Dataset Information

The Effect of Guided Web-Based Cognitive Behavioral Therapy on Patients With Depressive Symptoms and Heart Failure: A Pilot Randomized Controlled Trial.

ABSTRACT:

Background

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.

Objective

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.

Methods

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.

Results

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.

Conclusions

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.

Clinicaltrial

Clinicaltrials.gov NCT01681771; https://clinicaltrials.gov/ct2/show/NCT01681771 (Archived by WebCite at http://www.webcitation.org/6ikzbcuLN).

SUBMITTER: Lundgren JG

PROVIDER: S-EPMC5070581 | biostudies-literature | 2016 Aug

REPOSITORIES: biostudies-literature

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Publications

The Effect of Guided Web-Based Cognitive Behavioral Therapy on Patients With Depressive Symptoms and Heart Failure: A Pilot Randomized Controlled Trial.

Lundgren Johan Gustav JG Dahlström Örjan Ö Andersson Gerhard G Jaarsma Tiny T Kärner Köhler Anita A Johansson Peter P

Journal of medical Internet research 20160803 8

<h4>Background</h4>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 ...[more]

PMID: 27489077

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Project description:BackgroundA significant number of individuals with depression in Hong Kong remain undiagnosed and untreated through traditional face-to-face psychotherapy. Internet-based cognitive behavioral therapy (iCBT) has emerged as a tool to improve access to mental health services. However, iCBT remains underdeveloped in Chinese communities, particularly in Hong Kong.ObjectiveThis study aims to (1) develop and evaluate the effectiveness of a culturally and linguistically appropriate guided iCBT program for Hong Kong Chinese with depressive symptoms, and (2) explore their treatment adherence.MethodsAn 11-week guided iCBT program, "Confront and Navigate Depression Online" (CANDO), consisting of 8 online modules, was developed and implemented for Hong Kong residents. The program was accessible via either an online platform (web-based iCBT) or a smartphone app (app-based iCBT). A 3-arm randomized controlled trial was conducted, with participants recruited through open recruitment and referrals from 2 local non-governmental organizations. A total of 402 eligible participants with mild to moderate depressive symptoms were randomly allocated into 3 groups: (1) web-based iCBT (n=139); (2) app-based iCBT (n=131); and (3) waitlist control (WLC) group (n=132), who transitioned to the web-based iCBT group after waiting for 11 weeks. Therapist support was provided by a clinical psychologist through 3 counseling sessions and weekly assignment feedback. The primary outcomes were the Beck Depression Inventory-II (BDI-II) and the 9-item Patient Health Questionnaire (PHQ-9), while the secondary outcome measures included the 12-item General Health Questionnaire (GHQ-12), the Chinese Automatic Thoughts Questionnaire (CATQ), and the Chinese Affect Scale (CAS). These scales were administered at preintervention, postintervention, and at 3-month and 6-month follow-up assessments. Data analysis was conducted using linear mixed effects modeling, adhering to the intent-to-treat principle.ResultsParticipants in both the web- and app-based iCBT groups reported significant improvements compared with the WLC group on all primary (P<.001) and secondary measures (P<.001 and P=.009) at posttreatment. Large between-group effect sizes were observed in the reduction of depressive symptoms, with Cohen's d value of 1.07 (95% CI 0.81-1.34) for the web-based group and 1.15 (95% CI 0.88-1.43) for the app-based group on the BDI-II. Additionally, the web- and app-based groups showed effect sizes of 0.78 (95% CI 0.52-1.04) and 0.95 (95% CI 0.63-1.27) on PHQ-9, respectively. Medium to large effect sizes were observed for secondary outcomes at posttreatment. These positive effects were maintained at both the 3- and 6-month follow-ups, with medium to large within-group effect sizes. The adherence rate in the 2 iCBT groups was 154 out of 270 (57.0%) for completing all 8 online modules and 152 out of 270 (56.3%) for attending all 4 counseling sessions (including an intake interview). The recovery rate, as measured by the BDI-II at posttreatment, was 35 out of 90 (39%) for the web-based group and 36 out of 91 (40%) for the app-based group, compared with 3 out of 112 (3%) in the WLC group.ConclusionsCulturally and linguistically adapted iCBT is an effective and feasible treatment for Hong Kong Chinese with mild to moderate depressive symptoms, demonstrating a satisfactory recovery rate and treatment adherence. ICBT offers an accessible and viable alternative to face-to-face interventions in Hong Kong. The Hong Kong government should allocate more resources and support the use of iCBT as a tool to treat people with depressive symptoms.Trial registrationClinicalTrials.gov (NCT04388800); https://clinicaltrials.gov/study/NCT04388800.

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:BackgroundSelf-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.ObjectiveWe 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.MethodsWe 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.ResultsOur 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.ConclusionsA 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:BackgroundWhile support from family caregivers is essential in the care of patients with heart failure (HF), caregiving places a considerable burden on family caregivers. We examined the preliminary effects of cognitive behavioral therapy (CBT) for caregivers of individuals with HF.MethodsIn this pilot randomized controlled trial, patients with HF and their primary family caregivers (30 dyads) were randomized into CBT (n = 15) or general health education (GHE, n = 15) groups. Caregivers received 8 weekly individual sessions of either CBT (intervention) or GHE (attention control condition). Caregivers completed questionnaires at baseline, post-intervention, and 6 months. Saliva samples collected from caregivers at baseline and post-intervention were analyzed for salivary cortisol. The cortisol awakening response (CAR) and area under the curve (AUC) were calculated using log-transformed cortisol values. We analyzed data from 26 (14 receiving CBT and 12 receiving GHE) caregivers who received at least one session of CBT or GHE (modified intention-to treat) using linear mixed models. Each model included time, study group, and time-by-study group interaction as fixed effects.ResultsPatients were older (66.94 ± 14.01 years) than caregivers (55.09 ± 15.24 years), and 54% of patients and 54% of caregivers were female. Most caregivers (58%) were spouses. A total of 14 (93%) CBT and 12 (80%) GHE participants received at least 1 session (p = .60), and 11 (73%) CBT and 11 (73%) GHE participants completed all 8 sessions (p = 1.00). There were no significant between-group differences in change for salivary cortisol or psychological outcomes. However, the CBT group had significant within-group improvements in perceived stress (p = .011), stress symptoms (p = .017), depression (p = .002), and anxiety (p = .006) from baseline to post-intervention, while the control group had no significant within-group change in the outcomes except for anxiety (p = .03). The significant improvements observed in the CBT group lasted for 6 months. No adverse effects were observed.ConclusionsIn this pilot trial, although between-group differences in change were not significant, CBT resulted in significant improvements in some psychological outcomes with no improvement in the control group. Our findings suggest the potential of the intervention to alleviate psychological distress in HF caregivers. Further examination in larger randomized trials is warranted.Trial registrationClinicalTrials.gov Identifier: NCT01937936 (Registered on 10/09/2013).

Project description:BackgroundInternet-based cognitive behavioral interventions (iCBTs) are efficacious treatments for depression and anxiety. However, it is unknown whether adding human guidance is feasible and beneficial within a large educational setting.ObjectiveThis study aims to potentially demonstrate the superiority of 2 variants of a transdiagnostic iCBT program (human-guided and computer-guided iCBT) over care as usual (CAU) in a large sample of university students and the superiority of human-guided iCBT over computer-guided iCBT.MethodsA total of 801 students with elevated levels of anxiety, depression, or both from a large university in the Netherlands were recruited as participants and randomized to 1 of 3 conditions: human-guided iCBT, computer-guided iCBT, and CAU. The primary outcome measures were depression (Patient Health Questionnaire) and anxiety (Generalized Anxiety Disorder scale). Secondary outcomes included substance use-related problems (Alcohol Use Disorder Identification Test and Drug Abuse Screening Test-10 items). Linear mixed models were used to estimate the effects of time, treatment group, and their interactions (slopes). The primary research question was whether the 3 conditions differed in improvement over 3 time points (baseline, midtreatment, and after treatment) in terms of depression and anxiety symptoms. Results were analyzed according to the intention-to-treat principle using multiple imputation. Patients were followed exploratively from baseline to 6 and 12 months.ResultsIn both short-term and long-term analyses, the slopes for the 3 conditions did not differ significantly in terms of depression and anxiety, although both web-based interventions were marginally more efficacious than CAU over 6 months (P values between .02 and .03). All groups showed significant improvement over time (P<.001). For the secondary outcomes, only significant improvements over time (across and not between groups) were found for drug use (P<.001). Significant differences were found in terms of adherence, indicating that participants in the human-guided condition did more sessions than those in the computer-guided condition (P=.002).ConclusionsThe transdiagnostic iCBT program offers a practical, feasible, and efficacious alternative to usual care to tackle mental health problems in a large university setting. There is no indication that human guidance should be preferred over technological guidance. The potential preference of human support also depends on the scale of implementation and cost-effectiveness, which need to be addressed in future trials.Trial registrationInternational Clinical Trials Registry Platform NL7328/NTR7544; https://trialsearch.who.int/Trial2.aspx?TrialID=NL-OMON26795.

Dataset Information

The Effect of Guided Web-Based Cognitive Behavioral Therapy on Patients With Depressive Symptoms and Heart Failure: A Pilot Randomized Controlled Trial.

Background

Objective

Methods

Results

Conclusions

Clinicaltrial

Publications

The Effect of Guided Web-Based Cognitive Behavioral Therapy on Patients With Depressive Symptoms and Heart Failure: A Pilot Randomized Controlled Trial.

Similar Datasets

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