Guided Digital Cognitive Behavioral Program for Anxiety in Primary Care: Propensity-Matched Controlled Trial.
ABSTRACT: BACKGROUND:Cognitive behavioral therapy (CBT) is the gold standard treatment for adult anxiety disorders but is often not readily available in a scalable manner in many clinical settings. OBJECTIVE:This study examines the feasibility, acceptability, and effectiveness of a coach-facilitated digital cognitive behavioral program for anxious adults in primary care. METHODS:In an open trial, patients who screened positive for anxiety (General Anxiety Disorder-7 [GAD7] score ?5) were offered the digital cognitive behavioral program (active group, n=593). Primary outcomes included anxiety, quality of life (QoL), and ambulatory medical use over 6 months. Intent-to-treat (ITT) and modified intent-to-treat (mITT) analyses were completed. Subsequently, we compared the outcomes of participants with those of a matched control group receiving primary care as usual (CAU; n=316). RESULTS:More than half of the patients downloaded the cognitive behavioral mobile app program and about 60% of these were considered engaged, which was defined as completion of ?3 techniques. The active group demonstrated medium size effects on reducing anxiety symptoms (effect size d=0.44; P<.001) and improving mental health QoL (d=0.49; P<.001) and showed significantly improved physical health QoL (d=0.39; P=.002) and a decreased likelihood of high utilization of outpatient medical care (odds ratio=0.49; P<.001). The active group did not significantly outperform the CAU group in anxiety reduction or QoL improvement (d=0.20; P=.07). However, intent-to-treat analysis showed that the active group had a significantly lower likelihood of high utilization of outpatient medical care than the enhanced CAU group (P<.0001; odds ratio=0.09). CONCLUSIONS:A coach-facilitated digital cognitive behavioral program prescribed in primary care is feasible and acceptable. Primary care patients prescribed a digital cognitive behavioral program for anxiety experienced significant improvements in anxiety symptoms, QoL, and reduced medical utilization. This effect was observed even among patients with chronic medical conditions and behavioral health comorbidities. Although the primary outcomes in the active group did not improve significantly more than the CAU group, health care utilization declined, and some secondary outcomes improved in participants who engaged in the program compared to the CAU group. TRIAL REGISTRATION:ClinicalTrials.gov NCT03186872; https://clinicaltrials.gov/ct2/show/NCT03186872.
Project description:BACKGROUND:Anxiety and depressive symptoms are prevalent in patients with inflammatory bowel disease (IBD) and may negatively influence disease course. Disease activity could be affected positively by treatment of psychological symptoms. We investigated the effect of cognitive behavioral therapy (CBT) on clinical disease course in 10-25-year-old IBD patients experiencing subclinical anxiety and/or depression. METHODS:In this multicenter parallel group randomized controlled trial, IBD patients were randomized to disease-specific CBT in addition to standard medical care (CBT + care us usual [CAU]) or CAU only. The primary outcome was time to first relapse in the first 12 months. Secondary outcomes were clinical disease activity, fecal calprotectin, and C-reactive protein (CRP). Survival analyses and linear mixed models were performed to compare groups. RESULTS:Seventy patients were randomized (CBT+CAU = 37, CAU = 33), with a mean age of 18.3 years (±50% < 18 y, 31.4% male, 51.4% Crohn's disease, 93% in remission). Time to first relapse did not differ between patients in the CBT+CAU group vs the CAU group (n = 65, P = 0.915). Furthermore, clinical disease activity, fecal calprotectin, and CRP did not significantly change over time between/within both groups. Exploratory analyses in 10-18-year-old patients showed a 9% increase per month of fecal calprotectin and a 7% increase per month of serum CRP in the CAU group, which was not seen in the CAU+CBT group. CONCLUSIONS:CBT did not influence time to relapse in young IBD patients with subclinical anxiety and/or depression. However, exploratory analyses may suggest a beneficial effect of CBT on inflammatory markers in children.
Project description:BACKGROUND:The aim of this study was to test the efficacy of a tailored cognitive-behavioral therapy (CBT) mobile application (app) to treat anxiety in patients with incurable cancer. MATERIALS AND METHODS:Patients with incurable cancers (n = 145) who reported elevated anxiety symptoms at two cancer centers were randomized to receive either the CBT mobile app for anxiety or a mobile health education program (control) delivered via tablet computers, which patients self-administered over 12 weeks. To assess anxiety, depression symptoms, and quality of life (QOL), we used the Hamilton Anxiety Rating Scale (HAM-A, primary outcome), Clinical Global Impression Scale, Hospital Anxiety and Depression Scale (HADS), Patient Health Questionnaire-9, and Functional Assessment of Cancer Therapy-General at baseline and 12 weeks. Analysis of covariance models were calculated to assess intervention effects on patient outcomes. RESULTS:Patients (73.8% female; 91.0% white; mean age = 56.45 years, SD = 11.30) in both study groups reported improvements in anxiety, depression symptoms, and QOL from baseline to postassessment, with no significant differences in any outcome measure between groups. Secondary analyses showed that, among the subgroup of patients with severe baseline anxiety, those randomized to the CBT app had greater improvements on the HAM-A (Mean Difference = 7.44, standard error [SE] = 3.35, p = .037) and HADS-Anxiety Subscale (Mean Difference = 4.44, SE = 1.60, p = .010) compared with the control group. CONCLUSION:Both the tailored CBT app for anxiety and the health education program were associated with improvements in anxiety, mood, and QOL, but these outcomes did not differ between study groups. The CBT app was more beneficial than health education for patients with severe baseline anxiety. IMPLICATIONS FOR PRACTICE:A cognitive-behavioral therapy mobile application tailored to treat anxiety in patients with advanced cancer helps improve access to evidence-based supportive care in a convenient, private, and timely manner.
Project description:Objective:To evaluate the effectiveness of a disease-specific cognitive behavioral therapy (CBT) protocol on anxiety and depressive symptoms and health-related quality of life (HRQOL) in adolescents and young adults with inflammatory bowel disease (IBD). Method:A parallel group randomized controlled trial was conducted in 6 centers of (pediatric) gastroenterology. Included were 70 patients and young adults (10-25?years) with IBD and subclinical anxiety and/or depressive symptoms. Patients were randomized into 2 groups, stratified by center: (a) standard medical care (care-as-usual [CAU]) plus disease-specific manualized CBT (Primary and Secondary Control Enhancement Training for Physical Illness; PASCET-PI), with 10 weekly sessions, 3 parent sessions, and 3 booster sessions (n?=?37), or (b) CAU only (n?=?33). Primary analysis concerned the reliable change in anxiety and depressive symptoms after 3?months (immediate posttreatment assessment). Exploratory analyses concerned (1) the course of anxiety and depressive symptoms and HRQOL in subgroups based on age, and (2) the influence of age, gender, and disease type on the effect of the PASCET-PI. Results:Overall, all participants improved significantly in their anxiety and depressive symptoms and HRQOL, regardless of group, age, gender, and disease type. Primary chi-square tests and exploratory linear mixed models showed no difference in outcomes between the PASCET-PI (n?=?35) and the CAU group (n?=?33). Conclusions:In youth with IBD and subclinical anxiety and/or depressive symptoms, preliminary results of immediate post-treatment assessment indicated that a disease-specific CBT added to standard medical care did not perform better than standard medical care in improving psychological symptoms or HRQOL. ClinicalTrials.gov: NCT02265588.
Project description:The implantable cardioverter defibrillator (ICD) is generally well accepted, but 25-33% of patients experience clinical levels of anxiety, depression, and impaired quality of life (QoL) following implantation. Few trials in ICD patients have investigated whether behavioral intervention may mitigate the development of these adjustment problems. We present the rationale and study design of the WEB-based distress management program for implantable CARdioverter dEfibrillator patients (WEBCARE) trial.WEBCARE is a multi-center, multi-disciplinary, randomized, controlled behavioral intervention trial designed to examine the effectiveness of a web-based approach in terms of reducing levels of anxiety and device concerns and enhancing QoL. Consecutive patients hospitalized for the implantation of an ICD will be approached for study participation while in hospital and randomized to the intervention arm (n = 175) versus usual care (n = 175) at baseline (5-10 days post implantation). Patients will complete assessments of patient-centered outcomes at baseline, 14, 26, and 52 weeks after implantation. Patients randomized to the intervention arm will receive a 12-week web-based behavioral intervention starting 2 weeks after implantation. Primary endpoints include (i(i)) patient-centered outcomes (i.e., anxiety, depression, ICD acceptance, QoL); (i(ii)) health care utilization; and (i(iii)) cost-effectiveness. All primary endpoints will be assessed with standardized and validated disease-specific or generic questionnaires. Secondary endpoints include (ii(i)) cortisol awakening response; and (ii(ii)) ventricular arrhythmias.WEBCARE will show whether a behavioral intervention using a web-based approach is feasible and effective in reducing anxiety and ICD concerns and improving QoL in ICD patients.http://www.ClinicalTrials.gov. Identifier: NCT00895700.
Project description:<h4>Background</h4>In a recent trial, a 6-session intervention (BMT-CARE) integrating medical information with cognitive-behavioral strategies improved quality of life (QOL), mood, coping skills, and self-efficacy for family/friend caregivers of hematopoietic stem cell transplantation (HCT) recipients. This study examined whether improvements in coping and self-efficacy mediated the intervention effects on QOL and mood.<h4>Methods</h4>From December 2017 to April 2019, 100 caregivers of HCT recipients were enrolled into a randomized clinical trial of BMT-CARE versus usual care. Caregivers completed self-report measures of QOL (CareGiver Oncology Quality of Life questionnaire), depression and anxiety symptoms (Hospital Anxiety and Depression Scale), coping skills (Measure of Current Status), and self-efficacy (Cancer Self-Efficacy Scale-Transplant) at enrollment (before HCT) and 60 days after HCT. Causal mediation regression models were used to examine whether changes in coping and self-efficacy mediated intervention effects on QOL as well as depression and anxiety symptoms.<h4>Results</h4>Improvements in 60-day QOL in patients assigned to BMT-CARE were partially mediated by improved coping and self-efficacy (indirect effect, 6.93; SE, 1.85; 95% CI, 3.71-11.05). Similarly, reductions in 60-day depression and anxiety symptoms were partially mediated by improved coping and self-efficacy (indirect effect for depression, -1.19; SE, 0.42; 95% CI, -2.23 to -0.53; indirect effect for anxiety, -1.46; SE, 0.55; 95% CI, -2.52 to -0.43). Combined improvements in coping and self-efficacy accounted for 67%, 80%, and 39% of the total intervention effects on QOL and depression and anxiety symptoms, respectively.<h4>Conclusions</h4>Coping and self-efficacy are essential components of a brief psychosocial intervention that improves QOL and mood for caregivers of HCT recipients during the acute recovery period.<h4>Lay summary</h4>A 6-session program (BMT-CARE) focused on providing medical information, caregiving skills, and self-care and coping strategies has been previously reported to improve the quality of life and mood of caregivers of hematopoietic stem cell transplantation recipients in comparison with caregivers who receive care as usual. Using statistical models, this study suggests that learning coping skills and improving self-efficacy are the most essential components of this program that likely lead to better quality of life and mood for caregivers.
Project description:BACKGROUND:Adjustment disorder with anxiety (ADA) is the most frequent and best characterized stress-related psychiatric disorder. The rationale for prescription of benzodiazepine monotherapy is a public health issue. Cognitive behavioral stress management programs have been studied in many countries. Several reports have shown beyond reasonable doubt their efficiency at reducing perceived stress and anxiety symptoms and improving patient quality of life. Considering the number of people who could benefit from such programs but are unable to access them, self-help programs have been offered. First presented as books, these programs became enriched with computer-based and digital supports. Regrettably, programs for stress management based on cognitive behavioral therapy (CBT), both face-to-face and digital support, have been only minimally evaluated in France. To our knowledge, the Seren@ctif program is the first French language self-help program for stress management using digital supports. OBJECTIVE:The aim of this study is to assess the effectiveness of a 5-week standardized stress management program for reducing anxiety conducted via eLearning (iCBT) or through face-to-face interviews (CBT) with patients suffering from ADA compared with a wait list control group (WLC). These patients seek treatment in a psychiatric unit for anxiety disorders at a university hospital. The primary outcome is change in the State Trait Anxiety Inventory scale trait subscale (STAI-T) between baseline and 2-month visit. METHODS:This is a multicenter, prospective, open label, randomized controlled study in 3 parallel groups with balanced randomization (1:1:1): computer-based stress management with minimal contact (not fully automated) (group 1), stress management with face-to-face interviews (group 2), and a WLC group that receives usual health care from a general practitioner (group 3). Programs are based on standard CBT principles and include 5 modules in 5 weekly sessions that include the following topics: stress and stress reaction and assessment; deep respiration and relaxation techniques; cognitive restructuring, mindfulness, and acceptance; behavioral skills as problem solving; and time management, healthy behaviors, and emotion regulation. In the Internet-based group, patients have minimal contact with a medical professional before and after every session. In the first session, a flash memory drive is supplied containing videos, audio files, a self-help book portfolio in the form of an eGuide, and log books providing the exercises to be completed between 2 sessions. The patient is encouraged to practice a 20-minute daily exercise 5 or 6 times per week. In the face-to-face group, patients receive the same program from a therapist with 5 weekly sessions without digital support. Interviews and self-assessments were collected face-to-face with the investigator. RESULTS:The feasibility of this program is being tested, and results show good accessibility in terms of acceptance, understanding, and treatment credibility. Results are expected in 2018. CONCLUSIONS:To our knowledge, this is the first French study to examine the effectiveness of a computer-based stress management program for patients with ADA. The Seren@ctif program may be useful within the framework of a psychoeducative approach. It could also be advised for people suffering from other diseases related to stress and for people with a clinical level of perceived stress. TRIAL REGISTRATION:Clinicaltrials.gov NCT02621775; https://clinicaltrials.gov/ct2/show/NCT02621775 (Archived by WebCite at http://www.webcitation.org/6tQrkPs1u).
Project description:Background:Many patients with end-stage renal disease (ESRD) undergoing hemodialysis (HD) experience depression. Depression influences patient quality of life (QOL), dialysis compliance, and medical comorbidity. We developed and applied a group cognitive behavioral therapy (CBT) program including mindfulness meditation for ESRD patients undergoing HD, and measured changes in QOL, mood, anxiety, perceived stress, and biochemical markers. Methods:We conducted group CBT over a 12-week period with seven ESRD patients undergoing HD and suffering from depression. QOL, mood, anxiety, and perceived stress were measured at baseline and at weeks 8 and 12 using the World Health Organization Quality of Life scale, abbreviated version (WHOQOL-BREF), the Beck Depression Inventory II (BDI-II), the Hamilton Rating Scale for Depression (HAM-D), the Beck Anxiety Inventory (BAI), and the Perceived Stress Scale (PSS). Biochemical markers were measured at baseline and after 12 weeks. The Temperament and Character Inventory was performed to assess patient characteristics before starting group CBT. Results:The seven patients showed significant improvement in QOL, mood, anxiety, and perceived stress after 12 weeks of group CBT. WHOQOL-BREF and the self-rating scales, BDI-II and BAI, showed continuous improvement across the 12-week period. HAM-D scores showed significant improvement by week 8; PSS showed significant improvement after week 8. Serum creatinine levels also improved significantly following the 12 week period. Conclusion:In this pilot study, a CBT program which included mindfulness meditation enhanced overall mental health and biochemical marker levels in ESRD patients undergoing HD.
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.
Project description:<h4>Background</h4>In reality, pharmacotherapy still remains the most common treatment for insomnia.<h4>Objective</h4>This study aimed to examine the effectiveness of our internet-delivered computerized cognitive behavioral therapy (ICBT) program as an adjunct to usual care (UC) compared with UC alone in patients with insomnia who remain symptomatic following hypnotics.<h4>Methods</h4>We recruited 23 patients with insomnia who remained symptomatic following pharmacologic treatment including benzodiazepines, and we conducted an exploratory randomized controlled trial. The primary outcome was the Pittsburgh Sleep Quality Index (PSQI) at week 6 of the treatment. Secondary outcomes were sleep onset latency, total sleep time, sleep efficiency, number of awakenings, refreshment and soundness of sleep, anxiety by Hospital Anxiety and Depression Scale, depression measured by the Center for Epidemiologic Studies Depression Scale, and quality of life (QOL) measured by the EuroQol-5D. All parameters were measured at weeks 0 (baseline), 6 (postintervention), and 12 (follow-up).<h4>Results</h4>The adjusted mean reduction (-6.11) in PSQI at week 6 from baseline in the ICBT plus UC group was significantly (P<.001) larger than the adjusted mean reduction (0.40) in the UC alone group. Significant differences were also found in favor of ICBT plus UC for PSQI, sleep onset latency, sleep efficiency, number of awakenings, and depression at all assessment points. Refreshment, soundness of sleep, anxiety, and QOL improved by week 6 in ICBT plus UC compared with UC alone. There were no reports of adverse events in either group during the study.<h4>Conclusions</h4>These results indicated that our 6-week ICBT program is an effective treatment adjunct to UC for improving insomnia and related symptoms even after unsuccessful pharmacotherapy.<h4>Trial registration</h4>University Hospital Medical Information Network Clinical Trials Registry: UMIN000021509; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023545 (Archived by WebCite at http://www.webcitation. org/75tCmwnYt).
Project description:OBJECTIVE:Internet-delivered interventions may alleviate distress in cancer survivors with limited access to psychological face-to-face treatment. In collaboration with a group of cancer survivors, we developed and tested the efficacy of a therapist-assisted internet-delivered mindfulness-based cognitive therapy (iMBCT) program for anxiety and depression in cancer survivors. METHODS:A total of 1282 cancer survivors were screened for anxiety and depression during their routine oncology follow-up; eligible breast (n = 137) and prostate cancer (n = 13) survivors were randomized to iMBCT or care-as-usual (CAU) wait-list. Primary outcomes of anxiety and depression were assessed at baseline, 5 weeks, 10 weeks (post intervention), and 6 months. RESULTS:Significant effects were found for both anxiety (Cohen's d = 0.45; P = .017) and depressive symptoms (d = 0.42; P = .024) post intervention. The effects were maintained at follow-up for anxiety (d = 0.40; P = .029), but not for depressive symptoms (d = 0.28; P = .131). CONCLUSIONS:Our preliminary findings suggest iMBCT to be a helpful intervention for cancer survivors suffering from symptoms of anxiety. Further studies on the efficacy for symptoms of depression are needed.