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Effects of Internet Cognitive-Behavioral Therapy on Depressive Symptoms and Surrogates of Cardiovascular Risk in Human Immunodeficiency Virus: A Pilot, Randomized, Controlled Trial.

ABSTRACT: Background:Depression is associated with an increased risk of cardiovascular disease in human immunodeficiency virus (HIV). We hypothesized that reducing depressive symptoms would improve HIV-related cardiovascular risk. Methods:We conducted a single-center, randomized (1:1), controlled, parallel-group, assessor-blinded, pilot trial comparing Beating the Blues US (BtB)-an evidence-based, 8-session, internet cognitive-behavioral therapy for depression-with usual care (UC) in HIV-positive participants receiving virologically suppressive antiretroviral therapy and with Patient Health Questionnaire (PHQ)-9 scores??10. The primary endpoint was change in brachial artery flow-mediated dilation (FMD) at 12 weeks. Secondary endpoints were FMD change at 24 weeks and inflammation, coagulation, and metabolic biomarker changes at 12 and 24 weeks. Results:Fifty-four participants were randomized (27 in each arm). Mean reductions in PHQ-9 scores were significantly greater with BtB versus UC at 12 weeks (-5.60 vs -1.52; P?=?.007) and 24 weeks (-6.00 vs -1.38; P?=?.008); reductions in the Hopkins Symptom Checklist Depression Scale-20 scores were also significantly greater with BtB versus UC at 24 weeks (-0.72 vs -0.35; P?=?.029). Changes in FMD between arms were not significantly different at 12 or 24 weeks. Significantly larger reductions in soluble (s)CD14 and sCD163 with BtB versus UC were found at 12 and 24 weeks, respectively. Conclusions:Compared with UC, internet cognitive-behavioral therapy using BtB resulted in greater improvements in depressive symptoms and monocyte activation markers but did not improve FMD in this pilot trial. These data support performing larger studies to determine the potential salutatory effects of behavioral therapies for depression on HIV-related inflammation.

SUBMITTER: Gupta SK

PROVIDER: S-EPMC7393797 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Effects of Internet Cognitive-Behavioral Therapy on Depressive Symptoms and Surrogates of Cardiovascular Risk in Human Immunodeficiency Virus: A Pilot, Randomized, Controlled Trial.

Gupta Samir K SK Slaven James E JE Liu Ziyue Z Polanka Brittanny M BM Freiberg Matthew S MS Stewart Jesse C JC

Open forum infectious diseases 20200705 7

<h4>Background</h4>Depression is associated with an increased risk of cardiovascular disease in human immunodeficiency virus (HIV). We hypothesized that reducing depressive symptoms would improve HIV-related cardiovascular risk.<h4>Methods</h4>We conducted a single-center, randomized (1:1), controlled, parallel-group, assessor-blinded, pilot trial comparing Beating the Blues US (BtB)-an evidence-based, 8-session, internet cognitive-behavioral therapy for depression-with usual care (UC) in HIV-po ...[more]

PMID: 32760749

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Project description:BACKGROUND:Internet-delivered treatments for depressive symptoms have proved to be successful in high-income Western countries. There may be potential for implementing such treatments in low- and middle-income countries such as Colombia, where access to mental health services is limited. OBJECTIVE:The objective of this study was to assess the efficacy of a culturally adapted cognitive behavioral internet-delivered treatment for college students with depressive symptoms in Colombia. METHODS:This was a randomized controlled trial with a 3-month follow-up. The program comprised seven modules. A total of 214 Colombian college students were recruited. They were assessed and randomly assigned to either the treatment group (n=107) or a waiting list (WL) control group (n=107). Participants received weekly support from a trained supporter. The primary outcome was symptoms of depression, as measured by the Patient Health Questionnaire - 9, and the secondary outcomes were anxiety symptoms assessed by the Generalized Anxiety Disorder questionnaire - 7. Other measures, including satisfaction with treatment, were evaluated after 7 weeks. RESULTS:Research attrition and treatment dropouts were high in this study. On average, 7.6 sessions were completed per user. The mean time spent on the program was 3 hours and 18 min. The linear mixed model (LMM) showed significant effects after treatment (t197.54=-5.189; P<.001) for the treatment group, and these effects were maintained at the 3-month follow-up (t39.62=4.668; P<.001). Within-group results for the treatment group yielded a large effect size post treatment (d=1.44; P<.001), and this was maintained at the 3-month follow-up (d=1.81; P<.001). In addition, the LMM showed significant differences between the groups (t197.54=-5.189; P<.001). The results showed a large effect size between the groups (d=0.91; P<.001). In the treatment group, 76.0% (16/107) achieved a reliable change, compared with 32.0% (17/107) in the WL control group. The difference between groups was statistically significant (X22=10.5; P=.001). CONCLUSIONS:This study was the first contribution to investigating the potential impact of a culturally adapted internet-delivered treatment on depressive symptoms for college students as compared with a WL control group in South America. Future research should focus on identifying variables associated both with premature dropout and treatment withdrawal at follow-up. TRIAL REGISTRATION:ClinicalTrials.gov NCT03062215; https://clinicaltrials.gov/ct2/show/NCT03062215.

Project description:BACKGROUND:Internet-based cognitive behavioral therapy (ICBT) is a treatment approach recently developed and studied to provide frontline treatment to adolescents with anxiety disorders. OBJECTIVE:This study aimed to pilot procedures and obtain data on methodological processes and intervention satisfaction to determine the feasibility of a definitive randomized controlled trial (RCT) to test the effectiveness of a self-managed ICBT program, Breathe (Being Real, Easing Anxiety: Tools Helping Electronically), for adolescents with anxiety concerns. METHODS:This study employed a two-arm, multisite, pilot RCT. Adolescents aged 13 to 17 years with a self-identified anxiety concern were recruited online from health care settings and school-based mental health care services across Canada between April 2014 and May 2016. We compared 8 weeks of ICBT with ad hoc telephone and email support (Breathe experimental group) to access to a static webpage listing anxiety resources (control group). The primary outcome was the change in self-reported anxiety from baseline to 8 weeks (posttreatment), which was used to determine the sample size for a definitive RCT. Secondary outcomes were recruitment and retention rates, a minimal clinically important difference (MCID) for the primary outcome, intervention acceptability and satisfaction, use of cointerventions, and health care resource use, including a cost-consequence analysis. RESULTS:Of the 588 adolescents screened, 94 were eligible and enrolled in the study (49 adolescents were allocated to Breathe and 45 were allocated to the control group). Analysis was based on 74% (70/94) of adolescents who completed baseline measures and progressed through the study. Enrolled adolescents were, on average, 15.3 years old (SD 1.2) and female (63/70, 90%). Retention rates at 8 weeks were 28% (13/46; Breathe group) and 58% (24/43; control group). Overall, 39% (14/36) of adolescents provided feedback on completion of the Breathe program. Adolescents' scores on a satisfaction survey indicated a moderate level of satisfaction. All but one adolescent indicated that Breathe was easy to use and they understood all the material presented. The most frequent barrier identified for program completion was difficulty in completing exposure activities. The power analysis indicated that 177 adolescents per group would be needed to detect a medium effect size (d=0.3) between groups in a definitive trial. Data for calculating an MCID or conducting a cost-consequence analysis were insufficient due to a low response rate at 8 weeks. CONCLUSIONS:Adolescents were moderately satisfied with Breathe. However, program adjustments will be needed to address attrition and reduce perceived barriers to completing key aspects of the program. A definitive RCT to evaluate the effectiveness of the program is feasible if protocol adjustments are made to improve recruitment and retention to ensure timely study completion and increase the completeness of the data at each outcome measurement time point. TRIAL REGISTRATION:ClinicalTrials.gov NCT02059226; http://clinicaltrials.gov/ct2/show/NCT02059226.

Project description:BACKGROUND:Previous randomized controlled trials (RCTs) have shown a significant intervention effect of internet-based computerized cognitive behavioral therapy (iCBT) on improving nonclinical depressive symptoms among healthy workers and community residents in a primary prevention setting. Time preference is one's relative valuation for having a reward (eg, money) at present than at a later date. Time preference may affect the effectiveness of cognitive behavioral therapy. OBJECTIVE:This RCT aimed to test the difference of intervention effect of an iCBT program on improving nonclinical depressive symptoms between two subgroups classified post-hoc on the basis of time preference among workers in Japan. METHODS:All workers in one corporate group (approximate n=20,000) were recruited. Participants who fulfilled the inclusion criteria were randomly allocated to either intervention or control groups. Participants in the intervention group completed 6 weekly lessons and homework assignments within the iCBT program. The Beck Depression Inventory-II (BDI-II) and Kessler's Psychological Distress Scale (K6) measures were obtained at baseline and 3-, 6-, and 12-month follow-ups. Two subgroups were defined by the median of time preference score at baseline. RESULTS:Only few (835/20,000, 4.2%) workers completed the baseline survey. Of the 835 participants, 706 who fulfilled the inclusion criteria were randomly allocated to the intervention or control group. Participants who selected irrational time preference options were excluded (21 and 18 participants in the intervention and control groups, respectively). A three-way interaction (group [intervention/control] × time [baseline/follow-up] × time preference [higher/lower]) effect of iCBT was significant for BDI-II (t1147.42=2.33, P=.02) and K6 (t1254.04=2.51, P=.01) at the 3-month follow-up, with a greater effect of the iCBT in the group with higher time preference. No significant three-way interaction was found at the 6- and 12-month follow-ups. CONCLUSIONS:The effects of the iCBT were greater for the group with higher time preference at the shorter follow-up, but it was leveled off later. Workers with higher time preference may change their cognition or behavior more quickly, but these changes may not persist. TRIAL REGISTRATION:UMIN Clinical Trials Registry UMIN000014146; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi? recptno=R000016466 (Archived by WebCite at http://www.webcitation.org/70o2rNk2V).

Project description:BACKGROUND:Self-guided internet-based cognitive behavioral therapies (iCBTs) for depressive symptoms may substantially increase accessibility to mental health treatment. Despite this, questions remain as to the generalizability of the research on self-guided iCBT. OBJECTIVE:We sought to describe the clinical entry criteria used in studies of self-guided iCBT, explore the criteria's effects on study outcomes, and compare the frequency of use of these criteria with their use in studies of face-to-face psychotherapy and antidepressant medications. We hypothesized that self-guided iCBT studies would use more stringent criteria that would bias the sample toward those with a less complex clinical profile, thus inflating treatment outcomes. METHODS:We updated a recently published meta-analysis by conducting a systematic literature search in PubMed, MEDLINE, PsycINFO, and EMBASE. We conducted a meta-regression analysis to test the effect of the different commonly used psychiatric entry criteria on the treatment-control differences. We also compared the frequency with which exclusion criteria were used in the self-guided iCBT studies versus studies of face-to-face psychotherapy and antidepressants from a recently published review. RESULTS:Our search yielded 5 additional studies, which we added to the 16 studies identified by Karyotaki and colleagues in 2017. Few self-guided iCBT studies excluded patients with severe depressive symptoms (6/21, 29%), but self-guided iCBT studies were more likely than antidepressant (14/170, 8.2%) studies to use this criterion. However, self-guided iCBT studies did not use this criterion more frequently than face-to-face psychotherapy studies (6/16, 38%). Beyond this, we found no evidence that self-guided iCBTs used more stringent entry criteria. Strong evidence suggested that they were actually less likely to use most entry criteria, especially exclusions on the basis of substance use or personality pathology. None of the entry criteria used had an effect on outcomes. CONCLUSIONS:A conservative interpretation of our findings is that the patient population sampled in the literature on self-guided iCBT is relatively comparable with that of studies of antidepressants or face-to-face psychotherapy. Alternatively, studies of unguided cognitive behavioral therapy may sample from a more heterogeneous and representative patient population. Until evidence emerges to suggest otherwise, the patient population sampled in self-guided iCBT studies cannot be considered as less complex than the patient population from face-to-face psychotherapy or antidepressant studies.

Project description:Depressive symptoms, and the associated coexistence of symptoms of anxiety and decreased quality of life (QoL), are common in patients with heart failure (HF). However, treatment strategies for depressive symptoms in patients with HF still remain to be established. Internet-based cognitive behavioral therapy (ICBT), as guided self-help CBT programs, has shown good effects in the treatment of depression. Until now, ICBT has not been evaluated in patients with HF with depressive symptoms.The aims of this study were to (1) evaluate the effect of a 9-week guided ICBT program on depressive symptoms in patients with HF; (2) investigate the effect of the ICBT program on cardiac anxiety and QoL; and (3) assess factors associated with the change in depressive symptoms.Fifty participants were randomized into 2 treatment arms: ICBT or a Web-based moderated discussion forum (DF). The Patient Health Questionnaire-9 was used to measure depressive symptoms, the Cardiac Anxiety Questionnaire (CAQ) was used to measure cardiac-related anxiety, and the Minnesota Living with Heart Failure questionnaire was used to measure QoL. Data were collected at baseline and at follow-up at the end of the 9-week intervention. Intention-to-treat analysis was used, and missing data were imputed by the Expectation-Maximization method. Between-group differences were determined by analysis of covariance with control for baseline score and regression to the mean.No significant difference in depressive symptoms between the ICBT and the DF group at the follow-up was found, [F(1,47)=1.63, P=.21] and Cohen´s d=0.26. Secondary within-group analysis of depressive symptoms showed that such symptoms decreased significantly in the ICBT group from baseline to the follow-up (baseline M=10.8, standard deviation [SD]=5.7 vs follow-up M=8.6, SD=4.6, t(24)=2.6, P=.02, Cohen´s d=0.43), whereas in the DF group, there was no significant change (baseline M=10.6, SD=5.0, vs follow-up M=9.8, SD=4.3, t(24)=0.93, P=.36. Cohen´s d=0.18). With regard to CAQ and QoL no significant differences were found between the groups (CAQ [d(1,47)=0.5, P=.48] and QoL [F(1,47)=2.87, P=.09]). In the ICBT group in the CAQ subscale of fear, a significant within-group decrease was shown (baseline M=1.55 vs follow-up M=1.35, P=.04). In the ICBT group, the number of logins to the Web portal correlated significantly with improvement in depressive symptoms (P=.02), whereas higher age (P=.01) and male sex (P=.048) were associated with less change in depressive symptoms. This study is underpowered because of difficulties in the recruitment of patients.Guided ICBT adapted for persons with HF and depressive symptoms was not statistically superior to participation in a Web-based DF. However, within the ICBT group, a statically significant improvement of depressive symptoms was detected.Clinicaltrials.gov NCT01681771; https://clinicaltrials.gov/ct2/show/NCT01681771 (Archived by WebCite at http://www.webcitation.org/6ikzbcuLN).

Project description:BACKGROUND:Bipolar disorder is a chronic condition with recurring episodes that often lead to suffering, decreased functioning, and sick leave. Pharmacotherapy in the form of mood stabilizers is widely available, but does not eliminate the risk of a new depressive or (hypo)manic episode. One way to reduce the risk of future episodes is to combine pharmacological treatment with individual or group psychological interventions. However, access to such interventions is often limited due to a shortage of trained therapists. In unipolar depression there is now robust evidence of the effectiveness of Internet-based psychological interventions, usually comprising psychoeducation and cognitive behavioral therapy (CBT). Internet-based interventions for persons suffering from bipolar disorder could increase access to psychological treatment. OBJECTIVE:The aim of this study was to investigate the feasibility of an Internet-based intervention, as well as its effect on residual depressive symptoms in persons diagnosed with bipolar disorder type II (BP-II). The most important outcomes were depressive symptoms, treatment adherence, and whether the patient perceived the intervention as helpful. METHODS:A total of 7 patients diagnosed with bipolar disorder type II at a Swedish psychiatric outpatient clinic were offered the opportunity to participate. Of the 7 patients, 3 (43%) dropped out before treatment began, and 4 (57%) were treated by means of an online, Internet-based intervention based on CBT (iCBT). The intervention was primarily aimed at psychoeducation, treatment of residual depressive symptoms, emotion regulation, and improved sleep. All patients had ongoing pharmacological treatment at recruitment and established contact with a psychiatrist. The duration of BP-II among the treated patients was between 6 and 31 years. A single-subject design was used and the results of the 4 participating patients were presented individually. RESULTS:Initiating treatment was perceived as too demanding under current life circumstances for 3 patients who consequently dropped out during baseline assessment. Self-ratings using the Montgomery-Åsberg Depression Rating Scale-Self-rated (MADRS-S) showed symptom reduction in 3 (75%) of the 4 treated cases during iCBT. In the evaluation of the treatment, 2 patients reported that they perceived that the treatment had reduced symptoms a little, 1 that it had reduced symptoms very much, and 1 not at all. Treatment adherence (ie, module completion) was fairly high in 3 cases. In general, the modules were perceived as fairly helpful or very helpful by the patients. In one case, there was a reliable change-according to the Reliable Change Index-in self-rated symptoms of depression and perseverative thinking. CONCLUSIONS:The treatment seemed to have acceptable feasibility. The iCBT intervention could be an effective way to treat residual symptoms in some patients with bipolar disorder type II. This should be investigated in a larger study. TRIAL REGISTRATION:ClinicalTrials.gov NCT01742351; https://clinicaltrials.gov/ct2/show/NCT01742351 (Archived by WebCite at http://www.webcitation.org/6XnVpv4C3).

Dataset Information

Effects of Internet Cognitive-Behavioral Therapy on Depressive Symptoms and Surrogates of Cardiovascular Risk in Human Immunodeficiency Virus: A Pilot, Randomized, Controlled Trial.

Publications

Effects of Internet Cognitive-Behavioral Therapy on Depressive Symptoms and Surrogates of Cardiovascular Risk in Human Immunodeficiency Virus: A Pilot, Randomized, Controlled Trial.

Similar Datasets

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