Evaluating a novel online behavioural intervention to encourage cost-conscious strategies among US adults with chronic conditions who are enrolled in a high-deductible health plan: a proof-of-concept pilot study.

OBJECTIVES: Patients with chronic conditions enrolled in high-deductible health plans (HDHPs) face cost-related access barriers and high out-of-pocket spending. Our objectives were to develop a novel behavioural intervention to help HDHP enrollees with chronic conditions use cost-conscious strategies and evaluate the intervention's preliminary effectiveness, acceptability and feasibility. DESIGN: Prospective. SETTING: Online (USA). PARTICIPANTS: 36 US adults enrolled in an HDHP through their employer or an exchange with diabetes, hypertension, asthma, coronary artery disease and/or chronic obstructive pulmonary disease. 31/36 participants completed the study. INTERVENTION: We developed a 5-week intervention consisting of a website with educational modules on discussing costs with clinicians, saving for future healthcare costs, comparing healthcare prices and quality, preparing for appointments, following up after appointments and planning for future healthcare needs; and emails encouraging participants to access each module. OUTCOMES: We conducted a single-arm proof-of-concept pilot study of the intervention. Baseline and postintervention surveys measured primary outcomes of health insurance literacy and confidence in using cost-conscious strategies. 10 participants completed postintervention interviews. RESULTS: 31 (86%) participants completed a baseline and postintervention survey. Mean health insurance literacy scores (20-80 scale) improved from 56.5 to 67.1 (p<0.001). Mean confidence scores (0-10 scale) improved for talking to a healthcare provider about cost (6.1-7.6, p=0.0094), saving for healthcare (5.8-6.6, p=0.068), comparing prices (5.4-6.9, p=0.005) and comparing quality (6.1 to 7.6, p=0.0034). Participants found the website easy to use and helpful for learning about cost-conscious strategies on postintervention interviews. CONCLUSIONS: Our novel behavioural intervention was acceptable to HDHP enrollees with chronic conditions, feasible to deliver and associated with increased health insurance literacy and confidence in using cost-conscious strategies. This intervention should be tested in a definitive randomised controlled trial that is fully powered to evaluate its effects on cost-related access barriers, out-of-pocket spending and health outcomes in this growing patient population.

Economic evaluation of Be a Mom, a web-based intervention to prevent postpartum depression in high-risk women alongside a randomized controlled trial.

BACKGROUND: Postpartum depression (PPD) poses significant challenges, affecting both mothers and children, with substantial societal and economic implications. Internet-based cognitive behavioral therapy interventions (iCBT) offer promise in addressing PPD, but their economic impact remains unexplored. This study aimed to evaluate the cost-utility of Be a Mom, a self-guided iCBT intervention, compared with a waiting-list control among postpartum women at high risk of PPD. METHODS: This economic evaluation was conducted alongside a 14-month randomized controlled trial adopting a societal perspective. Participants were randomized to Be a Mom (n = 542) or a waitlisted control group (n = 511). Self-report data on healthcare utilization, productivity losses, and quality-adjusted life years (QALYs) were collected at baseline, post-intervention, and 4 and 12 months post-intervention. Incremental cost-effectiveness ratios (ICERs) were calculated, and cost-effectiveness acceptability curves were generated using nonparametric bootstrapping. Sensitivity analyses were conducted to assess result robustness. RESULTS: Over 14 months, Be a Mom generated a QALY gain of 0.0184 (0.0022, 0.0346), and cost savings of EUR 34.06 (-176.16, 108.04) compared to the control group. At a willingness to pay of EUR 20,000, Be a Mom had a 97.6 % probability of cost-effectiveness. LIMITATIONS: Results have limitations due to self-selected sample, potential recall bias in self-reporting, missing data, limited follow-up, and the use of a waiting-list control group. CONCLUSIONS: This study addresses a critical gap by providing evidence on the cost-utility of an iCBT intervention tailored for PPD prevention. Further research is essential to identify scalable and cost-effective interventions for reducing the burden of PPD.

Economic evaluation of an online single-session intervention for depression in Kenyan adolescents.

Objective: To evaluate the costs and cost-effectiveness of Shamiri-Digital, an online single-session intervention (SSI) for depression among Kenyan adolescents. Method: Data were drawn from a randomized clinical trial with n = 103 Kenyan high school students (64% female, Mage = 15.5). All students were eligible to participate, regardless of baseline depression symptomatology. We estimated delivery costs in 2020 U.S. dollars from multiple perspectives. To account for uncertainty, we performed sensitivity analyses with different cost assumptions and definitions of effectiveness. Using number needed to treat (NNT) estimates, we also evaluated the cost required to achieve a clinically meaningful reduction in depressive symptoms. Results: In the base-case (the most realistic cost estimate), it costs U.S. $3.57 per student to deliver Shamiri-Digital. Depending on the definition of clinically meaningful improvement, 7.1-9.7 students needed to receive the intervention for one student to experience a clinically meaningful improvement, which translated to a cost of U.S. $25.35 to U.S. $34.62 per student. Under a worst-case scenario (i.e., assuming the highest treatment cost and the strictest effectiveness definition), the cost to achieve clinically meaningful improvement was U.S. $92.05 per student. Conclusions: Shamiri-Digital is a low-cost intervention for reducing depression symptomatology. The public health benefit of empirically supported SSIs is especially important in low-income countries, where funding for mental health care is most limited. Future research can compare the cost-effectiveness of online SSIs to higher-cost treatments and estimate the robustness of Shamiri-Digital's effects over a longer time horizon. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Economic Evaluation of Web- versus Telephone-based Interventions to Simultaneously Increase Colorectal and Breast Cancer Screening Among Women.

Screening for colorectal and breast cancer is considered cost effective, but limited evidence exists on cost-effectiveness of screening promotion interventions that simultaneously target both cancers. Increasing Colorectal and Breast Cancer Screening (Project COBRA), a randomized controlled trial conducted in the community, examined the cost-effectiveness of an innovative tailored web-based intervention compared with tailored telephone counseling and usual care. Screening status at 6 months was obtained by participant surveys plus medical record reviews. Cost was prospectively measured from the patient and provider perspectives using time logs and project invoices. Relative efficiency of the interventions was quantified by the incremental cost-effectiveness ratios. Nonparametric bootstrapping and net benefit regression analysis were used to assess statistical uncertainty of the results. The average cost per participant to implement the Phone counseling, Web-based, and Web + Phone counseling interventions were $277, $314, and $337, respectively. Comparing Phone counseling with usual care resulted in an additional cost of $300 (95% confidence interval [CI]: $283-$320) per cancer screening test and $421 (95% CI: $400-$441) per additional person screened in the target population. Phone counseling alone was more cost-effective than the Web + Phone intervention. Web-based intervention alone was more costly but less effective than the Phone counseling. When simultaneously promoting screening for both colorectal and breast cancer the Web-based intervention was less cost-effective compared with Phone and Web + Phone strategies. The results suggest that targeting multiple cancer screening may improve the cost-effectiveness of cancer screening interventions. PREVENTION RELEVANCE: This study informs researchers, decision makers, healthcare providers, and payers about the improved cost-effectiveness of targeting multiple cancer screenings for cancer early detection programs.

Cost-effectiveness of Internet-Delivered vs In-Person Cognitive Behavioral Therapy for Children and Adolescents With Obsessive-Compulsive Disorder.

Importance: Therapist-guided, internet-delivered cognitive behavioral therapy is an effective treatment option for children and adolescents with obsessive-compulsive disorder, but to our knowledge, its cost-effectiveness compared with traditional in-person treatment has not been established. Objective: To evaluate the cost-effectiveness of guided internet-delivered cognitive behavioral therapy implemented within a stepped-care model compared with in-person cognitive behavioral therapy for young people with obsessive-compulsive disorder. Design, Setting, and Participants: This economic evaluation of a randomized noninferiority trial conducted at 2 specialist obsessive-compulsive disorder clinics in Sweden enrolled 152 children and adolescents aged 8 to 17 years with obsessive-compulsive disorder, mainly through clinician referrals (110 [72%]). Recruitment began October 6, 2017, and ended May 24, 2019. Follow-up ended April 14, 2020. Interventions: Participants were randomly assigned to receive either guided internet-delivered cognitive behavioral therapy or in-person cognitive behavioral therapy during a 16-week period. At the 3-month follow-up, nonresponders in both groups were offered additional in-person cognitive behavior therapy sessions. Main Outcomes and Measures: Health outcomes were treatment response rates (primary outcome), remission rates, and quality-adjusted life-years. Cost data were collected before treatment, after treatment, at 3-month follow-up, and at 6-month follow-up (primary end point) and are presented in 2020 US dollars. The differences in incremental costs and health outcomes were compared between the groups and presented from the health care professional, health care sector, and societal perspectives. Results: A total of 152 participants (94 girls [62%]; mean [SD] age, 13.4 [2.5] years) were randomized; 151 (99%) completed the trial. At the 6-month follow-up, 50 of 74 participants (68%) in the stepped-care group and 52 of 77 participants (68%) in the in-person cognitive behavioral therapy group were classified as treatment responders (odds ratio, 1.00 [95% CI, 0.51-1.98]; P = .99). Health economic analyses showed that the stepped-care group used fewer therapist resources than the in-person cognitive behavioral therapy group, resulting in a mean cost savings of $2104 (95% CI, $1202-$3006) per participant for the full study period of 10 months, corresponding to a relative savings of 39%. The cost savings remained largely comparable when taking wider health care sector and societal perspectives. Conclusions and Relevance: This study suggests that, for young people with obsessive-compulsive disorder, a low-cost digital intervention followed by in-person treatment for nonresponders was cost-effective compared with in-person cognitive behavior therapy alone.

A randomized controlled trial to evaluate the use of a web-based application to manage medications during in vitro fertilization.

OBJECTIVE: To evaluate the use of a web-based application that assists in medication management during in vitro fertilization (IVF) treatment. DESIGN: Multicenter randomized controlled trial. SETTING: University hospitals. PATIENT(S): Women undergoing IVF. INTERVENTION(S): Subjects were recruited to assess quality of life during IVF and were randomly assigned to use either the OnTrack application to assist with medication management or conventional medication management. Surveys were administered at four time points. MAIN OUTCOME MEASURE(S): Medication surplus, incidence of medication errors, amount of patient-initiated communication, and patient satisfaction. RESULT(S): A total of 153 women participated. The average number of portal messages and telephone calls was similar between groups. Twelve patients in the control group (12/69, 17.4%) and 8 patients in the case group (8/72, 11.1%) made medication errors. There were similar amounts of medication surplus in the two groups. The estimated cost of medication waste was $2,578 ± $2,056 in the control group and $2,554 ± $1,855 in the case group. Patient satisfaction was similar between the two groups. CONCLUSION(S): Use of a web-based application did not decrease medication errors, medication surplus, or patient-initiated messages. Many patients had a medication surplus, which can be an area of cost reduction during IVF. CLINICAL TRIAL REGISTRATION NUMBER: Clinicaltrials.gov NCT03383848.

Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN' (REGAIN): a structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: The primary objective is to determine which of two interventions: 1) an eight week, online, home-based, supervised, group rehabilitation programme (REGAIN); or 2) a single online session of advice (best-practice usual care); is the most clinically and cost-effective treatment for people with ongoing COVID-19 sequelae more than three months after hospital discharge. TRIAL DESIGN: Multi-centre, 2-arm (1:1 ratio) parallel group, randomised controlled trial with embedded process evaluation and health economic evaluation. PARTICIPANTS: Adults with ongoing COVID-19 sequelae more than three months after hospital discharge Inclusion criteria: 1) Adults ≥18 years; 2) ≥ 3 months after any hospital discharge related to COVID-19 infection, regardless of need for critical care or ventilatory support; 3) substantial (as defined by the participant) COVID-19 related physical and/or mental health problems; 4) access to, and able/supported to use email and internet audio/video; 4) able to provide informed consent; 5) able to understand spoken and written English, Bengali, Gujarati, Urdu, Punjabi or Mandarin, themselves or supported by family/friends. EXCLUSION CRITERIA: 1) exercise contraindicated; 2) severe mental health problems preventing engagement; 3) previous randomisation in the present study; 4) already engaged in, or planning to engage in an alternative NHS rehabilitation programme in the next 12 weeks; 5) a member of the same household previously randomised in the present study. INTERVENTION AND COMPARATOR: Intervention 1: The Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN) programme: an eight week, online, home-based, supervised, group rehabilitation programme. Intervention 2: A thirty-minute, on-line, one-to-one consultation with a REGAIN practitioner (best-practice usual care). MAIN OUTCOMES: The primary outcome is health-related quality of life (HRQoL) - PROMIS® 29+2 Profile v2.1 (PROPr) - measured at three months post-randomisation. Secondary outcomes include dyspnoea, cognitive function, health utility, physical activity participation, post-traumatic stress disorder (PTSD) symptom severity, depressive and anxiety symptoms, work status, health and social care resource use, death - measured at three, six and 12 months post-randomisation. RANDOMISATION: Participants will be randomised to best practice usual care or the REGAIN programme on a 1:1.03 basis using a computer-generated randomisation sequence, performed by minimisation and stratified by age, level of hospital care, and case level mental health symptomatology. Once consent and baseline questionnaires have been completed by the participant online at home, randomisation will be performed automatically by a bespoke web-based system. BLINDING (MASKING): To ensure allocation concealment from both participant and REGAIN practitioner at baseline, randomisation will be performed only after the baseline questionnaires have been completed online at home by the participant. After randomisation has been performed, participants and REGAIN practitioners cannot be blind to group allocation. Follow-up outcome assessments will be completed by participants online at home. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 535 participants will be randomised: 263 to the best-practice usual care arm, and 272 participants to the REGAIN programme arm. TRIAL STATUS: Current protocol: Version 3.0 (27th October 2020) Recruitment will begin in December 2020 and is anticipated to complete by September 2021. TRIAL REGISTRATION: ISRCTN:11466448 , 23rd November 2020 FULL PROTOCOL: The full protocol Version 3.0 (27th October 2020) is attached as an additional file, accessible from the Trials website (Additional file 1). In the interests of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.

Efficacy and cost-effectiveness of a therapist-assisted web-based intervention for depression and anxiety in patients with ischemic heart disease attending cardiac rehabilitation [eMindYourHeart trial]: a randomised controlled trial protocol.

BACKGROUND: One in five patients with ischaemic heart disease (IHD) develop comorbid depression or anxiety. Depression is associated with risk of non-adherence to cardiac rehabilitation (CR) and dropout, inadequate risk factor management, poor quality of life (QoL), increased healthcare costs and premature death. In 2020, IHD and depression are expected to be among the top contributors to the disease-burden worldwide. Hence, it is paramount to treat both the underlying somatic disease as well as depression and anxiety. eMindYourHeart will evaluate the efficacy and cost-effectiveness of a therapist-assisted eHealth intervention targeting depression and anxiety in patients with IHD, which may help fill this gap in clinical care. METHODS: eMindYourHeart is a multi-center, two-armed, unblinded randomised controlled trial that will compare a therapist-assisted eHealth intervention to treatment as usual in 188 CR patients with IHD and comorbid depression or anxiety. The primary outcome of the trial is symptoms of depression, measured with the Hospital Anxiety and Depression Scale (HADS) at 3 months. Secondary outcomes evaluated at 3, 6, and 12 months include symptoms of depression and anxiety (HADS), perceived stress, health complaints, QoL (HeartQoL), trial dropout (number of patients dropped out in either arm at 3 months) and cost-effectiveness. DISCUSSION: To our knowledge, this is the first trial to evaluate both the efficacy and cost-effectiveness of a therapist-assisted eHealth intervention in patients with IHD and comorbid psychological distress as part of CR. Integrating screening for and treatment of depression and anxiety into standard CR may decrease dropout and facilitate better risk factor management, as it is presented as "one package" to patients, and they can access the eMindYourHeart program in their own time and at their own convenience. The trial holds a strong potential for improving the quality of care for an increasing population of patients with IHD and comorbid depression, anxiety or both, with likely benefits to patients, families, and society at large due to potential reductions in direct and indirect costs, if proven successful. Trial registration The trial was prospectively registered on https://clinicaltrials.gov/ct2/show/NCT04172974 on November 21, 2019 with registration number [NCT04172974].

A Cost-effectiveness Analysis of an Internet-delivered Pain Management Program Delivered With Different Levels of Clinician Support: Results From a Randomised Controlled Trial.

There is growing interest in the potential of internet-delivered pain management programs (PMPs) to increase access to care for people with chronic pain. However, very few economic evaluations of these interventions have been reported. Using existing data, the current study examined the cost-effectiveness of an internet-delivered PMP for a mixed group chronic pain patients (n = 490) provided with different levels of clinician support. The findings indicated that each additional clinical outcome (defined as a ≥ 30% reduction in disability, depression, anxiety, and pain) was associated with cost-savings when the intervention was provided in a self-guided format (ICER range: -$404--$808 AUD) or an optional-guided format (ICER range: -$314--$541 AUD), and a relatively small fixed cost when provided in the clinician-guided format (ICER range: $88-$225 AUD). The results were driven by a reduction in service use costs among the treatment groups, which offset the costs of providing the internet-delivered PMP in the self-guided and optional-guided formats. The same general pattern of results was found when more stringent clinical outcomes (defined as a ≥ 50% reduction) were employed. These findings suggest that carefully developed and administered internet-delivered PMPs, provided with different levels of clinician support, can be highly cost effective for patients with a broad range of pain conditions. PERSPECTIVE: This study examines the cost-effectiveness of an internet-delivered PMP provided to adults with a broad range of chronic pain conditions. Evidence of cost-effectiveness was found across a broad range of clinical outcomes and with different levels of clinician support.

Feasibility, acceptability and cost efficiency of using webinars to deliver first-line patient education for people with Irritable Bowel Syndrome as part of a dietetic-led gastroenterology service in primary care.

BACKGROUND: Irritable bowel syndrome (IBS) is a chronic functional gastrointestinal disorder. International research suggests dietary intervention as a first-line approach, although dietetic services are struggling to cope with demand. Digital technology may offer a solution to deliver appropriate patient education. The present study aimed to assess the feasibility, acceptability and cost efficiency of using webinars to deliver first-line IBS advice to patients as part of a dietetic-led gastroenterology service in primary care. METHODS: Patients were directed to an IBS First Line Advice webinar on a specialist NHS website. Data were collected from patients pre- and post-webinar use using an online survey. RESULTS: In total, 1171 attendees completed the pre-webinar survey and 443 completed the post-webinar survey. Attendees ranged from under 17 years to over 75 years. Of the attendees, 95% found the webinar easy to access and 91% were satisfied with the content of the webinar. Those with excellent or good knowledge rose from 25% pre-webinar to 67% post-webinar, and confidence in managing their condition improved for 74% of attendees. Using the webinars led to a 44% reduction in referrals for one-to-one appointments with a specialist dietitian in the first year of use. The value of the clinical time saved is estimated at £3593 per annum. The one-off cost of creating the webinar was £3597. CONCLUSIONS: The use of webinars is a feasible, acceptable and cost-efficient way of delivering first-line patient education to people suffering with Irritable Bowel Syndrome as part of a dietetic-led gastroenterology service in primary care.

Economic Evaluation of Tailored Web versus Tailored Telephone-Based Interventions to Increase Colorectal Cancer Screening among Women.

Screening for colorectal cancer is cost-effective, but many U.S. women are nonadherent, and the cost-effectiveness of web-based tailored screening interventions is unknown. A randomized controlled trial, COBRA (Increasing Colorectal and Breast Cancer Screening), was the source of information for the economic evaluation. COBRA compared screening among a Usual Care group to: (i) tailored Phone Counseling intervention; (ii) tailored Web intervention; and (iii) tailored Web + Phone intervention groups. A sample of 1,196 women aged 50 to 75 who were nonadherent to colorectal cancer screening were recruited from Indiana primary care clinics during 2013 to 2015. Screening status was obtained through medical records at recruitment with verbal confirmation at consent, and at 6-month follow-up via medical record audit and participant self-report. A "best sample" analysis and microcosting from the patient and provider perspectives were applied to estimate the costs and effects of the interventions. Statistical uncertainty was analyzed with nonparametric bootstrapping and net benefit regression analysis. The per participant cost of implementing the Phone Counseling, Web-based, and Web + Phone Counseling interventions was $277, $314, and $336, respectively. The incremental cost per person screened for the Phone Counseling compared with no intervention was $995, while the additional cost of Web and the Web + Phone compared with Phone Counseling did not yield additonal persons screened. Tailored Phone Counseling significantly increased colorectal cancer screening rates compared with Usual Care. Tailored Web interventions did not improve the screening rate compared with the lower cost Phone Counseling intervention.

Relative Cost Effectiveness of In-Person and Internet Interventions for Relationship Distress.

While the efficacy of couple therapy has been repeatedly demonstrated, most distressed couples do not seek treatment. To improve reach and overcome barriers to therapy, Integrative Behavioral Couple Therapy (IBCT) was translated into a web-based program, OurRelationship (OR). While both IBCT and OR have been shown to improve relationship and individual functioning, the goal of the present study was to compare the relative cost effectiveness of these two treatment modalities. In IBCT, 74% of couples experienced reliable improvement, compared to 55% of couples in OR. Within-group Cohen's d effect sizes during treatment for relationship satisfaction were d = 0.87 for IBCT and d = 0.96 for OR. Relative cost effectiveness analyses revealed that even at the highest expense estimates for OR and the lowest expense estimates for IBCT, OR was more cost effective in creating reliable improvement once at least 229 couples were served and was more cost effective in creating large-size effects once at least 153 couples were served. Cost-effectiveness increases for both IBCT and OR as more couples are served; however, this cost savings occurs at a much more rapid rate for OR. These findings demonstrate that despite higher initial development costs, Internet programs are a cost-effective option for dissemination either as a stand-alone service or as an initial intervention in a stepped care model with more intensive in-person services.

Si bien la eficacia de la terapia de pareja se ha demostrado repetidamente, la mayoría de las parejas con distrés no recurren a un tratamiento. Para mejorar el alcance y superar los obstáculos para la terapia, la terapia conductual integradora de pareja (IBCT) se tradujo en un programa basado en la web, denominado en inglés: OurRelationship, OR ("Nuestra relación"). Si bien tanto la IBCT (Christensen, Atkins, Berns, Wheeler, Baucom, & Simpson, 2004) como el programa OR (Doss et al., 2016) han demostrado mejorar la relación y el funcionamiento individual, el objetivo del presente estudio fue comparar la conveniencia económica relativa de estas dos modalidades de tratamiento. En la IBCT, el 74 % de las parejas experimentaron una mejora fiable en comparación con el 55 % de las parejas del programa OR. Los tamaños del efecto de la d de Cohen dentro del grupo durante el tratamiento para la satisfacción con la relación fueron d = 0.87 para la IBCT y d = 0.96 para el programa OR. Los análisis de conveniencia económica relativa revelaron que incluso teniendo en cuenta los cálculos de mayor gasto del OR y los de menor gasto de la IBCT, el OR fue más económico a la hora de crear una mejora fiable una vez que se atendió al menos a 229 parejas y fue más económico a la hora de crear grandes tamaños del efecto una vez que se atendió a, por lo menos, 153 parejas. La conveniencia económica aumenta tanto para la IBCT como para el OR a medida que se atiende a más parejas; sin embargo, estos ahorros en los costos se producen a un ritmo mucho más rápido para el OR. A pesar de tener costos iniciales de desarrollo más altos, los programas de internet son una opción económica para su difusión como servicio independiente o como una intervención inicial en un modelo de atención escalonado con más servicios intensivos en persona.

Comparative Effectiveness of Two Interventions to Increase Colorectal Cancer Screening for Those at Increased Risk Based on Family History: Results of a Randomized Trial.

BACKGROUND: First-degree relatives (FDR) of patients with colorectal cancer are at risk for colorectal cancer, but may not be up to date with colorectal cancer screening. We sought to determine whether a one-time recommendation about needing colorectal cancer screening using patient navigation (PN) was better than just receiving the recommendation only. METHODS: Participants were FDRs of patients with Lynch syndrome-negative colorectal cancer from participating Ohio hospitals. FDRs from 259 families were randomized to a website intervention (528 individuals), which included a survey and personal colorectal cancer screening recommendation, while those from 254 families were randomized to the website plus telephonic PN intervention (515 individuals). Primary outcome was adherence to the personal screening recommendation (to get screened or not to get screened) received from the website. Secondary outcomes examined who benefited from adding PN. RESULTS: At the end of the 14-month follow-up, 78.6% of participants were adherent to their recommendation for colorectal cancer screening with adherence similar between arms (P = 0.14). Among those who received a recommendation to have a colonoscopy immediately, the website plus PN intervention significantly increased the odds of receiving screening, compared with the website intervention (OR: 2.98; 95% confidence interval, 1.68-5.28). CONCLUSIONS: Addition of PN to a website intervention did not improve adherence to a colorectal cancer screening recommendation overall; however, the addition of PN was more effective in increasing adherence among FDRs who needed screening immediately. IMPACT: These findings provide important information as to when the additional costs of PN are needed to assure colorectal cancer screening among those at high risk for colorectal cancer.

A Comparison of Low-Income Versus Higher-Income Individuals Seeking an Online Relationship Intervention.

Compared to higher-income couples, low-income couples experience higher rates of relationship disruption, including divorce and breakup of cohabiting relationships. In recognition of this disparity in relationship outcomes, relationship interventions have increasingly been targeted at this population. However, these interventions have had limited impacts on the relationships of low-income couples. Developing interventions that are effective and responsive to the needs of low-income couples requires descriptive data on the challenges those couples perceive in their own relationships and an assessment of how their needs compare to the more affluent couples typically served by relationship interventions. The current study sampled over 5,000 individuals at the time they were seeking an online relationship intervention and compared the relationship functioning and life circumstances reported by low-income individuals to that of higher-income individuals. Results indicate that low-income individuals seeking a relationship intervention had higher levels of relationship distress (lower relationship satisfaction, more intense primary relationship problems, and less relationship stability), and had greater levels of contextual stress (more children living at home, less likely to be employed full-time, and lower levels of perceived health). Results suggest that future interventions designed to target low-income couples, as well as practitioners working with low-income couples, should be prepared to handle higher levels of relationship distress and contextual stressors than they may typically see in more affluent couples.

En comparación con las parejas de recursos más altos, las parejas de bajos recursos tienen índices altos de dificultades en las relaciones, incluidos el divorcio y la ruptura de las relaciones de convivencia. En reconocimiento de esta disparidad en las consecuencias de las relaciones, se han destinado cada vez más a esta población intervenciones en las relaciones. Sin embargo, estas intervenciones han tenido efectos limitados en las relaciones de las parejas de bajos recursos. El desarrollo de intervenciones que sean eficaces y sensibles a las necesidades de las parejas de bajos recursos exige datos descriptivos sobre las dificultades que esas parejas perciben en sus propias relaciones y una evaluación de cómo sus necesidades se comparan con las de las parejas más pudientes que normalmente reciben intervenciones en las relaciones. El presente estudio tomó muestras de más de 5000 personas en el momento en que estaban buscando una intervención en las relaciones por internet y comparó el funcionamiento de las relaciones y las circunstancias de vida informadas por personas de bajos recursos con las de personas de recursos más altos. Los resultados indican que las personas de bajos recursos que buscaban una intervención en las relaciones tenían niveles más altos de distrés relacional (una menor satisfacción con las relaciones, problemas más intensos en las relaciones principales y menos estabilidad relacional) y tenían niveles más altos de estrés contextual (más niños viviendo en la casa, menos probabilidades de estar empleados tiempo completo y niveles más bajos de salud percibida). Los resultados sugieren que las futuras intervenciones diseñadas para las parejas de bajos recursos, así como los profesionales que trabajan con estas parejas deberían estar preparados para manejar niveles más altos de distrés relacional y factores de estrés contextual que los que pueden ver normalmente en las parejas más pudientes.

Cost-utility of individual internet-based and face-to-face Mindfulness-Based Cognitive Therapy compared with treatment as usual in reducing psychological distress in cancer patients.

OBJECTIVE: It was previously determined that group-based face-to-face Mindfulness-Based Cognitive Therapy (MBCT) and individual internet-based MBCT (eMBCT) are equally efficacious compared with treatment as usual (TAU) in reducing psychological distress. In this study, the incremental cost-utility of both interventions compared with TAU was assessed. METHODS: This cost-utility study included 245 self-referred heterogeneous cancer patients with psychological distress who were randomized to MBCT, eMBCT or TAU. Healthcare costs and (informal) work-related productivity losses were assessed by interview. Outcomes were expressed in EuroQol-5D-3L utility scores and quality-adjusted life years (QALY). An economic evaluation with a time-horizon of 3 months was conducted from the societal perspective in the intention-to-treat sample. In addition, secondary explorative analyses of costs and quality of life during the 9-month follow-up were conducted based on linear extrapolation of TAU. RESULTS: Paid work-related productivity losses and societal costs were lower in both intervention conditions compared with TAU during the 3-month intervention period. Moreover, quality of life (utility scores) improved in eMBCT versus TAU (Cohen's d: .54) and MBCT versus TAU (.53). At a willingness to pay of €20000 per QALY, the mean incremental net monetary benefit was €1916 (SD=€783) in eMBCT and €2365 (SD=€796) in MBCT versus TAU. Exploration of costs demonstrated an equal pattern of eMBCT and MBCT being superior to TAU. Quality of life at 9-month follow-up remained improved in both interventions. CONCLUSIONS: Results indicate that eMBCT and MBCT are cost-saving treatments whilst simultaneously improving quality of life for distressed cancer patients.

Interventions of computerized psychotherapies for depression in Primary Care in Spain.

Currently, depression is a global health problem recognized by the WHO. The prevalence of this pathology in Primary Care is estimated at 19.5% worldwide, and 20.2% in Spain. In addition, the current intervention policies and protocols involve significant costs, both personal and economic, for people suffering from this disorder, as well as for society in general. On the other hand, the relapse rates after pharmacological interventions that are currently applied and the lack of effective specialized attention in mental health services reflect the need to develop new therapeutic strategies that are more accessible and profitable. Therefore, one of the proposals that are being investigated in different parts of the world is the design and evaluation of therapeutic protocols applied through Information and Communication Technologies, especially through the Internet and computer programs. The objective of this work was to present the current situation in Spain regarding the use of these interventions for the treatment of depression in Primary Care. The main conclusion is that although there is scientific evidence on the effectiveness of these programs, there are still important barriers that hinder their application in the public system, and also the need to develop implementation studies that facilitate the transition from research to clinical practice.

Evaluating differences in the clinical impact of a free online weight loss programme, a resource-intensive commercial weight loss programme and an active control condition: a parallel randomised controlled trial.

BACKGROUND: Finding effective intervention strategies to combat rising obesity levels could significantly reduce the burden that obesity and associated non-communicable diseases places on both individuals and the National Health Service. METHODS: In this parallel randomised-controlled trial, 76 participants who are overweight or obese (50 female) were given free access to a fitness centre for the duration of the 12-week intervention and randomised to one of three interventions. The commercial intervention, the Healthy Weight Programme, (HWP, n = 25, 10/15 men/women) consisted of twelve 1-h nutrition coaching sessions with a nutritionist delivered as a mixture of group and 1 to 1 sessions. In addition, twice-weekly exercise sessions (24 in total) were delivered by personal trainers for 12 weeks. The NHS intervention (n = 25, 8/17 men/women) consisted of following an entirely self-managed 12-week online NHS resource. The GYM intervention (n = 26, 8/18 men/women) received no guidance or formal intervention. All participants were provided with a gym induction for safety and both the NHS and GYM participants were familiarised with ACSM physical activity guidelines by way of a hand-out. RESULTS: The overall follow-up rate was 83%. Body mass was significantly reduced at post-intervention in all groups (HWP: N = 18, - 5.17 ± 4.22 kg, NHS: N = 21-4.19 ± 5.49 kg; GYM: N = 24-1.17 ± 3.00 kg; p < 0.001) with greater reductions observed in HWP and NHS groups compared to GYM (p < 0.05). Out with body mass and BMI, there were no additional statistically significant time x intervention interaction effects. CONCLUSIONS: This is the first study to evaluate the efficacy of both a free online NHS self-help weight-loss tool and a commercial weight loss programme that provides face-to-face nutritional support and supervised exercise. The findings suggest that both interventions are superior to an active control condition with regard to eliciting short-term weight-loss. TRIAL REGISTRATION: ISRCTN Registry - ISRCTN31489026. Prospectively registered: 27/07/16.

Investigating the effectiveness and cost-effectiveness of FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to activity management to treat paediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME): amendment to the published protocol.

The FITNET-NHS Trial is a UK, national, trial investigating whether an online cognitive behavioural therapy program (FITNET-NHS) for treating chronic fatigue syndrome/ME in adolescents is clinically effective and cost-effective in the NHS. At the time of writing (September 2019), the trial was recruiting participants. This article presents an update to the planned sample size and data collection duration previously published within the trial protocol. TRIAL REGISTRATION: ISRCTN, ID: 18020851. Registered 8 April 2016.

The (cost) effectiveness of guided internet-based self-help CBT for dialysis patients with symptoms of depression: study protocol of a randomised controlled trial.

BACKGROUND: Only a minority of dialysis patients with depressive symptoms are diagnosed and receive treatment. Depressive symptoms are highly prevalent in this population and are associated with adverse clinical outcomes. Underlying factors for this undertreatment may be the lack of evidence for the safety and effectivity of antidepressant medication, the reluctance of patients to adhere to antidepressant medication, the lack of mental healthcare provision in somatic healthcare environments and end-stage renal disease (ESRD) related physical limitations that complicate face-to-face psychotherapy. Guided Internet-based self-help treatment has demonstrated to be effective for depressive symptoms in other chronic patient populations and may overcome these barriers. The aim of this study is to investigate the (cost) effectiveness of a guided Internet-based self-help intervention for symptoms of depression in dialysis patients. METHODS: This study is a cluster randomized controlled trial (RCT) that investigates the effectiveness of a 5-week Internet-based self-help Problem Solving Therapy (PST) for depressive symptoms in dialysis patients. Depressive symptoms will be measured using the Beck Depression Inventory - second edition (BDI-II), with a cut-off score of ≥10. We aim to include 206 dialysis patients with depressive symptoms who will be cluster randomized to the intervention or the Care as Usual (CAU) control group. Secondary outcomes will include anxiety symptoms, quality of life, economic costs and clinical outcomes, such as inflammatory factors and hair cortisol levels. Assessments will take place at baseline (T0), 2 weeks after intervention (T1) and 6 months (T2), 12 months (T3) and 18 months (T4) after intervention. The control group will be measured at the same time points. Analysis will be based on the intention-to-treat principle. Mixed models will be used to assess the changes within each condition between pre-treatment and post-treatment. DISCUSSION: If demonstrated to be (cost) effective, Internet-based PST will offer new possibilities to treat dialysis patients with depressive symptoms and to improve their quality of care. TRIAL REGISTRATION: Dutch Trial Register: Trial NL6648 (NTR6834) (prospectively registered 13th November 2017).

Effectiveness of internet-delivered cognitive behavioural therapy in reducing sickness absence among young employees with depressive symptoms: study protocol for a large-scale pragmatic randomised controlled trial.

INTRODUCTION: Depression is a highly prevalent condition with typical onset in early adulthood. Internet-delivered cognitive behavioural therapy (iCBT) is a promising cost-effective and more widely available alternative to face-to-face CBT. However, it is not known whether it can reduce sickness absence in employees showing depressive symptoms. The randomised controlled trial component of the DAQI (Depression and sickness absence in young adults: a quasi-experimental trial and web-based treatment intervention) project aims to investigate if iCBT is effective in reducing sickness absence compared with care as usual (CAU) among young employees with depressive symptoms in primary care provided in an occupational health setting. METHODS AND ANALYSIS: This study will use a randomised controlled single-centre service-based trial of an existing iCBT programme (Mental Hub iCBT for Depression) to evaluate whether or not this treatment can reduce the number of sickness absence days in public sector employees aged 18-34 years who present at the occupational health service with mild depressive symptoms (score ≥9 on the Beck Depression Inventory-IA). Control participants will be offered CAU, with no constraints regarding the range of treatments. The active condition will consist of seven weekly modules of iCBT, with support from a web therapist. Primary outcome will be participants' all-cause sickness absence as indicated in employer's and national administrative records up to 6 months from study entry. Secondary outcomes relating to long-term sickness absence (over 11 calendar days) for mental and musculoskeletal disorders and psychotropic medication use will be obtained from the Finnish Social Insurance Institution's administrative records; and short sickness absence spells (up to 11 calendar days) will be extracted from employer's records. Analyses will be conducted on an intention-to-treat basis. ETHICS AND DISSEMINATION: The Coordinating Ethics Committee of the Hospital District of Helsinki and Uusimaa has approved the study (HUS/974/2019). The results will be published in peer-reviewed scientific journals and in publications for lay audience. TRIAL REGISTRATION NUMBER: ISRCTN10877837.