scholarly journals Improving the Course of Depressive Symptoms After Inpatient Psychotherapy Using Adjunct Web-Based Self-Help: Follow-Up Results of a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Rüdiger Zwerenz ◽  
Carlotta Baumgarten ◽  
Jan Becker ◽  
Ana Tibubos ◽  
Martin Siepmann ◽  
...  

BACKGROUND We recently showed in a randomized controlled trial that Web-based self-help as an adjunct improved the effectiveness of multimodal inpatient psychotherapy for depression. OBJECTIVE The aims of this study were (1) to determine whether a Web-based self-help adjunctive to multimodal inpatient psychotherapeutic treatment could also improve the course of depressive symptoms and (2) to identify predictors of residual depressive symptoms at follow-up. METHODS Overall, 229 patients were randomized either to the Web-based self-help intervention group (Deprexis) or an active control group (Web-based information about depression and depressive symptoms) in addition to multimodal inpatient psychotherapy. Participants in both groups were able to access their respective Web-based programs for 12 weeks, which meant that they typically had access after discharge from the inpatient unit (mean hospitalization duration: 40 days, T1). Follow-up was performed 6 months after study intake (T3). RESULTS At follow-up, participants of the Web-based self-help group had considerably lower symptom load regarding depressive symptoms (<italic>d</italic>=0.58) and anxiety (<italic>d</italic>=0.46) as well as a better quality of life (<italic>d</italic>=0.43) and self-esteem (<italic>d</italic>=0.31) than participants of the control group. Nearly 3 times as many participants of the intervention group compared with the control group achieved remission in accordance with less deterioration. The number needed to treat based on the Beck Depression Inventory-II (BDI-II) improved over time (T1: 7.84, T2: 7.09, and T3: 5.12). Significant outcome predictors were BDI at discharge and treatment group. CONCLUSIONS Web-based self-help as an add-on to multimodal inpatient psychotherapy improved the short-term course of depressive symptoms beyond termination. Residual symptoms at discharge from inpatient treatment and utilization of the Web-based self-help were the major predictors of depressive symptoms at follow-up. Challenges and barriers (eg, costs, therapists’ concerns, or technical barriers) of adding Web-based interventions to inpatient treatment have to be addressed. CLINICALTRIAL ClinicalTrials.gov NCT02196896; https://clinicaltrials.gov/ct2/show/NCT02196896.

10.2196/13655 ◽  
2019 ◽  
Vol 21 (10) ◽  
pp. e13655 ◽  
Author(s):  
Rüdiger Zwerenz ◽  
Carlotta Baumgarten ◽  
Jan Becker ◽  
Ana Tibubos ◽  
Martin Siepmann ◽  
...  

Background We recently showed in a randomized controlled trial that Web-based self-help as an adjunct improved the effectiveness of multimodal inpatient psychotherapy for depression. Objective The aims of this study were (1) to determine whether a Web-based self-help adjunctive to multimodal inpatient psychotherapeutic treatment could also improve the course of depressive symptoms and (2) to identify predictors of residual depressive symptoms at follow-up. Methods Overall, 229 patients were randomized either to the Web-based self-help intervention group (Deprexis) or an active control group (Web-based information about depression and depressive symptoms) in addition to multimodal inpatient psychotherapy. Participants in both groups were able to access their respective Web-based programs for 12 weeks, which meant that they typically had access after discharge from the inpatient unit (mean hospitalization duration: 40 days, T1). Follow-up was performed 6 months after study intake (T3). Results At follow-up, participants of the Web-based self-help group had considerably lower symptom load regarding depressive symptoms (d=0.58) and anxiety (d=0.46) as well as a better quality of life (d=0.43) and self-esteem (d=0.31) than participants of the control group. Nearly 3 times as many participants of the intervention group compared with the control group achieved remission in accordance with less deterioration. The number needed to treat based on the Beck Depression Inventory-II (BDI-II) improved over time (T1: 7.84, T2: 7.09, and T3: 5.12). Significant outcome predictors were BDI at discharge and treatment group. Conclusions Web-based self-help as an add-on to multimodal inpatient psychotherapy improved the short-term course of depressive symptoms beyond termination. Residual symptoms at discharge from inpatient treatment and utilization of the Web-based self-help were the major predictors of depressive symptoms at follow-up. Challenges and barriers (eg, costs, therapists’ concerns, or technical barriers) of adding Web-based interventions to inpatient treatment have to be addressed. Trial Registration ClinicalTrials.gov NCT02196896; https://clinicaltrials.gov/ct2/show/NCT02196896.


2020 ◽  
Author(s):  
Takashi Sunami ◽  
Ryuhei So ◽  
Hironobu Ishii ◽  
Eiji Sadashima ◽  
Takefumi Ueno ◽  
...  

BACKGROUND In recent years, web-based interventions for problem drinkers have been developed, and they appear to be effective in reducing alcohol consumption in some studies. However, most of the subjects included in the studies were students or those who were recruited through web advertisements, and the dropout rates were high. OBJECTIVE This study aimed to assess the effectiveness of a web-based brief intervention (BI) program to record daily drinking among problem drinkers in a workplace setting. METHODS A two-armed, parallel-group, randomized controlled trial was conducted at six workplaces in Japan. A one-off 30-minute face-to-face lecture was organized at each workplace, and the study was explained. The audience who wished to participate were asked to provide their written consent immediately after the one-off lecture. Among those who wished to participate, problem drinkers with an Alcohol Use Disorders Identification Test (AUDIT) score of eight or higher were randomly assigned into two groups. The participants allocated to the intervention group recorded their daily alcohol consumption for four weeks using SNAPPY-DOC, while those allocated to the control group received no intervention. Outcome measures included the amount of alcohol consumption in past seven days using the Timeline Follow-Back (TLFB) method in SNAPPY-DOC at baseline (Week 0), 8th week (Week 8), and 12th week (Week 12) and written AUDIT score at baseline (Week 0) and 12th week (Week 12). If there was no login to the program at baseline (Week 0), 8th week (Week 8), and 12th week (Week 12), the researcher sent a reminder email to the participant one week later requesting a record. If there was still no response, a further week later, the researcher contacted the participants through the occupational health professionals or other personnel in their respective workplaces to request a record. RESULTS Hundred participants were assigned to either the intervention group (n=50) or the control group (n=50). All the participants logged into the program, and no participants dropped out of the follow-up. The results of two-way repeated measures ANOVA showed a statistically significant interaction between the Group and the Week factors in the two primary outcomes (number of alcohol-free days in the past seven days, total drinks in the past seven days in standard units) and secondary outcomes (AUDIT score) (P=.04, .02, and .03, respectively). The intervention group had reduced alcohol consumption from 329 g to 246 g per week on average at the 12-week evaluation (P<.001), while the control group had reduced from 294 g to 276 g per week on average (P=.83). CONCLUSIONS The web-based BI program for problem drinkers (SNAPPY-DOC program) was considered to be low-cost, effective, and acceptable for implementation in actual workplace settings. CLINICALTRIAL University Hospital Medical Information Network Clinical Trials Registry UMIN000037698; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042703


2020 ◽  
Author(s):  
Takashi Sunami ◽  
Ryuhei So ◽  
Hironobu Ishii ◽  
Eiji Sadashima ◽  
Takefumi Ueno ◽  
...  

BACKGROUND In recent years, web-based interventions for problem drinkers have been developed, and they appear to be effective in reducing alcohol consumption in some studies. However, most of the subjects included in the studies were students or those who were recruited through web advertisements, and the dropout rates were high. OBJECTIVE This study aimed to assess the effectiveness of a web-based brief intervention (BI) program to record daily drinking among problem drinkers in a workplace setting. METHODS A two-armed, parallel-group, randomized controlled trial was conducted at six workplaces in Japan. A one-off 30-minute face-to-face lecture was organized at each workplace, and the study was explained. The audience who wished to participate were asked to provide their written consent immediately after the one-off lecture. Among those who wished to participate, problem drinkers with an Alcohol Use Disorders Identification Test (AUDIT) score of eight or higher were randomly assigned into two groups. The participants allocated to the intervention group recorded their daily alcohol consumption for four weeks using SNAPPY-DOC, while those allocated to the control group received no intervention. Outcome measures included the amount of alcohol consumption in past seven days using the Timeline Follow-Back (TLFB) method in SNAPPY-DOC at baseline (Week 0), 8th week (Week 8), and 12th week (Week 12) and written AUDIT score at baseline (Week 0) and 12th week (Week 12). If there was no login to the program at 8th week (Week 8), and 12th week (Week 12), the researcher sent a reminder email to the participant one week later requesting a record. If there was still no response, a further week later, the researcher contacted the participants through the occupational health professionals or other personnel in their respective workplaces to request a record. RESULTS Hundred participants were assigned to either the intervention group (n=50) or the control group (n=50). All the participants logged into the program, and no participants dropped out of the follow-up. The results of two-way repeated measures ANOVA showed a statistically significant interaction between the Group and the Week factors in the two primary outcomes (number of alcohol-free days in the past seven days, total drinks in the past seven days in standard units) and secondary outcomes (AUDIT score) (P=.04, .02, and .03, respectively). The intervention group had reduced alcohol consumption from 329 g to 246 g per week on average at the 12-week evaluation (P<.001), while the control group had reduced from 294 g to 276 g per week on average (P=.83). CONCLUSIONS The web-based BI program for problem drinkers (SNAPPY-DOC program) was considered to be low-cost, effective, and acceptable for implementation in actual workplace settings. CLINICALTRIAL University Hospital Medical Information Network Clinical Trials Registry UMIN000037698; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042703


2021 ◽  
Author(s):  
Hui-Ling Hsieh ◽  
Chi-Wen Kao ◽  
Shu-Meng Cheng ◽  
Yue-Cune Chang

BACKGROUND Atrial fibrillation (AF) is related to a variety of chronic diseases and life-threatening complications. It is estimated that by 2050, there will be 72 million patients with AF in Asia, of which 2.9 million will have AF-associated stroke. AF has become a major issue for health care systems. OBJECTIVE We aimed to evaluate the effects of a web-based integrated management program on improving coping strategies, medication adherence, and health-related quality of life (HRQoL) in patients with AF, and to detect the effect on decreasing readmission events. METHODS The parallel-group, single-blind, prospective randomized controlled trial recruited patients with AF from a medical center in northern Taiwan and divided them randomly into intervention and control groups. Patients in the intervention group received the web-based integrated management program, whereas those in the control group received usual care. The measurement tools included the Brief Coping Orientation to Problems Experienced (COPE) scale, Medication Adherence Rating Scale (MARS), the three-level version of the EuroQoL five-dimension self-report questionnaire (EQ-5D-3L), and readmission events 2 years after initiating the intervention. Data were collected at 4 instances (baseline, 1 month, 3 months, and 6 months after initiating the intervention), and analyzed with generalized estimating equations (GEEs). RESULTS A total of 231 patients were recruited and allocated into an intervention (n=115) or control (n=116) group. The mean age of participants was 73.08 (SD 11.71) years. Most participants were diagnosed with paroxysmal AF (171/231, 74%), and the most frequent comorbidity was hypertension (162/231, 70.1%). Compared with the control group, the intervention group showed significantly greater improvement in approach coping strategies, medication adherence, and HRQoL at 1, 3, and 6 months (all <i>P</i>&lt;.05). In addition, the intervention group showed significantly fewer readmission events within 2 years (OR 0.406, <i>P</i>=.03), compared with the control group. CONCLUSIONS The web-based integrated management program can significantly improve patients' coping strategy and medication adherence. Therefore, it can empower patients to maintain disease stability, which is a major factor in improving their HRQoL and reducing readmission events within 2 years. CLINICALTRIAL ClinicalTrials.gov NCT04813094; https://clinicaltrials.gov/ct2/show/NCT04813094.


10.2196/12711 ◽  
2019 ◽  
Vol 6 (8) ◽  
pp. e12711 ◽  
Author(s):  
Sanne van Luenen ◽  
Vivian Kraaij ◽  
Philip Spinhoven ◽  
Tom F Wilderjans ◽  
Nadia Garnefski

Background Cognitive behavioral therapy (CBT) is frequently used to treat depressive symptoms in people living with HIV. We developed an internet-based cognitive behavioral intervention for people with HIV and depressive symptoms, which was based on an effective self-help booklet. The Web-based intervention was previously found to be effective. Objective The objective of this study was to investigate potential mediators of the Web-based intervention. Methods This study was part of a randomized controlled trial, in which the intervention was compared with an attention-only waiting list control condition. Participants were 188 (97 in intervention group and 91 in control group) people with HIV and mild to moderate depressive symptoms recruited in HIV treatment centers in the Netherlands. A total of 22 participants (22/188, 11.7%) in the study were female and 166 (166/188, 88.3%) were male. The average age of the participants was 46.30 years (SD 10.63). The intervention comprised Web-based self-help CBT for 8 weeks, 1 to 2 hours a week, including minimal telephone support from a coach. The participants received Web-based questionnaires at pretest, 3 times during the intervention/or waiting period, and post intervention. The outcome was depressive symptoms. Factors tested as potential mediators were changes in behavioral activation, relaxation, the cognitive coping strategies catastrophizing and positive refocusing, goal re-engagement, and coping self-efficacy. Results Using multilevel structural equation modeling, changes in behavioral activation (P=.006) and goal re-engagement (P=.009) were found to be significant mediators of the intervention effect. The mediation effect seemed to occur between weeks 3 and 5 for behavioral activation and weeks 1 and 3 for goal re-engagement. Using (bivariate) autoregressive latent trajectory analysis, we found a return effect (from the dependent variable to the mediator) for goal re-engagement but not for behavioral activation, which suggested that the mediation effect of changes in behavioral activation was stronger than that in goal re-engagement. Conclusions The results suggest that changes in behavioral activation and goal re-engagement may mediate the effect of the Web-based intervention for people with HIV and depressive symptoms. The results may lead to possible mechanisms of change of the intervention and improvement of therapy outcomes. Clinical Trial Netherlands Trial Register NTR5407; https://www.trialregister.nl/trial/5298


2018 ◽  
Author(s):  
Jiaxi Lin ◽  
Bianca Faust ◽  
David Daniel Ebert ◽  
Lena Krämer ◽  
Harald Baumeister

BACKGROUND Internet- and mobile-based interventions are effective for the treatment of chronic pain. However, little is known about patients’ willingness to engage with these types of interventions and how the uptake of such interventions can be improved. OBJECTIVE The aim of this study was to identify people’s acceptance, uptake, and adherence (primary outcomes) with regard to an internet- and mobile-based intervention for chronic pain and the influence of an information video as an acceptance-facilitating intervention (AFI). METHODS In this randomized controlled trial with a parallel design, we invited 489 individuals with chronic pain to participate in a Web-based survey assessing the acceptance of internet- and mobile-based interventions with the offer to receive an unguided internet- and mobile-based intervention for chronic pain after completion. Two versions of the Web-based survey (with and without AFI) were randomly sent to two groups: one with AFI (n=245) and one without AFI (n=244). Participants who completed the Web-based survey with or without AFI entered the intervention group or the control group, respectively. In the survey, the individuals’ acceptance of pain interventions, measured with a 4-item scale (sum score ranging from 4 to 20), predictors of acceptance, sociodemographic and pain-related variables, and physical and emotional functioning were assessed. Uptake rates (log in to the intervention) and adherence (number of completed modules) to the intervention was assessed 4 months after intervention access. To examine which factors influence acceptance, uptake rate, and adherence in the internet- and mobile-based interventions, we conducted additional exploratory subgroup analyses. RESULTS In total, 57 (intervention group) and 58 (control group) participants in each group completed the survey and were included in the analyses. The groups did not differ with regard to acceptance, uptake rate, or adherence (P=.64, P=.56, P=.75, respectively). Most participants reported moderate (68/115, 59.1%) to high (36/115, 31.3%) acceptance, with 9.6% (11/115) showing low acceptance (intervention group: mean 13.91, SD 3.47; control group: mean 13.61, SD 3.50). Further, 67% (38/57, intervention group) and 62% (36/58, control group) had logged into the intervention. In both groups, an average of 1.04 (SD 1.51) and 1.14 (SD 1.90) modules were completed, respectively. CONCLUSIONS The informational video was not effective with regard to acceptance, uptake rate, or adherence. Despite the high acceptance, the uptake rate was only moderate and adherence was remarkably low. This study shows that acceptance can be much higher in a sample participating in an internet- and mobile-based intervention efficacy trial than in the target population in routine health care settings. Thus, future research should focus not only on acceptance and uptake facilitating interventions but also on ways to influence adherence. Further research should be conducted within routine health care settings with more representative samples of the target population. CLINICALTRIAL German Clinical Trial Registration DRKS00006183; http://www.drks.de/drks_web/navigate.do ?navigationId=trial.HTML&TRIAL_ID=DRKS00006183 (Archived by WebCite at http://www.webcitation.org/70ebHDhne)


Author(s):  
Beáta Bőthe ◽  
Christian Baumgartner ◽  
Michael P. Schaub ◽  
Zsolt Demetrovics ◽  
Gábor Orosz

Abstract Background and Aims Despite problematic pornography use (PPU) being prevalent, no previous study has examined the effectiveness of evidence-based interventions for PPU, using rigorous methods. Using a two-armed randomized controlled trial study design, we examined the feasibility and initial effectiveness of a six-week online PPU intervention. Methods We recruited 264 participants (3.8% women, M age = 33.2, SD = 10.6) who were randomized and assigned to either the self-help intervention (n = 123) or waitlist control condition (n = 141), and completed self-report questionnaires at baseline and after the end of the intervention (six-week follow-up). Multivariable linear regression models were generated and tested on a complete case basis to investigate possible treatment effects. Participants provided quantitative and qualitative feedback regarding the intervention’s content and appearance. Results Participants evaluated all modules positively in the intervention in general. There were differential dropout rates (89.4% in intervention vs. 44.7% in control group) with an overall follow-up rate of 34.5%. The intervention group reported significantly lower levels of PPU (P < 0.001, d = 1.32) at the six-week follow-up. Moreover, they reported lower pornography use frequency (P < 0.001, d = 1.65), self-perceived pornography addiction (P = 0.01, d = 0.85), pornography craving (P = 0.02, d = 0.40), and higher pornography avoidance self-efficacy (P = 0.001, d = 0.87) at the six-week follow-up. Discussion and Conclusions The present study was only a first step in rigorous treatment studies for PPU, but the findings are promising and suggest that online interventions for PPU might help reduce PPU in some cases, even without the guidance of therapists, by reducing treatment barriers.


2019 ◽  
Author(s):  
Jan van Lieshout ◽  
Joyca Lacroix ◽  
Aart van Halteren ◽  
Martina Teichert

BACKGROUND Growing numbers of people use medication for chronic conditions; non-adherence is common, leading to poor disease control. A newly developed web-based tool to identify an increased risk for non-adherence with related potential individual barriers might facilitate tailored interventions and improve adherence. OBJECTIVE To assess the effectiveness of the newly developed tool to improve medication adherence. METHODS A cluster randomized controlled trial assessed the effectiveness of this adherence tool in patients initiating cardiovascular or oral blood glucose lowering medication. Participants were included in community pharmacies. They completed an online questionnaire comprising an assessments of their risk for medication non-adherence and subsequently of barriers to adherence. In pharmacies belonging to the intervention group, individual barriers displayed in a graphical profile on a tablet were discussed by pharmacists and patients at high non-adherence risk in face to face meetings and shared with their general practitioners and practice nurses. Tailored interventions were initiated by the healthcare providers. Barriers of control patients were not presented or discussed and these patients received usual care. The primary outcome was the difference in medication adherence at 8 months follow-up between patients with an increased non-adherence risk from intervention and control group, calculated from dispensing data. RESULTS Data from 492 participants in 15 community pharmacies were available for analyses (intervention 253, 7 pharmacies; control 239, 8 pharmacies). The intervention had no effect on medication adherence (-0.01; 95%CI -0.59 – 0.57; P= .96), neither in the post hoc per protocol analysis (0.19; 95%CI -0.50 – 0.89; P=.58). CONCLUSIONS This study showed no effectiveness of a risk stratification and tailored intervention addressing personal barriers for medication adherence. Various potential explanations for lack of effect were identified. These explanations relate for instance to high medication adherence in the control group, study power and fidelity. Process evaluation should elicit possible improvements and inform the redesign of intervention and implementation. CLINICALTRIAL The Netherlands National Trial Register: NTR5186. Date: May 18, 2015 (http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=5186)


2021 ◽  
Vol 27 (1) ◽  
pp. 146045822199640
Author(s):  
Faranak Kazemi Majd ◽  
Vahideh Zarea Gavgani ◽  
Ali Golmohammadi ◽  
Ali Jafari-Khounigh

In order to understand if a physician prescribed medical information changes, the number of hospital readmission, and death among the heart failure patients. A 12-month randomized controlled trial was conducted (December 2013–2014). Totally, 120 patients were randomly allocated into two groups of intervention ( n = 60) and control ( n = 60). Accordingly, the control group was given the routine oral information by the nurse or physician, and the intervention group received the Information Prescription (IP) prescribed by the physician as well as the routine oral information. The data was collected via telephone interviews with the follow-up intervals of 6 and 12 months, and also for 1 year after the discharge. The patients with the median age of (IQR) 69.5 years old (19.8) death upon adjusting a Cox survival model, [RR = 0.67, 95%CI: 0.46–0.97]. Few patients died during 1 year in the intervention group compared to the controls (7 vs 15) [RR = 0.47, 95%CI: 0.20–1.06]. During a period of 6-month follow-up there was not statistically significant on death and readmission between two groups. Physician prescribed information was clinically and statistically effective on the reduction of death and hospital readmission rates among the HF patients in long term follow-up.


Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  

Abstract Background Many students in Germany do not meet recommended amounts of physical activity. In order to promote physical activity in students, web-based interventions are increasingly implemented. Yet, data on effectiveness of web-based interventions in university students is low. Our study aims at investigating a web-based intervention for students. The intervention is based on the Health Action Process Approach (HAPA), which discriminates between processes of intention formation (motivational processes) and processes of intention implementation (volitional processes). Primary outcome is change in physical activity; secondary outcomes are motivational and volitional variables as proposed by the HAPA as well as quality of life and depressive symptoms. Methods A two-armed randomized controlled trial (RCT) of parallel design is conducted. Participants are recruited via the internet platform StudiCare (www.studicare.com). After the baseline assessment (t1), participants are randomized to either intervention group (immediate access to web-based intervention) or control group (access only after follow-up assessment). Four weeks later, post-assessment (t2) is performed in both groups followed by a follow-up assessment (t3) 3 months later. Assessments take place online. Main outcome analyses will follow an intention-to-treat principle by including all randomized participants into the analyses. Outcomes will be analysed using a linear mixed model, assuming data are missing at random. The mixed model will include group, time, and the interaction of group and time as fixed effects and participant and university as random effect. Discussion This study is a high-quality RCT with three assessment points and intention-to-treat analysis meeting the state-of-the-art of effectiveness studies. Recruitment covers almost 20 universities in three countries, leading to high external validity. The results of this study will be of great relevance for student health campaigns, as they reflect the effectiveness of self-help interventions for young adults with regard to behaviour change as well as motivational and volitional determinants. From a lifespan perspective, it is important to help students find their way into regular physical activity. Trial registration The German clinical trials register (DRKS) DRKS00016889. Registered on 28 February 2019


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