A multicentre randomised controlled trial of a guided self-help cognitive behavioural therapy to MANage the impact of hot flushes and night sweats in patients with prostate CANcer undergoing androgen deprivation therapy (MANCAN2).

BACKGROUND: Androgen deprivation therapy (ADT) is prescribed to almost half of all men diagnosed with prostate cancer. Although ADT is effective treatment, with virtually all men with advanced disease showing initial clinical response, it is associated with troublesome side effects including hot flushes and night sweats (HFNS). HFNS can be both frequent and severe and can have a significant impact on quality of life (QoL). They can occasionally be so debilitating that patients stop ADT altogether, despite the increased risk of disease relapse or death. Previous research has found that guided self-help cognitive behavioural therapy (CBT) can be effective in reducing HFNS due to ADT when delivered by a clinical psychologist. MANCAN2 aims test whether we can train the existing NHS Prostate Cancer Nurse Specialist (CNS) team to deliver guided self-help CBT and whether it is effective in reducing the impact of HFNS in men undergoing ADT. METHODS: MANCAN2 is a phase III multicentre randomised controlled trial and process evaluation. Between 144 and 196 men with prostate cancer who are currently receiving ADT and are experiencing problematic HFNS will be individually randomised in a 1:1 ratio in groups of 6-8 participants to either treatment as usual (TAU) or participation in the guided self-help CBT intervention plus TAU. A process evaluation using the normalisation process theory (NPT) framework will be conducted, to understand the CNS team's experiences of delivering the intervention and to establish the key influencers to its implementation as a routine practice service. Fidelity of implementation of the intervention will be conducted by expert assessment. The cost-effectiveness of the intervention and participant adherence to the trial intervention will also be assessed. DISCUSSION: MANCAN2 will advance the program of work already conducted in development of management strategies for HFNS. This research will determine whether the severity of ADT-induced HFNS in men with prostate cancer can be reduced by a guided self-help CBT intervention, delivered by the existing NHS prostate cancer CNS team, within a multicentre study. The emphasis on this existing team, if successful, should facilitate translation through to implementation in routine practice. TRIAL REGISTRATION: ISRCTN reference 58720120 . Registered 13 December 2022.

Digital Interventions for PTSD Symptoms in the General Population: a Review.

There has been a significant development of digital interventions for the treatment of Post-Traumatic Symptom Disorder (PTSD) over the past two decades. However, the majority of research has examined their clinical efficacy for military service members and veteran populations whereas community-based trauma survivors have received significantly less attention. Their effectiveness for this population, therefore, remains unclear. The aim of this review was to evaluate the effectiveness of digitally delivered psychological therapies to alleviate PTSD symptomatology in the general population. Findings showed that digitally delivered Cognitive Behavioural Therapy (iCBT) produced more consistently significant improvements in PTSD symptoms, compared to interapy, expressive writing, psychoeducation, mindfulness, cognitive tasks and psychosocial interventions. iCBT - associated improvements were also independent of the focus (i.e. trauma vs. non-trauma) of the intervention, the provision of therapeutic support (e.g. guided vs. unguided), type of feedback (e.g. automated vs. individualised) or the number of sessions provided. Nevertheless, the number of included studies for subgroup analyses was relatively low. Digital interventions have an enormous potential to improve accessibility, efficiency, clinical effectiveness and personalisation of mental health interventions. Future research is needed to investigate further the use of a wider range of therapeutic approaches across different clinical and subclinical groups and settings and test the impact of these interventions (or components) against a wider range of comparison conditions (e.g. face to face CBT) with optimal power.

Are digital interventions effective in reducing suicidal ideation and self-harm? A systematic review.

Background: There is a significant lack of outcomes research examining the effectiveness of digital interventions for reducing suicidal ideation and self-harm.Aims: To systematically review the effectiveness of digital interventions for reducing suicidal ideation and self-harm in adult populations. The possible mediating effects of depression are also discussed.Methods: The databases Pubmed, Medline, PsycInfo, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, IEEEXplore, ACM and CRESP were searched. Only randomised controlled trials (RCTs) were included. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used. Studies were assessed for methodological quality and risk of bias using standard assessment criteria.Results: Fourteen RCTs were reviewed, reporting data on 3455 participants. Although findings were more consistent for the effectiveness of online Cognitive Behavioural Therapy (CBT), Mindfulness-Based CBT and Dialectical Behavioural Therapy, there was insufficient research to consider any as evidence-based treatments for suicidal ideation and self-harm.Conclusions: Digital interventions for suicidal ideation and self-harm can be a safe and acceptable option for individuals unwilling or unable to access face-to-face interventions. However, further research is needed to understand the types of interventions that could support people and the risk-benefit ratio of digital interventions for these individuals.

Digitally Delivered Psychological Interventions for Anxiety Disorders: a Comprehensive Review.

Digital interventions for anxiety disorders have been well-researched over the past two decades. However, reviews to date have focused on internet-based cognitive behavioural therapy (iCBT), whereas other psychological interventions have received less attention. The aim of this review was therefore to evaluate the effectiveness of digitally delivered psychological therapies (CBT, Attention Bias Modification, Exposure Therapy, Applied Relaxation, Bibliotherapy, Psychodynamic Therapy, Mindfulness, Behavioural Stress Management, Counselling) compared with control conditions and/or other psychological interventions for anxiety disorders (Social Anxiety Disorder (SAD), Health Anxiety, Obsessive-Compulsive Disorder (OCD), Post-traumatic Stress Disorder (PTSD), Specific Phobias, Panic Disorder (PD), Generalised Anxiety Disorder (GAD)]. 68 randomised controlled trials (RCTs) were reviewed. SAD was the anxiety disorder for which the most RCTs were conducted. Overall, findings support the effectiveness of iCBT for SAD; for the remaining interventions, although some RCTs indicated significant improvement (within groups) at post-treatment and/or follow up, between group findings were less consistent and overall, methodological differences across trials failed to provide strong supporting evidence. Finally, the level of therapist contact or expertise did not appear to affect much treatment effectiveness. Additional large, methodologically rigorous trials are needed to investigate further whether different digitally delivered psychological interventions are equally effective for anxiety disorders. Moreover, further studies are pertinent in order to examine the maintenance of therapy gains after the end of treatments and understand how these work [(e.g. the influence of therapist factors, user engagement and/or satisfaction, potential access barriers and treatments with diverse population groups (e.g. BME groups)].

Are Digitally Delivered Psychological Interventions for Depression the Way Forward? A Review.

Digitally delivered interventions aim to make psychological treatments more widely accessible and minimize clinician input. Although their clinical efficacy against wait-list, control conditions is well established, comparative outcome studies are a much better way to examine if psychotherapies are equally effective. Such reviews are still relatively lacking. The aim of this review was therefore to evaluate the effectiveness of digitally delivered psychological therapies over traditionally delivered (face-to-face) ones to alleviate symptoms in adults experiencing sub-threshold and clinical depression. Findings showed that digital interventions produced consistently clinically significant improvements in depressive symptoms. Moreover, the level of therapist contact or expertise did not affect much treatment effectiveness. Future research is pertinent to investigate further the influence of therapist input, the reasons for dropout, how to improve users' experience and therapeutic engagement and maintain improvements at post-treatment.

Mind-body interventions for vasomotor symptoms in healthy menopausal women and breast cancer survivors. A systematic review.

Mind-body therapies are commonly recommended to treat vasomotor symptoms, such as hot flushes and night sweats (HFNS). The purpose of this systematic review was to evaluate the available evidence to date for the efficacy of different mind-body therapies to alleviate HFNS in healthy menopausal women and breast cancer survivors. Randomized controlled trials (RCTs) were identified using seven electronic search engines, direct searches of specific journals and backwards searches through reference lists of related publications. Outcome measures included HFNS frequency and/or severity or self-reported problem rating at post-treatment. The methodological quality of all studies was systematically assessed using predefined criteria. Twenty-six RCTs met the inclusion criteria. Interventions included yoga (n = 5), hypnosis (n = 3), mindfulness (n = 2), relaxation (n = 7), paced breathing (n = 4), reflexology (n = 1) and cognitive behavioural therapy (CBT) (n = 4). Findings were consistent for the effectiveness of CBT and relaxation therapies for alleviating troublesome vasomotor symptoms. For the remaining interventions, although some trials indicated beneficial effects (within groups) at post-treatment and/or follow up, between group findings were mixed and overall, methodological differences across studies failed to provide convincing supporting evidence. Collectively, findings suggest that interventions that include breathing and relaxation techniques, as well as CBT, can be beneficial for alleviating vasomotor symptoms. Additional large, methodologically rigorous trials are needed to establish the efficacy of interventions on vasomotor symptoms, examine long-term outcomes and understand how they work.

A randomised controlled trial of a brief cognitive behavioural intervention for men who have hot flushes following prostate cancer treatment (MANCAN).

OBJECTIVE: Hot flushes and night sweats (HFNS) are experienced by up to 80% of prostate cancer patients undergoing androgen deprivation therapy (ADT). This study evaluates the effects of a guided self-help cognitive behavioural therapy (CBT) intervention on HFNS problem-rating (primary outcome), HFNS frequency, mood and health-related quality of life (secondary outcomes) in patients undergoing ADT. METHODS: Patients reporting treatment-induced HFNS were randomly assigned to CBT (n = 33) or treatment as usual (TAU) (n = 35), stratified for cancer type. The CBT intervention included a booklet, CD plus telephone contact during a 4-week period. Validated self-report questionnaires were completed at baseline, 6 weeks and 32 weeks after randomisation. The primary outcome was HFNS problem rating (perceived burden of HFNS) at 6 weeks after randomisation. Potential moderators and mediators were examined. Data analysis was conducted on a modified intention-to-treat basis. RESULTS: Compared with TAU, CBT significantly reduced HFNS problem rating (adjusted mean difference: -1.33, 95% CI -2.07 to -0.58; p = 0.001) and HFNS frequency (-12.12, 95% CI -22.39 to -1.84; p = 0.02) at 6 weeks. Improvements were maintained at 32 weeks, but group differences did not reach significance. There were significant reductions in negative HFNS Beliefs and Behaviours following CBT, but not in mood or quality of life. CONCLUSIONS: Guided self-help CBT appears to be a safe and effective brief treatment for men who have problematic HFNS following prostate cancer treatments. Further research might test the efficacy of the intervention in a multicentre trial.

Neurokinin B administration induces hot flushes in women.

Neurokinin B (NKB) is a hypothalamic neuropeptide binding preferentially to the neurokinin 3 receptor. Expression of the gene encoding NKB is elevated in postmenopausal women. Furthermore, rodent studies suggest that NKB signalling may mediate menopausal hot flushes. However, the effects of NKB administration on hot flushes have not been investigated in humans. To address this, we performed a randomised, double-blinded, placebo-controlled, 2-way cross-over study. Ten healthy women were admitted to a temperature and humidity-controlled research unit. Participants received 30 minute intravenous infusions of NKB and vehicle in random order. Symptoms, heart rate, blood pressure, sweating and skin temperature were compared between NKB and vehicle in a double-blinded manner. Eight of ten participants experienced flushing during NKB infusion with none experiencing flushing during vehicle infusion (P = 0.0007). Significant elevations in heart rate (P = 0.0106 vs. pre-symptoms), and skin temperature measured using skin probe (P = 0.0258 vs. pre-symptoms) and thermal imaging (P = 0.0491 vs. pre-symptoms) characteristic of menopausal flushing were observed during hot flush episodes. Our findings provide evidence that NKB administration can cause hot flushes in women. Further studies are required to determine if pharmacological blockade of NKB signalling could inhibit hot flushes during the menopause and during treatment for sex-steroid dependent cancers.

Are attentional control resources reduced by worry in generalized anxiety disorder?

This is the first study to examine attentional control capacities in generalized anxiety disorder (GAD). GAD is characterized by uncontrollable worry. Individuals diagnosed with GAD and healthy participants (HPs) performed a random key-pressing task while thinking about a worrisome or a positive future event, to assess the extent to which attentional control resources are used by worry. Attentional control was also assessed when participants were not instructed to think about a specific topic using the N-back task, which varies in task difficulty, and therefore is sensitive to subtle differences in ability to handle increasing demands on attentional control within the same paradigm. GAD participants (but not HPs) were less random while worrying than thinking about a positive event during the key-pressing task, suggesting that worry consumed more attentional control resources in this population. During the N-Back task, GAD participants performed worse than HPs during the high load conditions only, indicating greater difficulty in sustaining focus on conditions requiring a higher degree of attentional control, even without concurrent task activity. Poor attentional control might underpin the difficulty of GAD individuals to stop worrying and switch to thinking more benign information. Further research could investigate whether worry consumes attentional control resources in other psychological disorders with high rates of worry (e.g., panic disorder, psychosis), as well as the extent to which attentional control is used by other forms of repetitive thinking, such as depressive rumination.

Symptom perception in healthy menopausal women: Can we predict concordance between subjective and physiological measures of vasomotor symptoms?

OBJECTIVES: Perception of physical symptoms is an important factor in medical help-seeking. We aimed to examine both physiological and subjective measures of a commonly reported physical symptom-vasomotor symptoms (hot flushes and night sweats; HF/NS), and to investigate factors that might influence symptom perception, that is, concordance, over-reporting, and under-reporting of symptoms in healthy menopausal women. METHODS: One hundred and forty women completed questionnaires assessing depressed mood, anxiety, stress, somatic symptoms, beliefs about HF/NS, and somatic amplification. Subjective and objective (24-h sternal skin conductance) measurements of HF/NS were obtained to assess concordance. RESULTS: Thirty-seven percent of HF/NS were concordant while 47 and 16 % were under-reported and over-reported, respectively. Depressed mood, anxiety, somatic symptoms, and negative beliefs about HF/NS were associated with (higher) concordance, (less) under-, or (more) over-reporting. Negative beliefs about night sweats and sleep were the strongest predictors of concordance, whereas additional somatic symptoms and smoking predicted over-reporting. CONCLUSIONS: Just over one third of physiologically recorded HF/NS were perceived as hot flushes; under-reporting of symptoms was more common than over-reporting. Interestingly, women who were more accurate in detecting physiological HF/NS tended to report more psychological and somatic symptoms and negative beliefs about HF/NS. Both measures should be included as outcomes of clinical trials.

Telephone-guided Self-Help Cognitive Behavioural Therapy for menopausal symptoms.

OBJECTIVES: Group and Self-Help forms of Cognitive Behavioural Therapy (CBT) are effective treatment options for women with problematic menopausal hot flushes and night sweats (HF/NS). However, some women are unable to attend face-to-face sessions. This study investigates whether Self-Help CBT for HF/NS is as effective when rolled out to women living at a distance with minimal telephone guidance. STUDY DESIGN: Forty-seven women completed a Self-Help CBT intervention (booklet and relaxation/paced breathing CD) during a 4-week period. They also received one 'guiding' telephone call from a clinical psychologist two weeks into treatment to provide support and discuss individual treatment goals. Questionnaires were collected at baseline, 6 weeks (post-treatment) and 3 months (follow-up) after the end of the intervention. MAIN OUTCOME MEASURES: HF/NS problem rating. SECONDARY OUTCOME MEASURES: HF/NS frequency, HF/NS beliefs and behaviours, sleep, anxiety and depressed mood. RESULTS: There was a significant reduction in HF/NS problem-rating following the intervention which was maintained at follow-up. Moreover, women reported less frequent HF/NS along with further improvements in sleep quality, mood and HF/NS beliefs and behaviours. CONCLUSIONS: Telephone-guided Self-Help interventions might provide an effective way of widening access to CBT treatment for HF/NS.

Does pattern recognition software using the Bahr monitor improve the sensitivity, specificity, and concordance of ambulatory skin conductance monitoring of hot flushes?

OBJECTIVE: The aim of this study was to validate the performance of a new pattern recognition method for quantifying physiological hot flushes against conventional fixed criterion methods and to explore its suitability for use in ambulatory clinical trials. METHODS: This study performed a secondary analysis of baseline and outcome sternal skin conductance monitoring data from two recent randomized controlled trials of cognitive-behavioral therapy (CBT) for hot flushes in breast cancer patients (MENOS1) and healthy peri- and postmenopausal women (MENOS2) using a revised pattern recognition method (Bahr monitor; software version 1.1.6). Sensitivity and specificity were recalculated and compared with previous findings, based on conventional criteria, using monitor-defined flushes as "gold standard" and combined baseline data. Outcome data for physiologically measured flushes between the CBT group and the treatment-as-usual group were separately reexamined using the revised method for each trial. RESULTS: Pattern recognition showed higher concordance (36%), sensitivity (0.64), and specificity (0.99) than the standard method. Hot flushes recorded during the day showed slightly higher concordance (39%) and fewer false-negatives than 24-hour recordings. Based on the revised method, well women randomized to CBT (MENOS2) had significantly fewer flushes than those randomized to treatment as usual at posttreatment (P < 0.04), but CBT did not impact on physiologically measured hot flushes for breast cancer patients (MENOS1). CONCLUSIONS: Pattern recognition can identify flushes more reliably by detecting the shape of physiological signals rather than by relying solely on the amplitude of their signals (as used in conventional criteria). With application of the revised method, ambulatory sternal skin conductance monitoring detects changes after a CBT intervention in well women but not in breast cancer survivors.

A randomised controlled trial of a cognitive behavioural intervention for men who have hot flushes following prostate cancer treatment (MANCAN): trial protocol.

BACKGROUND: This randomised controlled trial (RCT) aims to evaluate the effectiveness of a guided self-help cognitive behavioural intervention to alleviate problematic hot flushes (HF) and night sweats (NS) in men who are undergoing prostate cancer treatment. The trial and the self-help materials have been adapted from a previous RCT, which showed that a cognitive behavioural intervention reduced the self-reported problem-rating of hot flushes in women with menopausal symptoms, and in women undergoing breast cancer treatment. We hypothesize that guided self-help will be more effective than usual care in reducing HF/NS problem-rating at post treatment assessment. METHODS/DESIGN: Seventy men who are undergoing treatment for prostate cancer and who have been experiencing more than ten HF/NS weekly for over a month are recruited into the trial from urology clinics in London. They are randomly allocated to either a four-week self-help cognitive behavioural therapy (CBT) treatment or to their usual care (control group). The treatment includes information and discussion about hot flushes and night sweats in the context of prostate cancer, monitoring and modifying precipitants, relaxation and paced respiration, stress management, cognitive therapy for unhelpful thoughts and beliefs, managing sleep and night sweats, and advice on maintaining these changes. Prior to randomisation, men attend a clinical interview, undergo 24-48-hour sternal skin conductance monitoring, and complete pre-treatment questionnaires (e.g., problem-rating and frequency of hot flushes and night sweats; quality of life; mood; hot flush beliefs and behaviours). Post-treatment measures (sternal skin conductance and the above questionnaires) are collected four-six weeks later, and again at a six-month follow-up. DISCUSSION: MANCAN is the first randomised controlled trial of cognitive behavioural therapy for HF/NS for men that measures both self-reported and physiologically indexed symptoms. The results will inform future clinical practice by evaluating an evidence-based, non-medical treatment, which can be delivered by trained health professionals. TRIAL REGISTRATION: UK Clinical Research Network UKCRN10904.

Global assessment of psychosocial functioning and predictors of outcome in schizophrenia.

OBJECTIVE: This study identified predictors of psychosocial outcome in schizophrenia. METHOD: A mixed group of patients diagnosed with schizophrenia were assessed as part of a routine clinical evaluation. A linear regression analysis was conducted in order to examine the effect of duration of untreated illness, number of previous hospitalisations, history of psychotic episodes and age at illness onset on patients' functioning, as assessed with the Global Assessment of Functioning (GAF) scale. RESULTS: Number of previous psychotic episodes as well as duration of untreated illness were the strongest predictors of patients' levels of functioning amongst all main outcome measures. Older age at illness onset also predicted poorer functioning. Limitations. A principal limitation of our study is that our sample included predominantly Caucasian males; therefore, any extrapolation to other groups may remain speculative. CONCLUSIONS: Our preliminary results suggest that psychosocial outcome in schizophrenia may be affected by different factors. Longer history of psychotic episodes emerged as the most significant determinant of poorer outcome while longer duration of untreated illness and older age at illness onset were also associated with detrimental effects. Our findings may reflect the combined influences of neurodevelopmental abnormalities, exposure to psychotropic medication and psychosocial interventions as well as the vicissitudes of natural aging processes embedded in a chronic mental illness.

Health visitor views on consultation using the Solihull approach: a grounded theory study.

Consultation is integral to maintaining competence for health professionals and involves a collaborative relationship between specialist and primary care services. Although consultation aims to support them in their work, existing literature exploring health visitors' experiences of consultation is limited. This study explored health visitors' experiences of consultation in relation to their clinical practice, their experience of their work and its impact on the wider service. In all, 10 health visitors were interviewed using a semi-structured guide and analysis was subjected to a grounded theory framework. Participants' views were influenced by a combination of factors--consultants' training specific to their role, their communication and engagement, consultation's support of joint-working and/or transitions, and its relevance to and impact upon practice. Findings suggest that such interface activities require effective co-ordination, communication and structuring strategies, highlighting the importance of future initiatives in developing health visitors' mental health role further. Given the comparative lack of evaluation of such activities, these findings may inform policy-making and service development to ensure high quality of service delivery.

Insight, global functioning and psychopathology amongst in-patient clients with schizophrenia.

To explore whether cognitive impairment and global functioning can predict the degree of insight into illness as well as whether insight is mediated by specific symptom dimensions of psychopathology in schizophrenia. A dimensional/cross sectional approach was used. A mixed group of clients (n = 36) were assessed as part of a routine clinical evaluation. The Wechsler Adult Intelligence Scale (WAIS) was used as a measure of intellectual performance, the Brief Symptom Inventory (BSI) was used as a measure of general psychopathology while the Global Assessment of Functioning (GAF) scale assessed clients' psychosocial functioning; insight was assessed with the Insight and Treatment Attitudes Questionnaire (ITAQ). The correlation matrix of all outcome variables was examined; confounding effects of illness duration were tested by partial correlation analyses. GAF correlated with insight (rho = 0.41, P = 0.01) and the interpersonal sensitivity dimension of BSI (rho = -0.38, P = 0.03. Insight correlated positively with the anxiety (rho = 0.38, P = 0.03) and psychoticism (rho = 0.36, P = 0.04) dimensions of BSI. Our results suggest that insight is part of the phenomenology in schizophrenia, not being determined by neurocognitive disturbances. Improved insight was associated with more frequent psychotic symptoms endorsement, higher levels of anxiety and less severe psychopathological symptoms and difficulties in psychosocial functioning; clients with more pronounced difficulties in their personal and social interactions exhibited worse psychosocial functioning and more severe psychopathological symptoms.

Cognitive functioning in patients with affective disorders and schizophrenia: a meta-analysis.

There is considerable evidence for cognitive dysfunction in schizophrenia and affective disorders, but the pattern of potential similarities or differences between diagnostic groups remains uncertain. The objective of this study was to conduct a quantitative review of studies on cognitive performance in schizophrenia and affective disorders. Relevant articles were identified through literature search in major databases for the period between January 1980 and December 2005. Meta-analytic treatment of the original studies revealed widespread cognitive deficits in patients with schizophrenia and affective disorders in intellectual ability and speed of information processing, in encoding and retrieval, rule discovery and in response generation and response inhibition. Differences between diagnostic groups were quantitative rather than qualitative.