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Cluster randomised controlled trial of a guided self-help mental health intervention in primary care.

ABSTRACT: OBJECTIVES:To ascertain whether an ultrabrief intervention (UBI) improves mental health outcomes for patients in general practice with mild-to-moderate mental health concerns. TRIAL DESIGN:Two-arm cluster randomised controlled trial. METHODS:Participants: general practitioners (GPs) were invited based on working in a participating general practice. Patients were eligible to participate if aged 18-65 years, scored ?35 on the Kessler-10 (K10) and if meeting local mental health access criteria (based on age, low income or ethnic group). INTERVENTIONS:intervention arm GPs were trained on the UBI approach, with participating patients receiving three structured appointments over 5 weeks. GPs randomised to practice as usual (PAU) did not receive training, and delivered support following their existing practice approaches. OUTCOME MEASURES:primary outcome was patient-level K10 score at 6 months postrecruitment.Randomisation: GP practices were randomised to UBI training or PAU at the start of the study.Blinding: GPs were not blinded to group assignment. RESULTS:Numbers randomised: 62 GPs (recruiting 85 patients) were randomised to UBI, and 50 to PAU (recruiting 75 patients).Numbers analysed: 31 GPs recruited at least one patient in the UBI arm (70 patients analysed), and 21 GPs recruited at least one patient in the PAU arm (69 patients analysed). OUTCOME:K10 scores from an intention-to-treat analysis were similar in UBI and PAU arms, with a wide CI (mean adjusted K10 difference=1.68 points higher in UBI arm, 95% CI -1.18 to 4.55; p=0.255). Secondary outcomes were also similar in the two groups. CONCLUSIONS:the UBI intervention did not lead to better outcomes than practice as usual, although the study had lower than planned power due to poor recruitment. The study results can still contribute to the continuing debate about brief psychological therapy options for primary care and their development. TRIAL REGISTRATION NUMBER:ACTRN12613000041752; Pre-results.

SUBMITTER: Mathieson F

PROVIDER: S-EPMC6398763 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Cluster randomised controlled trial of a guided self-help mental health intervention in primary care.

Mathieson Fiona F Stanley James J Collings Catherine Sunny CS Tester Rachel R Dowell Anthony A

BMJ open 20190227 2

<h4>Objectives</h4>To ascertain whether an ultrabrief intervention (UBI) improves mental health outcomes for patients in general practice with mild-to-moderate mental health concerns.<h4>Trial design</h4>Two-arm cluster randomised controlled trial.<h4>Methods</h4>Participants: general practitioners (GPs) were invited based on working in a participating general practice. Patients were eligible to participate if aged 18-65 years, scored ≤35 on the Kessler-10 (K10) and if meeting local mental healt ...[more]

PMID: 30819700

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Project description:ObjectiveTo evaluate the effectiveness of different brief intervention strategies at reducing hazardous or harmful drinking in primary care. The hypothesis was that more intensive intervention would result in a greater reduction in hazardous or harmful drinking.DesignPragmatic cluster randomised controlled trial.SettingPrimary care practices in the north east and south east of England and in London.Participants3562 patients aged 18 or more routinely presenting in primary care, of whom 2991 (84.0%) were eligible to enter the trial: 900 (30.1%) screened positive for hazardous or harmful drinking and 756 (84.0%) received a brief intervention. The sample was predominantly male (62%) and white (92%), and 34% were current smokers.InterventionsPractices were randomised to three interventions, each of which built on the previous one: a patient information leaflet control group, five minutes of structured brief advice, and 20 minutes of brief lifestyle counselling. Delivery of the patient leaflet and brief advice occurred directly after screening and brief lifestyle counselling in a subsequent consultation.Main outcome measuresThe primary outcome was patients' self reported hazardous or harmful drinking status as measured by the alcohol use disorders identification test (AUDIT) at six months. A negative AUDIT result (score <8) indicated non-hazardous or non-harmful drinking. Secondary outcomes were a negative AUDIT result at 12 months, experience of alcohol related problems (alcohol problems questionnaire), health utility (EQ-5D), service utilisation, and patients' motivation to change drinking behaviour (readiness to change) as measured by a modified readiness ruler.ResultsPatient follow-up rates were 83% at six months (n=644) and 79% at 12 months (n=617). At both time points an intention to treat analysis found no significant differences in AUDIT negative status between the three interventions. Compared with the patient information leaflet group, the odds ratio of having a negative AUDIT result for brief advice was 0.85 (95% confidence interval 0.52 to 1.39) and for brief lifestyle counselling was 0.78 (0.48 to 1.25). A per protocol analysis confirmed these findings.ConclusionsAll patients received simple feedback on their screening outcome. Beyond this input, however, evidence that brief advice or brief lifestyle counselling provided important additional benefit in reducing hazardous or harmful drinking compared with the patient information leaflet was lacking.Trial registrationCurrent Controlled Trials ISRCTN06145674.

Project description:BackgroundInnovative solutions are required to provide mental health support at scale in low-resource humanitarian contexts. We aimed to assess the effectiveness of a facilitator-guided, group-based, self-help intervention (Self-Help Plus) to reduce psychological distress in female refugees.MethodsWe did a cluster randomised trial in rural refugee settlements in northern Uganda. Participants were female South Sudanese refugees with at least moderate levels of psychological distress (cutoff ≥5 on the Kessler 6). The intervention comprised access to usual care and five 2-h audio-recorded stress-management workshops (20-30 refugees) led by briefly trained lay facilitators, accompanied by an illustrated self-help book. Villages were randomly assigned to either intervention (Self-Help Plus or enhanced usual care) on a 1:1 basis. Within 14 villages, randomly selected households were approached. Screening of women in households continued until 20-30 eligible participants were identified per site. The primary outcome was individual psychological distress, assessed using the Kessler 6 symptom checklist 1 week before, 1 week after, and 3 months after intervention, in the intention-to-treat population. All outcomes were measured at the individual (rather than cluster) level. Secondary outcomes included personally identified problems, post-traumatic stress, depression symptoms, feelings of anger, social interactions with other ethnic groups, functional impairment, and subjective wellbeing. Assessors were masked to allocation. This trial was prospectively registered at ISRCTN, number 50148022.FindingsOf 694 eligible participants (331 Self-Help Plus, 363 enhanced usual care), 613 (88%) completed all assessments. Compared with controls, we found stronger improvements for Self-Help Plus on psychological distress 3 months post intervention (β -1·20, 95% CI -2·33 to -0·08; p=0·04; d -0·26). We also found larger improvements for Self-Help Plus 3 months post-intervention for five of eight secondary outcomes (effect size range -0·30 to -0·36). Refugees with different trauma exposure, length of time in settlements, and initial psychological distress benefited similarly. With regard to safety considerations, the independent data safety management board responded to six adverse events, and none were evaluated to be concerns in response to the intervention.InterpretationSelf-Help Plus is an innovative, facilitator-guided, group-based self-help intervention that can be rapidly deployed to large numbers of participants, and resulted in meaningful reductions in psychological distress at 3 months among South Sudanese female refugees.FundingResearch for Health in Humanitarian Crises (R2HC) Programme.

Project description:ObjectivesDizziness is common in older people. Physicians are often unable to identify a specific cause for dizziness in older people, even after an extensive diagnostic work-up. A prognosis-oriented approach, i.e. treating modifiable risk factors for an unfavourable course of dizziness, may reduce dizziness-related impairment in older people in primary care.DesignCluster randomized controlled trial.Setting45 primary care practices in The Netherlands.Participants168 participants aged ?65y who consulted their general practitioner for dizziness and experienced significant dizziness-related impairment (Dizziness Handicap Inventory (DHI) ?30). Participants were part of to the intervention group (n = 83) or control group (n = 85), depending on whether they were enlisted in an intervention practice or in a control practice.InterventionsThe multifactorial intervention consisted of: medication adjustment in case of ?3 prescribed fall-risk-increasing drugs (FRIDs) and/or stepped mental health care in case of anxiety disorder and/or depression and/or exercise therapy in case of impaired functional mobility. The intervention was compared to usual care.Outcome measuresThe primary outcome was dizziness-related impairment. Secondary outcomes were quality of life (QoL), dizziness frequency, fall frequency, anxiety and depression, use of FRIDs.ResultsIntention-to-treat analysis showed no significant intervention effect on dizziness-related impairment (DHI score difference -0.69 [95% CI -5.66;4.28]; p = 0.79). The intervention proved effective in reducing the number of FRIDs (FRID difference -0.48 [95% CI -0.89;-0.06]; p = 0.02). No significant intervention effects were found on other secondary outcomes. The uptake of and adherence to the interventions was significantly lower in patients eligible for ?2 interventions compared to patients eligible for one intervention (p<0.001).ConclusionsThe multifactorial intervention for dizziness in older patients showed no significant intervention effect on most outcomes and adherence to the multifactorial intervention was low. Although multifactorial treatment for older dizzy people seems promising in theory, we question its feasibility in daily practice. Future research could focus on a sequential treatment for dizziness, e.g. measuring effectiveness of various evidence-based therapies in a stepwise approach.

Project description:ObjectiveTo determine the effectiveness of a web-based self-management programme for people with type 2 diabetes in improving glycaemic control and reducing diabetes-related distress.Methods and designIndividually randomised two-arm controlled trial.Setting21 general practices in England.ParticipantsAdults aged 18 or over with a diagnosis of type 2 diabetes registered with participating general practices.Intervention and comparatorUsual care plus either Healthy Living for People with Diabetes (HeLP-Diabetes), an interactive, theoretically informed, web-based self-management programme or a simple, text-based website containing basic information only.Outcomes and data collectionJoint primary outcomes were glycated haemoglobin (HbA1c) and diabetes-related distress, measured by the Problem Areas in Diabetes (PAID) scale, collected at 3 and 12 months after randomisation, with 12 months the primary outcome point. Research nurses, blind to allocation collected clinical data; participants completed self-report questionnaires online.AnalysisThe analysis compared groups as randomised (intention to treat) using a linear mixed effects model, adjusted for baseline data with multiple imputation of missing values.ResultsOf the 374 participants randomised between September 2013 and December 2014, 185 were allocated to the intervention and 189 to the control. Final (12 month) follow-up data for HbA1c were available for 318 (85%) and for PAID 337 (90%) of participants. Of these, 291 (78%) and 321 (86%) responses were recorded within the predefined window of 10-14 months. Participants in the intervention group had lower HbA1c than those in the control (mean difference -0.24%; 95% CI -0.44 to -0.049; p=0.014). There was no significant overall difference between groups in the mean PAID score (p=0.21), but prespecified subgroup analysis of participants who had been more recently diagnosed with diabetes showed a beneficial impact of the intervention in this group (p = 0.004). There were no reported harms.ConclusionsAccess to HeLP-Diabetes improved glycaemic control over 12 months.Trial registration numberISRCTN02123133.

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Cluster randomised controlled trial of a guided self-help mental health intervention in primary care.

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Cluster randomised controlled trial of a guided self-help mental health intervention in primary care.

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