Summary Background Depression is a common, debilitating, and costly disorder. Many patients request psychological therapy, but the best-evidenced therapy—cognitive behavioural therapy (CBT)—is ...complex and costly. A simpler therapy—behavioural activation (BA)—might be as effective and cheaper than is CBT. We aimed to establish the clinical efficacy and cost-effectiveness of BA compared with CBT for adults with depression. Methods In this randomised, controlled, non-inferiority trial, we recruited adults aged 18 years or older meeting Diagnostic and Statistical Manual of Mental Disorders IV criteria for major depressive disorder from primary care and psychological therapy services in Devon, Durham, and Leeds (UK). We excluded people who were receiving psychological therapy, were alcohol or drug dependent, were acutely suicidal or had attempted suicide in the previous 2 months, or were cognitively impaired, or who had bipolar disorder or psychosis or psychotic symptoms. We randomly assigned participants (1:1) remotely using computer-generated allocation (minimisation used; stratified by depression severity Patient Health Questionnaire 9 (PHQ-9) score of <19 vs ≥19, antidepressant use, and recruitment site) to BA from junior mental health workers or CBT from psychological therapists. Randomisation done at the Peninsula Clinical Trials Unit was concealed from investigators. Treatment was given open label, but outcome assessors were masked. The primary outcome was depression symptoms according to the PHQ-9 at 12 months. We analysed all those who were randomly allocated and had complete data (modified intention to treat mITT) and also all those who were randomly allocated, had complete data, and received at least eight treatment sessions (per protocol PP). We analysed safety in the mITT population. The non-inferiority margin was 1·9 PHQ-9 points. This trial is registered with the ISCRTN registry, number ISRCTN27473954. Findings Between Sept 26, 2012, and April 3, 2014, we randomly allocated 221 (50%) participants to BA and 219 (50%) to CBT. 175 (79%) participants were assessable for the primary outcome in the mITT population in the BA group compared with 189 (86%) in the CBT group, whereas 135 (61%) were assessable in the PP population in the BA group compared with 151 (69%) in the CBT group. BA was non-inferior to CBT (mITT: CBT 8·4 PHQ-9 points SD 7·5, BA 8·4 PHQ-9 points 7·0, mean difference 0·1 PHQ-9 points 95% CI −1·3 to 1·5, p=0·89; PP: CBT 7·9 PHQ-9 points 7·3; BA 7·8 6·5, mean difference 0·0 PHQ-9 points –1·5 to 1·6, p=0·99). Two (1%) non-trial-related deaths (one 1% multidrug toxicity in the BA group and one 1% cancer in the CBT group) and 15 depression-related, but not treatment-related, serious adverse events (three in the BA group and 12 in the CBT group) occurred in three 2% participants in the BA group (two 1% patients who overdosed and one 1% who self-harmed) and eight (4%) participants in the CBT group (seven 4% who overdosed and one 1% who self-harmed). Interpretation We found that BA, a simpler psychological treatment than CBT, can be delivered by junior mental health workers with less intensive and costly training, with no lesser effect than CBT. Effective psychological therapy for depression can be delivered without the need for costly and highly trained professionals. Funding National Institute for Health Research.
Behaviour change interventions that promote physical activity have major implications for health and well-being. Measuring intervention fidelity is crucial in determining the extent to which an ...intervention is delivered as intended, therefore increasing scientific confidence about effectiveness. However, we lack a clear overview of how well intervention fidelity is typically assessed in physical activity trials.
A systematic literature search was conducted to identify peer - reviewed physical activity promotion trials that explicitly measured intervention fidelity. Methods used to assess intervention fidelity were categorised, narratively synthesised and critiqued using assessment criteria from NIH Behaviour Change Consortium (BCC) Treatment Fidelity Framework (design, training, delivery, receipt and enactment).
Twenty eight articles reporting of twenty one studies used a wide variety of approaches to measure intervention fidelity. Delivery was the most common domain of intervention fidelity measured. Approaches used to measure fidelity across all domains varied from researcher coding of observational data (using checklists or scales) to participant self-report measures. There was considerable heterogeneity of methodological approaches to data collection with respect to instruments used, attention to psychometric properties, rater-selection, observational method and sampling strategies.
In the field of physical activity interventions, fidelity measurement is highly heterogeneous both conceptually and methodologically. Clearer articulation of the core domains of intervention fidelity, along with appropriate measurement approaches for each domain are needed to improve the methodological quality of fidelity assessment in physical activity interventions. Recommendations are provided on how this situation can be improved.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Background
Muslims experience the lowest recovery rate from mental health difficulties across all religious groups. The aim of this research is to understand the barriers that prevent Muslims from ...accessing Cognitive Behavioral Therapy (CBT) and the extent to which these may vary across country of residence.
Methods
Systematic review and thematic synthesis for quantitative, qualitative, and mixed methods studies published in English and Arabic informed by the SPIDER search tool. Methodological quality and risk of bias of included papers were critically appraised independently according to the Mixed Methods Appraisal Tool.
Results
A search of seven databases in the Arabic and English language yielded 3836 studies with 210 studies assessed for eligibility. Employing the Mixed Methods Appraisal Tool resulted in 14 studies included in the thematic synthesis. Seven studies adopted a qualitative methodology employing semi-structured interviews and seven were quantitative descriptive studies.
Conclusions
Muslim communities experience barriers accessing Cognitive Behavioral Therapy at the level of the individual, culture, provider and management. The main barriers were experienced at the individual level which was dominated by the influence of Islam regarding the cause of mental health difficulties, which also influenced the way in which difficulties were managed.
Systematic review registration
: PROSPERO and registration number: CRD42020192854.
The well-being of informal caregivers of people living with chronic kidney disease is influenced by their experiences with support, however, few studies have focused on exploring these experiences. ...This study aimed to explore informal caregivers' experiences accessing and receiving support while caring for someone living with chronic kidney disease.
Informal caregivers of people living with chronic kidney disease (n = 13) in the United Kingdom were primarily recruited via community organisations and social media adverts to participate in semi-structured interviews. Interviews explored support needs, experiences of receiving support from different groups (e.g. healthcare professionals, family/friends), and barriers and facilitators to accessing support. Support was understood as including emotional, practical, and informational support. Data were analysed using reflexive thematic analysis.
Three themes were generated: (1) "Systems seem to get in the way" - challenges within support systems, illustrating the challenges informal caregivers encountered when navigating complex support systems; (2) Relying on yourself, describing how informal caregivers leveraged their existing skills and networks to access support independently, while recognising the limitations of having to rely on yourself to find support; and (3) Support systems can "take the pressure off", showing how support systems were able to help informal caregivers cope with the challenges they experienced if certain conditions were met.
In response to the challenges informal caregivers experienced when seeking support, improvements are needed to better consider informal caregiver needs within healthcare systems, and to develop interventions tailored to informal caregiver needs and context. Within the healthcare system, informal caregivers may benefit from system navigation support and better integration within healthcare teams to ensure their informational support needs are met. New interventions developed to support informal caregivers should fit within their existing support systems and incorporate the qualities of support, such as empathy, that were valued. Additionally, use of an equity framework and user-centered design approaches during intervention development could help ensure interventions are accessible and acceptable.
Informal caregivers (i.e. family and friends) provide essential support to people with chronic kidney disease (CKD). Many informal caregivers experience mental health problems such as anxiety and ...depression due to the caregiving role, and commonly have unmet psychological support needs. One potential solution is cognitive behavioural therapy (CBT) self-help interventions that are less reliant on extensive involvement of healthcare professionals, which may increase access. Within the intervention development phase of the MRC framework, the study's primary objective was to examine informal caregivers' self-help intervention preferences (e.g. delivery format, content). Secondary objectives were to describe the informal caregiver's situation (e.g. type of care activities) and mental health (symptoms of depression, anxiety, and stress).
An online cross-sectional survey conducted in the United Kingdom. Informal caregivers of adults living with CKD were recruited via social media, websites, newsletters, magazine articles, a podcast episode, and paid Facebook advertisements. The survey examined: informal caregiver characteristics; care recipient characteristics; self-help intervention preferences; and informal caregiver's mental health using the DASS-21. Data were analysed using descriptive statistics.
Sixty-five informal caregivers participated. The majority (85%) were female, caring for a male (77%) spouse/partner (74%). Responses indicated 58% of informal caregivers were experiencing at least mild depression. In total, 48% indicated they were likely to use a CBT self-help intervention, preferring an intervention provided via internet (e.g. website) (64%), workbook (56%), or individually in-person (54%). Regarding content, interventions should cover a wide range of topics including living with CKD, support services, informal caregiver's physical health, and diet. Overall, 48% reported a preference for a supported intervention, with support delivered in-person or via email by a trained professional at a community organisation.
Results suggest CBT self-help interventions may be an acceptable way to provide psychological support to informal caregivers, however the study is limited by the small sample size. A wide range of intervention preferences were identified indicating a need to tailor intervention content and delivery to enhance acceptability and engagement. Results will inform development of a CBT self-help intervention for informal caregivers of people with CKD.
Depression is commonly experienced by people with dementia, and associated with lower quality of life and functional decline. However, access to evidence-based psychological interventions for people ...with dementia and depression is limited. One potential solution is guided low-intensity behavioral activation. Following the new Medical Research Council Framework, considering factors such as potential barriers and facilitators to implementation is recommended during the development of new interventions. Aims of this study were to: (1) develop an understanding of existing healthcare and community support in the Swedish context for people with dementia and their informal caregivers; and (2) identify barriers and facilitators to intervention uptake informed by Normalization Process Theory.
Semi-structured interviews and focus groups were held with healthcare (n = 18) and community (n = 7) stakeholders working with people with dementia and/or informal caregivers. Interview questions were informed by Normalization Process Theory. Data was analysed utilizing a two-step deductive analysis approach using the Normalization Process Theory coding manual, with inductive categories applied to data related to the main mechanisms of the theory, but not captured by its sub-constructs.
Twelve deductive and three inductive categories related to three Normalization Process Theory primary mechanisms (Coherence, Cognitive Participation, and Collective Action) were identified. Identified barriers to intervention uptake included: (1) additional burden for informal caregivers; (2) lack of appropriate workforce to provide guidance; (3) lack of time and financial resources; (4) people with dementia not recognising their diagnosis of dementia and/or a need for support; and (5) stigma. Identified facilitators to intervention uptake included: (1) intervention has potential to fill a large psychological treatment gap in Sweden; (2) objectives and potential benefits understood and agreed by most stakeholders; and (3) some healthcare professionals recognized their potential role in providing intervention guidance.
Several barriers and facilitators for future implementation, specific to the intervention, individuals and families, as well as professionals, were identified during intervention development. Barriers were mapped into evidence-based implementation strategies, which will be adopted to overcome identified barriers. A feasibility study further examining implementation potential, acceptability and feasibility, alongside clinical, methodological, and procedural uncertainties associated with the intervention will be conducted.
Not applicable.
IntroductionMental health difficulties such as anxiety and depression have negative impacts on psychological well-being and are common in people with dementia and mild cognitive impairment. However, ...access to psychological treatments is limited. This mixed-method systematic review will: (1) examine the effectiveness of psychological interventions to improve mental health and psychological well-being in people with dementia or mild cognitive impairment; (2) examine the effectiveness of these psychological interventions to improve mental health and psychological well-being in informal caregivers; (3) examine potential clinical and methodological moderators associated with effectiveness; (4) explore factors associated with the acceptability of psychological interventions from the perspective of key stakeholders; and (5) examine the completeness and quality of intervention reporting.Methods and analysisElectronic databases (ASSIA, CENTRAL, CINAHL, EMBASE, PsycINFO and MEDLINE) will be systematically searched and supplemented with expert contact, reference and citation checking, and grey literature searches. If possible, we will conduct a meta-analysis to examine the overall effectiveness of psychological interventions to improve mental health and psychological well-being in people with dementia or mild cognitive impairment and their informal caregivers; and examine potential clinical and methodological moderators associated with effectiveness. We will conduct a deductive framework synthesis, informed by the theoretical framework of acceptability, to explore factors associated with the acceptability of psychological interventions from the perspective of key stakeholders. In accordance with Joanna Briggs Institute guidance, we will adopt a convergent segregated approach to data synthesis and integration of quantitative and qualitative findings. We will examine the completeness and quality of intervention reporting according to the Template for Intervention Description and Replication checklist and guide.Ethics and disseminationNo primary data will be collected, and therefore, ethical approval is not required. Results will be disseminated through a peer-reviewed publication, academic conferences, and plain language summaries.PROSPERO registration numberCRD42023400514.
Despite depression being prevalent in people with dementia, contributing to negative health outcomes and placing increased burden on individuals and family members, access to psychological ...interventions is limited. A potential solution is guided low-intensity behavioral activation, supported by informal caregivers and guided by healthcare professionals. However, it is necessary to adapt interventions to meet the needs and preferences of key stakeholders to enhance acceptability and relevance. Study objectives were to: (1) explore needs and preferences concerning the content and delivery model of the guided low-intensity behavioral activation intervention; and (2) adapt the intervention to ensure cultural appropriateness, relevancy, and acceptability to people with dementia and their caregivers in Sweden.
Semi-structured interviews and focus group discussions were conducted with key stakeholders, including healthcare professionals (n = 18), community stakeholders (n = 7), people with dementia (n = 8), and informal caregivers (n = 19). A draft of the written low-intensity behavioral activation intervention and a description of the proposed intervention delivery model were provided to participants. Open-ended questions explored the perceived relevance of the intervention, alongside needs and preferences concerning content and delivery. A manifest content analysis approach was adopted.
Content analysis resulted in three categories: Content, Delivery procedures, and Illness trajectory. Results highlighted a need to consider the intervention Content via increased cultural adaptation to the Swedish context, and increasing the inclusiveness of intervention content. Delivery procedures were identified as needing to be flexible given the unpredictable nature of caring for people with dementia, with the provision of additional guidance to informal caregivers supporting the intervention. Illness trajectory was viewed as essential to consider, with the intervention regarded as suitable for those early in the dementia trajectory, alongside a need to reduce workbook text to minimize burden given dementia symptomology.
The intervention and proposed delivery model were generally well received by all stakeholders. We were able to identify key adaptations to enhance cultural appropriateness, relevancy, and acceptability for a currently neglected population. Results will inform a feasibility study to explore the feasibility and acceptability of the intervention and study procedures to inform the design of a future superiority randomized controlled trial.
Not applicable.
IntroductionDementia is a worldwide health concern with incident rates continuing to increase. While depression prevalence is high in people with dementia and psychological interventions such as ...cognitive behavioural therapy (CBT) are effective, access to psychological interventions remains limited. Reliance on traditional CBT for people with dementia and depression may present difficulties given it is a complex psychological approach, costly to deliver, and professional training time is lengthy. An alternative approach is behavioural activation (BA), a simpler psychological intervention for depression. The present study seeks to work with people with dementia, informal caregivers, community stakeholders, and healthcare professionals, to adapt a guided low-intensity BA intervention for people with dementia and depression, while maximising implementation potential within the Swedish healthcare context.Methods and analysisA mixed methods study using codesign, principles from participatory action research (PAR) and normalisation process theory to facilitate the cultural relevance, appropriateness and implementation potential of the intervention. The study will consist of four iterative PAR phases, using focus groups with healthcare professionals and community stakeholders, and semi-structured interviews with people with dementia and informal caregivers. A content analysis approach will be adopted to analyse the transcribed focus groups and semi-structured interviews recordings.Ethics and disseminationThe study will be conducted in accordance with the Declaration of Helsinki and data handled according to General Data Protection Regulation. Written informed consent will be obtained from all study participants. In accordance with the Swedish Health and Medical Services Act, capacity to consent will be examined by a member of the research team. Ethical approval has been obtained from the Swedish Ethical Review Authority (Dnr: 2020-05542 and Dnr: 2021-00925). Findings will be published in an open access peer-reviewed journal, presented at academic conferences, and disseminated among lay and healthcare professional audiences.