Does cognitive behavioural therapy or mindfulness-based therapy improve mental health and emotion regulation among men who perpetrate intimate partner violence? A randomised controlled trial

2021 ◽  
Vol 113 ◽  
pp. 103795
Author(s):  
Merete Berg Nesset ◽  
Johan Håkon Bjørngaard ◽  
Richard Whittington ◽  
Tom Palmstierna
BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050661
Author(s):  
Håvard Kallestad ◽  
Simen Saksvik ◽  
Øystein Vedaa ◽  
Knut Langsrud ◽  
Gunnar Morken ◽  
...  

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.


BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e042365
Author(s):  
Jessica Leight ◽  
Negussie Deyessa ◽  
Vandana Sharma

ObjectivesExperience of intimate partner violence (IPV) is associated with adverse health and psychosocial outcomes for women. However, rigorous economic evaluations of interventions targeting IPV prevention are rare. This paper analyses the cost-effectiveness of Unite for a Better Life (UBL), a gender-transformative intervention designed to prevent IPV and HIV risk behaviours among men, women and couples.DesignWe use an economic evaluation nested within a large-scale cluster randomised controlled trial, analysing financial and economic costs tracked contemporaneously.SettingUBL was implemented in rural southern Ethiopia between 2013 and 2015.ParticipantsThe randomised controlled trial included 6770 households in 64 villages.InterventionsUBL is an intervention delivered within the context of the Ethiopian coffee ceremony, a culturally established forum for community discussion, and designed to assist participants to build skills for healthy, non-violent, equitable relationships.Primary and secondary outcome measuresThis paper reports on the unit cost and cost-effectiveness of the interventions implemented. Cost-effectiveness is measured as the cost per case of past-year physical and/or sexual IPV averted.ResultsThe estimated annualised cost of developing and implementing UBL was 2015 US$296 772, or approximately 2015 US$74 per individual directly participating in the intervention and 2015 US$5 per person annually for each community-level beneficiary (woman of reproductive age in intervention communities). The estimated cost per case of past-year physical and/or sexual IPV averted was 2015 US$2726 for the sample of direct beneficiaries, and 2015 US$194 for the sample of all community-level beneficiaries.ConclusionsUBL is an effective and cost-effective intervention for the prevention of IPV in a low and middle-income country setting. Further research should explore strategies to quantify the positive effects of the intervention across other domains.Trial registration numberNCT02311699 (ClinicalTrials.gov); AEARCTR-0000211 (AEA Registry)


2020 ◽  
Author(s):  
Helena Rose Bean ◽  
Lesley Stafford ◽  
Ruth Little ◽  
Justine Diggens ◽  
Maria Ftanou ◽  
...  

Abstract Background: Women with breast cancer experience a significantly higher prevalence of sleep disturbances and insomnia compared with the general population. The experience of persistent sleep disturbance places these women at a higher risk of psychological and physical morbidity and a reduced quality of life. Treatment of sleep in this population is not part of routine care, and often is managed inadequately. This randomised controlled trial will examine the combined effects of Cognitive Behavioural Therapy (CBT) and bright light therapy (BLT) on the symptoms of insomnia, fatigue, and mental health. Method/design: Women diagnosed with breast cancer who receive intravenous chemotherapy treatment at a quaternary referral metropolitan cancer centre in Melbourne Australia will be recruited. Recruitment will occur after diagnosis and prior to completion of chemotherapy. Eligible women will be randomised to the combined CBT and BLT intervention (CBT+) or relaxation audio enhanced treatment as usual (TAU+). The CBT+ group will receive one face-to-face session on sleep strategies, one subsequent telephone call, and seven email packages containing CBT-based information and strategies. CBT+ participants will also wear Luminette® light glasses for 20 minutes each morning for the six-week duration of the intervention. Women in TAU+ will receive two relaxation audio tracks via email. Outcomes will be measured at multiple points throughout the six weeks. Primary outcomes will be symptoms of insomnia and sleep efficiency, measured using the Insomnia Severity Index and a self-reported sleep diary. Secondary outcomes include objective measures of sleep assessed using the ActiGraph wGT3X-BT; and sleep-related complaints, fatigue and mental health, all assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) measure. Data will also be collected on potential treatment moderators and mechanisms, and adherence to treatment. There will be three-month follow-up measurements of fatigue, sleep-related impairment, sleep disturbance, depression, and anxiety. Discussion: This is the first randomised controlled trial to combine CBT and BLT for the treatment of sleep disturbances in women with breast cancer. This novel design addresses the multiple causal factors for sleep complaints in this population. Results from this trial will advance knowledge in this field and may have important clinical implications for how best to treat sleep disturbance and insomnia in this population. If effective, the largely email-based format of the intervention would allow for relatively easy translation. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR), Registration number: ACTRN12618001255279. Retrospectively registered on: 25/07/2018, recruitment began: 24/07/2018.


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