Evaluating complex interventions: Perspectives and issues for health behaviour change interventions

Objective: Health behaviour change interventions (HBCIs), used in health education, health promotion, patient education and psychotherapy areas, are considered complex interventions. The objective of this article is to discuss the value and limitations of using randomised clinical trials (RCTs) to asses HBCIs.

Methods: A scoping review of the literature was conducted to identify the main challenges of using RCTs for evaluating HBCIs. The issues were illustrated by case studies selected from research conducted by our multidisciplinary team.

Results: In complex interventions, effects are produced not only by the intervention, but are strongly linked to context. Issues relating to transferability of results are therefore critical, and require adjustments to the RCT model. Sampling bias, biases related to the experimental conditions and biases due to the absence of double-blindness were examined and illustrated by case studies.

Conclusion: The results underline the importance of a multidisciplinary approach. They call for adapted or alternative evaluation models that overcome the limitations of RCTs.     

From question-behaviour effects in trials to the social psychology of research participation

The ‘question-behaviour effect’ (QBE) has attracted much recent attention within health psychology, where it has also been referred to as the ‘mere measurement’ effect. There are other conceptualisations of similar phenomena in related disciplines. This paper explores the implications of the QBE for the safety of inferences about intervention effectiveness within the context of randomised controlled trials evaluating health behaviour change interventions. It draws attention to poorly understood mechanisms by which bias is introduced with conventional thinking about trial design and analysis. The threat to valid inference on intervention effectiveness posed by the QBE applies even when its effects are small and regardless of the specific content of the QBE. The nature of the resulting bias does not fit well within existing bias classification schemes, such as that proposed by the Cochrane Collaboration. The QBE is one possible consequence of research participation and it is suggested that the social psychology of research participation is very much underdeveloped. Possible future directions for health psychology research in this area are considered.     

Young People's Experiences of Participation in Clinical Trials: Reasons for Taking Part

Given the lack of knowledge about safety and efficacy of many treatments for children, pediatric clinical trials are important, but recruitment for pediatric research is difficult. Little is known about children's perspective on participating in trials. The purpose of this study was to understand the experiences and motivations of young people who took part in clinical trials. This is a qualitative interview study of 25 young people aged 10–23 who were invited to take part in clinical trials. Interviews were audio or video recorded and analyzed using framework analysis. Young peoples' motivations were both personal benefit and helping others. Both incentives appeared to be more complex than expected. We introduce the terms “network of exchange” and “intergenerational solidarity” to describe these motivations. To improve recruitment, professionals should be more open about research opportunities, provide better information, and give young people feedback after the trial has ended.     

Does the Method of Content Delivery Matter? Randomized Controlled Comparison of an Internet-Based Intervention for Eating Disorder Symptoms With and Without Interactive Functionality

Despite their potential as a scalable, cost-effective intervention format, self-guided Internet-based interventions for eating disorder (ED) symptoms continue to be associated with suboptimal rates of adherence and retention. Improving this may depend on the design of an Internet intervention and its method of content delivery, with interactive programs expected to be more engaging than static, text-based programs. However, causal evidence for the added benefits of interactive functionality is lacking. We conducted a randomized controlled comparison of an Internet-based intervention for ED symptoms with and without interactive functionality. Participants were randomized to a 4-week interactive (n = 148) or static (n = 145) version of an Internet-based, cognitive-behavioral program. The interactive version included diverse multimedia content delivery channels (video tutorials, graphics, written text), a smartphone app allowing users to complete the required homework exercises digitally (quizzes, symptom tracking, self-assessments), and progress monitoring features. The static version delivered identical intervention content but only via written text, and contained none of those interactive features. Dropout rates were high overall (58%), but were significantly—yet slightly—lower for the interactive (51%) compared to the static intervention (65%). There were no significant differences in adherence rates and symptom-level improvements between the two conditions. Adding basic interactive functionality to a digital intervention may help with study retention. However, present findings challenge prior speculations that interactive features are crucial for enhancing user engagement and symptom improvement.     

A THERAPEUTIC PLAYGROUP FOR DEPRESSED MOTHERS AND THEIR INFANTS: FEASIBILITY STUDY AND PILOT RANDOMIZED TRIAL OF COMMUNITY HUGS

Symptoms of depression negatively impact on mother?infant relationships and child outcomes. We evaluated a novel, 10‐session mother?infant therapeutic playgroup—Community HUGS (CHUGS)—which combines cognitive and experiential components through psychoeducation, play, music, and movement. Participants were mothers experiencing a range of postnatal mental health difficulties, including depression, with infants ≤12 months of age. However, the aim was not to treat maternal depression but to ameliorate associated problems in the mother?infant interaction. In the feasibility study, all participants received CHUGS. In the pilot randomized controlled trial (RCT), participants were randomized between intervention and a wait‐list. Outcomes were the Parenting Stress Index (PSI; R.R. Abidin, 1995), Parenting Sense of Competency Scale (Self‐Efficacy subscale; J. Gibaud‐Wallston & L.P. Wandersman, 1978), and the Depression, Anxiety, Stress Scales (P.F. Lovibond & S.H. Lovibond, 1995). In the feasibility study (n = 74), PSI scores dropped on all subscales, all ps < .01. Depression, p < .001, anxiety, p = .01, stress, p = .01, and self‐efficacy, p < .001, all showed improvements, as did observer‐rated mother?infant interactions, p < .001. In the RCT, depression, p < .001, anxiety, p = .005, and stress, p < .001, symptoms were significantly reduced for intervention participants (n = 16), as compared to wait‐list participants (n = 15). The CHUGS program had high participant satisfaction and produced improvements in self‐efficacy, depression, anxiety, stress, and mother?infant interactions that supported the program's acceptability and the utility of further rollout.     

反向对抗逻辑范式的创立与证实——人工语法PDP对抗逻辑的改进

人工语法对抗逻辑范式不能排除相似性和辨别力,导致自动反应不纯粹甚至虚假或无法检测到。本研究创立反向对抗逻辑范式,采用单因素(相容/对抗条件)被试间设计:内隐学习阶段将肯定标签与语法A绑定,否定标签与语法B绑定;测量阶段相容条件组对语法A和B做与学习阶段一致的判断,对抗条件组对语法B做与学习阶段对抗的肯定判断。实验证明:(1)外显否定标签可与语法B绑定学习而获得自动化特征,产生内隐联结自动化。(2)内隐否定知识比肯定知识更自动,知识从肯定转为否定易,从否定转为肯定难。(3)反向对抗逻辑范式能有效检测到自动反应,不受语法间形式相似性和辨别力影响。(4)首次析出高概率判断偏向效应,得到纯粹受控反应。     

Effects of school-based interventions on motivation towards physical activity in children and adolescents: A systematic review and meta-analysis

IntroductionAssuming that motivation is the key to initiate and sustain beneficial health behaviors, the aim of this systematic review was to analyze the effects of school-based physical activity interventions on a variety of motivational outcomes towards PA in school-aged children and adolescents.MethodsA comprehensive literature search was carried out in six electronic databases to identify randomized controlled trials and quasi-experimental trials examining the effects of PA interventions implemented during the regular school day, e.g., during physical education lessons or lunch breaks. Primary outcomes of interest were students' motivation, basic psychological needs, goal orientation, enjoyment, and motivational teaching climate in physical education. Meta-analyses were conducted for these outcomes using Comprehensive Meta-analysis software. Secondarily, intervention effects on students' PA behaviors were examined and the findings summarized narratively. Methodological quality of studies was evaluated using the Cochrane Collaboration's tool for assessing risk of bias for randomized trials; certainty of evidence on outcome level was evaluated using the GRADE approach.ResultsIn total, 57 studies carried out between 2001 and 2018 were included in this review. Sixteen individual meta-analyses were performed and revealed significant pooled effects for the outcomes enjoyment (g = 0.310), perceived autonomy (g = 0.152), identified regulation (g = 0.378), intrinsic motivation (g = 0.419), self-determination index (g = 0.672), task/mastery climate (g = 0.254), ego/performance climate (g = −0.438), autonomy supportive climate (g = 0.262), task goal orientation (g = 1.370), ego goal orientation (g = −0.188). The narrative data synthesis indicated an increase in students' PA behavior. The overall risk of bias was high across all studies and certainty of evidence of meta-analyzed outcomes ranged from very low to moderate. Moderate certainty of evidence was found for ego/performance climate and ego goal orientation. Conclusions: Meta-analyses suggest that school-based PA interventions may be effective in increasing a variety of motivational outcomes. However, the certainty of evidence was limited in the majority of outcomes. Further research is needed to identify effective intervention strategies that increase students’ motivation towards PA.     

If You Are Going to Pay Within the Next 24 Hours,Press 1: Automatic Planning Prompt Reduces Credit Card Delinquency

People often form intentions but fail to follow through on them. Mounting evidence suggests that such intention‐action gaps can be narrowed with prompts to make concrete plans about when, where, and how to act to achieve the intention. In this paper, we pushed the notion of plan‐concreteness to test the efficacy of a prompt under a minimalist automated calling setting, where respondents were only prompted to indicate a narrower duration within which they intent to act. In a field experiment, this planning prompt significantly helped people to pay their past dues and get out of debt delinquency. These results suggest that minimalist automatic planning prompts are a scalable, cost‐effective intervention.     

Internet-based acceptance and commitment therapy for psychological distress experienced by people with hearing problems: a pilot randomized controlled trial

Psychological distress is common among people with hearing problems, but treatments that specifically target this aspect have been almost non-existent. In this pilot randomized controlled trial, an eight-week long Internet-based treatment, informed by Acceptance and Commitment Therapy, was administered to explore the feasibility and efficacy of such a treatment. Included participants were randomized to either treatment (n = 31) or wait-list control (n = 30) condition. All participants were measured prior to randomization and immediately after treatment ended using standardized self-report instruments measuring hearing-related emotional and social adjustment (Hearing Handicap Inventory for the Elderly – S, HHIE-S), quality of life (Quality of Life Inventory, QOLI), and symptoms of depression and anxiety (Patient health Questionnaire, PHQ-9 and Generalized Anxiety Disorder scale, GAD-7). Linear mixed effects regression analysis using the full intention-to-treat sample demonstrated that the treatment had superior outcomes on the main outcome measure as compared with the control group, Cohen’s d = 0.93, 95% CI [0.24, 1.63]. The benefits of treatment over control were also evident in scores of depression, Cohen’s d = 0.61, 95% CI [0.04, 1.19], and quality of life, Cohen’s d = 0.88, 95% CI [0.14, 1.61]. The results provide preliminary support for Internet-delivered acceptance and commitment therapy as a potentially effective treatment of psychological symptoms associated with hearing problems.