Clinical effectiveness of the psychological therapy Mental Health Intervention for Children with Epilepsy in addition to usual care compared with assessment-enhanced usual care alone: a multicentre, randomised controlled clinical trial in the UK.

BACKGROUND: Mental health difficulties are common in children and young people with chronic health conditions, but many of those in need do not access evidence-based psychological treatments. The study aim was to evaluate the clinical effectiveness of integrated mental health treatment for children and young people with epilepsy, a common chronic health condition known to be associated with a particularly high rate of co-occurring mental health difficulties. METHODS: We conducted a parallel group, multicentre, open-label, randomised controlled trial of participants aged 3-18 years, attending epilepsy clinics across England and Northern Ireland who met diagnostic criteria for a common mental health disorder. Participants were randomised (1:1; using an independent web-based system) to receive the Mental Health Intervention for Children with Epilepsy (MICE) in addition to usual care, or assessment-enhanced usual care alone (control). Children and young people in both groups received a full diagnostic mental health assessment. MICE was a modular psychological intervention designed to treat common mental health conditions in children and young people using evidence-based approaches such as cognitive behaviour therapy and behavioural parenting strategies. Usual care for mental health disorders varied by site but typically included referral to appropriate services. Participants, along with their caregivers, and clinicians were not masked to treatment allocation but statisticians were masked until the point of analysis. The primary outcome, analysed by modified intention-to-treat, was the parent-report Strengths and Difficulties Questionnaire (SDQ) at 6 months post-randomisation. The study is complete and registered with ISRCTN (57823197). FINDINGS: 1401 young people were potentially deemed eligible for study inclusion. Following the exclusion of 531 young people, 870 participants were assessed for eligibility and completed the SDQ, and 480 caregivers provided consent for study inclusion between May 20, 2019, and Jan 31, 2022. Between Aug 28, 2019, and Feb 21, 2022, 334 participants (mean ages 10·5 years [SD 3·6] in the MICE group vs 10·3 [4·0] in control group at baseline) were randomly assigned to an intervention using minimisation balanced by age, primary mental health disorder, diagnosis of intellectual disability, and autistic spectrum disorder at baseline. 168 (50%) of the participants were female and 166 (50%) were male. 166 participants were randomly assigned to the MICE group and 168 were randomly assigned to the control group. At 6 months, the mean SDQ difficulties for the 148 participants in the MICE group was 17·6 (SD 6·3) and 19·6 (6·1) for the 148 participants in the control group. The adjusted effect of MICE was -1·7 (95% CI -2·8 to -0·5; p=0·0040; Cohen's d, 0·3). 14 (8%) patients in the MICE group experienced at least one serious adverse event compared with 24 (14%) in the control group. 68% percent of serious adverse events (50 events) were admission due to seizures. INTERPRETATION: MICE was superior to assessment-enhanced usual care in improving symptoms of emotional and behavioural difficulties in young people with epilepsy and common mental health disorders. The trial therefore shows that mental health comorbidities can be effectively and safely treated by a variety of clinicians, utilising an integrated intervention across ages and in the context of intellectual disability and autism. The evidence from this trial suggests that such a model should be fully embedded in epilepsy services and serves as a model for other chronic health conditions in young people. FUNDING: UK National Institute for Health Research Programme Grants for Applied Research programme and Epilepsy Research UK Endeavour Project Grant.

Which psychological interventions improve quality of life in patients with schizophrenia-spectrum disorders? A meta-analysis of randomized controlled trials.

Quality of life (QoL) is a major patient reported outcome used to measure the psychological treatments success in people with schizophrenia-spectrum disorders. To date, the specific impact of different interventions on QoL remains undefined. A meta-analysis of Randomized Controlled Trials (RCTs) was carried out for this purpose. We searched Proquest, PUBMED/MEDLINE, PsycINFO, WOS, Scopus, the Cochrane Library for RCTs published until January 2023. We used multilevel meta-analysis to examine differences between intervention effectiveness of experimental and control conditions whilst accounting for data dependencies. By means of subgroup analyses, we investigated influences of intervention types (i.e. psychoeducation v. CBT v. cognitive v. combination of several types v. other, such as psychodynamic, systemic, etc.) and continuous moderators were examined with precision-weighted meta-regressions. The generalizability of results across moderators, their combinations, and analytical approaches was investigated with multiverse meta-analyses. We examined data of 60 independent studies, reporting intervention effects for objective and subjective QoL (k = 19 and 70 effect sizes based on N = 1024 and 6254 participants, respectively). Overall, psychological interventions seemed to be more effective for objective than for subjective QoL. However, specific intervention results were differentiated, suggesting largest effects of psychoeducation on objective and combined interventions on subjective QoL. Our findings suggest that QoL is a valid outcome criterion for testing intervention effectiveness, as it is sensitive to change. Additionally, psychological interventions can improve patients' QoL, though the effects are small. Further testing of less widely used interventions and a shift toward the multidimensional nature of QoL is still necessary.

Peri-operative individually tailored psychological intervention in breast cancer patients improves psychological indices and molecular biomarkers of metastasis in excised tumors.

Perioperative stress and inflammatory signaling can invigorate pro-metastatic molecular processes in patients' tumors, potentially worsening long-term survival. Yet, it is unknown whether pre-operative psychotherapeutic interventions can attenuate such effects. Herein, three weeks before surgery, forty women diagnosed with stage I-III invasive ductal/lobular breast carcinoma were randomized to a 6-week one-on-one psychological intervention (6 meetings with a medical psychologist and bi-weekly phone calls) versus standard nursing-staff-attention. The intervention protocol was individually tailored based on evaluation of patients' emotional, cognitive, physiological, and behavioral stress response-patterns, and also included psychoeducation regarding medical treatments and recruitment of social support. Resected primary tumors were subjected to whole-genome RNA sequencing and bioinformatic analyses, assessing a priori hypothesized cancer-relevant molecular signatures. Self-report questionnaires (BSI-18, Hope-18, MSPSS, and a stress-scale) were collected three (T1) and one (T2) week before surgery, a day before (T3) and after (T4) surgery, and three weeks (T5) and 3-months (T6) following surgery. The intervention reduced distress (GSI), depression, and somatization scores (BSI-18: p < 0.01, p < 0.05, p < 0.05; T5 vs. T1). Additionally, tumors from treated patients (vs. controls) showed: (i) decreased activity of transcription control pathways involved in adrenergic and glucocorticoid signaling (CREB, GR) (p < 0.001), pro-inflammatory signaling (NFkB) (p < 0.01), and pro-malignant signaling (ETS1, STAT and GATA families) (p < 0.001, p < 0.01, p < 0.005); (ii) increased M1 macrophage polarization (p < 0.05), and CD4+ T cell activity (p < 0.01); and an unexpected increase in epithelial-to-mesenchymal-transition (EMT) signature (p < 0.005). This is the first randomized controlled trial to show beneficial effects of a psychological perioperative intervention on tumor pro-metastatic molecular biomarkers.

Predicting psychosocial intervention response from baseline gene expression.

To address the challenge of predicting psychological response to a psychosocial intervention we tested the possibility that baseline gene expression profiles might provide information above and beyond baseline psychometric measures. The genomics strategy utilized individual level inferences of transcription factor activity to predict changes in loneliness and affect in response to two well-established meditation interventions. Initial algorithm development analyses focused on three a-priori defined stress-related gene regulation pathways (CREB, GR, and NF-ĸB) as inferred from TELiS promoter-based bioinformatic analysis of basal (pre-intervention) blood samples from a randomized-controlled trial comparing a compassion-based meditation (CM, n = 45) with mindfulness meditation (MM, n = 44). Greater baseline CREB activity (but not GR or NF-ĸB) predicted greater reductions from pre- to post-intervention in loneliness (b = -0.24, p = 0.016) and negative emotions (b = -0.23, p = 0.017) for CM, but not for MM. A second algorithm validation analysis applied the same approach to another randomized controlled trial comparing CM (n = 42) with MM (n = 38) and a health education control condition (n = 41). Similarly, greater baseline CREB activity predicted greater pre- to post-intervention decreases in loneliness (b = -0.24, p = 0.029) and greater increases in satisfaction with life (b = 0.21, p = 0.046) for the CM condition only. Baseline CREB activity was not associated with baseline psychometric measures in either study. Results raise the possibility that pre-intervention gene expression profiles may reflect non-conscious psychobiological states that affect psychological responses to distinct psychosocial interventions, and thereby help personalize intervention selection.

Efficacy and acceptability of psychosocial interventions in schizophrenia: systematic overview and quality appraisal of the meta-analytic evidence.

Psychosocial interventions are recommended in schizophrenia and first-episode psychosis/early psychosis (EP). Nevertheless, literature is heterogeneous and often contradictory. We conducted an umbrella review of (network) meta-analyses of randomized controlled trials (RCTs) comparing psychosocial interventions vs treatment as usual (TAU)/active interventions(ACTIVE)/MIXED controls. Primary outcome was total symptoms (TS); secondary outcomes were positive/negative/depressive symptoms (PS/NS/DS), cognition, functioning, relapse, hospitalization, quality of life (QoL), treatment discontinuation. Standardized mean difference (SMD)/odds ratio (OR)/risk ratio (RR) vs TAU/ACTIVE/MIXED were summarized at end-of-treatment (EoT)/follow-up (FU). Quality was rated as high/medium/low (AMSTAR-PLUS). Eighty-three meta-analyses were included (RCTs = 1246; n = 84,925). Against TAU, regarding TS, Early Intervention Services (EIS) were superior EoT/FU in EP (SMD = -0.32/-0.21), cognitive behavioral therapy (CBT) in schizophrenia EoT/FU (SMD = -0.38/-0.19). Regarding secondary outcomes, in EP, EIS were superior for all outcomes EoT except cognition, and at FU for PS/NS/QoL, specific family interventions (FI-s) prevented relapse EoT; in schizophrenia, superiority emerged EoT for CBT for PS/NS/relapse/functioning/QoL; psychoeducation (EDU)/any FI for relapse; cognitive remediation therapy (CRT) for cognition/functioning; and hallucination-focused integrative treatment for PS. Against ACTIVE, in EP, mixed family interventions (FI-m) were superior at FU regarding TS (SMD = -0.61) and for functioning/relapse among secondary outcomes. In schizophrenia, regarding TS, mindfulness and social skills training (SST) were superior EoT, CBT at FU; regarding secondary outcomes superiority emerged at EoT for computerized cognitive drill-and-practice training for PS/DS, CRT for cognition/functioning, EDU for relapse, individual placement and support (IPS) for employment; and at FU CBT for PS/NS. Against MIXED, in schizophrenia, CRT/EDU were superior for TS EoT (d = -0.14/SMD = -0.33), CRT regarding secondary outcomes EoT for DS/social functioning, both EoT/FU for NS/cognition/global functioning; compensatory cognitive interventions for PS/functioning EoT/FU and NS EoT; CBT for PS at FU, and EDU/SST for relapse EoT. In conclusion, mental health services should consider prioritizing EIS/any FI in EP and CBT/CRT/any FI/IPS for schizophrenia, but other interventions may be helpful for specific outcomes.

Business case for psychosocial interventions in clinics: potential for decrease in treatment discontinuation and costs.

RESEARCH QUESTION: From a value-based healthcare (VBHC) perspective, does an assessment of clinical outcomes and intervention costs indicate that providing cognitive behavioural therapy (CBT) or mindfulness to women seeking fertility treatment add value compared with no such intervention? DESIGN: Proof-of-concept business case based on a VBHC perspective that considers clinical outcomes and costs. Potential effects on psychological and fertility outcomes were based on existing research. Cost outcomes were estimated with a costing model for the Dutch fertility treatment setting. RESULTS: Thirty-two studies were identified; 13 were included. Women who received CBT had 12% lower anxiety, 40% lower depression and 6% higher fertility quality of life; difference in clinical pregnancy rates was six percentage points (CBT [30.2%]; control [24.2%]); difference in fertility discontinuation rates was 10 percentage points (CBT [5.5%]; control [15.2%]). Women who received training in mindfulness had 8% lower anxiety, 45% lower depression and 21% higher fertility quality of life; difference in mean clinical pregnancy rate was 19 percentage points (mindfulness [44.8%]; control [26.0%]). Potential total cost savings was about €1.2 million per year if CBT was provided and €11 million if mindfulness was provided. Corresponding return on investment for CBT was 30.7%, and for mindfulness 288%. Potential cost benefits are influenced by the assumed clinical pregnancy rates; such data related to mindfulness were limited to one study. CONCLUSIONS: The provision of CBT or mindfulness to women seeking fertility treatment could add value. Higher quality primary studies are needed on the effect of mindfulness on clinical pregnancy rates.

Editorial Perspective: Adapting western psychological interventions for children and adolescents in LMICs: lessons from Nepal.

Nepal is a low-middle income country which is considered to be a collectivist culture and has a significant mental health treatment gap for young people. The dominant approach in the global mental health literature has been to import western treatments with varying degrees of cultural adaptation. We argue that this approach is at best cost-ineffective, and at worst harmful, particularly where young people receive interventions outside of their community. The existing literature suggests that the type of intervention delivered, is of less importance than the situating of it within a young person's community, and that leveraging existing cultural resources for resilience within a community, may ultimately be of more benefit than the translating and delivering western ones.

Psychosocial interventions for ovarian cancer survivors: A systematic review.

OBJECTIVES: Ovarian cancer survivorship is complex and is associated with greater symptom burden, fear of reoccurrence, sexual dysfunction, lower quality of life and heightened existential distress in contrast to other cancers. This systematic review aimed to investigate the effectiveness for, and perspective of, psychosocial interventions encompassing psychological, social, and emotional support, tailored to, or involving ovarian cancer survivors at all stages of disease. METHODS: Adhering to the PRISMA-SR statement guidelines, a systematic search was conducted across PsycINFO, MEDLINE, Embase, Emcare, CINAHL, Scopus, Cochrane Library databases, Google, and Google Scholar. Two reviewers independently undertook a two-stage screening process. The Mixed Methods Appraisal Tool was utilised to assess the methodological quality of included studies. Data were extracted using customised data extraction tools and narratively synthesised. RESULTS: Thirteen studies were included in this review. Generally positive effects of psychosocial interventions were observed across a range of outcome domains (meaning enhancing, cognitive, social, emotional, and cancer-specific). However, the characteristics of interventions and outcome measures varied across studies. Psychoeducational interventions were identified as the most common psychosocial approach, while Acceptance and Commitment Therapy showed promise in addressing the disease's high symptom burden. Women's perspectives of psychosocial interventions were described as "useful" and promoted positive self-regard. CONCLUSION: While the evidence base largely support positive effects of psychosocial interventions for ovarian cancer survivors, this finding is constrained by heterogeneity of interventions and modest gains. Future research may explore the standardisation of psychosocial interventions for this demographic, investigating its effects on less explored but prevalent concerns among ovarian cancer survivors such as fear of cancer recurrence and sexual dysfunction.

Guided versus non-guided digital psychological interventions for cancer patients: A systematic review and meta-analysis of engagement and efficacy.

OBJECTIVE: To evaluate engagement with and efficacy of guided versus non-guided digital interventions targeting psychological symptoms of cancer via a systematic review of current evidence. METHODS: PubMed, Scopus, PsychINFO, MEDLINE, and CINAHL databases were searched. Eligible publications were randomised controlled trials of guided or non-guided digital psychological interventions used in cancer settings reporting intervention efficacy and/or engagement. Study methodological quality was assessed using the Cochrane risk of bias (RoB) tool. Random effects meta-analyses were performed on outcomes with sufficient data, with sub-group analyses of intervention type and follow-up period. RESULTS: Forty-three studies were included. Studies varied by level of guidance, type of technology used, duration, and outcomes assessed. Most studies had a high overall RoB. Meta-analysis indicated that guided interventions significantly reduced distress, anxiety, and fatigue, while non-guided did not. For depression and quality of life, both guided and non-guided interventions produced significant improvements. Guided interventions reported higher levels of intervention engagement than non-guided. CONCLUSIONS: Guided digital psychological interventions were likely to be more effective than non-guided ones for cancer patients, particularly in reducing distress, anxiety, and fatigue. Whilst both types were found to improve depression and life quality, guided interventions were associated with higher patient engagement. These findings suggest digital interventions could supplement traditional cancer care, warranting further research concerning long-term effects and cost-efficiency.

Feasibility and acceptability of study methods and psychosocial interventions for body image among women diagnosed with breast cancer: A systematic review and narrative synthesis.

OBJECTIVE: This systematic review aimed to summarize evidence for the feasibility and acceptability of psychosocial interventions for body image among women diagnosed with breast cancer and the study methods used to evaluate the interventions in question. METHODS: Articles were identified via MEDLINE, CINAHL, CENTRAL, PsychINFO, and EMBASE. Inclusion criteria were: (1) peer-reviewed publication in English from 2000 onward with accessible full-text, (2) reported data on the feasibility and/or acceptability of psychosocial interventions and/or study methods, (3) included at least one measure of body image or reported a body-related theme, and (4) sample comprised women diagnosed with breast cancer. All study designs were eligible. Two reviewers independently performed study selection, data extraction, and quality assessment. RESULTS: Sixty-two articles were included. Participants and comparator groups varied as did interventions. Feasibility and acceptability of the interventions and study methods were inconsistently operationalized and reported across studies. Evidence of feasibility and acceptability was heterogeneous within and across studies, though mostly positive. CONCLUSION: Published psychosocial interventions for body image and study methods are generally feasible and acceptable. Findings should be used to advance the development, implementation, and evaluation of interventions designed to improve outcomes (body image or otherwise) for women diagnosed with breast cancer. SYSTEMATIC REVIEW REGISTRATION: This review was registered with the International Prospective Register of Systematic Reviews (PROSPERO; ID: CRD42021269062, 11 September 2021).

Interventions to Reduce Lung Cancer and COPD-Related Stigma: A Systematic Review.

BACKGROUND: Many individuals with lung cancer and chronic obstructive pulmonary disease (COPD) experience high levels of stigma, which is associated with psychological distress and delayed help-seeking. PURPOSE: To identify interventions aimed at reducing the stigma of lung cancer or COPD and to synthesize evidence on their efficacy. METHODS: A systematic review was conducted by searching PubMed, Scopus, PsycINFO, and CINAHL for relevant records until March 1, 2024. Studies were eligible if they described an intervention designed to reduce internalized or external stigma associated with COPD or lung cancer and excluded if they did not report empirical findings. RESULTS: We identified 476 papers, 11 of which were eligible for inclusion. Interventions included educational materials, guided behavior change programs, and psychotherapeutic approaches. Interventions targeted people diagnosed with, or at high risk of developing COPD or lung cancer or clinical staff. No interventions that aimed to reduce stigma associated with lung cancer or COPD in the general community were identified. Most interventions yielded a statistically significant reduction in at least one measure of stigma or a decrease in qualitatively reported stigma. CONCLUSIONS: The emerging literature on interventions to reduce stigma associated with lung cancer and COPD suggests that such interventions can reduce internalized stigma, but larger evaluations using randomized controlled trials are needed. Most studies were in the pilot stage and required further evaluation. Research is needed on campaigns and interventions to reduce stigma at the societal level to reduce exposure to external stigma amongst those with COPD and lung cancer.

Many people with lung cancer and chronic obstructive pulmonary disease experience stigma, such as negative judgments from others or feelings of guilt or shame. This can lead to feelings of distress and delays in seeking medical support. We reviewed existing studies that evaluated interventions aiming to reduce the stigma associated with these diseases. The results showed that there are programs and strategies that may reduce the stigma that patients with these diseases experience. The most promising programs were psychosocial interventions that included established psychological methods, such as mindfulness-based stress reduction, cognitive behavioral therapy or acceptance and commitment therapy. However, the evidence is limited because of the small number of studies and the lack of randomized trials. Most of the evidence focuses on the individual with the illness, and future research is needed on how to reduce the stigma associated with these illnesses at a community or societal level.

Adverse Events of Psychological Interventions: Definitions, Assessment, Current State of the Research and Implications for Research and Clinical Practice.

BACKGROUND: The effectiveness of psychological interventions is undisputed. But while in other fields of health care the safety of interventions is studied alongside effectiveness, adverse events (AEs) have only recently been assessed in clinical studies of psychological interventions. This critical review summarizes the definition, assessment and current research status of AEs of psychological interventions. SUMMARY: AEs are defined as any untoward event or unfavorable change that occurs in the course of a psychological intervention. AEs that are caused by the intervention can be classified into side effects of correctly applied treatment, malpractice (i.e., incorrectly applied treatment) and unethical conduct (e.g., sexual abuse). Ideally, they are assessed by independent raters or alternatively by self-report questionnaires that should also cover serious adverse events (SAEs, e.g., suicide attempts or self-injurious behaviors). About 1 to 2 in 3 patients report at least 1 AE and results of meta-analyses suggest that treatments might differ in frequency and/or severity of AE and in treatment acceptability (measured as dropout rates). KEY MESSAGES: Measures of AEs and SAEs as well as more nuanced descriptions of dropout should be included in all clinical studies of psychological interventions. If this happens, we might learn that psychological interventions differ with respect to AEs, SAEs and acceptability. As many psychological interventions are about equally effective, they might one day be chosen based on differences in their safety profile rather than their differential effectiveness. Ideally, reducing AEs might also lead to more effective interventions.

Flexibly Incorporating the Dyad into Psychosocial Intervention: Considerations for Neuropalliative Care.

This paper reviews dyadic psychosocial intervention approaches that flexibly incorporate both dyad members despite challenges to equitable involvement due to cognitive limitations or limited availability. We provide an overview, analysis, and examples for the following dyadic intervention approaches: (1) shared interventions that involve each dyad member equitably (i.e., higher care recipient cognition, higher care-partner availability); (2) patient-focused interventions that primarily engage care recipients with early stages of neurocognitive disorders, yet include care-partners in select sessions and target dyadic and relationship needs (i.e., higher care recipient cognition, lower care-partner availability); and (3) care-partner focused interventions that primarily engage care-partners, yet still address care recipient and relationship needs (i.e., lower care recipient cognition, higher care-partner availability). In our review, we propose a flexible definition of dyadic psychosocial intervention that considers the continuum of individuals' involvement, measurement, content, and conceptual background. We conclude with a discussion of implications for neuropalliative care.

Online, group, low-intensity psychological intervention for adults, children, and parents with food allergy.

BACKGROUND: Food allergy (FA) impairs psychological wellbeing because of constant vigilance, planning and preparation, dietary and social restrictions, and fear of accidental ingestion, though psychological interventions are sparse. OBJECTIVE: To examine online, group, low-intensity psychological interventions for adults, children, young people (CYP), and parents with food allergies. METHODS: The randomized controlled trials assessed the feasibility and signal of the efficacy of a psychological intervention for adults, CYP, and parents with FA. Participants were randomized to receive the psychological intervention or treatment as usual. The intervention consisted of two, 3-hour manualized online sessions spaced 1 week apart. All participants completed relevant Food Allergy Quality of Life Questionnaires (FAQLQ) and worry (Penn State Worry Questionnaires), in addition to exploratory outcomes, at baseline, 1 month, and 3 months. RESULTS: A total of 129 participants (n = 44 adults, n = 52 CYP, and n = 33 parents) were recruited and randomized; 95 (74%) (n = 36 adults, n = 35 CYP, and n = 24 parents) were retained at 3 months. Owing to baseline differences, mean change was used for parent and CYP outcomes. The psychological intervention demonstrated large FAQLQ benefits across adults (g = -1.12, 95% CI -0.41 to -1.28), CYP (g = 1.23, 95% CI 0.51-1.95), and parents (g = 1.43, 95% CI 0.54-2.30) compared with controls at 3-months. CONCLUSION: This study provides encouraging findings regarding the feasibility of online, group, low-intensity psychological interventions, in terms of recruitment and retention as well as a signal of efficacy on FAQLQ. A definitive trial including health economic analysis and FA-specific psychological measures with consideration of best routes to implementation, is warranted. TRIAL REGISTRATION: Clinicaltrials.gov Identifiers: NCT04763889 (adults), NCT04770727 (CYP), and NCT04774796 (parents).

Testing the effectiveness of two psychosocial interventions - ACCENT and Didactic - to prevent HIV/AIDS behavioral risk factors in Mozambican women: a randomized controlled study.

In Mozambique, women are the most affected by HIV/AIDS and heterosexual encounters remain the main route for HIV/AIDS. Condom use is the most effective method of HIV/AIDS prevention, and the intention to use and buy/get condoms has a significant role in safe sex behavior. This study aimed to evaluate the efficacy of two psychosocial interventions - the Didactic and ACCENT Interventions - to prevent HIV/AIDS among Mozambican Women. Participants were Mozambican women (n = 150), users of the gynecology clinic of the Central Hospital of Beira. The study design was a randomized controlled trial (RCT) with assignment to three groups: Didactic intervention, ACCENT intervention, and Control group. Measures were from an adaption of the Women's Health Questionnaire, which includes questions about sociodemographic, clinical, and behavioral variables related to HIV prevention/risk. There was a significant group effect on condom use and safer sex preparatory behaviors, F(2, 146) = 6.45, p = .002, with Bonferroni post-hoc tests showing differences between the ACCENT vs. Control groups and ACCENT vs. Didactic groups (all p = .022). There were no statistically significant time effects on both condom use and safer sex preparatory behaviors. Results are promising for HIV/AIDS prevention in Mozambican women at sexual risk, but replication is needed for generalizability of findings.

The effect of psychosocial interventions for sexual health in patients with pelvic cancer: a systematic review and meta-analysis.

AIM: The aim of this systematic review and meta-analysis was to explore and evaluate the effect of psychosocial interventions in improving sexual health outcomes among post-treatment patients with pelvic cancer. METHODS: Inclusion and exclusion criteria were pelvic cancer survivors; psychosocial interventions; studies with a control group and measures of sexual health. Five databases were searched for literature along with an inspection of the included studies' reference lists to extend the search. Risk of bias was assessed with the RoB2 tool. Standardised mean difference (SMD) with a random effects model was used to determine the effect size of psychosocial interventions for sexual health in patients with pelvic cancers. RESULTS: Thirteen studies were included, with a total number of 1,541 participants. There was a large heterogeneity regarding the type of psychosocial intervention used with the source found in a leave one out analysis. Six studies showed statistically significant improvements in sexual health, while three showed positive but non-significant effects. The summary effect size estimate was small SMD = 0.24 (95% confidence interval [CI]: 0.05 to 0.42, p = 0.01). DISCUSSION: There is limited research on psychosocial interventions for sexual health in pelvic cancer patients. There are also limitations in the different pelvic cancer diagnoses examined. Commonly, the included articles examined physical function rather than the whole sexual health spectrum. The small effect sizes may in part be due to evaluation of psychosocial interventions by measuring physical dysfunction. Future research should broaden sexual health assessment tools and expand investigations to more cancer types.

Feasibility, acceptability, and preliminary efficacy of a self-directed online psychosocial intervention for women with metastatic breast cancer: Finding My Way-Advanced.

PURPOSE: Few digital interventions target patients with advanced cancer. Hence, we feasibility-tested Finding My Way-Advanced (FMW-A), a self-guided program for women with metastatic breast cancer. METHODS: A single-site randomised controlled pilot trial was conducted. Participants were recruited through clinicians, professional networks, and social media and randomised to intervention or usual-care control. Participants were randomly allocated to either the intervention (FMW-A; a 6-week, 6-module CBT-based online self-directed psychosocial program for women with MBC + usual care resources) or control (usual care resources: BCNA's Hope and Hurdles kit). Feasibility outcomes included rates of recruitment, uptake, engagement, and attrition. Distress, QOL, and unmet needs were evaluated for signals of efficacy, and qualitative feedback was collected to assess acceptability. RESULTS: Due to COVID-19 and funding constraints, the target recruitment of 40 was not reached (n = 60 approached; n = 55 eligible; n = 35 consented). Uptake was high (n = 35/55; 63.6%), engagement modest (median 3/6 modules per user), and attrition acceptable (66% completed post-treatment). Efficacy signals were mixed: compared to controls, FMW-A participants experienced small improvements in fear of progression (d = 0.21) and global QOL (d = 0.22) and demonstrated a trend towards improvements in cancer-specific distress (d = 0.13) and role functioning (d = 0.18). However, FMW-A participants experienced small-to-moderate deteriorations in general distress (d = 0.23), mental QOL (d = 0.51), and social functioning (d = 0.27), whereas controls improved. Qualitatively, participants (n = 4) were satisfied with the program, perceived it as appropriate, but noted some sections could evoke transient distress. CONCLUSION: The study demonstrated feasibility (high uptake and acceptable retention) and generated realistic recruitment estimates. While FMW-A appears promising for targeting cancer-specific distress and fear of progression, the mixed findings in quality of life and general distress warrant further revisions and testing.

The effectiveness of digital psychosocial interventions on psychological distress, depression, anxiety, and health-related quality of life in patients with gynaecological cancer: a systematic review and meta-analysis.

PURPOSE: Patients with gynaecological cancer often experience psychological issues due to multiple stressors. Psychological disturbances have debilitating effects on patients with gynaecological cancer. In recent decades, digital psychosocial interventions have rapidly advanced and been incorporated into mental health interventions. Digital psychosocial interventions could provide patients with several benefits over traditional in-person interventions, including convenience, anonymity, flexible scheduling, and geographic mobility. The aim of this systematic review was to synthesize the effectiveness of digital psychosocial intervention in reducing psychological distress, depression, and anxiety and improving health-related quality of life in patients with gynaecological cancer. METHODS: Three-step extensive search was performed on 22 December 2022 from nine bibliographic databases, trial registries and grey literature. Experimental studies involving patients with gynaecological cancer utilizing digital psychosocial interventions for the improvement of mental health outcomes were included. Meta-analysis was conducted using RevMan 5.4 software. Heterogeneity was analysed by Cochran's Q test and I2. Subgroup analyses were attempted to evaluate relative effect sizes of subgroup features. RESULTS: Meta-analysis of nine studies revealed small effect size in reduction of depression post-intervention (d = 0.24, 95% CI - 0.46 to - 0.02) and medium effect size in reduction of psychological distress post-intervention (d = 0.51, 95% CI - 0.81 to - 0.21) and follow-up (d = 0.65, 95% CI - 1.25 to - 0.05) compared to the control group. The effects of digital psychosocial interventions on anxiety and health-related quality of life were not statistically significant. CONCLUSIONS: Digital psychosocial interventions probably reduced psychological distress and slightly reduced depression amongst patients with gynaecological cancer compared to the control group, which can be integrated into clinical practice. Additional trials with rigorous methodology and bigger sample sizes are needed to validate findings. TRIAL REGISTRATION: PROSPERO (CRD42023389502).

Psychosocial Interventions for Children and Young People With Visible Differences Resulting From Appearance-Altering Conditions, Injury, or Treatment Effects: An Updated Systematic Review.

OBJECTIVE: Children and young people with visible differences can experience psychosocial difficulties, such as anxiety and teasing by others. Interventions targeting difficulties have previously been reviewed by Jenkinson et al. This review aimed to identify and critically assess recent studies evaluating the effectiveness of psychosocial interventions for children and young people with visible differences on psychosocial wellbeing, self-esteem, and social experiences and compare the findings with Jenkinson et al. using a replacement review process. METHODS: Inclusion criteria are as follows: studies with participants aged 0-18 years with visible differences; investigating a psychosocial intervention; including comparison with an alternative intervention, control group, or pre- and post-intervention; and including a quantitative measure assessed pre- and post-intervention. Exclusion criteria are as follows: participants with body dysmorphic disorder or appearance changes due to eating disorders or obesity and studies not written in English. MEDLINE, AMED, and PsycInfo were searched and grey literature was included. Results were reviewed against eligibility criteria, data were extracted, and studies were evaluated using the Cochrane Risk of Bias 2 tool. RESULTS: Using Jenkinson et al. as one source of studies, 24 studies were included evaluating a range of interventions such as social interaction skills training, residential social camps, and cognitive behavioral therapy. Risk of bias was high in 20 studies and of some concern in four studies. CONCLUSION: There is some evidence of the effectiveness of hypnotherapy, a relaxation response resiliency program, integrative body-mind-spirit group, and therapeutic patient education, but more rigorous research is needed to confirm their impact on psychosocial outcomes.

Process evaluation of a New psychosocial goal-setting and manualised support intervention for Independence in Dementia (NIDUS-Family).

INTRODUCTION: We report a mixed-methods process evaluation embedded within a randomised controlled trial. We aimed to test and refine a theory of change model hypothesising key causal assumptions to understand how the New Interventions for Independence in Dementia Study (NIDUS)-Family (a manualised, multimodal psychosocial intervention), was effective relative to usual care, on the primary outcome of Goal Attainment Scaling (GAS) over 1 year. METHODS: In 2021-2022, intervention-arm dyads completed an acceptability questionnaire developed to test causal assumptions. We conducted qualitative interviews with dyads and intervention facilitators, purposively selected for diverse follow-up GAS scores. We collected observational data from intervention session recordings. We thematically analysed data, then integrated qualitative and quantitative data. RESULTS: 174/204 (85.3%) dyads allocated to NIDUS-Family, fully completed it, 18 partially completed, while 12 received no intervention. We interviewed 27/192 (14%) of dyads receiving any sessions, and 9/10 facilitators; and observed 12 sessions. 47/192 (24.5%) of carers completed the acceptability questionnaire. We identified four themes: (A) 'Someone to talk to helps dyads feel supported'; (B) 'NIDUS-Family helps carers change their perspective'; (C) 'Personalisation helps people living with dementia maintain their identity' and (D) 'Small steps help dyads move forward'. CONCLUSION: Key causal pathway mechanisms were: a respectful, trusting and impartial relationship with the facilitator: supporting the development of meaningful goals and support to find manageable solutions. Core implementation factors were delivery of the modules from a consistent facilitator across regular sessions. Core contextual factors influencing these mechanisms were dyadic participation and understanding of abilities.