A tailored Internet-delivered modular intervention based on cognitive behavioral therapy for depressed older adults: a study protocol for a randomized controlled trial.
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ABSTRACT: Background
Depression is most common among the elderly and is associated with major impairment. With limited accessible treatments available, remotely provided interventions are needed. Internet-based interventions have been proven effective for a number of mental and somatic health problems. However, the elderly population has received relatively limited attention in previous studies. This study aims to address this gap by investigating the effectiveness of a tailored Internet-delivered modular intervention based on cognitive behavioral therapy (CBT).Methods
A minimum of 60 participants will be recruited and randomly assigned to groups in a two-armed parallel controlled trial with a waiting list. The intervention group will have access to an 8-week therapist-supported modular intervention. The waiting list group will be instructed to wait for 8 weeks and then granted access to the intervention for 8 weeks. Pre, post, and 3-, 12-, and 24-month follow-up assessments are planned for measuring changes in depression symptoms, anxiety symptoms, and psychological well-being using PHQ-9, GDS, GAD-7, and WHO-5. Primary outcomes of all the participants will be analyzed using the intention-to-treat principle, and within- and between-group effect sizes will be calculated.Discussion
Internet-based interventions could help address the existing treatment gap for depressed older adults. However, to date, the effectiveness of Internet-based CBT (ICBT) for depressed older adults has only been tested in a few studies. This trial will demonstrate if Internet-based CBT is effective for this population when compared to a waiting list control. Further analysis of secondary outcomes and participant behavior in the intervention will potentially reveal effectiveness moderating factors.Trial registration
ClinicalTrials.gov NCT04728204. Registered on 15 January 2021. https://www.clinicaltrials.gov/ct2/show/NCT04728204?term=NCT04728204&draw=2&rank=1.
SUBMITTER: Eimontas J
PROVIDER: S-EPMC8674830 | biostudies-literature |
REPOSITORIES: biostudies-literature
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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.
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Project description:BackgroundInternet-delivered interventions can provide remarkable opportunities in addressing breast cancer survivors' unmet support care needs, as they present an effective strategy to improve care coordination and provide access to efficacious, cost-efficient and convenient survivorship care. Nevertheless, research focusing on improving survivors' psychosocial needs using internet-based tools is scarce and its practical implementation is limited.ObjectivesTo study the acceptability, feasibility, efficacy and cost-effectiveness of iNNOVBC, a 10 weeks guided internet-delivered individually-tailored Acceptance and Commitment Therapy (ACT)-influenced cognitive behavioural (CBT) intervention developed to improve mild to moderate anxiety and depression in Breast cancer survivors when compared to treatment as usual (TAU) in a waiting list control group (WLC).MethodsA two-arm, parallel, open label, multicentre, waiting list randomized controlled trial will be conducted to investigate the efficacy and cost-effectiveness of INNOVBC. The primary outcomes in this research will be anxiety and depression. Secondary outcomes will include psychological flexibility, fatigue, insomnia, sexual dysfunction and Health Related Quality of Life (HRQoL).Ethical approvalThis study has been reviewed and approved by Comissão Nacional de Proteção de Dados; Instituto Português de Oncologia do Porto Francisco Gentil; Unidade Local de Saúde de Matosinhos, EPE; Centro Hospitalar de São João and Ordem dos Psicólogos ethical committees.Expected resultsIt is anticipated that iNNOVBC will show to be an efficacious and cost-effective program in improving the outcomes of interest in this study, as opposed to a WLC under TAU. The results of this research will be published in accordance with CONSORT-EHEALTH guidelines.ConclusionsThis study will inform on the acceptability, feasibility, efficacy and cost-effectiveness of iNNOVBC, in improving psychosocial outcomes in breast cancer survivors when compared to TAU in a WLC. Its conclusions will contribute to understand the idiosyncrasies of designing and implementing internet-delivered interventions in breast cancer survivors.Trial Registration code: INNOVBC (NCT03275727).
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Project description:ImportanceBlack women are at risk for insomnia disorder. Despite interest in addressing sleep health disparities, there is limited research investigating the efficacy of criterion-standard treatment (cognitive behavioral therapy for insomnia [CBT-I]) among this racial minority population.ObjectiveTo compare the efficacy of a standard version of an internet-delivered CBT-I program, a culturally tailored version, and a sleep education control at improving insomnia symptoms.Design, setting, and participantsIn this single-blind, 3-arm randomized clinical trial, participants in a national, longitudinal cohort (Black Women's Health Study [BWHS]) were recruited between October 2019 and June 2020. BWHS participants with elevated insomnia symptoms were enrolled and randomized in the current study.InterventionsParticipants were randomized to receive (1) an automated internet-delivered treatment called Sleep Healthy Using the Internet (SHUTi); (2) a stakeholder-informed, tailored version of SHUTi for Black women (SHUTi-BWHS); or (3) patient education (PE) about sleep.Main outcomes and measuresThe primary outcome was insomnia severity (Insomnia Severity Index [ISI]). Index score ranged from 0 to 28 points, with those scoring less than 8 points considered to not have clinically significant insomnia symptoms and a score of 15 points or higher suggesting insomnia disorder. An ISI score reduction of more than 7 points was considered a clinically significant improvement in insomnia symptoms. The SHUTi-BWHS program was hypothesized to be more effective at significantly decreasing insomnia severity compared with the SHUTi program and PE.ResultsA total of 333 Black women were included in this trial, and their mean (SD) age was 59.5 (8.0) years. Those randomized to receive either SHUTi or SHUTi-BWHS reported significantly greater reductions in ISI score at 6-month follow-up (SHUTi: -10.0 points; 95% CI, -11.2 to -8.7; SHUTi-BWHS: -9.3 points; 95% CI, -10.4 to -8.2) than those randomized to receive PE (-3.6 points; 95% CI, -4.5 to -2.1) (P < .001). Significantly more participants randomized to SHUTi-BWHS completed the intervention compared with those randomized to SHUTi (86 of 110 [78.2%] vs 70 of 108 [64.8%]; P = .008). Participants who completed either intervention showed greater reductions in insomnia severity compared with noncompleters (-10.4 points [95% CI, -11.4 to -9.4] vs -6.2 points [95% CI, -8.6 to -3.7]).Conclusions and relevanceIn this randomized clinical trial, both the SHUTi and SHUTi-BWHS programs decreased insomnia severity and improved sleep outcomes more than PE. The culturally tailored SHUTi-BWHS program was more effective at engaging participants with the program, as a greater proportion completed the full intervention. Program completion was associated with greater improvements in sleep.Trial registrationClinicalTrials.gov Identifier: NCT03613519.
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Project description:Background:Cognitive-behavioral therapy for insomnia (CBTi) is considered the standard treatment. The internet has proven to be a useful and successful tool of providing CBTi. However, few studies have investigated the possible effect of unguided internet-delivered CBTi (ICBTi) on comorbid psychological symptoms and fatigue. Methods:Based on a randomized controlled trial, we investigated whether unguided ICBTi had an effect on comorbid psychological symptoms. Adults with insomnia (n?=?181; 67% women; mean age 44.9?years [SD 13.0]) were randomized to ICBTi (n?=?95) or to an online patient education condition (n?=?86) for a nine-week period. Results:The results from mixed linear modelling yielded medium to large between-group effect sizes from pre- to post-treatment for symptoms of anxiety or depression (d?=?-0.57; 95% CI?=?0.79-0.35) and fatigue (d?=?0.92; 95% CI?=?1.22-0.62). The ICBTi group was reassessed at a 6-month non-randomized follow-up, and the completing participants had on the average a significant increase (from the post-assessment) on symptoms of anxiety or depression, while the reduction in symptoms of fatigue (on post-assessment) was maintained. However, due to high dropout attrition and no control group data, caution should be made regarding the long-term effects. In conclusion, the present findings show that unguided ICBTi positively influence comorbid symptoms in the short-term, thereby emphasizing the clinical relevance of unguided ICBTi. Trial registration:ClinicalTrials.gov identifier: NCT02261272.
| S-EPMC6096334 | biostudies-literature
Project description:BackgroundTreatment dropout continues to be reported from internet-delivered cognitive behavioral therapy (iCBT) interventions, and lower completion rates are generally associated with lower treatment effect sizes. However, evidence is emerging to suggest that completion of a predefined number of modules is not always necessary for clinical benefit or consideration of the needs of each individual patient.ObjectiveThe aim of this study is to perform a qualitative analysis of patients' experiences with an iCBT intervention in a routine care setting to achieve a deeper insight into the phenomenon of dropout.MethodsA total of 15 purposively sampled participants (female: 8/15, 53%) from a larger parent randomized controlled trial were interviewed via telephone using a semistructured interview schedule that was developed based on the existing literature and research on dropout in iCBT. Data were analyzed using a descriptive-interpretive approach.ResultsThe experience of treatment leading to dropout can be understood in terms of 10 domains: relationship to technology, motivation to start, background knowledge and attitudes toward iCBT, perceived change in motivation, usage of the program, changes due to the intervention, engagement with content, experience interacting with the supporter, experience of web-based communication, and termination of the supported period.ConclusionsPatients who drop out of treatment can be distinguished in terms of their change in motivation: those who felt ready to leave treatment early and those who had negative reasons for dropping out. These 2 groups of participants have different treatment experiences, revealing the potential attributes and nonattributes of dropout. The reported between-group differences should be examined further to consider those attributes that are strongly descriptive of the experience and regarded less important than those that have become loosely affiliated.
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Project description:ObjectivesTo evaluate the efficacy of an Internet behavioral weight loss program; and determine if adding periodic in-person sessions to an Internet intervention improves outcomes.Methods481 healthy overweight adults (28% minority) were randomized to one of 3 delivery methods of a behavioral weight loss program with weekly meetings: Internet (n=161), InPerson (n=158), or Hybrid (Internet+InPerson, n=162). Outcome variables were weight at baseline and 6 months and percent of subjects achieving a 5 and 7% weight loss. The study took place in two centers in Vermont and Arkansas from 2003 to 2008.ResultsConditions differed significantly in mean weight loss [8.0 (6.1) kg vs. 5.5 (5.6) kg vs. 6.0 (5.5) kg], for InPerson, Internet, and Hybrid respectively, p<0.01, n=462). Weight loss for InPerson was significantly greater than the Internet and Hybrid conditions (p<0.05). Although the proportion reaching a 5% weight loss did not differ, the proportion losing 7% did differ significantly (56.3% vs. 37.3% vs. 44.4% for InPerson, Internet, and Hybrid respectively, p<0.01).ConclusionsThese results demonstrate that the Internet is a viable alternative to in-person treatment for the delivery and dissemination of a behavioral weight-control intervention. The addition of periodic in-person sessions did not improve outcomes.
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Project description:BACKGROUND:Patient adherence is defined as the extent to which a patient complies with medical or health advice. At present, there is a lack of reliable and valid measures specifically designed to measure adherence to internet-delivered behavioral interventions. OBJECTIVE:The objective of this study was to develop and psychometrically evaluate a novel measure of adherence to guided internet-delivered behavioral interventions. METHODS:In collaboration with experienced clinicians and researchers in the field, a 5-item, clinician-rated internet intervention Patient Adherence Scale (iiPAS) was developed. The initial scale was tested in a sample of children and adolescents (N=50) participating in internet-delivered cognitive behavioral therapy (ICBT) studies. A revised version of the iiPAS was then administered to a larger sample of children and adolescents (N=148) with various behavioral problems participating in ICBT trials. The scale was evaluated according to a classical test theory framework. RESULTS:The iiPAS demonstrated excellent internal consistency. Factor analyses revealed one underlying factor, explaining about 80% of the variance, suggesting that the scale captures a homogeneous adherence construct. The iiPAS was strongly associated with objective measures of patient activity in ICBT (number of logins, number of written characters, and completed modules). Furthermore, mid- and posttreatment ratings of the iiPAS were significantly correlated with treatment outcomes. By contrast, objective measures of patient activity in the Web-based platform did not correlate with treatment outcomes. CONCLUSIONS:The iiPAS could be a useful tool to measure adherence in a broad range of internet-delivered behavioral interventions.
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