scholarly journals Effectiveness of a Web- and Mobile-Guided Psychological Intervention for Depressive Symptoms in Turkey: Protocol for a Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Burçin Ünlü Ince ◽  
Didem Gökçay ◽  
Heleen Riper ◽  
Pim Cuijpers
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
Mobile App ◽  
Direct Access ◽  
Control Group ◽  
Clinical Effects ◽  
Randomized Controlled ◽  
Experimental Group ◽  
The Web

BACKGROUND In Turkey, there are serious deficiencies in mental health care. Although depression is highly prevalent, only a small number of people seek professional help. Innovative solutions are needed to overcome this treatment gap. Web-based problem-solving therapy (PST) is an intervention proven to be effective in the treatment of depression, although little is known about its clinical effects in Turkey. OBJECTIVE This study aims to test the clinical effects of a Web and mobile app of an adapted PST for depressive symptoms among the general population in Turkey. METHODS Participants will be recruited through announcements in social media and the Middle East Technical University. Adults (18-55 years) with mild to moderate depressive symptoms (Beck Depression Inventory-II [BDI-II] score between 10-29) will be included in the study. Participants with a medium-to-high suicidal risk (according to the Mini-International Neuropsychiatric Interview) will be excluded. A 3-armed randomized controlled trial with a waiting control group will be utilized. A sample size of 444 participants will be randomized across 3 groups. The first experimental group will receive direct access to the Web version of the intervention; the second experimental group will receive direct access to the mobile app of the intervention as well as automated supportive short message service text messages based on PST. The control group consists of a wait-list and will gain access to the intervention 4 months after the baseline. The intervention is based on an existing PST for the Turkish population, Her Şey Kontrol Altında (HŞKA), consisting of 5 modules each with a duration of 1 week and is guided by a clinical psychologist. The primary outcome is change in depressive symptoms measured by the BDI-II. Secondary outcomes include symptoms of anxiety, stress, worry, self-efficacy, and quality of life. Furthermore, satisfaction with, usability and acceptability of the intervention are important features that will be evaluated. All outcomes will take place online through self-assessment at posttest (6-8 weeks after baseline) and at follow-up (4 months after baseline). RESULTS We will recruit a total of 444 participants with mild to moderate depressive symptoms from March 2018 to February 2019 or until the recruitment is complete. We expect the final trial results to be available by the end of May 2019. This trial is funded by the Scientific and Technological Research Council of Turkey (National Postdoctoral Research Fellowship Programme 2016/1). CONCLUSIONS Results from this study will reveal more information about the clinical effects of HŞKA as well as its applicability in a Turkish setting through the Web and mobile platforms. On the basis of the results, a guided Web- and mobile-based PST intervention might become an appropriate alternative for treating mild to moderate depressive symptoms. CLINICALTRIAL ClinicalTrials.gov NCT03754829; https://clinicaltrials.gov/ct2/show/NCT03754829 (Archived by WebCite at http://www.webcitation.org/74HugwLo7). INTERNATIONAL REGISTERED REPOR DERR1-10.2196/13239

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 Usefulness of Abdominal Massage and ST-36 (Zusanli) Acupressure in Improving The Appetite of COVID-19 Patients Treated in a Makeshift Hospital: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Lei Wang ◽  
Jifang Peng ◽  
Hairong Liu ◽  
Yan Jia ◽  
Cui Yao ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Mobile App ◽  
Older Age ◽  
Control Group ◽  
Clinical Trial Registry ◽  
Poor Appetite ◽  
Randomized Controlled ◽  
Abdominal Massage ◽  
Experimental Group

Abstract Objectives: To investigate the appetite of COVID-19 patients treated in a makeshift hospital and to evaluate the effectiveness of abdominal massage and ST-36 (Zusanli) acupressure in improving their appetite.Design: Randomized controlled trial.Methods: This study was performed between February 15 and March 2, 2020, in a sports centre makeshift hospital in Wuhan, China. The appetite of 110 COVID-19 patients was assessed using a mobile app-based Simplified Nutritional Appetite Questionnaire (SNAQ). The experimental and control groups, 55 patients each, were randomized using a prepared randomization checklist. Through video guidance and on-the-spot instruction, patients in the experimental group mastered the methods of abdominal massage and ST-36 (Zusanli) acupressure and implemented the intervention for 7 days by themselves. The appetite of the patients was assessed again after intervention.Results: In a total of 110 participants, 43 (39.1%) patients suffered from a poor appetite. A positive correlation between poor appetite and older age as well as fever was observed (p<0.05). In the experimental group, the SNAQ scores were significantly increased (14.07±2.46 vs 15.55±1.77, p=0.0004), and the proportion of patients with a poor appetite was markedly reduced after the intervention (41.8% vs 10.9%, p=0.0002). Compared with the control group, the rate of poor appetite in the experimental group was significantly decreased postintervention (27.3% vs 10.9%, p=0.029).Conclusion: In COVID-19 patients, a poor appetite may be correlated with older age and fever. Abdominal massage and ST-36 (Zusanli) acupressure are applicable and effective in improving the appetite of COVID-19 patients during isolation treatment.Trial registration: Chinese clinical trial registry (ChiCTR2000033261), the trial was registered retrospectively.

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.

Cluster Symptoms Reduction via Telephone-Based Intervention in Thai Breast Cancer Patients Undergoing 4-Cycle Adjuvant Chemotherapy: A Randomized-Controlled Trial

2021 ◽  
Vol 104 (6) ◽  
pp. 887-894
Keyword(s):  
Breast Cancer ◽  
Randomized Controlled Trial ◽  
Adjuvant Chemotherapy ◽  
Energy Conservation ◽  
Cancer Patients ◽  
Controlled Trial ◽  
Control Group ◽  
Breast Cancer Patients ◽  
Randomized Controlled ◽  
Experimental Group

Background: Cluster symptoms are a common occurrence in breast cancer patients undergoing chemotherapy. The telephone is a well-recognized, convenient device for reaching out to patients for monitoring and managing their symptoms in an efficient, prompt, and appropriate manner. Objective: To investigate the efficacy of telephone-based intervention to achieve energy conservation among breast cancer patients with the aim of alleviating fatigue, pain, sleep disturbance, and depression. Materials and Methods: The present study was a two-armed, randomized control trial conducted in the university hospital between March and September 2019. Seventy-four breast cancer patients, receiving four courses of adjuvant chemotherapy, were randomly recruited and assigned into the experimental group and the control group. One face-to-face intervention interview for energy conservation was conducted, followed by 20-minutes telephone brief counselling and assessment sessions, scheduled on day 1, 2, 7, and 14. Results: The scores for symptoms of median fatigue and pain in the experimental group were shown to be significantly reduced at the end of the study as compared to those scores within the control group (p<0.05). Similarly, scores for median sleep time and depression were greater at the end of cycle 1 and highest in cycle 2 (p<0.05, 0.001, respectively). Physical activity levels were also higher in the experimental group than in the control group in every cycle, with a statistical significance (p<0.001). Conclusion: The present study intervention demonstrated an effectiveness for the reduction of cluster symptoms. Further studies would be needed in a larger population scale in the customary, randomized controlled trial manner. Keywords: Cancer; Energy conservation; Fatigue; Pain; Sleep; Telephone

Testing the Effectiveness of a Strengths-Based Intervention Targeting All 24 Strengths: Results From a Randomized Controlled Trial

2020 ◽  
pp. 003329412093744
Author(s):  
Lobna Chérif ◽  
Valerie M. Wood ◽  
Christian Watier
Keyword(s):  
Randomized Controlled Trial ◽  
Character Strengths ◽  
Controlled Trial ◽  
Control Group ◽  
Strength Development ◽  
Character Strength ◽  
Significant Group ◽  
Randomized Controlled ◽  
Time Interaction ◽  
Experimental Group

This study assessed the effectiveness of a strengths-based randomized controlled trial focused on fostering all 24 character strengths in a group of 75 participants from a University in Tunisia. Participants randomly assigned to the challenge condition (n = 40) received an email each day for 24 days, that highlighted a particular strength of the day including why the strength is valuable, how to implement the strength behaviourally, and a motto related to that strength. Those in the control condition (n = 35) simply received emails containing the motto for each strength daily for 24 days. We assessed all participants’ levels of happiness before the experiment (T0), the day following the experiment (T1), and one-month following the experiment (T2). Results from a 2 (group) X 3 (time) split plot ANOVA revealed a significant group-by-time interaction, such that at T2 the experimental group had greater happiness scores than the control group. These findings provide some evidence that even “minimalist” interventions (involving the receipt of emails encouraging character-strength development), might be effective for promoting gains in happiness even one month after the intervention.

Acceptance and commitment therapy for the treatment of depression in persons with physical disability: a randomized controlled trial

2020 ◽  
Vol 34 (7) ◽  
pp. 938-947 ◽  
Author(s):  
Mehdi Zemestani ◽  
Sharmin Mozaffari
Keyword(s):  
Emotion Regulation ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
Psychological Flexibility ◽  
Well Being ◽  
Control Group ◽  
Psychological Well Being ◽  
Randomized Controlled ◽  
Acceptance And Commitment ◽  
Experimental Group

Objective: To evaluate the effectiveness of acceptance and commitment therapy (ACT) on depressive symptoms in physically disabled persons. Design: Randomized controlled trial. Setting: State welfare organization in Kamyaran, Kurdistan, Iran. Participants: Fifty-two physically disabled participants with a primary diagnosis of depression were randomly assigned to either ACT or control groups. Interventions: Participants in the ACT group ( n = 23) received eight weekly 90-minute group sessions based on standard ACT protocol for depression. Participants in the control group ( n = 29) received psychoeducation regarding depression. Main measures: Measures were recorded at baseline, eight weeks (end of treatment), and 16 weeks (follow-up). The outcomes were the change in the depressive symptoms, measured by Beck Depression Inventory-II (BDI-II), psychological flexibility, emotion regulation, and psychological well-being measured by Acceptance and Action Questionnaire-II (AAQ-II), Emotion Regulation Questionnaire (ERQ), and Scales of Psychological Well-Being (SPWB), respectively. Results: After eight weeks, significant changes in depressive symptoms was observed in the experimental group (ACT –10.39 ± 0.79 vs control 0.66 ± 0.68, P < 0.001). Compared to the control group, the experimental group also showed significant improvement in psychological flexibility (ACT 8.13 ± 0.52 vs control –0.03 ± 0.51, P < 0.001), adaptive emotion regulation strategies (ACT 10.74 ± 0.62 vs control 0.03 ± 1.03, P < 0.001), and psychological well-being (ACT 66.95 ± 4.01 vs control –1.90 ± 1.04, P < 0.001). Conclusion: Compared with control group, ACT significantly reduced the participants’ depression, and changed psychological flexibility, emotion regulation, and psychological well-being in persons with physical disability.

scholarly journals Effects of Monopolar Dielectric Radiofrequency Signals on the Symptoms of Fibromyalgia: A Single-Blind Randomized Controlled Trial

2020 ◽  
Vol 17 (7) ◽  
pp. 2465
Author(s):  
Alfonso Javier Ibáñez-Vera ◽  
Jerónimo Carmelo García-Romero ◽  
José Ramón Alvero-Cruz ◽  
Rafael Lomas-Vega
Keyword(s):  
Randomized Controlled Trial ◽  
Usual Care ◽  
Sham Group ◽  
Controlled Trial ◽  
Depression Scale ◽  
Physical Factor ◽  
Control Group ◽  
Local Pain ◽  
Randomized Controlled ◽  
Experimental Group

Monopolar dielectric radiofrequency (MDR) is a non-invasive treatment for pain based on the local application of electromagnetic signals. The study’s goal was to analyze the effects of MDR on the symptoms of fibromyalgia. For this aim, a randomized controlled trial was conducted on 66 female participants (aged 47 ± 17.7) diagnosed with fibromyalgia. Participants were randomly allocated to either an experimental group (n = 23), which received eight 20-minute sessions of MDR; a sham group, which received the same number of sessions of a sham MDR therapy (n = 22); or a control group (n = 21), which received usual care. The outcome variables included pain measured by the visual analogue scale (VAS), score on the hospital anxiety and depression scale (HADS) and quality of life measured by the combined index of fibromyalgia severity (ICAF). A large effect size was observed for the local pain (R2 = 0.46), total ICAF (R2 = 0.42) and ICAF physical factor scores (R2 = 0.38). Significant mean differences were found for the local pain (p = 0.025) and ICAF physical factor (p = 0.031) scores of the experimental group in comparison with the sham group. No statistically significant differences between groups were found in HADS. In conclusion, MDR is more effective than either sham treatment or usual care in the short-term improvement of pain and the physical wellbeing of participants with fibromyalgia.

scholarly journals Effectiveness of Hydrogalvanic Bath on Improving Pain, Disability, and Quality of Life in Individuals with Chronic Nonspecific Neck Pain: A Randomized Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-7
Author(s):  
Mastour Saeed Alshahrani ◽  
Jaya Shanker Tedla ◽  
Ravi Shankar Reddy ◽  
Faisal Asiri
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Pain Disability ◽  
Sf 36 ◽  
Neck Disability ◽  
Experimental Group

Background. Neck pain is one of the world’s leading factors in years lived with disability. Ambiguity in the effect of electrotherapy modalities for the treatment of chronic nonspecific neck pains (CNSNP) needs to be examined further. This study sought to elucidate the effectiveness of hydrogalvanic bath on improving pain, disability, and quality of life among individuals with CNSNP. Methods. Thirty-four individuals with a diagnosis of CNSNP were selected through convenient sampling and randomly divided into two groups by block randomization. The control group treatment underwent low Transcutaneous Electrical Nerve Stimulation (TENS) and exercise, and the experimental group was subjected to hydrogalvanic bath therapy (HGBT) and exercise. Individuals were evaluated for pain using a visual analog scale (VAS), disability with the Neck Disability Index (NDI), and quality of life with Short Form-36 (SF-36). These measures were applied at baseline and after 12 weeks of treatment. Results. The pretreatment and posttreatment results for VAS, NDI, and SF-36 were compared for both control and experimental groups. We found that all the three variables showed significant differences between the two time points with p < 0.05 in both the groups but the experimental group improvements were more significant than the control group with p < 0.05 . Conclusion. Twelve weeks of low TENS or HGBT along with exercises can decrease pain and neck disability and increase the quality of life in individuals with CNSNP. However, HGBT along with exercise has superior effects relative to low TENS along with exercise. This randomized controlled trial was registered in the International Standard Randomized Controlled Trials Number-ISRCTN29695190 and registered on 05/02/2020. This study is a retrospective registration.

scholarly journals Effects of an Interactive Computer Game Exercise Regimen on Balance Impairment in Frail Community-Dwelling Older Adults: A Randomized Controlled Trial

2011 ◽  
Vol 91 (10) ◽  
pp. 1449-1462 ◽  
Author(s):  
Tony Szturm ◽  
Aimee L. Betker ◽  
Zahra Moussavi ◽  
Ankur Desai ◽  
Valerie Goodman
Keyword(s):  
Randomized Controlled Trial ◽  
Video Game ◽  
Dynamic Balance ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Control Group ◽  
Day Hospital ◽  
Randomized Controlled ◽  
Balance Exercises ◽  
Experimental Group

Background Due to the many problems associated with reduced balance and mobility, providing an effective and engaging rehabilitation regimen is essential to progress recovery from impairments and to help prevent further degradation of motor skills. Objectives The purpose of this study was to examine the feasibility and benefits of physical therapy based on a task-oriented approach delivered via an engaging, interactive video game paradigm. The intervention focused on performing targeted dynamic tasks, which included reactive balance controls and environmental interaction. Design This study was a randomized controlled trial. Setting The study was conducted in a geriatric day hospital. Participants Thirty community-dwelling and ambulatory older adults attending the day hospital for treatment of balance and mobility limitations participated in the study. Interventions Participants were randomly assigned to either a control group or an experimental group. The control group received the typical rehabilitation program consisting of strengthening and balance exercises provided at the day hospital. The experimental group received a program of dynamic balance exercises coupled with video game play, using a center-of-pressure position signal as the computer mouse. The tasks were performed while standing on a fixed floor surface, with progression to a compliant sponge pad. Each group received 16 sessions, scheduled 2 per week, with each session lasting 45 minutes. Measurements Data for the following measures were obtained before and after treatment: Berg Balance Scale, Timed “Up & Go” Test, Activities-specific Balance Confidence Scale, modified Clinical Test of Sensory Interaction and Balance, and spatiotemporal gait variables assessed in an instrumented carpet system test. Results Findings demonstrated significant improvements in posttreatment balance performance scores for both groups, and change scores were significantly greater in the experimental group compared with the control group. No significant treatment effect was observed in either group for the Timed “Up & Go” Test or spatiotemporal gait variables. Limitations The sample size was small, and there were group differences at baseline in some performance measures. Conclusion Dynamic balance exercises on fixed and compliant sponge surfaces were feasibly coupled to interactive game-based exercise. This coupling, in turn, resulted in a greater improvement in dynamic standing balance control compared with the typical exercise program. However, there was no transfer of effect to gait function.

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