depression treatment: medication only, therapy only, medication + therapy, and no treatment. Number of opioid pain prescriptions within 180 days prior to surgery and >90 days after hip arthroscopy were also compared.ResultsDepression and anxiety claims were identified in 5,208/14,830 (35.1%) patients. Preoperative treatment for depression and anxiety included medication only (n = 648, 12.4%), therapy only (n = 899, 17.3%), medication + therapy (n = 252, 4.8%), and no treatment (n = 3,409, 65.5%). Of the 900 patients who filled an anxiety/depression-related prescription prior to surgery, 422 (46.9%) patients did not fill a similar prescription in the postoperative year. Of the 1,151 patients receiving anxiety/depression-related therapy prior to surgery, 549 (47.7%) did not receive therapy in the postoperative year. Preoperative opioid prescriptions were filled for 393 patients (60.6%) in medication-only group, 275 (30.6%) in therapy-only group, 156 (61.9%) in medication + therapy group, and 1,059 (31.1%) in the group receiving no treatment. Opioid prescriptions >90 days postoperatively were filled for 330 (50.9%), 225 (25.0%), 120 (47.6%), and 861 (25.3%) patients, respectively.ConclusionHip arthroscopy for FAIS is associated with a decreased postoperative use of health care resources for the treatment of depression and anxiety. Clinicians should also be aware of the potential interplay between preoperative psychotropic medication use and prolonged opioid use when counseling patients.Level of evidenceIV, therapeutic case series.

Project description:BackgroundMajor depressive disorder (MDD) is a highly prevalent mental disorder with large disease burden, high levels of relapse or persistence, and overall suboptimal outcomes of protocolized pharmacological and psychotherapeutic treatments. There is an urgent need to improve treatment effectiveness, possibly through systematic treatment personalization. In psychotherapeutic treatments this can be achieved by case conceptualization. To support this process, we developed the Therap-i module, which consists of personalized Experienced Sampling Methodology (ESM) and feedback. The Therap-i module is integrated into outpatient psychotherapeutic treatment as usual (TAU) for depression. The study aim is to investigate the efficacy of the Therap-i module in decreasing symptomatology in unresponsive or relapsing patients diagnosed with MDD. We hypothesize that the Therap-i module will contribute to TAU by i) decreasing depressive symptoms, and ii) improving general functioning, therapeutic working alliance, and illness perception. This paper provides details of the study rationale, aims, procedures, and a discussion on potential pitfalls and promises of the module.MethodsPatients diagnosed with MDD (n = 100) will enrol in a pragmatic two-armed randomized controlled trial. Randomization is stratified according to the patient's treatment resistance level assessed with the Dutch Method for quantification of Treatment Resistance in Depression (DM-TRD). All fill-out the Inventory of Depressive Symptomatology Self Report (IDS-SR), Outcome Questionnaire (OQ-45), Illness Perception Questionnaire Mental Health (IPQ-MH), and Work Alliance Inventory Self Report (WAI-SR). In the intervention arm, through close collaboration between patient, clinician, and researcher, a personalized ESM diary is developed based on the patient's case conceptualization. During the ESM monitoring period (8 weeks, 5 assessments/day), patients receive feedback three times, which is discussed among the abovementioned three parties. Both patients and clinicians will evaluate the Therap-i module.ResultsData collection is ongoing.DiscussionThis is the first study in which personalized ESM and feedback is integrated in outpatient psychotherapeutic TAU for depression. The labour intensive procedure and methodological pitfalls are anticipated challenges and were taken into account when designing the study. When hypotheses are confirmed, the Therap-i module may advance treatment for depression by providing insights into personalized patterns driving or perpetuating depressive complaints.Trial registrationTrial NL7190 (NTR7381) , registered prospectively 03-08-2018.

Dataset Information

Effectiveness of psychological treatments for depression and alcohol use disorder delivered by community-based counsellors: two pragmatic randomised controlled trials within primary healthcare in Nepal.

Publications

Effectiveness of psychological treatments for depression and alcohol use disorder delivered by community-based counsellors: two pragmatic randomised controlled trials within primary healthcare in Nepal.

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