scholarly journals Feasibility of Group Problem Management Plus (PM+) to improve mental health and functioning of adults in earthquake-affected communities in Nepal

2020 ◽  
Vol 29 ◽  
Author(s):  
M. Sangraula ◽  
E. L. Turner ◽  
N. P. Luitel ◽  
E. van ‘t Hof ◽  
P. Shrestha ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Clinical Outcome ◽  
Health Workers ◽  
Controlled Trial ◽  
Family Members ◽  
Depression Symptoms ◽  
Problem Management ◽  
Randomised Controlled ◽  
Programme Staff

Abstract Aims Psychological interventions that are brief, acceptable, effective and can be delivered by non-specialists are especially necessary in low- and middle-income countries, where mental health systems are unable to address the high level of psychosocial needs. Problem Management Plus (PM+) is a five-session intervention designed for those impaired by psychological distress while living in communities affected by adversity. Individual PM+ has demonstrated effectiveness in reducing distress in Kenya and Pakistan, and a group version of PM+ (Group PM+) was effective for conflict-affected women in Pakistan. This paper describes a feasibility and acceptability trial of locally adapted Group PM+ for women and men in an earthquake-affected region of rural Nepal. Methods In this feasibility cluster randomised controlled trial, participants in the experimental arm were offered five sessions of Group PM+ and participants in the control arm received enhanced usual care (EUC), which entailed brief psycho-education and providing referral options to primary care services with health workers trained in the mental health Gap Action Programme Intervention Guide (mhGAP-IG). A mixed-methods design was used to assess the feasibility and acceptability of Group PM+. Feasibility was assessed with criteria including fidelity and retention of participants. Acceptability was assessed through in-depth interviews with participants, family members, programme staff and other stakeholders. The primary clinical outcome was depression symptoms assessed using the Patient Health Questionnaire (PHQ-9) administered at baseline and 8–8.5 weeks post-baseline (i.e. after completion of Group PM+ or EUC). Results We recruited 121 participants (83% women and 17% men), with equal allocation to the Group PM+ and EUC arms (1:1). Group PM+ was delivered over five 2.5–3 hour sessions by trained and supervised gender-matched local non-specialists, with an average attendance of four out of five sessions. The quantitative and qualitative results demonstrated feasibility and acceptability for non-specialists to deliver Group PM+. Though the study was not powered to assess for effectiveness, for all five key outcome measures, including the primary clinical outcome, the estimated mean improvement was larger in the Group PM+ arm than the EUC arm. Conclusion The intervention and trial procedures were acceptable to participants, family members, and programme staff. The communities and participants found the intervention to be beneficial. Because feasibility and acceptability were established in this trial, a fully powered randomised controlled trial will be conducted for larger scale implementation to determine the effectiveness of the intervention in Nepal.

scholarly journals The Effectiveness of a Media-Based Intervention Promoting Help-Seeking for Mental Health Difficulties By Australian Men: Study Protocol for a Randomised Controlled Trial

2021 ◽  
Author(s):  
ANGELA NICHOLAS ◽  
Simone Scotti Requena ◽  
Maria Ftanou ◽  
Simon Rice ◽  
Justine Fletcher ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Help Seeking ◽  
Mental Health Problems ◽  
Controlled Trial ◽  
Depression Symptoms ◽  
Media Campaigns ◽  
Mental Health Difficulties ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Approximately one fifth of Australian males aged 16 + experience mood, anxiety or substance use disorders in a given year, and suicide by males accounts for three quarters of all suicides annually. However, males with mental health problems are less likely to seek and receive help than their female counterparts. Media campaigns with videos at their core are gaining popularity as a means of promoting help-seeking for mental health difficulties, but few studies have rigorously tested the impact of such videos. This randomised controlled trial tests the effectiveness of a short video promoting help-seeking by Australian men. Methods This study is an online randomised controlled trial (RCT). Participants will attend an online group orientation session, where they will provide consent to participate and complete a baseline questionnaire (T1). After completion of the T1 questionnaire, participants will be randomised to watch either the intervention or control video on a 1:1 basis. After randomisation, participants will be able to access their allocated video for one week. Seven days after T1, participants will again be sent links to the video and to the post-exposure questionnaire (T2). One month after T2, participants will be emailed the follow-up questionnaire (T3). The primary outcome will be change in help-seeking intentions from T1 to T2. Secondary outcomes will be changes in help-seeking intentions from T1 to T3, changes in intentions to encourage other males to seek help, self-reliance, and male depression symptoms from T1 to T2 and from T1 to T3. The cost-effectiveness of the intervention will be evaluated. Participants will also complete questions about their opinions of the video and its effects at T2 and T3. Discussion Our video-based intervention is designed to promote help-seeking for mental health difficulties among Australian men. If a lack of net harm is shown to be associated with viewing the intervention video, the video will be publicly released and could have broad impacts on individual and community attitudes towards help-seeking for mental health difficulties, and ultimately enhance men’s mental health and wellbeing. An evaluation of the effectiveness of the intervention is essential to ensure the intervention is achieving its objectives. Trial registration: anzctr.org.au: 2621001008819

scholarly journals Behavioural activation delivered by the non-specialist: phase II randomised controlled trial

2011 ◽  
Vol 198 (1) ◽  
pp. 66-72 ◽  
Author(s):  
David Ekers ◽  
David Richards ◽  
Dean McMillan ◽  
J. Martin Bland ◽  
Simon Gilbody
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Mental Health Professionals ◽  
Social Adjustment ◽  
Large Scale ◽  
Health Workers ◽  
Controlled Trial ◽  
Behavioural Activation ◽  
Cognitive Behaviour ◽  
Randomised Controlled

BackgroundBehavioural activation appears as effective as cognitive– behaviour therapy (CBT) in the treatment of depression. If equally effective, then behavioural activation may be the preferred treatment option because it may be suitable for delivery by therapists with less training. This is the first randomised controlled trial to look at this possibility.AimsTo examine whether generic mental health workers can deliver effective behavioural activation as a step-three high-intensity intervention.MethodA randomised controlled trial (ISRCTN27045243) comparing behavioural activation (n = 24) with treatment as usual (n = 23) in primary care.ResultsIntention-to-treat analyses indicated a difference in favour of behavioural activation of –15.79 (95% CI –24.55 to –7.02) on the Beck Depression Inventory–II and Work and Social Adjustment Scale (mean difference –11.12, 95% CI –17.53 to –4.70).ConclusionsEffective behavioural activation appears suitable for delivery by generic mental health professionals without previous experience as therapists. Large-scale trial comparisons with an active comparator (CBT) are needed.

scholarly journals Efficacy of a transdiagnostic self-help internet intervention for reducing depression, anxiety, and suicidal ideation in adults: a randomised controlled trial (Preprint)

2020 ◽  
Author(s):  
Philip J Batterham ◽  
Alison L Calear ◽  
Louise Farrer ◽  
Amelia Gulliver ◽  
Ella Kurz
Keyword(s):  
Mental Health ◽  
Clinical Trials ◽  
Suicidal Ideation ◽  
Randomised Controlled Trial ◽  
Repeated Measures ◽  
Mixed Model ◽  
Controlled Trial ◽  
Anxiety Symptoms ◽  
Depression Symptoms ◽  
Randomised Controlled

BACKGROUND Low-intensity self-guided mental health interventions that are delivered online may meet the needs and preferences of adults with mild to moderate symptoms. However, there are few clinical trials examining the effectiveness of self-guided transdiagnostic interventions within a naturalistic setting. OBJECTIVE This randomised controlled trial (RCT) tested the effectiveness of the video-based transdiagnostic intervention FitMindKit in reducing depression symptoms (primary outcome), anxiety symptoms, disability and suicidal ideation, relative to an attention-matched control condition called HealthWatch. METHODS The RCT was conducted with adults living in the Australian Capital Territory, Australia. Participants (n=1,986) were recruited online using social media advertisements, screened for psychological distress, and then randomised to receive one of two 4-week programs: FitMindKit (12-module psychotherapy intervention) or HealthWatch (12-module program providing general health information). Participants were assessed at baseline and 4 weeks post-baseline. To maintain the ecological validity of the trial, participants completed brief assessments and the interventions without direct researcher contact or incentives. RESULTS Mixed model repeated measures ANOVA demonstrated that FitMindKit significantly improved depression symptoms (F1,701.7=3.97, P=.047), along with panic symptoms (F1,706.5=5.59, P=.018) and social anxiety symptoms (F1,680.0=12.37, P<.001) relative to the attention control condition. There were no significant effects on other outcomes. CONCLUSIONS Self-guided transdiagnostic interventions can be beneficial when delivered directly to end-users through the internet. Despite low adherence and small effect sizes, the availability of such interventions is likely to fill a critical gap in the accessibility of mental health services for the community. CLINICALTRIAL This trial was registered with the Australian New Zealand Clinical Trials Registry (number ACTRN12618001688270) INTERNATIONAL REGISTERED REPORT RR2-10.1016/j.conctc.2019.100341

scholarly journals Digital cognitive–behavioural therapy for insomnia compared with digital patient education about insomnia in individuals referred to secondary mental health services in Norway: protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050661
Author(s):  
Håvard Kallestad ◽  
Simen Saksvik ◽  
Øystein Vedaa ◽  
Knut Langsrud ◽  
Gunnar Morken ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Patient Education ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Group Differences ◽  
Post Intervention ◽  
Cognitive Behavioural ◽  
Randomised Controlled

IntroductionInsomnia is highly prevalent in outpatients receiving treatment for mental disorders. Cognitive–behavioural therapy for insomnia (CBT-I) is a recommended first-line intervention. However, access is limited and most patients with insomnia who are receiving mental healthcare services are treated using medication. This multicentre randomised controlled trial (RCT) examines additional benefits of a digital adaptation of CBT-I (dCBT-I), compared with an online control intervention of patient education about insomnia (PE), in individuals referred to secondary mental health clinics.Methods and analysisA parallel group, superiority RCT with a target sample of 800 participants recruited from treatment waiting lists at Norwegian psychiatric services. Individuals awaiting treatment will receive an invitation to the RCT, with potential participants undertaking online screening and consent procedures. Eligible outpatients will be randomised to dCBT-I or PE in a 1:1 ratio. Assessments will be performed at baseline, 9 weeks after completion of baseline assessments (post-intervention assessment), 33 weeks after baseline (6 months after the post-intervention assessment) and 61 weeks after baseline (12 months after the post-intervention assessment). The primary outcome is between-group difference in insomnia severity 9 weeks after baseline. Secondary outcomes include between-group differences in levels of psychopathology, and measures of health and functioning 9 weeks after baseline. Additionally, we will test between-group differences at 6-month and 12-month follow-up, and examine any negative effects of the intervention, any changes in mental health resource use, and/or in functioning and prescription of medications across the duration of the study. Other exploratory analyses are planned.Ethics and disseminationThe study protocol has been approved by the Regional Committee for Medical and Health Research Ethics in Norway (Ref: 125068). Findings from the RCT will be disseminated via peer-reviewed publications, conference presentations, and advocacy and stakeholder groups. Exploratory analyses, including potential mediators and moderators, will be reported separately from main outcomes.Trial registration numberClinicalTrials.gov Registry (NCT04621643); Pre-results.

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