scholarly journals A Culturally Adapted Cognitive Behavioral Internet-Delivered Intervention for Depressive Symptoms: Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Alicia Salamanca-Sanabria ◽  
Derek Richards ◽  
Ladislav Timulak ◽  
Sarah Connell ◽  
Monica Mojica Perilla ◽  
...  
Keyword(s):  
College Students ◽  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Treatment Group ◽  
Controlled Trial ◽  
Control Group ◽  
Large Effect Size ◽  
Randomized Controlled ◽  
Culturally Adapted

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 (<i>t</i> <sub>197.54</sub>=−5.189; <i>P</i>&lt;.001) for the treatment group, and these effects were maintained at the 3-month follow-up (<i>t</i> <sub>39.62</sub>=4.668; <i>P</i>&lt;.001). Within-group results for the treatment group yielded a large effect size post treatment (<i>d</i>=1.44; <i>P</i>&lt;.001), and this was maintained at the 3-month follow-up (<i>d</i>=1.81; <i>P</i>&lt;.001). In addition, the LMM showed significant differences between the groups (<i>t</i> <sub>197.54</sub>=−5.189; <i>P</i>&lt;.001). The results showed a large effect size between the groups (<i>d</i>=0.91; <i>P</i>&lt;.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 (X<sup>2</sup><sub>2</sub>=10.5; <i>P</i>=.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. CLINICALTRIAL ClinicalTrials.gov NCT03062215; https://clinicaltrials.gov/ct2/show/NCT03062215

scholarly journals A Culturally Adapted Cognitive Behavioral Internet-Delivered Intervention for Depressive Symptoms: Randomized Controlled Trial

10.2196/13392 ◽  
2020 ◽  
Vol 7 (1) ◽  
pp. e13392 ◽  
Author(s):  
Alicia Salamanca-Sanabria ◽  
Derek Richards ◽  
Ladislav Timulak ◽  
Sarah Connell ◽  
Monica Mojica Perilla ◽  
...  
Keyword(s):  
College Students ◽  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Treatment Group ◽  
Controlled Trial ◽  
Control Group ◽  
Large Effect Size ◽  
Randomized Controlled ◽  
Culturally Adapted

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

Psychodynamic therapy for adolescents suffering from co-morbid disorders of conduct and emotions in an in-patient setting: a randomized controlled trial

2013 ◽  
Vol 44 (10) ◽  
pp. 2213-2222 ◽  
Author(s):  
S. Salzer ◽  
C. Cropp ◽  
U. Jaeger ◽  
O. Masuhr ◽  
A. Streeck-Fischer
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Controlled Trial ◽  
Academic Failure ◽  
Psychodynamic Therapy ◽  
Post Treatment ◽  
Control Group ◽  
Global Severity Index ◽  
Randomized Controlled

BackgroundCo-morbid disorders of conduct and emotions can be regarded as childhood antecedents of further negative developments (e.g. manifestation of personality disorders in adulthood). We evaluated a manualized psychodynamic therapy (PDT) for adolescents with these co-morbid disorders.MethodIn a randomized controlled trial (RCT), 66 adolescents diagnosed with mixed disorders of conduct and emotions (F92 in ICD-10) were randomly assigned to a manualized in-patient PDT group or a waiting list/treatment-as-usual (WL/TAU) control condition. Diagnoses according to DSM-IV were also documented. Patients were compared using rates of remission as the primary outcome. The Global Severity Index (GSI) and the Strengths and Difficulties Questionnaire (SDQ) were used as secondary measures. Assessments were performed at baseline, post-treatment and at the 6-month follow-up.ResultsThe sample consisted of severely impaired adolescents with high rates of further co-morbid disorders and academic failure. Patients in the treatment group had a significantly higher rate of remission [odds ratio (OR) 26.41, 95% confidence interval (CI) 6.42–108.55, p < 0.001]. Compared with the control group, the PDT group resulted in significantly better outcomes on the SDQ (p = 0.04) but not the GSI (p = 0.18), with small between-group effect sizes (SDQ: d = 0.38, GSI: d = 0.18). However, the scores of patients treated with PDT were post-treatment no longer significantly different from normative data on the GSI and within the normal range on the SDQ. The effects in the treatment group were stable at follow-up. Furthermore, most patients were reintegrated into educational processes.ConclusionPDT led to remarkable improvement and furthered necessary preconditions for long-term stabilization. In future, PDT should be compared to other strong active treatments.

Investigating the Effects of a Personalized, Spectrally Altered Music-Based Sound Therapy on Treating Tinnitus: A Blinded, Randomized Controlled Trial

2016 ◽  
Vol 21 (5) ◽  
pp. 296-304 ◽  
Author(s):  
Shelly-Anne Li ◽  
Lin Bao ◽  
Michael Chrostowski
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Psychological Functioning ◽  
Classical Music ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Sound Therapy ◽  
Tinnitus Distress

Objective: This blinded, randomized controlled trial assessed the effectiveness of a personalized, spectrally altered music-based sound therapy over 12 months of use. Method: Two groups of participants (n = 50) were randomized to receive either altered or unaltered classical music. The treatment group received classical music that had been modified based on spectral alterations specific to their tinnitus characteristics. Tinnitus and psychological functioning were assessed at baseline and 3, 6, and 12 months after initial testing using self-reports. Participants, investigators and research assistants were blinded from group assignment. Results: Data from 34 participants were analyzed. The treatment group reported significantly lower levels of tinnitus distress (primary outcome, assessed using the Tinnitus Handicap Inventory) than the control group throughout the follow-up period. Among the treatment group, there were statistically significant and clinically meaningful levels of reduction in tinnitus distress, severity, and functional impairment at 3- and 6-month follow-ups, which was sustained at the 12-month follow-up. Conclusion: The personalized music therapy was effective in reducing subjective tinnitus and represents a meaningful advancement in tinnitus intervention.

Randomized Controlled Trial: Cognitive-Narrative Therapy for IPV Victims

2020 ◽  
pp. 088626052094371
Author(s):  
André Moreira ◽  
Ana Cristina Moreira ◽  
José Carlos Rocha
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Narrative Therapy ◽  
Stress Disorder ◽  
Controlled Trial ◽  
Assessment Instrument ◽  
Control Group ◽  
Randomized Controlled ◽  
Treatment Of Depression

The objective is to test the efficacy of cognitive-narrative therapy in the treatment of depression, post-traumatic stress disorder (PTSD), complex posttraumatic stress disorder (CPTSD) and borderline symptoms on a sample of women who suffered from intimate partner violence (IPV). Trial design is a longitudinal randomized controlled trial with a sample of 19 battered women allocated in two groups, a control group and treatment group, assessed twice at baseline before intervention, and at follow-up. The outcome measures were the Patient Health Questionnaire, International Trauma Questionnaire, PTSD and CPTSD Diagnostic Interview Schedule for International Classification of Diseases (ICD)-11, Conjugal Violence Exposure Scale (CVES), Life Events Checklist and Intervention Program Satisfaction Assessment Instrument. The treatment group received a four-session cognitive-narrative manualized intervention. There were no statistically significant differences between groups at baseline and follow-up, however, positive effect sizes ranging between 0.04 and 0.43 were found in depression, PTSD, and borderline, as well in some CPTSD dimensions when analyzing baseline-follow-up deltas between groups. There was also a negative effect size of –0.28 in the CPTSD total. This intervention is effective in the treatment of depression, PTSD and borderline and is an important tool in the treatment of these disorders.

scholarly journals Artificial Intelligence Chatbot for Anxiety and Depression for University Students: a Pilot Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Maria Carolina Klos ◽  
Milagros Escoredo ◽  
Angie Joerin ◽  
Viviana Noemí Lemos ◽  
Michiel Rauws ◽  
...  
Keyword(s):  
Artificial Intelligence ◽  
College Students ◽  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
Anxiety Symptoms ◽  
Control Group ◽  
Depression And Anxiety ◽  
Randomized Controlled ◽  
Experimental Group

BACKGROUND The use of artificial intelligence based chatbots as an instrument of psychological intervention is emerging, however no studies have been reported in Latin America. OBJECTIVE This study aims to evaluate usage patterns and whether the use of a chatbot is effective for relieving depression and anxiety symptoms compared to a control group utilizing a psychoeducation book in Argentina. METHODS This was a randomized controlled trial study utilizing the chabot Tess throughout eight weeks. The initial sample consisted of 181 Argentinian college students ages 18 to 33, 87.2% female. Of those, 33 participants in the experimental condition and 30 in the control condition provided data on depressive symptoms at week eight, and 27 participants in the experimental condition and 23 in the control condition provided data on anxiety symptoms at week eight. Between and within group comparisons were analysed using Mann-Whitney U and Wilcoxon tests for depression symptoms, and Independent and Paired Samples t Tests to analyze anxiety symptoms. RESULTS There was no significant intergroup differences between the experimental group and the control group for depression and anxiety symptoms from baseline to week eight (P>.05). However, there were significant intragroup differences, where the experimental group showed a significant decrease in anxiety symptoms (P=.04) and no differences were observed for the control group (P=.33). No significant differences were found for depressive symptoms within the groups (P>.05). The effect size of the intervention was moderate for anxiety (d=.50) and small for depression (r=.09). In regards to participants engagement after eight weeks, there was an average of 472 exchanged messages (M=472.15; SD=249.52) and a higher number of messages exchanged with Tess was associated with positive feedback (F2,36=4.37; P=.02). CONCLUSIONS Students engaged a considerable amount of time exchanging messages with Tess and positive feedback was associated with higher numbers of messages exchanged. The initial results show promising evidence for the use of Tess for anxiety symptoms and a lower effect on depressive symptoms in Argentinian college students. Research on chatbots is still in its initial stages and further research is needed.

scholarly journals A randomized controlled trial of an internet-delivered treatment: Its potential as a low-intensity community intervention for adults with symptoms of depression

2016 ◽  
Vol 33 (S1) ◽  
pp. S112-S112
Author(s):  
D. Richards ◽  
L. Timulak ◽  
N. Vigano ◽  
E. O’Brien ◽  
G. Doherty ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Treatment Group ◽  
Primary Outcome ◽  
Community Intervention ◽  
Controlled Trial ◽  
Control Group ◽  
Behavioural Intervention ◽  
Symptoms Of Depression ◽  
Randomized Controlled

IntroductionInternet-delivered treatments for depression have proved successful, with supported programs offering the potential for improved adherence and outcomes. Internet interventions are particularly interesting in the context of increasing access to interventions, and delivering interventions population-wide.ObjectiveInvestigate the potential feasibility and effectiveness of an online intervention for depression in the community.AimsEstablish the effectiveness of a supported online delivered cognitive behavioural intervention for symptoms of depression in adults in the community.MethodsThe study was a randomized controlled trial of an 8-module internet-delivered cognitive behavioral therapy (iCBT) program for adults with depressive symptoms (n = 96) compared to a waiting-list control group (n = 92). Participants received weekly support from a trained supporter. The primary outcome was depressive symptoms as measured by the Beck Depression Inventory (BDI-II). The program was made available nationwide from an established and recognized charity for depression.ResultsFor the treatment group, post-treatment effect sizes reported were large for the primary outcome measure (d = 0.91). The between-group effects were moderate to large and statistically significant for the primary outcomes (d = 0.50) favoring the treatment group. Gains were maintained at 6-month follow-up.ConclusionThe study has demonstrated the efficacy of the online delivered space from depression treatment. Participants demonstrated reliable and statistically significant changes in symptoms from pre- to post-intervention. The study supports a model for delivering online depression interventions population-wide using trained supporters.Disclosure of interestThe authors have not supplied their declaration of competing interest.

scholarly journals Effect of physician prescribed information on hospital readmission and death after discharge among patients with health failure: A randomized controlled trial

2021 ◽  
Vol 27 (1) ◽  
pp. 146045822199640
Author(s):  
Faranak Kazemi Majd ◽  
Vahideh Zarea Gavgani ◽  
Ali Golmohammadi ◽  
Ali Jafari-Khounigh
Keyword(s):  
Randomized Controlled Trial ◽  
Hospital Readmission ◽  
Medical Information ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Long Term Follow Up ◽  
Oral Information

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.

scholarly journals Effectiveness of a psychological online training to promote physical activity among students: protocol of a randomized-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Lena Violetta Krämer ◽  
Nadine Eschrig ◽  
Lena Keinhorst ◽  
Luisa Schöchlin ◽  
Lisa Stephan ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Mixed Model ◽  
Controlled Trial ◽  
Control Group ◽  
Web Based ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Link Type

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

scholarly journals A randomized controlled trial on a self-guided Internet-based intervention for gambling problems

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Lara Bücker ◽  
Josefine Gehlenborg ◽  
Steffen Moritz ◽  
Stefan Westermann
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Group Differences ◽  
Control Group ◽  
Gambling Problems ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Internet Based Intervention

AbstractThe majority of individuals with problematic and pathological gambling remain untreated, and treatment barriers are high. Internet-based interventions can help to address existing barriers, and first studies suggest their potential for this target group. Within a randomized controlled trial (N = 150) with two assessment times (baseline and post-intervention), we aimed to investigate the feasibility, acceptance, and effectiveness of a self-guided Internet-based intervention targeted at gambling problems. We expected a significant reduction in gambling symptoms (primary outcome) and depressive symptoms as well gambling-specific dysfunctional thoughts (secondary outcomes) in the intervention group (IG) compared to a wait-list control group with access to treatment-as-usual (control group, CG) after the intervention period of 8 weeks. Results of the complete cases, per protocol, intention-to-treat (ITT), and frequent user analyses showed significant improvements in both groups for primary and secondary outcomes but no significant between-group differences (ITT primary outcome, F(1,147) = .11, p = .739, ηp2 < .001). Moderation analyses indicated that individuals in the IG with higher gambling and depressive symptoms, older age, and comorbid anxiety symptoms showed significant improvement relative to the CG. The intervention was positively evaluated (e.g., 96.5% rated the program as useful). Possible reasons for the nonsignificant between-group differences are discussed. Future studies should include follow-up assessments and larger samples to address limitations of the present study. Trial Registration ClinicalTrials.gov (NCT03372226), http://clinicaltrials.gov/ct2/show/NCT03372226, date of registration (13/12/2017).

scholarly journals Preventing depression in final year secondary students: School-based randomized controlled trial

2020 ◽  
Author(s):  
Y Perry ◽  
A Werner-Seidler ◽  
A Calear ◽  
A Mackinnon ◽  
C King ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Secondary Students ◽  
Controlled Trial ◽  
School Level ◽  
Control Group ◽  
Depression Symptoms ◽  
Randomized Controlled ◽  
Control Intervention ◽  
The Impact

Background: Depression often emerges for the first time during adolescence. There is accumulating evidence that universal depression prevention programs may have the capacity to reduce the impact of depression when delivered in the school environment. Objective: This trial investigated the effectiveness of SPARX-R, a gamified online cognitive behavior therapy intervention for the prevention of depression relative to an attention-matched control intervention delivered to students prior to facing a significant stressor-final secondary school exams. It was hypothesized that delivering a prevention intervention in advance of a stressor would reduce depressive symptoms relative to the control group. Methods: A cluster randomized controlled trial was conducted in 10 government schools in Sydney, Australia. Participants were 540 final year secondary students (mean 16.7 [SD 0.51] years), and clusters at the school level were randomly allocated to SPARX-R or the control intervention. Interventions were delivered weekly in 7 modules, each taking approximately 20 to 30 minutes to complete. The primary outcome was symptoms of depression as measured by the Major Depression Inventory. Intention-to-treat analyses were performed. Results: Compared to controls, participants in the SPARX-R condition (n=242) showed significantly reduced depression symptoms relative to the control (n=298) at post-intervention (Cohen d=0.29) and 6 months post-baseline (d=0.21) but not at 18 months post-baseline (d=0.33). Conclusions: This is the first trial to demonstrate a preventive effect on depressive symptoms prior to a significant and universal stressor in adolescents. It demonstrates that an online intervention delivered in advance of a stressful experience can reduce the impact of such an event on the potential development or exacerbation of depression.

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