scholarly journals Clinical efficacy of COMPASS, a digital cognitive-behavioural therapy programme for treating anxiety and depression in patients with long-term physical health conditions: a protocol for randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e053971
Author(s):  
Katrin Hulme ◽  
Joanna L Hudson ◽  
Federica Picariello ◽  
Natasha Seaton ◽  
Sam Norton ◽  
...  

IntroductionApproximately 30% of people with long-term physical health conditions (LTCs) experience mental health problems, with negative consequences and costs for individuals and healthcare services. Access to psychological treatment is scarce and, when available, often focuses on treating primary mental health problems rather than illness-related anxiety/depression. The aim of this study is to evaluate the clinical efficacy of a newly developed, therapist-supported, digital cognitive-behavioural treatment (COMPASS) for reducing LTC-related psychological distress (anxiety/depression), compared with standard charity support (SCS).Methods and analysisA two-arm, parallel-group randomised controlled trial (1:1 ratio) with nested qualitative study will be conducted. Two-hundred adults with LTC-related anxiety and depression will be recruited through national LTC charities. They will be randomly allocated to receive COMPASS or SCS only. An independent administrator will use Qualtrics randomiser for treatment allocation, to ensure allocation concealment. Participants will access treatment from home over 10 weeks. The COMPASS group will have access to the digital programme and six therapist contacts: one welcome message and five fortnightly phone calls. Data will be collected online at baseline, 6 weeks and 12 weeks post-randomisation for primary outcome (Patient Health Questionnaire Anxiety and Depression Scale) and secondary outcomes (anxiety, depression, daily functioning, COVID-19-related distress, illness-related distress, quality of life, knowledge and confidence for illness self-management, symptom severity and improvement). Analyses will be conducted following the intention-to-treat principle by a data analyst blinded to treatment allocation. A purposively sampled group of COMPASS participants and therapists will be interviewed. Interviews will be thematically analysed.Ethics and disseminationThe study is approved by King’s College London’s Psychiatry, Nursing and Midwifery Research Ethics Subcommittee (reference: LRS-19/20–20347). All participants will provide informed consent to take part if eligible. Findings will be published in peer-reviewed journals and presented at conferences.Trial registration numberNCT04535778.

2021 ◽  
pp. 1-10
Author(s):  
Peter Tyrer ◽  
Helen Tyrer ◽  
Tony Johnson ◽  
Min Yang

Abstract Background Cohort studies of the long-term outcome of anxiety, depression and personality status rarely join together. Methods Two hundred and ten patients recruited with anxiety and depression to a randomised controlled trial between 1983 and 1987 (Nottingham Study of Neurotic Disorder) were followed up over 30 years. At trial entry personality status was assessed, together with the general neurotic syndrome, a combined diagnosis of mixed anxiety–depression (cothymia) linked to neurotic personality traits. Personality assessment used a procedure allowing conversion of data to the ICD-11 severity classification of personality disorder. After the original trial, seven further assessments were made. Observer and self-ratings of psychopathology and global outcome were also made. The primary outcome at 30 years was the proportion of those with no Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnosis. Data were analysed using multilevel repeated measures models that adjusted for age and gender. Missing data were assumed to be missing at random, and the models allowed all subjects to be included in the analysis with missing data automatically handled in the model estimation. Results At 30 years, 69% of those with a baseline diagnosis of panic disorder had no DSM diagnosis compared to 37–47% of those with generalised anxiety disorder, dysthymia or mixed symptoms (cothymia) (p = 0.027). Apart from those with no personality dysfunction at entry all patients had worse outcomes after 30 years with regard to total psychopathology, anxiety and depression, social function and global outcome. Conclusions The long-term outcome of disorders formerly called ‘neurotic’ is poor with the exception of panic disorder. Personality dysfunction accentuates poor recovery.


Author(s):  
Huiyang Dai ◽  
Stephen X. Zhang ◽  
Kim Hoe Looi ◽  
Rui Su ◽  
Jizhen Li

Research identifying adults’ mental health during the coronavirus disease 2019 (COVID-19) pandemic relies solely on demographic predictors without examining adults’ health condition as a potential predictor. This study aims to examine individuals’ perception of health conditions and test availability as potential predictors of mental health—insomnia, anxiety, depression, and distress—during the COVID-19 pandemic. An online survey of 669 adults in Malaysia was conducted during 2–8 May 2020, six weeks after the Movement Control Order (MCO) was issued. We found adults’ perception of health conditions had curvilinear relationships (horizontally reversed J-shaped) with insomnia, anxiety, depression, and distress. Perceived test availability for COVID-19 also had curvilinear relationships (horizontally reversed J-shaped) with anxiety and depression. Younger adults reported worse mental health, but people from various religions and ethnic groups did not differ significantly in reported mental health. The results indicated that adults with worse health conditions had more mental health problems, and the worse degree deepened for unhealthy people. Perceived test availability negatively predicted anxiety and depression, especially for adults perceiving COVID-19 test unavailability. The significant predictions of perceived health condition and perceived COVID-19 test availability suggest a new direction for the literature to identify the psychiatric risk factors directly from health-related variables during a pandemic.


BMJ Open ◽  
2018 ◽  
Vol 8 (9) ◽  
pp. e022382 ◽  
Author(s):  
Wendy Ingram ◽  
Douglas Webb ◽  
Rod S Taylor ◽  
Nana Anokye ◽  
Lucy Yardley ◽  
...  

IntroductionPhysical activity is recommended for improving health among people with common chronic conditions such as obesity, diabetes, hypertension, osteoarthritis and low mood. One approach to promote physical activity is via primary care exercise referral schemes (ERS). However, there is limited support for the effectiveness of ERS for increasing long-term physical activity and additional interventions are needed to help patients overcome barriers to ERS uptake and adherence.This study aims to determine whether augmenting usual ERS with web-based behavioural support, based on the LifeGuide platform, will increase long-term physical activity for patients with chronic physical and mental health conditions, and is cost-effective.Methods and analysisA multicentre parallel two-group randomised controlled trial with 1:1 individual allocation to usual ERS alone (control) or usual ERS plus web-based behavioural support (intervention) with parallel economic and mixed methods process evaluations. Participants are low active adults with obesity, diabetes, hypertension, osteoarthritis or a history of depression, referred to an ERS from primary care in the UK.The primary outcome measure is the number of minutes of moderate-to-vigorous physical activity (MVPA) in ≥10 min bouts measured by accelerometer over 1 week at 12 months.We plan to recruit 413 participants, with 88% power at a two-sided alpha of 5%, assuming 20% attrition, to demonstrate a between-group difference of 36–39 min of MVPA per week at 12 months. An improvement of this magnitude represents an important change in physical activity, particularly for inactive participants with chronic conditions.Ethics and disseminationApproved by North West Preston NHS Research Ethics Committee (15/NW/0347). Dissemination will include publication of findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals.Results will be disseminated to ERS services, primary healthcare providers and trial participants.Trial registration numberISRCTN15644451; Pre-results.


2018 ◽  
Vol 9 (2) ◽  
pp. 63
Author(s):  
Anil Kumar Roy ◽  
Nilesh Maruti Gujar ◽  
Arif Ali ◽  
Utpal Borah

Background: Studies have shown that caregivers of the persons with the neurological illness have high levels of psychological distress, depression and caregiver’s burden. The aim of the study was to find out anxiety, depression and caregiver’s burden among the caregivers of persons with neurological illness (PWNI). Method: Thirty caregivers of PWNI attending the Centre of Rehabilitation Sciences, LGB Regional Institute of Mental Health, Tezpur, Assam were selected using purposive sampling technique for the present study. Socio-demographic and clinical data sheet, Zarit Burden Interview Scale and The Hospital Anxiety and Depression Scale were used. Results: The results shown that in Hospital Anxiety and Depression Scale, 26.6% of the caregivers' scores were in the abnormal range in the domain of depression. While in the domain of anxiety, 16.6% scored in the abnormal range. In Zarit Burden of Scale, 13.3% of the caregivers were having little or no burden, 26.6% of the caregivers were having mild to moderate level of burden, 20% were having moderate to severe burden and 30% were having a severe burden of care. Care burden has significant positive correlation with depression (r= .124, p≤ 0.01 and anxiety (r= .124, p≤ 0.05). Conclusion: Caregivers of PWNI have been found to be at higher risk of mental health problems and care burden. The importance of addressing the burden of caregivers involved in the care of PWNI need to be taken into consideration while providing treatment and rehabilitation of PWNI.     Keywords: Anxiety, depression, burden, neurological illness


2021 ◽  
Vol 6 (6) ◽  
pp. e003902
Author(s):  
Rachana Parikh ◽  
Adriaan Hoogendoorn ◽  
Daniel Michelson ◽  
Jeroen Ruwaard ◽  
Rhea Sharma ◽  
...  

IntroductionWe evaluated a classroom-based sensitisation intervention that was designed to reduce demand-side barriers affecting referrals to a school counselling programme. The sensitisation intervention was offered in the context of a host trial evaluating a low-intensity problem-solving treatment for common adolescent mental health problems.MethodsWe conducted a stepped-wedge, cluster randomised controlled trial with 70 classes in 6 secondary schools serving low-income communities in New Delhi, India.The classes were randomised to receive a classroom sensitisation session involving a brief video presentation and moderated group discussion, delivered by a lay counsellor over one class period (intervention condition, IC), in two steps of 4 weeks each. The control condition (CC) was whole-school sensitisation (teacher-meetings and whole-school activities such as poster displays). The primary outcome was the proportion of students referred into the host trial. Secondary outcomes were the proportion of students who met mental health caseness criteria and the proportion of self-referred adolescents.ResultsBetween 20 August 2018 and 9 December 2018, 835 students (23.3% of all students) were referred into the host trial. The referred sample included 591 boys (70.8%), and had a mean age of 15.8 years, SD=0.06; 194 students (31.8% of 610 with complete data) met mental health caseness criteria. The proportion of students referred in each trial conditionwas significantly higher in the IC (IC=21.7%, CC=1.5%, OR=111.36, 95% CI 35.56 to 348.77, p<0.001). The proportion of self-referred participants was also higher in the IC (IC=98.1%, CC=89.1%, Pearson χ2 (1)=16.92, p<0.001). Although the proportion of referred students meeting caseness criteria was similar in both conditions (IC=32.0% vs CC=28.1%), the proportion weighted for the total student population was substantially higher in the IC (IC=5.2%, CC=0.3%, OR=52.39, 95% CI 12.49 to 219.66,p<0.001).ConclusionA single, lay counsellor-delivered, classroom sensitisation session increased psychological help-seeking for common mental health problems among secondary school pupils from urban, low-income communities in India.Trial registration numberNCT03633916.


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.


2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
Andrew J. Lewis ◽  
Melanie D. Bertino ◽  
Narelle Robertson ◽  
Tess Knight ◽  
John W. Toumbourou

Background. This paper presents findings derived from consumer feedback, following a multicentre randomised controlled trial for adolescent mental health problems and substance misuse. The paper focuses on the implementation of a family-based intervention, including fidelity of delivery, family members’ experiences, and their suggestions for program improvements.Methods. Qualitative and quantitative data (n=21) were drawn from the Deakin Family Options trial consumer focus groups, which occurred six months after the completion of the trial. Consumer focus groups were held in both metropolitan and regional locations in Victoria, Australia.Findings. Overall reductions in parental isolation, increases in parental self-care, and increased separation/individuation were the key therapeutic features of the intervention. Sharing family experiences with other parents was a key supportive factor, which improved parenting confidence and efficacy and potentially reduced family conflict. Consumer feedback also led to further development of the intervention, with a greater focus on aiding parents to engage adolescents in services and addressing family factors related to adolescent’s mood and anxiety symptoms.Conclusions. Participant feedback provides valuable qualitative data, to monitor the fidelity of treatment implementation within a trial, to confirm predictions about the effective mechanisms of an intervention, and to inform the development of new interventions.


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