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Treatment of depression and anxiety with internet-based cognitive behavior therapy in patients with a recent myocardial infarction (U-CARE Heart): study protocol for a randomized controlled trial.

ABSTRACT: Major depression and depressive symptoms are common in patients with a recent myocardial infarction (MI), and depression is associated with adverse cardiovascular outcomes. Anxiety post-MI is less studied, but occurs commonly in patients with heart disease, and is also considered a risk factor for recurrence of cardiac events. Cognitive behavior therapy (CBT) is an established therapy for depression and anxiety disorders. To the best of our knowledge, there have not been any studies to determine if internet-based CBT (iCBT) can reduce the symptoms of depression and anxiety in patients with a recent MI. The main aim of the U-CARE Heart trial is to evaluate an iCBT intervention for patients with a recent MI.This is a randomized, controlled, prospective study with a multicenter design. A total of 500 participants will be randomized at a 1:1 ratio, around two months after an acute MI, to either iCBT or to a control group. Both groups will receive an optimal standard of care according to guidelines. The intervention consists of a self-help program delivered via the internet with individual online support from a psychologist. Treatment duration is 14 weeks. The primary outcome is change in patients' self-rated anxiety and depression symptoms from baseline to end of treatment. An internal pilot study was conducted indicating sufficient levels of study acceptability and engagement in treatment.The present study is designed to evaluate an iCBT intervention targeting symptoms of depression and anxiety in a post-MI population. If effective, iCBT has several advantages, and will potentially be implemented as an easily accessible treatment option added to modern standard of care.This trial was registered with Clinicaltrials.gov (identifier: NCT01504191 ) on 19 December 2011.

SUBMITTER: Norlund F

PROVIDER: S-EPMC4404081 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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Treatment of depression and anxiety with internet-based cognitive behavior therapy in patients with a recent myocardial infarction (U-CARE Heart): study protocol for a randomized controlled trial.

Norlund Fredrika F Olsson Erik M G EM Burell Gunilla G Wallin Emma E Held Claes C

Trials 20150411

<h4>Background</h4>Major depression and depressive symptoms are common in patients with a recent myocardial infarction (MI), and depression is associated with adverse cardiovascular outcomes. Anxiety post-MI is less studied, but occurs commonly in patients with heart disease, and is also considered a risk factor for recurrence of cardiac events. Cognitive behavior therapy (CBT) is an established therapy for depression and anxiety disorders. To the best of our knowledge, there have not been any s ...[more]

PMID: 25873137

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Project description:BackgroundThe U-CARE Heart trial was one of the first randomized controlled trials to evaluate the effect of internet-based cognitive behavioral therapy on self-reported symptoms of anxiety or depression for patients with a recent myocardial infarction. While the effects of internet-based cognitive behavioral therapy on Hospital Anxiety and Depression Scale (HADS) scores at 14 weeks postbaseline were not significant, in this study, we investigated possible long-term effects of treatment.ObjectiveThe aim of this study was to evaluate the long-term effectiveness of internet-based cognitive behavioral therapy on self-reported symptoms of anxiety and depression in patients 12 months after a myocardial infarction and to explore subsequent occurrences of cardiovascular disease events.MethodsShortly after acute myocardial infarction, 239 patients (33% female, mean age 59.6 years) reporting mild-to-moderate symptoms of anxiety or depression were randomized to 14 weeks of therapist-guided internet-based cognitive behavioral therapy (n=117) or treatment as usual (n=122). Data from national registries were used to explore group differences in clinical outcomes such as cardiovascular disease and cardiovascular-related mortality for a follow-up period of up to 5 years: group differences in HADS total score 1 year post-myocardial infarction, the primary outcome, was analyzed using multiple linear regression. Secondary outcomes, such as HADS anxiety and depression subscales and the Cardiac Anxiety Questionnaire total score (CAQ), which measures heart-focused anxiety, were analyzed in the same way. Multiple imputation was used to account for missing data, and a pooled treatment effect was estimated. Adjusted Cox proportional hazards models were used to estimate hazard ratios (HRs) for data pertaining to registry outcomes.ResultsBoth groups reported lower HADS total scores 1 year after myocardial infarction than those at baseline. HADS total scores were not significantly different between the treatment and control groups 1 year after myocardial infarction (β=-1.14, 95% CI -2.73 to 0.45, P=.16). CAQ was the only measure improved significantly by internet-based cognitive behavioral therapy when compared with treatment as usual (β=-2.58, 95% CI -4.75 to -0.42, P=.02) before adjusting for multiple comparisons. The composite outcome of nonfatal cardiovascular events and cardiovascular-related mortality did not differ between groups but was numerically higher in the internet-based cognitive behavioral therapy group, who were at slightly greater risk (HR 1.8, 95% CI 0.96 to 3.4, P=.07). Adjusting for previous myocardial infarction and diabetes attenuated this estimate (HR 1.5, 95% CI 0.8 to 2.8, P=.25).ConclusionsInternet-based cognitive behavioral therapy was not superior in reducing self-reported symptoms of depression or anxiety compared to treatment as usual at the 1-year follow-up after myocardial infarction. A reduction in cardiac-related anxiety was observed but was not significant after adjusting for multiple comparisons. There was no difference in risk of cardiovascular events between the treatment groups. Low treatment adherence, which might have affected treatment engagement and outcomes, should be considered when interpreting these results.Trial registrationClinicalTrials.gov NCT01504191; https://clinicaltrials.gov/ct2/show/NCT01504191.International registered report identifier (irrid)RR2-10.1186/s13063-015-0689-y.

Project description:BACKGROUND:Knowledge about user experiences may lead to insights about how to improve treatment activity in Internet-based cognitive behavioral therapy (iCBT) to reduce symptoms of depression and anxiety among people with a somatic disease. There is a need for studies conducted alongside randomized trials, to explore treatment activity and user experiences related to such interventions, especially among people with older age who are recruited in routine care. OBJECTIVE:The aim of the study was to explore treatment activity, user satisfaction, and usability experiences among patients allocated to treatment in the U-CARE Heart study, a randomized clinical trial of an iCBT intervention for treatment of depression and anxiety following a recent myocardial infarction. METHODS:This was a mixed methods study where quantitative and qualitative approaches were used. Patients were recruited consecutively from 25 cardiac clinics in Sweden. The study included 117 patients allocated to 14 weeks of an iCBT intervention in the U-CARE Heart study. Quantitative data about treatment activity and therapist communication were collected through logged user patterns, which were analyzed with descriptive statistics. Qualitative data with regard to positive and negative experiences, and suggestions for improvements concerning the intervention, were collected through semistructured interviews with 21 patients in the treatment arm after follow-up. The interviews were analyzed with qualitative manifest content analysis. RESULTS:Treatment activity was low with regard to number of completed modules (mean 0.76, SD 0.93, range 0-5) and completed assignments (mean 3.09, SD 4.05, range 0-29). Most of the participants initiated the introduction module (113/117, 96.6%), and about half (63/117, 53.9%) of all participants completed the introductory module, but only 18 (15.4%, 18/117) continued to work with any of the remaining 10 modules, and each of the remaining modules was completed by 7 or less of the participants. On average, patients sent less than 2 internal messages to their therapist during the intervention (mean 1.42, SD 2.56, range 0-16). Interviews revealed different preferences with regard to the internet-based portal, the content of the treatment program, and the therapist communication. Aspects related to the personal situation and required skills included unpleasant emotions evoked by the intervention, lack of time, and technical difficulties. CONCLUSIONS:Patients with a recent myocardial infarction and symptoms of depression and anxiety showed low treatment activity in this guided iCBT intervention with regard to completed modules, completed assignments, and internal messages sent to their therapist. The findings call attention to the need for researchers to carefully consider the preferences, personal situation, and technical skills of the end users during the development of these interventions. The study indicates several challenges that need to be addressed to improve treatment activity, user satisfaction, and usability in internet-based interventions in this population.

Project description:BACKGROUND:Low adherence to recommended treatments is a multifactorial problem for patients in rehabilitation after myocardial infarction (MI). In a nationwide trial of internet-delivered cognitive behavior therapy (iCBT) for the high-risk subgroup of patients with MI also reporting symptoms of anxiety, depression, or both (MI-ANXDEP), adherence was low. Since low adherence to psychotherapy leads to a waste of therapeutic resources and risky treatment abortion in MI-ANXDEP patients, identifying early predictors for adherence is potentially valuable for effective targeted care. OBJECTIVES:The goal of the research was to use supervised machine learning to investigate both established and novel predictors for iCBT adherence in MI-ANXDEP patients. METHODS:Data were from 90 MI-ANXDEP patients recruited from 25 hospitals in Sweden and randomized to treatment in the iCBT trial Uppsala University Psychosocial Care Programme (U-CARE) Heart study. Time point of prediction was at completion of the first homework assignment. Adherence was defined as having completed more than 2 homework assignments within the 14-week treatment period. A supervised machine learning procedure was applied to identify the most potent predictors for adherence available at the first treatment session from a range of demographic, clinical, psychometric, and linguistic predictors. The internal binary classifier was a random forest model within a 3×10-fold cross-validated recursive feature elimination (RFE) resampling which selected the final predictor subset that best differentiated adherers versus nonadherers. RESULTS:Patient mean age was 58.4 years (SD 9.4), 62% (56/90) were men, and 48% (43/90) were adherent. Out of the 34 potential predictors for adherence, RFE selected an optimal subset of 56% (19/34; Accuracy 0.64, 95% CI 0.61-0.68, P<.001). The strongest predictors for adherence were, in order of importance, (1) self-assessed cardiac-related fear, (2) sex, and (3) the number of words the patient used to answer the first homework assignment. CONCLUSIONS:For developing and testing effective iCBT interventions, investigating factors that predict adherence is important. Adherence to iCBT for MI-ANXDEP patients in the U-CARE Heart trial was best predicted by cardiac-related fear and sex, consistent with previous research, but also by novel linguistic predictors from written patient behavior which conceivably indicate verbal ability or therapeutic alliance. Future research should investigate potential causal mechanisms and seek to determine what underlying constructs the linguistic predictors tap into. Whether these findings replicate for other interventions outside of Sweden, in larger samples, and for patients with other conditions who are offered iCBT should also be investigated. TRIAL REGISTRATION:ClinicalTrials.gov NCT01504191; https://clinicaltrials.gov/ct2/show/NCT01504191 (Archived at Webcite at http://www.webcitation.org/6xWWSEQ22).

Project description:Background: The UK's Improving Access to Psychological Therapies (IAPT) program is a stepped-care model treating individuals with depression and anxiety disorders. Internet-delivered cognitive behavioral therapy (iCBT) is routinely offered to individuals with mild to moderate symptoms, but its applicability to individuals with severe clinical symptoms and requiring a high-intensity intervention is relatively unknown. The current study sought to investigate the potential impacts of using iCBT as a prequel for patients requiring high-intensity treatment (HIT; face-to-face) for depression and anxiety in IAPT. Methods: The study utilized an open study design. One hundred and twenty-four participants who were on a waiting list for high-intensity, face-to-face psychological treatment were offered iCBT. Psychometric data on symptoms of depression, anxiety, and functioning were collected from participants before starting and on finishing iCBT and at the point of service exit. Therapeutic alliance data were collected from patients and clinicians during treatment. Patient pathway data, such as number of treatment sessions and time in treatment, was also collected and incorporated into the analysis. Results: Significant reductions across primary outcome measures of depression and anxiety, as well as improved functioning, were observed from baseline to iCBT treatment exit, and from iCBT exit to service exit. Analysis of the therapeutic alliance data for patients and clinicians illustrated differences in outcome for those who dropped out and those who completed treatment. Discussion: This study illustrates the potential for using iCBT as a prequel to high-intensity therapy for depression and anxiety disorders and is the first of its kind to do so within IAPT stepped care. The results show that iCBT is a valuable option reducing waiting times and enhancing clinical efficiency. The study contributes to the well-established evidence on online psychological treatments worldwide, but further clinical and service development research is necessary to scale these treatments appropriately.

Project description:BACKGROUND:Digital mental health interventions offer a scalable solution that reduces barriers to seeking care for clinical depression and anxiety. OBJECTIVE:We aimed to examine the effectiveness of a 12-week therapist supported, app-based cognitive behavioral therapy program in improving symptoms of depression and anxiety within 9 months. METHODS:A total of 323 participants with mild to moderately severe depression or anxiety were enrolled in a 12-week digital cognitive behavior therapy program. The analysis was restricted to participants who provided at least one follow-up assessment after baseline. As a result, 146 participants (45.2%) were included in the analysis-74 (50.7%) participants completed assessments at 3 months, 31 participants (21.2%) completed assessments at 6 months, and 21 participants (14.4%) completed assessments at 9 months. The program included structured lessons and tools (ie, exercises and practices) as well as one-on-one weekly video counseling sessions with a licensed therapist for 12 weeks and monthly check-in sessions for 1 year. The clinically validated Patient Health Questionnaire (PHQ-8) and Generalized Anxiety Disorder Scale (GAD-7) were used to assess depression and anxiety, respectively. Linear mixed-effects modeling was employed to examine changes in depression and anxiety over time. RESULTS:We observed a significant positive effect of program time on improvement in depression (?=-0.12, P<.001) and anxiety scores (?=-0.10, P<.001). At the end of the 12-week intervention, we observed an average reduction of 3.76 points (95% CI -4.76 to -2.76) in PHQ-8 scores. Further reductions in depression were seen at program month 6 (4.75-point reduction, 95% CI -6.61 to -2.88) and program month 9 (6.42-point reduction, 95% CI -8.66 to -6.55, P<.001). A similar pattern of improvement emerged for anxiety, with a 3.17-point reduction at the end of the 12-week intervention (95% CI -4.21 to -2.13). These improvements were maintained at program month 6 (4.87-point reduction, 95% CI -6.85 to -2.87) and program month 9 (5.19-point, 95% -6.85 to 4.81). In addition, greater program engagement during the first 12 weeks predicted a greater reduction in depression (?=-0.29, P<.001). CONCLUSIONS:The results suggest that digital interventions can support sustained and clinically meaningful improvements in depression and anxiety. Furthermore, it appears that strong initial digital mental health intervention engagement may facilitate this effect. However, the study was limited by postintervention participant attrition as well as the retrospective observational study design.

Dataset Information

Treatment of depression and anxiety with internet-based cognitive behavior therapy in patients with a recent myocardial infarction (U-CARE Heart): study protocol for a randomized controlled trial.

Publications

Treatment of depression and anxiety with internet-based cognitive behavior therapy in patients with a recent myocardial infarction (U-CARE Heart): study protocol for a randomized controlled trial.

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