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Tailored internet-administered treatment of anxiety disorders for primary care patients: study protocol for a randomised controlled trial.

ABSTRACT: Internet-administered cognitive behavioural therapy (ICBT) has been found to be effective for a range of anxiety disorders. However, most studies have focused on one specific primary diagnosis and co-morbidity has not been considered. In primary care settings, patients with anxiety often suffer from more than one psychiatric condition, making it difficult to disseminate ICBT for specific conditions. The aim of this study will be to investigate if ICBT tailored according to symptom profile can be a feasible treatment for primary care patients with anxiety disorders. It is a randomised controlled trial aimed to evaluate the treatment against an active control group.Participants with anxiety disorders and co-morbid conditions (N = 128), will be recruited from a primary care population. The Clinical Outcome in Routine Evaluation (CORE-OM) will serve as the primary outcome measure. Secondary measures include self-reported depression, anxiety, quality of life and loss of production and the use of health care. All assessments will be collected via the Internet and measure points will be baseline, post treatment and 12 months post treatment.This trial will add to the body of knowledge on the effectiveness of ICBT for anxiety disorders in primary care. The trial will also add knowledge on the long term effects of ICBT when delivered for regular clinic patientsClinicalTrials.gov: NCT01390168.

SUBMITTER: Nordgren LB

PROVIDER: S-EPMC3305469 | biostudies-literature | 2012 Feb

REPOSITORIES: biostudies-literature

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Tailored internet-administered treatment of anxiety disorders for primary care patients: study protocol for a randomised controlled trial.

Nordgren Lise Bergman LB Andersson Gerhard G Kadowaki Åsa Å Carlbring Per P

Trials 20120209

<h4>Background</h4>Internet-administered cognitive behavioural therapy (ICBT) has been found to be effective for a range of anxiety disorders. However, most studies have focused on one specific primary diagnosis and co-morbidity has not been considered. In primary care settings, patients with anxiety often suffer from more than one psychiatric condition, making it difficult to disseminate ICBT for specific conditions. The aim of this study will be to investigate if ICBT tailored according to sym ...[more]

PMID: 22321916

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Project description:IntroductionMost people suffering from depression and anxiety disorders are entirely treated in primary care. Due to growing challenges in ageing societies, for example, patients' immobility and multimorbidity, the transition to specialised care becomes increasingly difficult. Although the co-location of general practitioners and mental health specialists improves the access to psychosocial care, integrated in-person approaches are not practical for rural and single-doctor practices with limited personnel and financial resources. Treating primary care patients via internet-based video consultations by remotely located mental health specialists bears the potential to overcome structural barriers and provide low-threshold care. The aim of this randomised controlled feasibility trial is to investigate the feasibility of implementing of mental health specialist video consultations in primary care practices.Methods and analysisFifty primary care patients with significant depression and/or anxiety symptomatology will be randomised in two groups receiving either the treatment as usual as provided by their general practitioner or up to five video consultations conducted by a mental health specialist. The video consultations focus on (1) systematic diagnosis plus proactive monitoring using validated clinical rating scales, (2) the establishment of an effective working alliance and (3) a stepped-care algorithm within integrated care adjusting treatments based on clinical outcomes. We will investigate the following outcomes: effectiveness of the recruitment strategies, patient acceptance of randomisation, practicability of the technical and logistical processes related to implementing video consultations in the practices' workflows, feasibility of the data collection and clinical parameters.Ethics and disseminationThis trial has undergone ethical scrutiny and has been approved by the Medical Faculty of the University of Heidelberg Ethics Committee (S-634/2018). The findings will be disseminated to the research community through presentations at conferences and publications in scientific journals. This feasibility trial will prepare the ground for a large-scale, fully powered randomised controlled trial.Trial registration numberDRKS00015812.

Project description:Internet-based self-help psychotherapy (IBT) could be an important alternative or supplement to ordinary face-to-face therapy. The findings of randomised controlled trials indicate that the effects of various IBT programmes for anxiety disorders seem better than no intervention and in some instances are equivalent to usual therapy. In Denmark, IBT is part of future treatment plans in mental health care services, but the verification level of the current clinical scientific knowledge is insufficient. The objective of this trial is feasibility assessment of benefits and harms of the Internet-based cognitive behavioural therapy (ICBT) programme FearFighter™ versus no intervention for anxiety disorders in adults.We will conduct an investigator-initiated, feasibility randomised controlled trial. Sixty-four participants are expected to be recruited via an advertisement posted on the homepage of the Student Counselling Service in Denmark. The inclusion criterion for participation in the trial will be the presence of anxiety disorder as assessed with the Mini International Neuropsychiatric Interview. The exclusion criteria will be suicidal risk, an ongoing episode of bipolar disorder or psychosis, concurrent psychological treatment for the anxiety disorder, considered unable to attend the intervention as planned (due to vacation, work/study placement, sickness, or similar occurrences), or lack of informed consent. The intervention group will be offered nine sessions with the ICBT programme FearFighter™ and a weekly telephone contact to support compliance. The control group will receive no intervention. We define the feasibility outcomes as follows: the fraction of randomised participants out of the eligible people (the lower 95 % confidence interval (CI)???50 %); and the fraction of compliant participants (those receiving at least six out of nine sessions) in the intervention group (the lower 95 % CI???60 %). The exploratory clinical outcomes are the number of participants no longer meeting the diagnostic criteria for an anxiety disorder at the end of the trial and level of distress (Beck Anxiety Inventory, Symptom Checklist-90-R, WHO Well-Being Index, Sheehan Disability Scale); the number of severe adverse events; and the occurrence of any psychological treatment outside the trial. To prevent bias in design, and in the gathering and analysis of data throughout the trial, we will follow the SPIRIT 2013 statement which defines standard protocol items for clinical trials.Based on our findings, we will discuss the feasibility of a future randomised controlled trial examining the benefits and harms of FearFighter™ versus no intervention for anxiety disorders in adults.ClinicalTrials.gov Identifier: NCT02499055 , registered on 1 July 2015.

Project description:BackgroundThe effect of internet-delivered cognitive behavioral therapy (iCBT) on anxiety in adults is well-known. However, patient dropouts and poor adherence to treatment are common. Feelings of belonging and empowerment from the treatment might be key to the completion of iCBT. Peer support workers are people with a personal experience of mental health problems, trained to provide professional support to people who require mental health care.ObjectiveThis study aims to assess patient experiences; the feasibility, safety, and acceptability; and preliminary effectiveness on anxiety and depression, empowerment, and adherence to treatment in an 8-week peer-supported iCBT program for patients with anxiety disorders treated in primary care.MethodsThis was a single-arm mixed methods feasibility study. Participants were patients referred to a central unit for iCBT in primary care. Quantitative data were collected pre-, post-, and 3 months postintervention. Qualitative data were collected through semistructured interviews.ResultsA total of 9 participants completed the quantitative outcome assessment. Statistically significant improvements were observed in perceived empowerment at a 3-month follow-up, and significant decreases in anxiety, depression, and psychological distress at the end of the treatment were maintained at a 3-month follow-up. In total, 8 of the 9 patients showed improvement in the severity of their symptoms of anxiety. Adherence to treatment was good among the participants. No serious adverse events were reported. Eight participants were enrolled in the qualitative analysis. The qualitative results showed 3 main themes: (1) real contact in an online world, (2) empowering experiences, and (3) being behind the wheel. Qualitative results largely emphasized the personal relationship and supported the acceptability of adding peer support to iCBT.ConclusionsPeer support in digital treatment seems to be a safe and acceptable intervention. The preliminary results suggest the effectiveness of peer support on patient empowerment, anxiety, depression, psychological distress, and adherence to treatment. The results indicate the need for future studies to evaluate the effect of adding peer support to iCBT in larger randomized controlled trials.

Project description:BackgroundAnxiety disorders are the most common mental disorders in community settings, and they are associated with significant psychological distress, functional and social impairment. While cognitive behaviour therapy (CBT) is the most consistently efficacious psychological treatment for anxiety disorders, barriers preclude widespread implementation of CBT in primary care. Transdiagnostic group CBT (tCBT) focuses on cognitive and behavioural processes and intervention strategies common to different anxiety disorders, and could be a promising alternative to conventional CBT. This study aims to examine the effectiveness of a transdiagnostic group CBT for anxiety disorders program as a complement to treatment-as-usual (TAU) in primary mental health care.Methods/designThe trial is a multicentre pragmatic randomized controlled trial with a pre-treatment, post-treatment, and follow-up at 4, 8 and 12-months design. Treatment and control groups. a) tCBT (12 weekly 2-h group sessions following a manualized treatment protocol); b) TAU for anxiety disorders. Inclusion criteria comprise meeting DSM-5 criteria for primary Panic Disorder, Agoraphobia, Social Anxiety Disorder and/or Generalized Anxiety Disorder. Patients are recruited in three regions in the province of Quebec, Canada. The primary outcome measures are the self-reported Beck Anxiety Inventory and the clinician-administered Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5); secondary outcome measures include treatment responder status based on the ADIS-5, and self-reported instruments for specific anxiety and depression symptoms, quality of life, functioning, and service utilisation.Statistical analysisIntention-to-treat analysis. A mixed effects regression model will be used to account for between- and within-subject variations in the analysis of the longitudinal effects of the intervention.DiscussionThis rigorous evaluation of tCBT in the real world will provide invaluable information to decision makers, health care managers, clinicians and patients regarding the effectiveness of the intervention. Widespread implementation of tCBT protocols in primary care could lead to better effectiveness, efficiency, access and equity for the large number of patients suffering from anxiety disorders that are currently not obtaining evidence-based psychotherapy.Trial registrationClinicalTrials.gov: NCT02811458 .

Project description:IntroductionLiving in an area with no or deficient structures for trans health care is disadvantageous for trans people. By providing an internet-based health care programme, i²TransHealth aims at reducing structural disadvantages for trans people living in areas lacking specialised care. The e-health intervention consists of video consultations and a 1:1 chat with a study therapist. Additionally, the i²TransHealth network cooperates with physicians, who especially offer crisis intervention close to the participants' place of residence. The aim of this study is to evaluate the (cost-)effectiveness of the internet-based health care programme for trans people compared with a control (waiting) group. The following research questions will be examined with a sample of 163 trans people: Does a 4-month treatment with the i²TransHealth internet-based health care programme improve patient-reported health-outcomes? Is i²TransHealth cost-effective compared with standard care from a societal or health care payers' perspective? Does the participation in and support by i²TransHealth lead to an increase of trans-related expertise in the physician network?Methods and analysisIn a randomised controlled trial, the outcomes of an internet-based health care programme for trans people will be investigated. In the intervention group, participants are invited to use i²TransHealth for 4 months. Participants allocated to the control group will be able to start with their transition-related care after 4 months of study participation. The primary outcome measure is defined as the reduction of psychosomatic symptoms, as assessed by the Brief Symptom Inventory-18, 4 months after using the i²TransHealth programme. Participants in both groups will undergo an assessment at baseline and 4 months after using i²TransHealth.Ethics and disseminationPositive ethical approval was obtained from the Hamburg Medical Association (PV7131). The results will be disseminated to service users and their families via media, to health care professionals via professional training and meetings and to researchers via conferences and publications.Trial registration numberNCT04290286.Protocol version22 December 2021 (V.1.0).

Project description:IntroductionThe control rate of hypertension is low in China, especially in rural, western and minority areas. This is related to poor medical skills among physicians in primary care institutions and low levels of trust among patients. However, primary healthcare institutions are the main battleground for the prevention and treatment of hypertension. It is worth exploring how to most effectively integrate patients, primary care physicians and cardiologists in tertiary hospitals, to build a long-term mechanism for the prevention and treatment of hypertension. In this study, we aim to evaluate the clinical effectiveness and conduct a health economic evaluation of an internet-based patient-primary care physician-cardiologist integrated management model of hypertension in areas of China with different socioeconomic levels.Methods and analysisThis is a 12-month, multicentre, randomised controlled trial involving patients with hypertension in urban communities and rural areas of Sichuan Province, China. Each primary healthcare institution will cooperate with their tertiary hospital through the Red Shine Chronic Disease Management System (RSCDMS). Patients will be randomly assigned 1:1 to two groups: (1) a traditional care group; (2) an intervention group in which primary care physicians and cardiologists can share patient data and manage patients together through the RSCDMS. Patients can upload their blood pressure (BP) values and communicate with physicians using the system. The primary outcome is the change in systolic BP over a 12-month period. Secondary outcomes are changes in diastolic BP, BP control rate, values of 24-hour ambulatory BP monitoring, difference in cost-effectiveness between the groups, patient satisfaction, medication adherence and home BP monitoring compliance. All data will be recorded and stored in the RSCDMS and analysed using IBM SPSS V.26.0.Ethics and disseminationThis study has been approved by the Biomedical Research Ethics Committee of the West China Hospital of Sichuan University in Sichuan, China (No. 2020-148). Written informed consent will be obtained from all participants. The results of this study will be disseminated to the public through academic conferences and peer-reviewed journals.Trial registration numberChiCTR2000030677.

Project description:The prevalence of depression is high and the elderly have an increased risk of developing chronic course. International data suggest that depression in the elderly is under-recognised, the latency before clinicians provide a treatment plan is longer and elderly patients with depression are not offered psychotherapy to the same degree as younger patients. Although recommendations for the treatment of elderly patients with depression exist, health-care professionals adhere to these recommendations to a limited degree only. We conducted a systematic review to identify recommendations for managing depression in the elderly and prioritised six recommendations. We identified and prioritised the determinants of practice related to the implementation of these recommendations in primary care, and subsequently discussed and prioritised interventions to address the identified determinants. The objective of this study is to evaluate the effectiveness of these tailored interventions for the six recommendations for the management of elderly patients with depression in primary care.We will conduct a pragmatic cluster randomised trial comparing the implementation of the six recommendations using tailored interventions with usual care. We will randomise 80 municipalities into one of two groups: an intervention group, to which we will deliver tailored interventions to implement the six recommendations, and a control group, to which we will not deliver any intervention. We will randomise municipalities rather than patients, individual clinicians or practices, because we will deliver the intervention for the first three recommendations at the municipal level and we want to minimise the risk of contamination across GP practices for the other three recommendations. The primary outcome is the proportion of actions taken by GPs that are consistent with the recommendations.This trial will investigate whether a tailored implementation approach is an effective strategy for improving collaborative care in the municipalities and health-care professionals' practice towards elderly patients with depression in primary care. The effectiveness evaluation described in this protocol will be accompanied with a process evaluation exploring why and how the interventions were effective or ineffective.ClinicalTrials.gov: NCT01913236.

Project description:BackgroundInternet-administered cognitive behavioral therapy (ICBT) has been demonstrated to be an effective intervention for adults with depression and/or anxiety and is recommended in national guidelines for provision within Swedish primary care. However, the number and type of organizations that have implemented ICBT within primary care in Sweden is currently unclear. Further, there is a lack of knowledge concerning barriers and facilitators to ICBT implementation.ObjectiveThe two primary objectives were to identify and describe primary care organizations providing ICBT in Sweden and compare decision makers' (ie, directors of primary care organizations) views on barriers and facilitators to implementation of ICBT among ICBT implementers (ie, organizations that offered ICBT) and nonimplementers (ie, organizations that did not offer ICBT).MethodsAn online survey based on a checklist for identifying barriers and facilitators to implementation was developed and made accessible to decision makers from all primary care organizations in Sweden. The survey consisted of background questions (eg, provision of ICBT and number of persons working with ICBT) and barriers and facilitators relating to the following categories: users, therapists, ICBT programs, organizations, and wider society.ResultsThe participation rate was 35.75% (404/1130). The majority (250/404, 61.8%) of participants were health care center directors and had backgrounds in nursing. Altogether, 89.8% (363/404) of the participating organizations provided CBT. A minority (83/404, 20.5%) of organizations offered ICBT. Most professionals delivering ICBT were psychologists (67/83, 80%) and social workers (31/83, 37%). The majority (61/83, 73%) of organizations had 1 to 2 persons delivering ICBT interventions. The number of patients treated with ICBT during the last 12 months was 1 to 10 in 65% (54/83) of the organizations, ranging between 1 and 400 treated patients across the whole sample. There were 9 significant (P<.05) differences out of 37 possible between implementers and nonimplementers. For example, more implementers (48/51, 94%) than nonimplementers (107/139, 76.9%) perceived few technical problems (P<.001), and more implementers (53/77, 68%) than nonimplementers (103/215, 47.9%) considered that their organization has resources to offer ICBT programs (P<.001).ConclusionsDespite research demonstrating the effectiveness of ICBT for depression and anxiety and national guidelines recommending its use, ICBT is implemented in few primary care organizations in Sweden. Several interesting differences between implementers and nonimplementers were identified, which may help inform interventions focusing on facilitating the implementation of ICBT.

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Tailored internet-administered treatment of anxiety disorders for primary care patients: study protocol for a randomised controlled trial.

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Tailored internet-administered treatment of anxiety disorders for primary care patients: study protocol for a randomised controlled trial.

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