Comment on—Effects of family participatory dignity therapy on the psychological well-being and family function of patients with haematological malignancies and their family caregivers: a randomised controlled trial

2021 ◽  
pp. 103945
Author(s):  
Professor Richard Gray
Keyword(s):  
Randomised Controlled Trial ◽  
Family Caregivers ◽  
Controlled Trial ◽  
Well Being ◽  
Haematological Malignancies ◽  
Psychological Well Being ◽  
Family Function ◽  
Dignity Therapy ◽  
Randomised Controlled

scholarly journals Evaluating the impact of a common elements-based intervention to improve maternal psychological well-being and mother–infant interaction in rural Pakistan: study protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e047609
Author(s):  
Zill-e- Huma ◽  
Ayella Gillani ◽  
Fakhira Shafique ◽  
Alina Rashid ◽  
Bushra Mahjabeen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Common Elements ◽  
Psychological Well Being ◽  
Low Resource Settings ◽  
Low Resource ◽  
Secondary Outcomes ◽  
Randomised Controlled ◽  
Self Reporting Questionnaire

IntroductionMillions of children in low resource settings are at high risk of poor development due to factors such as under nutrition, inadequate stimulation and maternal depression. Evidence-based interventions to address these risk factors exist, but often as a separate and overlapping package. The current study aims to evaluate the effectiveness of a common elements-based intervention to improve mother–infant interaction at 12 months post-partum.Method and analysisA two-arm, single-blinded, individual randomised controlled trial is being carried out in the community settings of the rural subdistrict of Gujar Khan in Rawalpindi, Pakistan. 250 pregnant women in third trimester with distress (Self-Reporting Questionnaire, cut-off score >9) have been randomised on 1:1 allocation ratio into intervention (n=125) and treatment-as-usual arms (n=125). The participants in the intervention arm will receive 15 individual sessions of intervention on a monthly basis by non-specialist facilitators. The intervention involves components of early stimulation, learning through play, responsive feeding, guided discovery using pictures, behavioural activation and problem solving. The primary outcome is caregiver–infant interaction at 12 months postpartum. The secondary outcomes include maternal psychological well-being, quality of life, social support and empowerment. Infant secondary outcomes include growth, nutrition and development. The data will be collected at baseline, 6 and 12 months postpartum. A qualitative process evaluation will be conducted to inform the feasibility of intervention delivery.EthicsEthics approval for the present study was obtained from the Human Development Research Foundation Institutional Review Board, Islamabad Pakistan.DisseminationIf proven effective, the study will contribute to scale-up care for maternal and child mental health in low resource settings, globally. The findings of the present study will be published in peer-reviewed journals and presented at conferences and community forums.Trial registration numberNCT04252807.

scholarly journals Study protocol of a randomised controlled trial on SISU, a software agent providing a brief self-help intervention for adults with low psychological well-being

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041573
Author(s):  
Eileen Bendig ◽  
Dominik Meißner ◽  
Benjamin Erb ◽  
Lena Weger ◽  
Ann-Marie Küchler ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Emotion Regulation ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Software Agents ◽  
Well Being ◽  
Psychological Well Being ◽  
Randomised Controlled

IntroductionOnly a minority of people living with mental health problems are getting professional help. As digitalisation moves on, the possibility of providing internet/mobile-based interventions (IMIs) arises. One type of IMIs are fully automated conversational software agents (chatbots). Software agents are computer programs that can hold conversations with a human by mimicking a human conversational style. Software agents could deliver low-threshold and cost-effective interventions aiming at promoting psychological well-being in a large number of individuals. The aim of this trial is to evaluate the clinical effectiveness and acceptance of the brief software agent-based IMI SISU in comparison with a waitlist control group.Methods and analysisWithin a two-group randomised controlled trial, a total of 120 adult participants living with low well-being (Well-being Scale/WHO-5) will be recruited in Germany, Austria and Switzerland. SISU is based on therapeutic writing and acceptance and commitment therapy-based principles. The brief intervention consists of three modules. Participants work through the intervention on 3 consecutive days. Assessment takes place before (t1), during (t2) and after (t3) the interaction with SISU, as well as 4 weeks after randomisation (t4). Primary outcome is psychological well-being (WHO-5). Secondary outcomes are emotional well-being (Flourishing Scale), psychological flexibility (Acceptance and Action Questionnaire-II), quality of life (Assessment of Quality of Life -8D), satisfaction with the intervention (Client Satisfaction Questionnaire-8) and side effects (Inventory for the assessment of negative effectsof psychotherapy). Examined mediators and moderators are sociodemographic variables, personality (Big Five Inventory-10), emotion regulation (Emotion Regulation Questionnaire), alexithymia (Toronto Alexithymia Scale-20), centrality of events (Centrality of Events Scale), treatment expectancies (Credibility Expectancy Questionnaire) and technology alliance (Inventory of Technology Alliance–Online Therapy). Data analysis will be based on intention-to-treat principles. SISU guides participants through a 3-day intervention.Ethics and disseminationThis trial has been approved by the ethics committee of the Ulm University (No. 448/18, 18.02.2019). Results will be submitted for publication in a peer-reviewed journal and presented at conferences.Trial registrationThe trial is registered at the WHO International Clinical Trials Registry Platform via the German Clinical Trials Register (DRKS): DRKS00016799 (date of registration: 25 April 2019). In case of important protocol modifications, trial registration will be updated. This is protocol version number 1.

scholarly journals An explanatory randomised controlled trial testing the effects of targeting worry in patients with persistent persecutory delusions: the Worry Intervention Trial (WIT)

2015 ◽  
Vol 2 (1) ◽  
pp. 1-36 ◽  
Author(s):  
Daniel Freeman ◽  
Graham Dunn ◽  
Helen Startup ◽  
David Kingdon
Keyword(s):  
Randomised Controlled Trial ◽  
Outcome Measures ◽  
Standard Care ◽  
Controlled Trial ◽  
Well Being ◽  
Secondary Outcome ◽  
Persecutory Delusions ◽  
Psychological Well Being ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundPersecutory delusions are a key experience in psychosis, at the severe end of a paranoia continuum in the population. Treatments require significant improvement. Our approach is to translate recent advances in understanding delusions into efficacious treatment. In our research we have found worry to be an important factor in the occurrence of persecutory delusions. Worry brings implausible ideas to mind, keeps them there and makes the experience distressing. Reducing worry should lead to reductions in persecutory delusions.ObjectiveThe objective was to test the clinical efficacy of a brief cognitive–behavioural intervention for worry for patients with persistent persecutory delusions and determine how the treatment might reduce delusions. Embedded within the trial were theoretical studies to improve the understanding of worry in psychosis.DesignParticipants were randomised either to the psychological intervention added to standard care or to standard care. Assessments, carried out by an assessor blind to allocation, were carried out at 0 weeks, 8 weeks (post treatment) and 24 weeks.SettingPatients were recruited from mental health secondary services: Oxford Health NHS Foundation Trust and Southern Health NHS Foundation Trust.ParticipantsA total of 150 patients with persistent persecutory delusions in the context of non-affective psychosis took part.InterventionThe six-session manualised cognitive–behavioural therapy (CBT) intervention aimed to reduce time worrying and did not dispute the content of delusions.Main outcome measuresThe main outcomes measures were of worry (Penn State Worry Questionnaire; PSWQ) and persecutory delusions (Psychotic Symptom Rating Scales; PSYRATS). Secondary outcome measures were paranoia, overall psychiatric symptoms, psychological well-being, rumination and a patient-chosen outcome.ResultsIn total, 95% of the patients provided primary outcome follow-up data. For the primary outcomes, in an intention-to-treat analysis, when compared with treatment as usual, the therapy led to highly significant reductions in both worry [PSWQ: 6.35, 95% confidence interval (CI) 3.30 to 9.40;p < 0.001] and the persecutory delusions (PSYRATS: 2.08, 95% CI 0.64 to 3.51;p = 0.005). The intervention also led to significant improvements in all of the secondary outcomes. All gains were maintained. A planned mediation analysis indicated that change in worry explained 66% of the change in the delusions. We also found that patients without intervention report a passive relationship with worry, feeling unable to do anything about it; worry brings on depersonalisation experiences; and the patient group has very low levels of psychological well-being.ConclusionsThis was the first large randomised controlled trial specifically focused on the treatment of persecutory delusions. Long-standing delusions were significantly reduced by a brief CBT intervention targeted at worry. The intervention also improved well-being and overall levels of psychiatric problems. An evaluation of the intervention in routine clinical setting is now indicated. We envisage developing the intervention booklets for online and app delivery so that the intervention, with health professional support, has the possibility for greater self-management.Trial registrationCurrent Controlled Trials ISRCTN23197625.FundingThis project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a MRC and NIHR partnership.

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