Study protocol: a randomised, controlled trial of a nurse navigator program for the management of hepatitis C virus in patients with severe mental disorder.

BACKGROUND: To evaluate the impact of a nurse navigation program on treatment adherence and resolution of hepatitis C infection in patients with severe mental disorder. METHODS: An open, randomized, controlled trial with blinded outcome assessment. The intervention group will engage in a nurse navigation program designed by mental health nurses. The program involves active screening for patients with severe mental disorder. The patients and caregivers included in the program will receive information, training, support and guidance throughout the treatment and recovery process, which involves different healthcare professionals and units. The control group will receive the standard of care, which includes follow-up by a family physician, referral to the hepatologist, serological testing, new referral to the hepatologist, onset of treatment, and follow-up. Multidisciplinary care will be provided along a coordinated and seamless clinical pathway led by a nurse navigator. The primary endpoints are total recovery (hepatitis C cure) and treatment adherence. Occurrence of symptoms of schizophrenia and health-related quality of life will be also recorded. Follow-up of patients will be performed three and six months after the administration of antiviral treatment. The study was authorised by the Ethics Committee of Malaga in December 2021. Funding was approved in March 2021. DISCUSSION: If this intervention is proven to be effective in improving treatment access and adherence, it will represent a step forward in addressing a chronic health issue that is 16 times more prevalent in the population with severe mental disease. Finally, this intervention may lead to the detection of undertreated HCV infection in this population of patients. TRIAL REGISTRATION: This protocol has been registered in ClinicalTrials.gov with identifier code NCT04891445 on May 18, 2021.

Development of a guideline for the treatment of generalized anxiety disorder with the ADAPTE method.

OBJECTIVE: The aim was to develop a clinical guideline for managing generalised anxiety disorder in Primary Health Care and Mental Health, using guideline adaptation methods. DESIGN: A clinical guideline was developed, following the methods of the ADAPTE group, and implemented in a Primary Health Care District and in Mental Health Services in Spain. SETTING: Regional University Hospital of Málaga and District of Primary Health Care Málaga-Guadalhorce (Spain). PARTICIPANTS: The participants were family physicians, psychiatrists and clinical psychologists. The phases of the process included definition of clinical scenarios, literature search and guidelines appraisal, elaboration of recommendations, conducting focus groups with users diagnosed with generalised anxiety disorder, linking the testimonials of users with recommendations, external review and implementation by multifaceted interventions. RESULTS: The final release included 49 Recommendations, of which 47 are from the 2011 NICE guidance for GAD and 2 of the 2011 NICE guideline for common mental disorder. Finally, seven recommendations needed to be adapted to the Spanish health care context, and three recommendations were excluded. CONCLUSIONS: A guideline aimed to improve the quality and effectiveness of the care provided to people with generalised anxiety disorder has been released. The use of adaptation methods has simplified the use of resources and time. This guideline and the process designed for its implementation constitute a suitable collection of resources for the improvement on detection and treatment of GAD in primary health care. Adaptation methods play a key role in the knowledge translation continuum.

Efficacy of Three Low-Intensity, Internet-Based Psychological Interventions for the Treatment of Depression in Primary Care: Randomized Controlled Trial.

BACKGROUND: Primary care is a major access point for the initial treatment of depression, but the management of these patients is far from optimal. The lack of time in primary care is one of the major difficulties for the delivery of evidence-based psychotherapy. During the last decade, research has focused on the development of brief psychotherapy and cost-effective internet-based interventions mostly based on cognitive behavioral therapy (CBT). Very little research has focused on alternative methods of treatment for depression using CBT. Thus, there is a need for research into other therapeutic approaches. OBJECTIVE: This study aimed to assess the effectiveness of 3 low-intensity, internet-based psychological interventions (healthy lifestyle psychoeducational program [HLP], focused program on positive affect promotion [PAPP], and brief intervention based on mindfulness [MP]) compared with a control condition (improved treatment as usual [iTAU]). METHODS: A multicenter, 4-arm, parallel randomized controlled trial was conducted between March 2015 and March 2016, with a follow-up of 12 months. In total, 221 adults with mild or moderate major depression were recruited in primary care settings from 3 Spanish regions. Patients were randomly distributed to iTAU (n=57), HLP (n=54), PAPP (n=56), and MP (n=54). All patients received iTAU from their general practitioners. The main outcome was the Spanish version of the Patient Health Questionnaire-9 (PHQ-9) from pretreatment (time 1) to posttreatment (time 2) and up to 6 (time 3) and 12 (time 4) months' follow-up. Secondary outcomes included the visual analog scale of the EuroQol, the Short-Form Health Survey (SF-12), the Positive and Negative Affect Schedule (PANAS), and the Pemberton Happiness Index (PHI). We conducted regression models to estimate outcome differences along study stages. RESULTS: A moderate decrease was detected in PHQ-9 scores from HLP (ß=-3.05; P=.01) and MP (ß=-3.00; P=.01) compared with iTAU at posttreatment. There were significant differences between all intervention groups and iTAU in physical SF-12 scores at 6 months after treatment. Regarding well-being, MP and PAPP reported better PHI results than iTAU at 6 months post treatment. PAPP intervention significantly decreased PANAS negative affect scores compared with iTAU 12 months after treatment. CONCLUSIONS: The low-intensity, internet-based psychological interventions (HLP and MP) for the treatment of depression in primary care are more effective than iTAU at posttreatment. Moreover, all low-intensity psychological interventions are also effective in improving medium- and long-term quality of life. PAPP is effective for improving health-related quality of life, negative affect, and well-being in patients with depression. Nevertheless, it is important to examine possible reasons that could be implicated for PAPP not being effective in reducing depressive symptomatology; in addition, more research is still needed to assess the cost-effectiveness analysis of these interventions. TRIAL REGISTRATION: ISRCTN Registry ISRCTN82388279; http://www.isrctn.com/ISRCTN82388279. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12888-015-0475-0.

Predictors of Adherence in Three Low-Intensity Intervention Programs Applied by ICTs for Depression in Primary Care.

Depression is one of the most common disorders in psychiatric and primary care settings, and is associated with disability, loss in quality of life, and economic costs. Internet-based psychological interventions have been shown to be effective in depression treatment but present problems with a low degree of adherence. The main aim of this study is to analyze the adherence predictors in three low-intensity interventions programs applied by Information and Communication Technologies (ICTs) for depression. A multi-center, randomized, controlled clinical trial was conducted with 164 participants with depression, who were allocated to: Healthy Lifestyle Program, Positive Affect Promotion Program or Mindfulness Program. Sociodemographic characteristics, Patient Health Questionnaire-9, Visual Analog Scale, Short Form Health Survey, Positive and Negative Affect Schedule, Five Facets Mindfulness Questionnaire, Pemberton Happiness Index and Treatment Expectancy Questionnaire were used to study adherence. Results showed that positive affect resulted in a predictor variable for Healthy Lifestyle Program and Positive Affect Promotion Program. Perceived health was also a negative adherence predictor for the Positive Affect Promotion Program. Our findings demonstrate that there are differences in clinical variables between treatment completers and non-completers and we provide adherence predictors in two intervention groups. Although new additional predictors have been examined, further research is essential in order to improve tailored interventions and increase adherence treatment.

Use of the ADAPTE Method to Develop a Guideline for the Improvement of Depression Care in Primary Care.

Depression is the most frequent psychiatric disorder in primary health care, and the evidence shows that there is suboptimal management by primary care practitioners, perhaps owing to difficulties in decision making. Because clinical guidelines can improve decision making and management, a clinical guideline to manage depression in primary health care was developed in adherence to the ADAPTE method and was implemented in the Málaga Primary Health Care District in Spain. This column reports on the guideline development process, which produced a set of resources to improve the quality of primary health care-based depression care in Spain.