scholarly journals An Internet-Based Self-Help Intervention for Skin Picking (SaveMySkin): Pilot Randomized Controlled Trial

10.2196/15011 ◽  
2019 ◽  
Vol 21 (9) ◽  
pp. e15011
Author(s):  
Christina Gallinat ◽  
Markus Moessner ◽  
Holger A Haenssle ◽  
Julia K Winkler ◽  
Matthias Backenstrass ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Willingness To Participate ◽  
Skin Picking ◽  
Randomized Controlled ◽  
Self Help ◽  
Secondary Outcomes ◽  
Skin Picking Disorder ◽  
Post Assessment

Background In spite of the psychosocial burden and medical risks associated with skin picking disorder, the health care system does not provide sufficient treatment for affected individuals to date. Therefore, an internet-based self-help program for skin picking was developed to offer easily accessible support for this population. Objective This pilot study evaluated the internet-based self-help program SaveMySkin. The 12-week program is based on cognitive-behavioral therapy and contains comprehensive information and exercises, a daily supportive monitoring system, and dermatological and psychological counseling via internet chat. Primary objectives were the investigation of attitudes and expectations toward the program, intervention effects on skin picking severity, user satisfaction, adherence, and willingness to participate. Secondary outcomes included the feasibility of study procedures, adequacy of assessment instruments, effects on skin picking–related impairment, dimensions of skin picking, and general psychological impairment. Methods A two-arm randomized controlled trial was conducted in a sample of 133 participants (female: 124/133, 93.2%; mean age 26.67 [SD 6.42]) recruited via the internet. Inclusion required a minimum age of 17 years and at least mild skin picking severity. Participants were randomly allocated to the intervention (64/133, 48.1%) or waitlist control group (69/133, 51.9%). All assessments were conducted online and based on self-report. Results The willingness to participate was very high in the study, so the initially planned sample size of 100 was exceeded after only 18 days. Participant expectations indicate that they believed the program to be beneficial for them (131/133, 98.5%) and provide a feeling of support (119/133, 89.5%). Reasons for study participation were insufficient outpatient health care (83/133, 62.4%) and flexibility regarding time (106/133, 79.7%) and location (109/133, 82.0%). The post-assessment was completed by 65.4% (87/133) of the sample. The majority of the intervention group who completed the entire post-assessment were satisfied with SaveMySkin (28/38, 74%) and agreed that the program is an appropriate support service (35/38, 92%). On average, participants viewed 29.31 (SD 42.02) pages in the program, and 47% (30/64) of the intervention group used the monitoring at least once a week. In comparison with the control group, the intervention group displayed substantial improvements in the skin picking severity total score (Cohen d=0.67) and especially on the subscale Symptom Severity (Cohen d=0.79). No effects on secondary outcomes were found. Conclusions This study confirms the need for easily accessible interventions for skin picking disorder and the high interest in internet-based self-help within the target population. It provides important insights into the attitudes toward online support and actual user experiences. Participant feedback will be used to further enhance the intervention. Our results point to the preliminary efficacy of SaveMySkin and may lay the foundation for future research into the efficacy and cost-effectiveness of the program in a multicenter clinical trial. Trial Registration German Clinical Trial Register DRKS00015236; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00015236 International Registered Report Identifier (IRRID) RR2-10.1016/j.conctc.2018.100315

scholarly journals An Internet-Based Self-Help Intervention for Skin Picking (SaveMySkin): Pilot Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Christina Gallinat ◽  
Markus Moessner ◽  
Holger A Haenssle ◽  
Julia K Winkler ◽  
Matthias Backenstrass ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Willingness To Participate ◽  
Skin Picking ◽  
Randomized Controlled ◽  
Self Help ◽  
Skin Picking Disorder ◽  
Post Assessment

BACKGROUND In spite of the psychosocial burden and medical risks associated with skin picking disorder, the health care system does not provide sufficient treatment for affected individuals to date. Therefore, an internet-based self-help program for skin picking was developed to offer easily accessible support for this population. OBJECTIVE This pilot study evaluated the internet-based self-help program SaveMySkin. The 12-week program is based on cognitive-behavioral therapy and contains comprehensive information and exercises, a daily supportive monitoring system, and dermatological and psychological counseling via internet chat. Primary objectives were the investigation of attitudes and expectations toward the program, intervention effects on skin picking severity, user satisfaction, adherence, and willingness to participate. Secondary outcomes included the feasibility of study procedures, adequacy of assessment instruments, effects on skin picking–related impairment, dimensions of skin picking, and general psychological impairment. METHODS A two-arm randomized controlled trial was conducted in a sample of 133 participants (female: 124/133, 93.2%; mean age 26.67 [SD 6.42]) recruited via the internet. Inclusion required a minimum age of 17 years and at least mild skin picking severity. Participants were randomly allocated to the intervention (64/133, 48.1%) or waitlist control group (69/133, 51.9%). All assessments were conducted online and based on self-report. RESULTS The willingness to participate was very high in the study, so the initially planned sample size of 100 was exceeded after only 18 days. Participant expectations indicate that they believed the program to be beneficial for them (131/133, 98.5%) and provide a feeling of support (119/133, 89.5%). Reasons for study participation were insufficient outpatient health care (83/133, 62.4%) and flexibility regarding time (106/133, 79.7%) and location (109/133, 82.0%). The post-assessment was completed by 65.4% (87/133) of the sample. The majority of the intervention group who completed the entire post-assessment were satisfied with SaveMySkin (28/38, 74%) and agreed that the program is an appropriate support service (35/38, 92%). On average, participants viewed 29.31 (SD 42.02) pages in the program, and 47% (30/64) of the intervention group used the monitoring at least once a week. In comparison with the control group, the intervention group displayed substantial improvements in the skin picking severity total score (Cohen <italic>d</italic>=0.67) and especially on the subscale Symptom Severity (Cohen <italic>d</italic>=0.79). No effects on secondary outcomes were found. CONCLUSIONS This study confirms the need for easily accessible interventions for skin picking disorder and the high interest in internet-based self-help within the target population. It provides important insights into the attitudes toward online support and actual user experiences. Participant feedback will be used to further enhance the intervention. Our results point to the preliminary efficacy of SaveMySkin and may lay the foundation for future research into the efficacy and cost-effectiveness of the program in a multicenter clinical trial. CLINICAL TRIAL German Clinical Trial Register DRKS00015236; https://www.ncbi.nlm.nih.gov/pubmed/31011654 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR2-10.1016/j.conctc.2018.100315

scholarly journals Culturally adapted trauma-focused CBT-based guided self-help (CatCBT GSH) for female victims of domestic violence in Pakistan: feasibility randomized controlled trial

2020 ◽  
pp. 1-12
Author(s):  
Madeeha Latif ◽  
M. Ishrat Husain ◽  
Mirrat Gul ◽  
Saiqa Naz ◽  
Muhammad Irfan ◽  
...  
Keyword(s):  
Domestic Violence ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Female Victims ◽  
Randomized Controlled ◽  
Self Help ◽  
Culturally Adapted ◽  
Cognitive Behaviour ◽  
Secondary Outcomes

Abstract Background: Cognitive behaviour therapy (CBT), self-help and guided self-help interventions have been found to be efficacious and cost effective for victims of trauma, but there are limited data from low- and middle-income countries on culturally adapted interventions for trauma. Aims: To investigate the feasibility and acceptability of culturally adapted trauma-focused CBT-based guided self-help (CatCBT GSH) for female victims of domestic violence in Pakistan. Method: This randomized controlled trial (RCT) recruited 50 participants from shelter homes in Karachi and randomized them to two equal groups. The intervention group received GSH in nine sessions over 12 weeks. The control group was a waitlist control. The primary outcomes were feasibility and acceptability. Secondary outcomes included Impact of Event Scale-Revised (IES-R), Hospital Anxiety and Depression Scale (HADS) and the WHO Disability Assessment Schedule 2 (WHO DAS 2). Assessments were carried out at baseline and at 12 weeks. Results: Out of 60 clients who met DSM-5 criteria for post-traumatic stress disorder (PTSD), 56 (93.3%) agreed to participate in the study. Retention to the intervention group was excellent, with 92% (23/25) attending more than six sessions. Statistically significant differences were noted post-intervention in secondary outcomes in favour of the intervention. Conclusions: A trial of CatCBT GSH was feasible and the intervention was acceptable to Pakistani women who had experienced domestic violence. Furthermore, it may be helpful in improving symptoms of PTSD, depression, anxiety and overall functioning in this population. The results provide a rationale for a larger, confirmatory RCT of CatCBT GSH.

scholarly journals Effectiveness of self-help workbook intervention on quality of life in cancer patients receiving chemotherapy: results of a randomized controlled trial

2020 ◽  
Author(s):  
Toshimi Takano ◽  
Ayako Matsuda ◽  
Noriko Ishizuka ◽  
Yukinori Ozaki ◽  
Koichi Suyama ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Randomized Controlled Trial ◽  
Cancer Patients ◽  
Emotional Functioning ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Randomized Controlled ◽  
Self Help

Abstract Background: A self-help workbook is expected to support cancer patients to cope with physical and psychosocial distress, to facilitate communication with medical staff, and to improve quality of life (QOL). We conducted a randomized controlled trial to evaluate the effectiveness of a self-help workbook intervention on QOL and survival. Methods: From June 2014 to March 2015, patients with breast, colorectal, gastric, and lung cancer receiving outpatient chemotherapy were randomized into an intervention group (n = 100) or control group (n = 100). Intervention group participants received workbooks originally made for this study, read advice on how to cope with distress, and filled out questionnaires on the workbooks periodically. EORTC QLQ-C30 was evaluated at baseline, at 12 weeks, and at 24 weeks. The primary endpoint was Global Health Status / QOL scale (GQOL). Results: No significant interaction was observed between the intervention and time in terms of GQOL or any of the functional scales. Among the 69 patients who continued cytotoxic chemotherapy at 24 weeks, the intervention was significantly associated with improved emotional functioning scores (P = 0.0007). Overall survival was not significantly different between the two groups. Conclusions: Self-help workbook intervention was feasible in cancer patients receiving chemotherapy. Although the effect of the intervention was limited, the intervention may improve emotional functioning among patients who receive long-term cytotoxic chemotherapy.Trial registration: UMIN Clinical Trials Registry, UMIN000012842. Registered 14 January 2014, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015002

Effect of Reactive Balance Training Involving Repeated Slips and Trips on Balance Recovery Among Older Adults: A Blinded Randomized Controlled Trial

2019 ◽  
Vol 74 (9) ◽  
pp. 1489-1496 ◽  
Author(s):  
Yoshiro Okubo ◽  
Daina L Sturnieks ◽  
Matthew A Brodie ◽  
Lionne Duran ◽  
Stephen R Lord
Keyword(s):  
Older Adults ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Balance Training ◽  
Control Group ◽  
Balance Recovery ◽  
Randomized Controlled ◽  
Post Assessment ◽  
Reactive Balance

Abstract Background This study examined whether reactive balance training (exposures to slips and trips) could improve balance recovery and reduce perturbation-induced falls among older adults. Methods Forty-four community-dwelling older adults participated in a parallel, blinded randomized controlled trial conducted in a research institute in Sydney, Australia in 2017–2018 (ACTRN12617000564358). The intervention group (n = 22) underwent three 40 minutes sessions (total 120 minutes) that exposed them to (1) 20 trips, (2) 20 slips, and (3) 10 trips and 10 slips in mixed order, over 2 days. The control group (n = 22) received one 40 minutes session of sham training. The primary outcome was falls (>30% body weight in harness) when exposed to trips and slips at post-assessment. Results At post-assessment, a total of 51 falls (23 and 27 falls from induced slips and trips, respectively) were recorded in the laboratory. Relative to the control group, the intervention group experienced fewer total falls (rate ratio [RR] = 0.40, 95% confidence interval [CI] = 0.22–0.76), slip falls (RR = 0.33, 95% CI = 0.12–0.90) and trip falls (RR = 0.49, 95% CI = 0.21–1.12). Eight participants reported adverse events (5 in the intervention group and 3 in the control group) which were related mainly to discomfort caused by a suboptimal harness used in the initial stages of the trial. Conclusions The reactive balance training reduced perturbation-induced falls by 60% indicating improved balance recovery from trips and slips. A comfortable safety harness system is essential to prevent discomfort. Reactive balance training may complement traditional exercise programs in fall prevention interventions.

scholarly journals Social Mobile Approaches to Reducing Weight (SMART) 2.0: protocol of a randomized controlled trial among young adults in university settings

Trials ◽  
2022 ◽  
Vol 23 (1) ◽  
Author(s):  
Shadia J. Mansour-Assi ◽  
Natalie M. Golaszewski ◽  
Victoria Lawhun Costello ◽  
David Wing ◽  
Hailey Persinger ◽  
...  
Keyword(s):  
Weight Loss ◽  
Young Adults ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Activity Tracker ◽  
Randomized Controlled ◽  
Wearable Activity Tracker ◽  
Secondary Outcomes ◽  
Weight Loss Interventions

Abstract Background Excess weight gain in young adulthood is associated with future weight gain and increased risk of chronic disease. Although multimodal, technology-based weight-loss interventions have the potential to promote weight loss among young adults, many interventions have limited personalization, and few have been deployed and evaluated for longer than a year. We aim to assess the effects of a highly personalized, 2-year intervention that uses popular mobile and social technologies to promote weight loss among young adults. Methods The Social Mobile Approaches to Reducing Weight (SMART) 2.0 Study is a 24-month parallel-group randomized controlled trial that will include 642 overweight or obese participants, aged 18–35 years, from universities and community colleges in San Diego, CA. All participants receive a wearable activity tracker, connected scale, and corresponding app. Participants randomized to one intervention group receive evidence-based information about weight loss and behavior change techniques via personalized daily text messaging (i.e., SMS/MMS), posts on social media platforms, and online groups. Participants in a second intervention group receive the aforementioned elements in addition to brief, technology-mediated health coaching. Participants in the control group receive a wearable activity tracker, connected scale, and corresponding app alone. The primary outcome is objectively measured weight in kilograms over 24 months. Secondary outcomes include anthropometric measurements; physiological measures; physical activity, diet, sleep, and psychosocial measures; and engagement with intervention modalities. Outcomes are assessed at baseline and 6, 12, 18, and 24 months. Differences between the randomized groups will be analyzed using a mixed model of repeated measures and will be based on the intent-to-treat principle. Discussion We hypothesize that both SMART 2.0 intervention groups will significantly improve weight loss compared to the control group, and the group receiving health coaching will experience the greatest improvement. We further hypothesize that differences in secondary outcomes will favor the intervention groups. There is a critical need to advance understanding of the effectiveness of multimodal, technology-based weight-loss interventions that have the potential for long-term effects and widespread dissemination among young adults. Our findings should inform the implementation of low-cost and scalable interventions for weight loss and risk-reducing health behaviors. Trial registration ClinicalTrials.govNCT03907462. Registered on April 9, 2019

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

10.2196/13655 ◽  
2019 ◽  
Vol 21 (10) ◽  
pp. e13655 ◽  
Author(s):  
Rüdiger Zwerenz ◽  
Carlotta Baumgarten ◽  
Jan Becker ◽  
Ana Tibubos ◽  
Martin Siepmann ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Inpatient Psychotherapy ◽  
Web Based ◽  
Randomized Controlled ◽  
Self Help ◽  
The Web

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.

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 ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Inpatient Psychotherapy ◽  
Web Based ◽  
Randomized Controlled ◽  
Self Help ◽  
The Web

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.

scholarly journals Hands-off: Feasibility and preliminary results of a two-armed randomized controlled trial of a web-based self-help tool to reduce problematic pornography use

2021 ◽  
Author(s):  
Beáta Bőthe ◽  
Christian Baumgartner ◽  
Michael P. Schaub ◽  
Zsolt Demetrovics ◽  
Gábor Orosz
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Report ◽  
Control Group ◽  
Linear Regression Models ◽  
Randomized Controlled ◽  
Self Help ◽  
Pornography Use

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.

scholarly journals Efficacy of a Six-Week-Long Therapist-Guided Online Therapy Versus Self-help Internet-Based Therapy for COVID-19–Induced Anxiety and Depression: Open-label, Pragmatic, Randomized Controlled Trial

10.2196/26683 ◽  
2021 ◽  
Vol 8 (2) ◽  
pp. e26683
Author(s):  
Mohammed Al-Alawi ◽  
Roopa K McCall ◽  
Alya Sultan ◽  
Naser Al Balushi ◽  
Tamadhir Al-Mahrouqi ◽  
...  
Keyword(s):  
Behavioral Therapy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Anxiety And Depression ◽  
Control Group ◽  
Online Therapy ◽  
Pragmatic Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Self Help ◽  
Acceptance And Commitment

Background The COVID-19 pandemic has led to a notable increase in psychological distress, globally. Oman is no exception to this, with several studies indicating high levels of anxiety and depression among the Omani public. There is a need for adaptive and effective interventions that aim to improve the elevated levels of psychological distress due to the COVID-19 pandemic. Objective This study aimed to comparatively assess the efficacy of therapist-guided online therapy with that of self-help, internet-based therapy focusing on COVID-19–induced symptoms of anxiety and depression among individuals living in Oman during the COVID-19 pandemic. Methods This was a 6-week-long pragmatic randomized controlled trial involving 60 participants who were recruited from a study sample surveyed for symptoms of anxiety or depression among the Omani public amid the COVID-19 pandemic. Participants in the intervention group were allocated to receive 1 online session per week for 6 weeks from certified psychotherapists in Oman; these sessions were conducted in Arabic or English. The psychotherapists utilized cognitive behavioral therapy and acceptance and commitment therapy interventions. Participants in the control group received an automatic weekly newsletter via email containing self-help information and tips to cope with distress associated with COVID-19. The information mainly consisted of behavioral tips revolving around the principles of cognitive behavioral therapy and acceptance and commitment therapy. The primary outcome was measured by comparing the change in the mean scores of Patient Health Questionnaire-9 (PHQ-9) and General Anxiety Disorder-7 (GAD-7) scale from the baseline to the end of the study (ie, after 6 sessions) between the two groups. The secondary outcome was to compare the proportions of participants with depression and anxiety between the two groups. Results Data from 46 participants were analyzed (intervention group n=22, control group n=24). There was no statistical difference in the baseline characteristics between both groups. Analysis of covariance indicated a significant reduction in the GAD-7 scores (F1,43=7.307; P=.01) between the two groups after adjusting for baseline scores. GAD-7 scores of participants in the intervention group were considerably more reduced than those of participants in the control group (β=−3.27; P=.01). Moreover, a greater reduction in mean PHQ-9 scores was observed among participants in the intervention group (F1,43=8.298; P=.006) than those in the control group (β=−4.311; P=.006). Although the levels of anxiety and depression reduced in both study groups, the reduction was higher in the intervention group (P=.049) than in the control group (P=.02). Conclusions This study provides preliminary evidence to support the efficacy of online therapy for improving the symptoms of anxiety and depression during the COVID-19 crisis in Oman. Therapist-guided online therapy was found to be superior to self-help, internet-based therapy; however, both therapies could be considered as viable options. Trial Registration ClinicalTrials.gov NCT04378257; https://clinicaltrials.gov/ct2/show/NCT04378257

Effectiveness of an Educational Intervention in Reducing New International Postgraduates’ Acculturative Stress in Malaysian Public Universities: Protocol for a Cluster Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Musheer Abdulwahid Al-Jaberi ◽  
Muhamad Hanafiah Juni ◽  
Hayati Kadir Shahar ◽  
Siti Irma Fadhilah Ismail ◽  
Murad Abdu Saeed ◽  
...  
Keyword(s):  
International Students ◽  
Acculturative Stress ◽  
Educational Program ◽  
Public Universities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Policy Makers ◽  
Randomized Controlled ◽  
Cluster Randomized

BACKGROUND Universities around the world, including Malaysia, have attracted many international students from different countries. Research has reported that acculturative stress resulting from international students’ attempts to adjust to the cultures of host countries is one of the most challenging issues that affects their lives in general and academic lives in particular. OBJECTIVE This study aims to examine the effectiveness of an educational intervention on acculturative stress among new postgraduate international students joining Malaysian public universities. METHODS A cluster randomized controlled trial design with Malaysian public universities as the unit of randomization will be used in this study. Public universities will be randomized in a 1:1 ratio to be either in the intervention (educational program) or control group (waiting list). Participants in the intervention group will receive 7 sessions in 9 hours delivered by an expert in psychology and the researcher. The control group will receive the intervention once the 3-month follow-up evaluation is completed. RESULTS The data will be analyzed using the generalized estimation equation with a confidence interval value of 95%; significant differences between and within groups are determined as <i>P</i>&lt;.05. The results of the study underlie the effectiveness of educational program in decreasing acculturative stress of new international students and enabling them to cope with a new environment. The results of this study will contribute to previous knowledge of acculturative stress, acculturation, and adjustment of international students. Furthermore, such results are expected to play a role in raising university policy makers’ awareness of their postgraduate international students’ acculturative stress issues and how they can help them avoid such stress and perform well in their academic life. CONCLUSIONS We expect that the intervention group will score significantly lower than the wait-list group on the immediate and 3-month postintervention evaluation of acculturative stress and achieve a higher level of adjustment. Results will have implications for international students, policy makers at universities, the Malaysian Ministry of Higher Education, and future research. CLINICALTRIAL Clinical Trials Registry India CTRI/2018/01/011223; http://ctri.nic.in/Clinicaltrials/showallp.php?mid1= 21978&amp;amp;EncHid=&amp;amp;userName=Muhamad%20Hanafiah%20Juni INTERNATIONAL REGISTERED REPORT PRR1-10.2196/12950

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