A pilot randomised controlled trial of a home-based writing intervention for individuals with seizures

Objective: We investigated the feasibility, acceptability and preliminary effectiveness of a writing intervention for individuals with epilepsy or psychogenic nonepileptic seizures.

Methods: Individuals were randomised to write about potentially ‘therapeutic’ topics (n = 43) or about their daily events (n = 25). Participants were asked to write on four separate occasions for at least 20 min. Repeated-measures analysis of variance was used to investigate change in measures of health-related quality of life (NEWQoL-6D), depression (NDDI-E), anxiety (GAD-7) and illness perception (B-IPQ) from baseline to one and three-month follow-ups. Qualitative and quantitative data taken from a Writing Task Questionnaire was analysed between the two conditions.

Results: Recruitment was acceptable with 52% of those randomised completing the full writing intervention. In both conditions, participants wrote for longer than 20 min suggesting those who completed the study engaged well with the procedure. Greater benefits were observed in the ‘therapeutic’ condition (p < 0.05), which was associated with an improvement in health-related quality of life at one-month follow-up (p = 0.02). No differences were found in the other measures.

Conclusions: A writing intervention is acceptable in this population. Self-reported benefits were modest, suggesting therapeutic writing may be more suitable as a supplement to other therapies rather than a stand-alone therapeutic intervention.     

Evidence of improved fluid management in patients receiving haemodialysis following a self-affirmation theory-based intervention: A randomised controlled trial

Objective: Haemodialysis patients are at risk of serious health complications; yet, treatment non-adherence remains high. Warnings about health risks associated with non-adherence may trigger defensive reactions. We studied whether an intervention based on self-affirmation theory reduced resistance to health-risk information and improved fluid treatment adherence.

Design: In a cluster randomised controlled trial, 91 patients either self-affirmed or completed a matched control task before reading about the health-risks associated with inadequate fluid control.

Outcome measures: Patients’ perceptions of the health-risk information, intention and self-efficacy to control fluid were assessed immediately after presentation of health-risk information. Interdialytic weight gain (IDWG), excess fluid removed during haemodialysis, is a clinical measure of fluid treatment adherence. IDWG data were collected up to 12 months post-intervention.

Results: Self-affirmed patients had significantly reduced IDWG levels over 12 months. However, contrary to predictions derived from self-affirmation theory, self-affirmed participants and controls did not differ in their evaluation of the health-risk information, intention to control fluid or self-efficacy.

Conclusion: A low-cost, high-reach health intervention based on self-affirmation theory was shown to reduce IDWG over a 12-month period, but the mechanism by which this apparent behaviour change occurred is uncertain. Further work is still required to identify mediators of the observed effects.     

A cluster randomised controlled trial of an intervention based on the Health Action Process Approach for increasing fruit and vegetable consumption in Iranian adolescents

Objective: To evaluate an intervention programme based on the Health Action Process Approach and designed to increase the intake of fruit and vegetables (F&V) among Iranian adolescents aged 13 to 18.

Design: A randomised controlled trial with three arms examined the short- (1 month) and long-term (6 months) effects of the intervention. There were two intervention groups (one included adolescents only [A group; n = 510]; the second included mothers and adolescents [M + A group; n = 462]) and a control group (n = 483). All participants were recruited from schools.

Main outcome measures: Social cognitions, self-regulatory processes and F&V intake.

Results: The intervention led to an increase in F&V intake for adolescents in the short and long terms. Adolescents in the M + A group increased their F& V intake more than adolescents in the A group. Outcome expectancies, self-monitoring, intentions, action and coping planning, perceived social support and behavioural automaticity mediated the effect of the intervention on F&V intake.

Conclusion: The theory-based intervention led to an increase in F&V intake and promoted more positive social cognitions and self-regulatory processes among Iranian adolescents. The findings also provide evidence that involving mothers in an intervention can confer additional benefit.     

A randomised controlled trial of a brief online mindfulness-based intervention

ObjectivesThere is growing evidence that mindfulness has positive consequences for both psychological and physical health in both clinical and non-clinical populations. The potential benefits of mindfulness underpin a range of therapeutic intervention approaches designed to increase mindfulness in both clinical and community contexts. Self-guided mindfulness-based interventions may be a way to increase access to the benefits of mindfulness. This study explored whether a brief, online, mindfulness-based intervention can increase mindfulness and reduce perceived stress and anxiety/depression symptoms within a student population.MethodOne hundred and four students were randomly allocated to either immediately start a two-week, self-guided, online, mindfulness-based intervention or a wait-list control. Measures of mindfulness, perceived stress and anxiety/depression were administered before and after the intervention period.ResultsIntention to treat analysis identified significant group by time interactions for mindfulness skills, perceived stress and anxiety/depression symptoms. Participation in the intervention was associated with significant improvements in all measured domains, where no significant changes on these measures were found for the control group.ConclusionsThis provides evidence in support of the feasibility and effectiveness of shorter self-guided mindfulness-based interventions. The limitations and implications of this study for clinical practice are discussed.     

My Disaster Recovery: a pilot randomized controlled trial of an Internet intervention

Abstract

This pilot study tested the efficacy of the My Disaster Recovery (MDR) website to decrease negative affect and increase coping self-efficacy. Fifty-six survivors of Hurricane Ike were recruited from a larger study being conducted at the University of Texas Medical Branch at the first anniversary of the storm. Restricted randomization was used to assign participants to the MDR website, an information-only website, or a usual care condition. Group×time interactions indicated that MDR reduced participant worry more than the other conditions. A similar trend was also identified for depression. Both websites were accessed a small to moderate amount and participants reported mixed satisfaction for both websites. Although the effect sizes for worry and depression were in the moderate to large range, small sample size and timing of the intervention qualify the findings. These preliminary findings encourage further evaluation of MDR with a larger, demographically diverse sample and indicate that the MDR website might be helpful in reducing worry and depression.     

My Disaster Recovery: a pilot randomized controlled trial of an Internet intervention

This pilot study tested the efficacy of the My Disaster Recovery (MDR) website to decrease negative affect and increase coping self-efficacy. Fifty-six survivors of Hurricane Ike were recruited from a larger study being conducted at the University of Texas Medical Branch at the first anniversary of the storm. Restricted randomization was used to assign participants to the MDR website, an information-only website, or a usual care condition. Group×time interactions indicated that MDR reduced participant worry more than the other conditions. A similar trend was also identified for depression. Both websites were accessed a small to moderate amount and participants reported mixed satisfaction for both websites. Although the effect sizes for worry and depression were in the moderate to large range, small sample size and timing of the intervention qualify the findings. These preliminary findings encourage further evaluation of MDR with a larger, demographically diverse sample and indicate that the MDR website might be helpful in reducing worry and depression.     

School-based,randomised controlled trial of an evidence-based condom promotion leaflet

A condom use promotion leaflet was designed for use with older teenagers in schools. The text targeted a series of cognitive and behavioural antecedents of condom use identified in the literature. Given previous evidence that motivational incentives can enhance the effectiveness of health promotion leaflets, the leaflet was presented in conjunction with a quiz and prize draw. Students were randomly assigned to either the intervention condition or a (no leaflet or incentive) control condition. Measures were taken immediately, pre-intervention and 4 weeks later from 404 students. The 20-min intervention successfully promoted six of the eight measured cognitions, namely (1) attitude towards using condoms with a new partner (2) attitude towards using condoms with a steady partner (3) normative beliefs in relation to preparatory actions (4) self-efficacy in relation to both preparatory actions and (5) condom use (6) intention to use condoms, as well as three measured preparatory actions, that is, purchasing condoms, carrying condoms and discussing condom use. The intervention did not increase condom use with steady or new partners but power to test intervention impact on condom use was curtailed.     

Investigating the effects of a virtual reality-based stress management programme on inpatients with mental disorders: A pilot randomised controlled trial

This study aimed to examine the effects and feasibility of a virtual screen-based stress management programme (V-DESSERTS) on inpatients with mental disorders. A single-blinded, pilot randomised controlled trial was conducted in a tertiary hospital in Singapore. Convenience sampling was used and participants were randomised into either the intervention group or the waitlisted control group (WL). The intervention group received individual-based, twice-daily sessions of the programme. Each session comprised education and virtual screen-based relaxation practice. Data were collected through self-reported questionnaires and physiological measures. The intervention group showed a significant increase in perceived relaxation and knowledge in comparison with the WL group. However, inconclusive results were observed on subjective and objective stress. The findings in this study indicated that the V-DESSERTS programme is feasible to be implemented for patients with schizophrenia, depression and bipolar disorders.     

A randomized controlled trial of instructional coaching in high-poverty urban schools: Examining teacher practices and student outcomes

Job-embedded professional development is needed to effectively and efficiently enhance teachers' use of evidence-based practices in high-poverty urban communities. This study employed a three-cohort, waitlist controlled, randomized block design to investigate the effectiveness of the Classroom Strategies Coaching Model (CSC) in 14 high-poverty urban elementary schools. The CSC Model is guided by observations of teachers' instructional and behavioral management practices as measured by the Classroom Strategies Assessment System. Primary dependent measures included teacher use of evidence-based practices, student academic engagement, and teacher ratings of class wide student academic and behavior functioning along with perceived instrumental support, emotional support, and stress. The sample included 2195 students and 106 teachers randomly assigned to CSC coaching or waitlist control. Multilevel negative binomial modeling revealed that teachers in the CSC coaching condition had significant improvements in the frequency of academic praise (used 1.74 times more frequently) and behavior praise (used 2.10 times more frequently) as compared to teachers in the waitlist control condition. Multilevel linear models revealed that, relative to the waitlist control condition, teachers in the CSC coaching condition demonstrated significant improvements in quality of instruction (d = 0.52), behavior management (d = 0.60), and class wide student academic engagement (d = 0.41). Teachers reported significant improvements in class wide student academic (d = 0.96) and behavioral functioning (d = 1.24), instrumental support (d = 0.90) and emotional support (d = 1.04). No change was found for teacher stress. Implications for research and practice are reviewed.     

Hybrid cognitive-behaviour therapy for individuals with insomnia and chronic pain: A pilot randomised controlled trial

ObjectiveInsomnia is a debilitating comorbidity of chronic pain. This pilot trial tested the utility of a hybrid treatment that simultaneously targets insomnia and pain-related interference.MethodsChronic pain patients with clinical insomnia were randomly allocated to receive 4 weekly 2-h sessions of hybrid treatment (Hybrid Group; n = 10) or to keep a pain and sleep diary for 4 weeks, before receiving the hybrid treatment (Monitoring Group; n = 10). Participants were assessed at the beginning and end of this 4-week period. Primary outcomes were insomnia severity and pain interference. Secondary outcomes were fatigue, anxiety, depression and pain intensity. Ancillary information about the hybrid treatment's effect on psychological processes and sleep (as measured with sleep diary and actigraphy) are also presented, alongside data demonstrating the treatment's clinical significance, acceptability and durability after one and six months. Data from all participants (n = 20) were combined for this purpose.ResultsCompared to symptom monitoring, the hybrid intervention was associated with greater improvement in sleep (as measured with the Insomnia Severity Index and sleep diary) at post-treatment. Although pain intensity did not change, the Hybrid Group reported greater reductions in pain interference, fatigue and depression than the Monitoring Group. Overall, changes associated with the hybrid intervention were clinically significant and durable at 1- and 6-month follow-ups. Participants also rated highly on treatment acceptability.ConclusionThe hybrid intervention appeared to be an effective treatment for chronic pain patients with insomnia. It may be a treatment approach more suited to tackle challenges presented in clinical practice, where problems seldom occur in isolation.     

A randomised controlled trial of the effects of implementation intentions on women's walking behaviour

The combination of low physical activity rates and increased cardiovascular deaths indicate the overwhelming need for behaviour change interventions that can effectively promote physical activity among sedentary women. This 11-week randomised controlled trial examined the effects of an implementation intentions intervention on sedentary women's walking behaviour. Seventy-five women (M age = 48.17) were randomly assigned to either a control group where they were required to self-monitor their daily pedometer-determined step count or to an experimental group where they were asked to form specific walking plans (i.e. implementation intentions) every 6 weeks and to self-monitor their daily pedometer-determined step count. Measures of exercise intentions, perceived behavioural control, scheduling and barrier self-efficacy were administered at baseline, week 6 and week 11. Analyses indicated higher step counts over the first 6 weeks for women in the experimental condition (p < 0.02). Furthermore, higher self-efficacy to schedule (p < 0.01) and overcome walking barriers (p < 0.03), as well as higher perceptions of behavioural control (p < 0.02) were found at week 11 for women in the experimental versus control condition. However, none of the control beliefs were found to mediate the effects of the intervention on the women's walking behaviour. Furthermore, the intervention did not have any effect on the strength of the goal intention–behaviour relationship. The findings suggest implementation intentions are an effective strategy for initiating leisure-time walking within sedentary women.     

Early childhood educator outcomes from online professional development for physical literacy: A randomised controlled trial

IntroductionEarly childhood is recognised as a critical window of opportunity for physical literacy development, however early childhood educators typically lack the training required to effectively provide appropriate physical literacy opportunities for children. We examined the effects of an online physical literacy professional development program—relative to continuing with ‘standard’ practice—on early childhood educators’ physical literacy knowledge and application.MethodsWe conducted a parallel two-arm randomised controlled trial, in which 88 early childhood educators were randomly assigned to an online professional development program designed to support educators’ physical literacy instructional skills (intervention arm; n = 37), or a ‘standard practice’ control condition (n = 51). Data were collected prior to and after the four-week intervention period. We measured educators’ physical literacy knowledge and application (our primary outcome) through independent coding of open-ended survey responses, and educators’ self-reported perceptions of values, confidence, behaviours, and barriers (secondary outcomes). Between-group differences were assessed through analysis of covariance.ResultsOne intervention arm participant withdrew from the study, resulting in 87 participants included in analysis. Educators in the intervention arm scored significantly higher on post-intervention physical literacy knowledge (d = 0.62) and application (d = 0.33) than those in the control arm. Educators in the intervention arm also scored significantly higher than controls on confidence in teaching physical activity (d = 0.42) and significantly lower than controls on perceived personal barriers to physical activity (d = 0.53). Thirteen participants in the intervention arm (36%) did not begin the online professional development program.ConclusionImprovements in physical literacy instructional outcomes indicate the potential for further investigation into broader implementation of online professional development programs of this nature in the future.     

The different effects of personality on prosocial and aggressive driving behaviour in a Chinese sample

Dangerous driving behaviours, as a direct cause of accidents and death, are the focus of considerable research attention. However, unlike unsafe driving behaviours, few studies have explored safe driving behaviours and their effects on road traffic. This study aims to verify the Chinese version of the Prosocial and Aggressive Driving Inventory (PADI) and then investigate the relationship between personality and aggressive/prosocial driving behaviours. A total of 303 licensed drivers were recruited, and they voluntarily and anonymously completed the PADI, the Driving Behaviours Questionnaire (DBQ), and personality scales (anger, sensation-seeking and altruism). The results of this research confirmed the reliability and validity of the Chinese PADI. Most importantly, it was found that different relationships between different personalities and aggressive/prosocial driving behaviours. Specifically, individuals with high altruism exhibited more prosocial driving behaviours, while individuals with high sensation seeking presented more aggressive driving behaviours. The importance of these findings lies in two main potential implications: developing an effective measurement of prosocial driving behaviours in China and providing favourable evidence to guide drivers toward more prosocial driving behaviours.     

Primary school teacher outcomes from online professional development for physical literacy: A randomised controlled trial

IntroductionPrimary (or elementary) school teachers are often relied upon to provide children with opportunities for physical literacy development; however, many of these teachers feel they lack the skills to effectively promote or ‘teach’ physical literacy. We examined the effects of an online physical literacy professional development program—relative to receiving widely-available online resources or continuing with ‘normal’ practice—on primary school teachers’ physical literacy knowledge and application.MethodsA parallel three-arm randomised controlled trial in which 92 primary school teachers were assigned to (a) an online professional development program designed to support teachers’ physical literacy instructional skills (‘intervention’), (b) receive widely-available online physical literacy resources (‘comparison’), or (c) a typical practice ‘control’ condition. Data were collected at baseline and following the four-week intervention period. The primary outcome was teachers’ physical literacy knowledge and application; secondary outcomes included teachers’ self-reported perceptions of confidence, values, and barriers. Between-group differences were assessed using the intention-to-treat principle with analysis of covariance accounting for demographic factors and baseline differences in the focal outcome.ResultsTeachers in the intervention arm scored significantly higher on post-intervention physical literacy knowledge and application than their counterparts in both the control (d = .47, p = .044) and comparison (d = 0.87, p = .007) arms. This pattern of differences was also observed for teachers’ value of physical literacy, autonomy support, and perceived personal barriers.ConclusionTo the best of our knowledge, this is the first adequately powered randomised controlled trial to demonstrate improvements in physical literacy instructional outcomes as a result of primary school teacher participation in targeted online professional development.     

3-D bone models to improve treatment initiation among patients with osteoporosis: A randomised controlled pilot trial

Objective: To investigate the efficacy of 3-D printed bone models as a tool to facilitate initiation of bisphosphonate treatment among individuals who were newly diagnosed with osteoporosis.

Design: Fifty eight participants with estimated fracture risk above that at which guidelines recommend pharmacological intervention were randomised to receive either a standard physician interview or an interview augmented by the presentation of 3-D bone models.

Main outcome measures: Participants’ beliefs about osteoporosis and bisphosphonate treatment, initiation of bisphosphonate therapy assessed at two months using self-report and pharmacy dispensing data.

Results: Individuals in the 3-D bone model intervention condition were more emotionally affected by osteoporosis immediately after the interview (p = .04) and reported a greater understanding of osteoporosis at follow-up (p = .04), than the control group. While a greater proportion of the intervention group initiated an oral bisphosphonate regimen (alendronate) (52%) in comparison with the control group (21%), the overall initiation of medication for osteoporosis, including infusion (zoledronate), did not differ significantly (intervention group 62%, control group 45%, p = .19).

Conclusion: The presentation of 3-D bone models during a medical consultation can modify cognitive and emotional representations relevant to treatment initiation among people with osteoporosis and might facilitate commencement of bisphosphonate treatment.     

Randomized controlled trial of an intervention to change cardiac misconceptions in myocardial infarction patients

There is converging evidence that changing beliefs about an illness leads to positive recovery outcomes. However, cardiac misconceptions interventions have been investigated mainly in Angina or Coronary Heart Disease patients, and less in patients following Myocardial Infarction (MI). In these patients, cardiac misconceptions may play a role in the adjustment or lifestyle changes. This article reports a randomized controlled trial of an intervention designed to reduce the strength of misconceptions in patients after a first MI. The primary outcome was the degree of change in misconceptions and the secondary outcomes were: exercise, smoking status, return to work and mood (anxiety and depression). Patients in the intervention condition (n = 60) were compared with a control group (n = 67) receiving usual care. Both groups were evaluated at baseline and 4, 8 and 12 months after hospital discharge. There was a significant time-by-group interaction for the total score of cardiac misconceptions. Patients in the intervention group significantly decreased their total score of cardiac misconceptions at 4 months compared with the control group and this difference was sustained over time. Patients in the intervention group were also more likely to exercise at the follow-up period after MI than the control group. This intervention was effective in reducing the strength of cardiac misconceptions in MI patients and had a positive impact on health behaviour outcomes. These results support the importance of misconceptions in health behaviours and the utility of belief change interventions in promoting health in patients with Myocardial Infarction.     

Working mechanisms of a web-based self-management intervention for cancer survivors: a randomised controlled trial

Objective: The aim of this study was to investigate whether problem-solving skills and perceived personal control over cancer recovery mediated the intervention effects on depression and fatigue of a web-based computer-tailored intervention for cancer survivors – the Kanker Nazorg Wijzer (Cancer Aftercare Guide).

Design: Patients were recruited through 21 Dutch hospitals (November 2013–June 2014). The mediation model was tested in a randomised controlled trial with an intervention group (n = 231) and a waiting list control group (n = 231).

Main outcome measures: Hypothesised mediators problem-solving skills (SPSI-R) and personal control (IPQ-R) were measured at baseline and 3 months from baseline. Outcomes depression (HADS) and fatigue (CIS) were measured at baseline and 6 months from baseline.

Results: The intervention effects in decreasing depression and fatigue were mediated by personal control. Problem-solving skills did not mediate the intervention effects on depression and fatigue.

Conclusion: While personal control in the control group decreased in the first three months after baseline, levels of personal control within the intervention group were maintained. This effect partially explained the intervention effects on depression and fatigue. The results provide evidence for the relevance of addressing personal control in web-based interventions in order to improve psychosocial well-being in early cancer survivors.     

A controlled trial of an internet-based intervention program for cannabis users

In the last decade, several programs for the treatment of cannabis-related disorders were developed. Until now, no information is available on the efficacy of Internet-based counseling approaches for this target group. This article describes the evaluation of "quit the shit," a web-based intervention developed to help young people to quit or reduce their cannabis use significantly. Cannabis users seeking web-based treatment were included in a two-arm controlled trial conducted on a website for drug-related information and prevention. After the baseline assessment, members of the treatment condition were randomized to a 50-day intervention program. Other trial participants were put on a waiting list. A post-test was conducted 3 months after randomization. Of all 1,292 subjects included in the trial, a total of 206 participants took part at the post-test. Per-protocol- and intention-to-treat analyses were conducted. Members of the treatment condition showed a significantly stronger reduction in cannabis use (primary outcome) than the control group. In the per-protocol analyses, moderate-to-strong effects were found for the reduction of the frequency and the reduction of the quantity of consumed cannabis. Small-to-moderate effects were observed on the secondary outcomes (use-related self-efficacy, anxiety, depression, and life satisfaction). Despite limitations concerning the interpretation of the results, the intervention seems to offer an effective treatment option for persons with cannabis-related problems.