Optimizing internet-delivered cognitive behaviour therapy for alcohol misuse—a randomized factorial trial examining effects of a pre-treatment assessment interview and guidance

Background: Internet-delivered cognitive behavioral therapy (ICBT) for alcohol misuse has potential to radically improve access to evidence-based care, and there is a need to investigate ways to optimize its delivery in clinical settings. Guidance from a clinician has previously been shown to improve drinking outcomes in ICBT, and some studies suggest that pre-treatment assessments may contribute in initiating early change. The objective of this study was to investigate the added and combined effects of a pre-treatment assessment interview and guidance on the outcomes of ICBT for alcohol misuse delivered in an online therapy clinic. Methods: A 2X2 factorial randomized controlled trial was conducted where participants received access to an 8-week ICBT program, and either a pre-treatment assessment interview (Factor 1), guidance (Factor 2), a combination of these, or neither of these. Participants were 270 individuals (66.8% female, mean age = 46.5) scoring 8 or more on the Alcohol Use Disorders Identification Test and consuming 14 standard drinks or more in the preceding week. Primary outcomes were number of drinks consumed and number of heavy drinking days during the preceding week, 3 months post-treatment. Results: Large within-group effects were found in terms of alcohol reductions (dw ≥ 0.82, p < 0.001), but neither of the factors significantly improved drinking outcomes. Guidance was associated with greater adherence (i.e. completed modules). Conclusions: Neither a pre-treatment assessment interview nor guidance from a clinician appears to improve drinking outcomes resulting from internet-delivered cognitive behaviour therapy for alcohol misuse when delivered in a routine online therapy clinic. Trial registration: NCT03984786. Registered 13 June 2019, https://clinicaltrials.gov/ct2/show/NCT03984786. Keywords: Alcohol; Assessment reactivity; Cognitive behavior therapy; Guidance; Internet; Treatmen

Rethinking rehabilitation after percutaneous coronary intervention: a protocol of a multicentre cohort study on continuity of care, health literacy, adherence and costs at all care levels (the CONCARD PCI )

Introduction: Percutaneous coronary intervention (PCI) aims to provide instant relief of symptoms, and improve functional capacity and prognosis in patients with coronary artery disease. Although patients may experience a quick recovery, continuity of care from hospital to home can be challenging. Within a short time span, patients must adjust their lifestyle, incorporate medications and acquire new support. Thus, CONCARDPCI will identify bottlenecks in the patient journey from a patient perspective to lay the groundwork for integrated, coherent pathways with innovative modes of healthcare delivery. The main objective of the CONCARDPCI is to investigate (1) continuity of care, (2) health literacy and self-management, (3) adherence to treatment, and (4) healthcare utilisation and costs, and to determine associations with future short and long-term health outcomes in patients after PCI. Methods and analysis: This prospective multicentre cohort study organised in four thematic projects plans to include 3000 patients. All patients undergoing PCI at seven large PCI centres based in two Nordic countries are prospectively screened for eligibility and included in a cohort with a 1-year follow-up period including data collection of patient-reported outcomes (PRO) and a further 10-year follow-up for adverse events. In addition to PROs, data are collected from patient medical records and national compulsory registries. Ethics and dissemination: Approval has been granted by the Norwegian Regional Committee for Ethics in Medical Research in Western Norway (REK 2015/57), and the Data Protection Agency in the Zealand region (REG-145-2017). Findings will be disseminated widely through peer-reviewed publications and to patients through patient organisations. Trial registration number: NCT03810612

Examining differential responses to the Take Care of Me trial: A latent class and moderation analysis

Given prevalent alcohol misuse-emotional comorbidities among young adults, we developed an internet-based integrated treatment called Take Care of Me. Although the treatment had an impact on several secondary outcomes, effects were not observed for the primary outcome. Therefore, the goal of the current study was to examine heterogeneity in treatment responses. The initial RCT randomized participants to either a treatment or psychoeducational control condition. We conducted an exploratory latent class analysis to distinguish individuals based on pre-treatment risk and then used moderated regressions to examine differential treatment responses based on class membership. We found evidence for three distinct groups. Most participants fell in the “low severity” group (n = 123), followed by the “moderate severity” group (n = 57) who had a higher likelihood of endorsing a previous mental health diagnosis and treatment and higher symptom severity than the low group. The “high severity” group (n = 42) endorsed a family history of alcoholism, and the highest symptom severity and executive dysfunction. Moderated regressions revealed significant class differences in treatment responses. In the treatment condition, high severity (relative to low) participants reported higher alcohol consumption and hazardous drinking and lower quality of life at follow-up, whereas moderate severity (relative to low) individuals had lower alcohol consumption at follow-up, and lower hazardous drinking at end-of-treatment. No class differences were found for participants in the control group. Higher risk individuals in the treatment condition had poorer responses to the program. Tailoring interventions to severity may be important to examine in future research

Bridging the gap from medical to psychological safety assessment: consensus study in a digital mental health context

Background: Digital Mental Health Interventions (DMHIs) that meet the definition of a medical device are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. The MHRA uses procedures that were originally developed for pharmaceuticals to assess the safety of DMHIs. There is recognition that this may not be ideal, as is evident by an ongoing consultation for reform led by the MHRA and the National Institute for Health and Care Excellence. Aims: The aim of this study was to generate an experts’ consensus on how the medical regulatory method used for assessing safety could best be adapted for DMHIs. Method: An online Delphi study containing three rounds was conducted with an international panel of 20 experts with experience/knowledge in the field of UK digital mental health. Results: Sixty-four items were generated, of which 41 achieved consensus (64%). Consensus emerged around ten recommendations, falling into five main themes: Enhancing the quality of adverse events data in DMHIs; Re-defining serious adverse events for DMHIs; Reassessing short-term symptom deterioration in psychological interventions as a therapeutic risk; Maximising the benefit of the Yellow Card Scheme; and Developing a harmonised approach for assessing the safety of psychological interventions in general. Conclusion: The implementation of the recommendations provided by this consensus could improve the assessment of safety of DMHIs, making them more effective in detecting and mitigating risk

Efficacy of a novel online integrated treatment for problem gambling and tobacco smoking: Results of a randomized controlled trial

Background and aimsProblem gambling and tobacco use are highly comorbid among adults. However, there are few treatment frameworks that target both gambling and tobacco use simultaneously (i.e., an integrated approach), while also being accessible and evidence-based. The aim of this two-arm open label RCT was to examine the efficacy of an integrated online treatment for problem gambling and tobacco use.MethodsA sample of 209 participants (M$_{age}$ = 37.66, SD = 13.81; 62.2% female) from North America were randomized into one of two treatment conditions (integrated [n = 91] or gambling only [n = 118]) that lasted for eight weeks and consisted of seven online modules. Participants completed assessments at baseline, after treatment completion, and at 24-week follow-up.ResultsWhile a priori planned generalized linear mixed models showed no condition differences on primary (gambling days, money spent, time spent) and secondary outcomes, both conditions did appear to significantly reduce problem gambling and smoking behaviours over time. Post hoc analyses showed that reductions in smoking and gambling craving were correlated with reductions in days spent gambling, as well as with gambling disorder symptoms. Relatively high (versus low) nicotine replacement therapy use was associated with greater reductions in gambling behaviours in the integrated treatment condition.Discussion and conclusionsWhile our open label RCT does not support a clear benefit of integrated treatment, findings suggest that changes in smoking and gambling were correlated over time, regardless of treatment condition, suggesting that more research on mechanisms of smoking outcomes in the context of gambling treatment may be relevant

Feasibility of trial procedures for a randomised controlled trial of a community based group exercise intervention for falls prevention for visually impaired older people: the VIOLET study

Background Visually impaired older people (VIOP) have a higher risk of falling than their sighted peers, and are likely to avoid physical activity. The aim was to adapt the existing Falls Management Exercise (FaME) programme for VIOP, delivered in the community, and to investigate the feasibility of conducting a definitive randomised controlled trial (RCT) of this adapted intervention. Methods Two-centre randomised mixed methods pilot trial and economic evaluation of the adapted group-based FaME programme for VIOP versus usual care. A one hour exercise programme ran weekly over 12 weeks at the study sites (Newcastle and Glasgow), delivered by third sector (voluntary and community) organisations. Participants were advised to exercise at home for an additional two hours over the week. Those randomised to the usual activities group received no intervention. Outcome measures were completed at baseline, 12 and 24 weeks. The potential primary outcome was the Short Form Falls Efficacy Scale – International (SFES-I). Participants’ adherence was assessed by reviewing attendance records and self-reported compliance to the home exercises. Adherence with the course content (fidelity) by instructors was assessed by a researcher. Adverse events were collected in a weekly phone call. Results Eighteen participants, drawn from community-living VIOP were screened; 68 met the inclusion criteria; 64 participants were randomised with 33 allocated to the intervention and 31 to the usual activities arm. 94% of participants provided data at the 12 week visit and 92% at 24 weeks. Adherence was high. The intervention was found to be safe with 76% attending nine or more classes. Median time for home exercise was 50 min per week. There was little or no evidence that fear of falling, balance and falls risk, physical activity, emotional, attitudinal or quality of life outcomes differed between trial arms at follow-up. Conclusions The intervention, FaME, was implemented successfully for VIOP and all progression criteria for a main trial were met. The lack of difference between groups on fear of falling was unsurprising given it was a pilot study but there may have been other contributory factors including suboptimal exercise dose and apparent low risk of falls in participants. These issues need addressing for a future trial

Psychological and behavioural correlates of acute and chronic congruent and incongruent low back pain

The purpose of the study was to examine how the psychological reactions to pain of acute low back pain (LBP) patients would compare to the psychological reactions to pain of chronic LBP patients who displayed signs and symptoms which were either congruent or incongruent with underlying anatomy and physiology. It was also of interest to examine whether negative cognitive and affective variables would mediate the expression of pain in these pain groups, and whether verbal and nonverbal facial measures of pain could be used to discriminate among pain groups. Subjects were assigned to the acute pain group if they had recurring or persistent pain for less than a three month period, and to the chronic pain group if they had recurring or persistent pain for longer than a three month period. The Pain Drawing (Ransford, Cairns & Mooney, 1976), the Nonorganic Physical Signs Assessment (Waddell, McCulloch, Kummell & Venner, 1980) and the Inappropriate Symptom Inventory (Waddell, Main, Morris, Di Paolo & Gray, 1984) were used to assign chronic pain patients to either the congruent or incongruent chronic LBP group. A physiotherapy protocol in which patients were asked to genuinely express pain, exaggerate and mask pain in response to a painful range of motion task was used to obtain a wide range of facial behaviour that would likely be relevant to understanding the expression of pain in these patient populations. Verbal reports of pain in response to the painful range of motion task, and in response to the pain that patients experienced on a daily basis were also examined. In addition, questionnaires concerned with coping strategies, worry and emotionality were used to tap cognitive and affective components of pain. Several demographic and patient pain related variables (e.g., medication use, disability, physical impairment) were also collected. The results of the study suggested that the acute and chronic incongruent pain patients had a similar psychological reaction to pain that was greater than the psychological reaction to pain of chronic congruent pain patients. In addition, the results suggested that the acute patients and chronic incongruent patients reported the unpleasantness of their pain to be similar, although only chronic incongruent patients differed significantly from chronic congruent patients. Acute and chronic incongruent patients were also similar on several demographic (socioeconomic status, compensation status) and pain related variables (regular use of opiate analgesics, and disability). Both groups differed significantly on the variables from the chronic congruent pain group. One final difference among groups was observed on a measure of physical impairment in which it was found that the chronic incongruent patients had the greatest physical impairment followed by the chronic congruent and acute pain patients. All differences among groups were significant. The most important variable for optimally discriminating among acute and chronic pain groups was physical impairment. This, however, may have been an artifact since the physical impairment measure was biased toward chronic pain patients obtaining higher scores. The most important variables for discriminating among chronic congruent and incongruent pain groups were related to the patient's negative interpretation of pain, compensation status, and reported regular use of painkillers. In general, all subjects reported the pain they experienced on a daily basis to be more intense and unpleasant than the pain they experienced in response to the painful leg movements. The facial actions that patients displayed when they were asked to genuinely express pain corresponded to facial expressions that have been found to be associated with pain in previous studies, and included brow lowering, orbit tightening, levator contraction, and mouth opening. Also consistent with previous research were findings suggesting that, although subjects were successful in masking and exaggerating pain, there were still some cues to deception apparent on the face.Arts, Faculty ofPsychology, Department ofGraduat

Cognitive and behavioural responses to illness information in health anxiety

A cognitive-behavioural theory (CBT) has been put forth to explain hypochondriasis and less extreme forms of health anxiety (Warwick & Salkovskis, 1990). The extent to which less extreme forms of health anxiety are relevant for understanding illness behaviour remains unclear, however. Further, the independence of health anxiety from a more general construct of negative affectivity, as well as response styles is not known. The CBT of health anxiety predicts that in response to illness information health anxious individuals will show a characteristic cognitive (e.g., attend to and misinterpret information) and behavioural (e.g., avoidance and reassurance seeking) response. Although the predictions are supported by clinical observations, rigorous and systematic contrasts of health anxious and non-health anxious individuals to the same objective health related information have not yet been carried out. Further, there are a number of additional issues that need to be clarified with respect to the theory, including: (a) Are there additional cognitive and behavioural responses involved in health anxiety not predicted by the CBT?; (b) Are health anxious individuals deficient in there use of certain adaptive responses to illness information?; and (c) Are the cognitive and behavioural responses shown by health anxious individuals moderated under certain circumstances? In the present study, students scoring either within normal or nonclinically high ranges on a measure of health anxiety underwent a physiological test ostensibly examining risk for medical complications and were randomly assigned to receive positive, negative, or ambiguous test results. They then underwent a cold pressor task ostensibly to examine physiological activity and were asked questions tapping their responses to the diagnostic information and painful procedure. They were also judged for facial expressiveness. Unmistakable support was found for a dysfunctional cognitive (e.g., negative interpretational focus) and behavioural (e.g., reassurance seeking) response style among health anxious individuals. Little support was found for either cognitive or behavioural avoidance in health anxiety. Not anticipated by the CBT, as time went on health anxious individuals became more expressive of their pain; this may have important implications, since increased expressiveness could result in an increase in the felt emotional experience. Adding to the CBT, evidence was found to suggest that health anxious individuals may have a deficit or be deficient in their use of a positive concrete somatic monitoring strategy. Finally, the results suggested that there are statistically and clinically significant differences among nonclinically health anxious individuals and normals that can not be accounted for by differences in negative affectivity or response styles.Arts, Faculty ofPsychology, Department ofGraduat

Appearance-based information about coping with pain: Valid or biased?

Previous research led to the conclusion that patient characteristics such as physical attractiveness and non-verbal expressiveness affected judgements of patient pain and distress. This study investigated whether this represents an intrusive bias or whether there indeed are psychological differences between physically attractive vs physically unattractive and expressive vs inexpressive pain patients. The findings led to the conclusion that both variables are related to the types of coping strategies pain patients use. Specifically, physically attractive and nonverbally expressive patients were found to be less likely to utilize passive coping strategies. Coping style also was found to be related to demographic characteristics of the patients. Theoretical reasons for the identified relationships are discussed as are the implications of these findings for the assessment of pain.physical attractiveness pain non-verbal expressiveness

Optimizing internet-delivered cognitive behaviour therapy for alcohol misuse: a study protocol for a randomized factorial trial examining the effects of a pre-treatment assessment interview and health educator guidance

Background Alcohol misuse is a common, disabling, and costly issue worldwide, but the vast majority of people with alcohol misuse never access treatment for varying reasons. Internet-delivered cognitive behaviour therapy (ICBT) may be an attractive treatment alternative for individuals with alcohol misuse who are reluctant to seek help due to stigma, or who live in rural communities with little access to face-to-face treatment. With the growing development of ICBT treatment clinics, investigating ways to optimize its delivery within routine clinic settings becomes a crucial avenue of research. Some studies in the alcohol treatment literature suggest that assessment interviews conducted pre-treatment may improve short- and long-term drinking outcomes but no experimental evaluation of this has been conducted. Further, research on internet interventions for alcohol misuse suggests that guidance from a therapist or coach improves outcomes, but more research on the benefits of guidance in ICBT is still needed. Methods This study is a 2X2 factorial randomized controlled trial where all of the expected 300 participants receive access to the Alcohol Change Course, an eight-week ICBT program. A comprehensive pre-treatment assessment interview represents factor 1, and guidance from a health educator represents factor 2. All participants will be asked to respond to measures at screening, pre-treatment, mid-treatment, post-treatment and 3, 6 and 12 months after treatment completion. Discussion This study will provide valuable information on optimization of ICBT for alcohol misuse within routine clinic settings