Dataset Information

Internet-Based Cognitive Behavioral Therapy for Symptoms of Depression and Anxiety Among Patients With a Recent Myocardial Infarction: The U-CARE Heart Randomized Controlled Trial.

ABSTRACT: BACKGROUND:Symptoms of depression and anxiety are common after a myocardial infarction (MI). Internet-based cognitive behavioral therapy (iCBT) has shown good results in other patient groups. OBJECTIVE:The aim of this study was to evaluate the effectiveness of an iCBT treatment to reduce self-reported symptoms of depression and anxiety among patients with a recent MI. METHODS:In total, 3928 patients were screened for eligibility in 25 Swedish hospitals. Of these, 239 patients (33.5%, 80/239 women, mean age 60 years) with a recent MI and symptoms of depression or anxiety were randomly allocated to a therapist-guided, 14-week iCBT treatment (n=117), or treatment as usual (TAU; n=122). The iCBT treatment was designed for post-MI patients. The primary outcome was the total score of the Hospital Anxiety and Depression Scale (HADS) 14 weeks post baseline, assessed over the internet. Treatment effect was evaluated according to the intention-to-treat principle, with multiple imputations. For the main analysis, a pooled treatment effect was estimated, controlling for age, sex, and baseline HADS. RESULTS:There was a reduction in HADS scores over time in the total study sample (mean delta=-5.1, P<.001) but no difference between the study groups at follow-up (beta=-0.47, 95% CI -1.95 to 1.00, P=.53). Treatment adherence was low. A total of 46.2% (54/117) of the iCBT group did not complete the introductory module. CONCLUSIONS:iCBT treatment for an MI population did not result in lower levels of symptoms of depression or anxiety compared with TAU. Low treatment adherence might have influenced the result. TRIAL REGISTRATION:ClinicalTrials.gov NCT01504191; https://clinicaltrials.gov/ct2/show/NCT01504191 (Archived at Webcite at http://www.webcitation.org/6xWWSEQ22).

SUBMITTER: Norlund F

PROVIDER: S-EPMC5874001 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Internet-Based Cognitive Behavioral Therapy for Symptoms of Depression and Anxiety Among Patients With a Recent Myocardial Infarction: The U-CARE Heart Randomized Controlled Trial.

Norlund Fredrika F Wallin Emma E Olsson Erik Martin Gustaf EMG Wallert John J Burell Gunilla G von Essen Louise L Held Claes C

Journal of medical Internet research 20180308 3

<h4>Background</h4>Symptoms of depression and anxiety are common after a myocardial infarction (MI). Internet-based cognitive behavioral therapy (iCBT) has shown good results in other patient groups.<h4>Objective</h4>The aim of this study was to evaluate the effectiveness of an iCBT treatment to reduce self-reported symptoms of depression and anxiety among patients with a recent MI.<h4>Methods</h4>In total, 3928 patients were screened for eligibility in 25 Swedish hospitals. Of these, 239 patien ...[more]

PMID: 29519777

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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:BackgroundInternet-based cognitive behavioral therapy (iCBT) is a promising new treatment method for depression and anxiety. However, it is important to determine whether its results can be replicated in routine care before its implementation on a large scale. Although many studies have demonstrated the efficacy of iCBT under controlled conditions, only a few studies have investigated its effectiveness in routine care. Furthermore, several effects of iCBT such as treatment effects in routine care are unclear.ObjectiveThis study aimed to evaluate the clinical effectiveness of iCBT for depression and anxiety in routine secondary care.Methodsn a retrospective cohort study, we analysed patients treated for depression or anxiety in a dedicated iCBT clinic in secondary care in Denmark. Patients were examined before treatment and weekly thereafter by using the Patient Health Questionnaire-9 and the Generalized Anxiety Disorder-7 scales for the diagnoses of depression and anxiety, respectively. Primary analyses were conducted using a linear mixed-effects model with random slope and intercept. Secondary analyses were conducted using baseline characteristics as predictors (gender, age, highest level of education, occupational status, marital status, psychotropic medication use, consumption of alcohol, and leisure drugs). Additionally, logistic regression analyses were used to predict noncompletion of treatment.ResultsA total of 203 (depression, N=60; anxiety, N=143) patients were included. Participants were mainly female (78.3% with depression and 65.7% with anxiety), with a mean age of 36.03 (SD 10.97) years (range, 19-67 years) for patients with depression and 36.80 (SD 13.55) years (range, 19-69 years) for patients with anxiety. The completion rates were 62% (37) and 40% (57) for depression and anxiety treatments, respectively. The primary analyses revealed large and significant reductions in the symptom levels of depression (beta=-6.27, SE 0.83, P<.001, d=1.0) and anxiety (beta=-3.78, SE 0.43, P<.001, d=1.1). High baseline severity of the primary disorder was associated with high treatment gains (r=-0.31 for depression; r=-0.41 for anxiety). In patients with anxiety, high baseline severity also predicted a high risk of noncompletion (odds ratio=1.08, CI=1.01-1.16, P=.03). An increase in the baseline severity of the comorbid disorder slightly increased the risk of noncompletion for both disorders (depression: odds ratio=1.03, CI=1.01-1.06, P=.02; anxiety: odds ratio=1.08, CI=1.01-1.16, P=.03).ConclusionsiCBT can be clinically effective in routine care. Since depression and anxiety are costly and debilitating disorders that are vastly undertreated, this finding is important. Additionally, iCBT may help bridge the gap between the need for treatment and its provision. Our results are comparable to the within-group results of efficacy and effectiveness studies. Our noncompletion rates are similar to those observed in psychotherapy but are higher than those reported in similar clinics. Multiple factors predicted outcome and noncompletion. However, all predictor effects were statistically weak.

Dataset Information

Internet-Based Cognitive Behavioral Therapy for Symptoms of Depression and Anxiety Among Patients With a Recent Myocardial Infarction: The U-CARE Heart Randomized Controlled Trial.

Publications

Internet-Based Cognitive Behavioral Therapy for Symptoms of Depression and Anxiety Among Patients With a Recent Myocardial Infarction: The U-CARE Heart Randomized Controlled Trial.

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