Dataset Information

Efficacy of a guided internet-based intervention (iSOMA) for somatic symptoms and related distress in university students: study protocol of a randomised controlled trial.

ABSTRACT:

Introduction

Persistent and distressing somatic symptoms are common in younger age cohorts such as university students. However, the majority does not receive adequate psychosocial care. Internet-based and mobile-based interventions may represent low threshold and effective extensions to reduce somatic and associated mental symptom severity. The planned study aims to investigate the feasibility and efficacy of an internet-based intervention in reducing somatic and psychological symptoms in an international population of university students with somatic symptom burden.

Methods and analysis

This parallel two-armed randomised controlled trial evaluates an 8-week guided intervention, including web-based consecutive modules based on cognitive behavioural therapy (CBT) principles against a waitlist control group. Guidance will be provided by trained psychologists with weekly written supportive feedback. As part of the 'Studicare' project, the present study aims to recruit n=154?university students indicating somatic symptom burden at baseline in German-speaking universities. Self-report assessments will take place at baseline and after intervention completion (8, 16 weeks after randomisation). The primary outcome will be the severity of somatic symptoms and associated mental distress. Secondary outcomes include depression, (health) anxiety, disability, intervention satisfaction and adherence.

Ethics and dissemination

Ethics approval has been granted. Results from this study will be published in peer-reviewed journals and presented at international conferences.

Trial registration number

DRKS00014375; Pre-results.

SUBMITTER: Hennemann S

PROVIDER: S-EPMC6318514 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Publications

Efficacy of a guided internet-based intervention (iSOMA) for somatic symptoms and related distress in university students: study protocol of a randomised controlled trial.

Hennemann Severin S Böhme Katja K Baumeister Harald H Bendig Eileen E Kleinstäuber Maria M Ebert David Daniel DD Witthöft Michael M

BMJ open 20181231 12

<h4>Introduction</h4>Persistent and distressing somatic symptoms are common in younger age cohorts such as university students. However, the majority does not receive adequate psychosocial care. Internet-based and mobile-based interventions may represent low threshold and effective extensions to reduce somatic and associated mental symptom severity. The planned study aims to investigate the feasibility and efficacy of an internet-based intervention in reducing somatic and psychological symptoms ...[more]

PMID: 30598489

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Project description:BackgroundPsychological distress is prevalent among university students. However, the availability of evidence-based mental health treatment remains limited in many low- and middle-income countries, including Indonesia. Internet-delivered, mindfulness-based interventions that reduce distress have potential for treating university student distress at scale. Unfortunately, evidence-based, internet-delivered mindfulness treatments are not yet available in Indonesia. Cultural adaptation of established evidence-based, internet-delivered mindfulness interventions is needed.ObjectiveIn this paper, we describe the process of culturally adapting an Australian internet-delivered mindfulness program (Introduction to Mindfulness) to be relevant and appropriate for treating Indonesian university students' psychological distress.MethodsTo assist the cultural adaptation process, we used a systematic cultural adaptation framework and a mixed methods approach combining quantitative and qualitative methods. In study 1 (information gathering), we administered an internet-delivered questionnaire to Indonesian university students (n=248) to examine their preferences regarding an internet-delivered mindfulness intervention. In study 2 (preliminary design), a draft program was developed and independently reviewed by Indonesian stakeholders. Stakeholders (n=25) included local Indonesian mindfulness and mental health professionals (n=6) and university students (n=19), who were selected to maximize sample representativeness regarding personal and professional characteristics. To evaluate the initial design and cultural congruence of the internet-delivered mindfulness program in the Indonesian context, we conducted interviews and focus groups with stakeholders. Stakeholders also completed the Cultural Relevance Questionnaire.ResultsIn study 1, most Indonesian university students (240/248, 96.8%) reported openness to an internet-delivered mindfulness program. Most of interested students (127/240, 52.9%) preferred the length of the program to be 3 to 4 sessions, with 45.8% (110/240) preferring brief lessons taking only 15 to 30 minutes to complete. They (194/240, 80.8%) recommended that the program be accessible both through websites and mobile phones. In study 2, Indonesian stakeholders generally found the internet-delivered program to be highly culturally appropriate in terms of language, concepts, context, treatment goals, and depictions of students' emotional and behavioral experiences. However, stakeholders also recommended some specific adaptations regarding the program's delivery model (eg, combining visual and audio modalities when delivering psychoeducation), cultural components (eg, including more social and spiritual activities), program practicality (eg, including rewards to promote engagement), and design elements (eg, including additional culturally relevant illustrations). Following stakeholder feedback, a new culturally adapted Indonesian internet-delivered mindfulness program called Program Intervensi Mindfulness Daring Mahasiswa Indonesia was created.ConclusionsThis study highlights the process and importance of cultural adaptation of an evidence-based mindfulness treatment and demonstrates how this may be achieved for internet-delivered psychotherapy programs. We found that a culturally adapted internet-delivered mindfulness program was relevant for Indonesian students with some adjustments to the programs' content and delivery. Future research is now needed to evaluate the clinical benefit of this program.

Project description:Procrastination is a widespread problem that is highly prevalent among the young adult population and is associated with several negative consequences. However, current evidence on the effectiveness of e-health interventions for procrastination either lack a comparison to an inactive control, do not include a student population or are of poor quality. This protocol describes the design of a trial that will overcome these limitations and examine the effectiveness of a guided internet-based intervention (GetStarted) to reduce problematic procrastinating behaviors in college students compared to a waitlist control. This study will be a two-armed randomized controlled trial with a calculated sample size of N = 176. Participants will be students from seven universities in the Netherlands. The intervention group will receive a four-week e-coach-guided intervention for procrastination. The waitlist control group will get access to treatment four weeks after randomization. Assessments will take place at baseline, post-test (4 weeks post-baseline) and follow-up (6 months post-baseline). Data will be analyzed with an intent-to-treat principle. The primary outcome is change in procrastination behaviors measured on the Irrational Procrastination scale (IPS). Secondary outcomes are depression, anxiety, stress, and quality of life. Additionally, sociodemographic characteristics of the participants, satisfaction with treatment, program usability, satisfaction with e-coach and treatment adherence will be examined as potential moderators. The results from this study can build evidence for the effectiveness of a guided internet-based intervention for treating procrastination in college students. Should it be effective, GetStarted could provide a flexible, low-intense and cost-effective treatment for procrastination and prevent common mental health problems in college students.Trial registrationThis trial is registered at ClinicalTrials.gov Protocol Registration and Results System (Trial number: NCT05478096).

Project description:BackgroundUniversity students are at high risk of various mental health problems due to high levels of psychological distress. However, university counseling services are often inadequate to meet their mental health needs due to shortage of mental health professionals, especially in Hong Kong. Internet-based cognitive behavioral therapy (iCBT) has shown similar effects as those of face-to-face CBT in addressing these mental health concerns, but few iCBT programs have been developed for Hong Kong university students.ObjectiveThis study protocol aims to develop and evaluate a culturally and linguistically appropriate iCBT program called "REST Online" to reduce the psychological distress and improve the mental health of Chinese university students in Hong Kong in a randomized controlled trial (RCT).MethodThe contents and functionality of the "REST Online" program which includes both web- and app-based versions, are described. A blended mode of service delivery is adopted, with 8 online modules and 2 counseling sessions. Therapist support will be provided by a CBT therapist. A total of 338 Chinese university students with mild to moderate levels of psychological distress will be openly recruited and randomized to three groups: the (1) web-based and (2) app-based "REST Online" groups, and (3) waitlist control group. The program effectiveness is evaluated in psychological distress, depression and anxiety symptoms, and positive and negative emotions and positive and negative thoughts at pre-, post- and 3-month follow-up tests. Linear mixed effect models will be conducted for data analysis.DiscussionThe "REST Online" program is among the first of its kind to address the mental health needs of Hong Kong university students by an internet intervention. Theoretically, this study will provide some empirical evidence for the effectiveness of this iCBT program in the Hong Kong context for Chinese clients. Practically, if proven effective, this program can be provided to local university counselors as an option for service delivery. Strengths and limitations are also discussed.

Project description:ObjectiveIncreasing numbers of young people attending university has raised concerns about the capacity of student mental health services to support them. We conducted a randomised controlled trial (RCT) to explore whether provision of an 8 week mindfulness course adapted for university students (Mindfulness Skills for Students-MSS), compared with university mental health support as usual (SAU), reduced psychological distress during the examination period. Here, we conduct an economic evaluation of MSS+SAU compared with SAU.Design and settingEconomic evaluation conducted alongside a pragmatic, parallel, single-blinded RCT comparing provision of MSS+SAU to SAU.Participants616 university students randomised.Primary and secondary outcome measuresThe primary economic evaluation assessed the cost per quality-adjusted life year (QALY) gained from the perspective of the university counselling service. Costs relate to staff time required to deliver counselling service offerings. QALYs were derived from the Clinical Outcomes in Routine Evaluation Dimension 6 Dimension (CORE-6D) preference based tool, which uses responses to six items of the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM; primary clinical outcome measure). Primary follow-up duration was 5 and 7 months for the two recruitment cohorts.ResultsIt was estimated to cost £1584 (2022 prices) to deliver an MSS course to 30 students, £52.82 per student. Both costs (adjusted mean difference: £48, 95% CI £40-£56) and QALYs (adjusted mean difference: 0.014, 95% CI 0.008 to 0.021) were significantly higher in the MSS arm compared with SAU. The incremental cost-effectiveness ratio (ICER) was £3355, with a very high (99.99%) probability of being cost-effective at a willingness-to-pay threshold of £20 000 per QALY.ConclusionsMSS leads to significantly improved outcomes at a moderate additional cost. The ICER of £3355 per QALY suggests that MSS is cost-effective when compared with the UK's National Institute for Health and Care Excellence thresholds of £20 000 per QALY.Trial registration numberAustralian and New Zealand Clinical Trials Registry, ACTRN12615001160527.

Project description:Depression is highly prevalent among university students. Internet-based interventions have been found to be effective in addressing depressive symptoms, but it is open if this also applies to interventions directed at academic stress. It is also largely unclear if the techniques employed in such programs provide significant additional benefits when controlling for non-specific intervention effects. A sample of N = 200 students with elevated levels of depression (CES-D ? 16) of a large distance-learning university were randomly assigned to either an Internet- and App-based stress intervention group (IG; n = 100) or an active control group (CG; n = 100) receiving an Internet-based psychoeducational program of equal length. Self-report data was assessed at baseline, post-treatment (7 weeks) and three-month follow-up. The primary outcome was depression (CES-D) post-treatment. Secondary outcomes included mental health outcomes, modifiable risk factors, and academic outcomes. We found significant between-group effects on depressive symptom severity (d = 0.36; 95% CI: 0.08-0.64), as well as behavioral activation (d = 0.61; 95% CI: 0.30-0.91), perceived stress (d = 0.45; 95% CI: 0.18-0.73), anxiety (d = 0.35; 95% CI: 0.03-0.67) and other secondary outcomes post-treatment. Effects on depression were sustained at three-month follow-up. Response rates for depressive symptoms were significantly higher in the IG (26%) than the CG (14%) at post-test (? 2=4.5, p = 0.04), but not at three-month follow-up (p = 0.454). We also found significant effects on relevant academic outcomes, including work impairment (follow-up; d = 0.36), work output (post-treatment; d = 0.27) and work cutback (follow-up; d = 0.36). The intervention was more effective for depressive symptoms compared to the CG, and so controlling for unspecific intervention effects. This suggests that specific techniques of the intervention may provide significant additional benefits on depressive symptoms. Trial registration: German Clinical Trial Registration (DRKS): DRKS00011800 (https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00011800).

Project description:ObjectiveThe etiology of somatization is incompletely understood, but could be elucidated by models of psychosocial stress. Academic exam stress has effectively been applied as a naturalistic stress model, however its effect on somatization symptoms according to ICD-10 and DSM-IV criteria has not been reported so far. Baseline associations between somatization and personality traits, such as alexithymia, have been studied exhaustively. Nevertheless, it is largely unknown if personality traits have an explanatory value for stress induced somatization.MethodsThis longitudinal, quasi-experimental study assessed the effects of university exams on somatization - and the reversal of effects after an exam-free period. Repeated-observations were obtained within 150 students, measuring symptom intensity before, during and after an exam period, according to the Screening for Somatoform Symptoms 7-day (SOMS-7d). Additionally, self-reports on health status were used to differentiate between medically explained and medically unexplained symptoms. Alexithymia, neuroticism, trait-anxiety and baseline depression were surveyed using the Toronto-Alexithymia Scale (TAS-20), the Big-Five Personality Interview (NEO-FFI), the State Trait Anxiety Inventory (STAI) and Beck's Depression Inventory (BDI-II). These traits were competitively tested for their ability to explain somatization increases under exam stress.ResultsSomatization significantly increased across a wide range of symptoms under exam stress, while health reports pointed towards a reduction in acute infections and injuries. Neuroticism, alexithymia, trait anxiety and depression explained variance in somatization at baseline, but only neuroticism was associated with symptom increases under exam stress.ConclusionExam stress is an effective psychosocial stress model inducing somatization. A comprehensive quantitative description of bodily symptoms under exam stress is supplied. The results do not support the stress-alexithymia hypothesis, but favor neuroticism as a personality trait of importance for somatization.

Project description:Introduction:Academic education is often associated with increased stress and adverse effects on mental health. Internet-based interventions have shown to be effective in reducing stress-related symptoms. However, college students as target group so far have not been reached appropriately with psychological interventions and little is known about college students' perception of Internet-based stress management interventions. The objective of this study was to explore the experiences of students participating in an Internet- and App-based stress management intervention originally developed for stressed employees and subsequently adapted and tailored to college students. Method:Semi-structured interviews were conducted with ten participants selected from a randomized controlled trial that evaluated the effectiveness of an Internet- and App-based stress training. The selection of participants aimed to include students with different levels of treatment success. In order to enable an in-depth examination of intervention elements causing dissatisfaction, the interviews were systematically adapted regarding participants' statements in a precedent questionnaire. The interview material was analyzed based on the grounded theory method and thematic analysis. Results:Results suggest students perceive a necessity to adapt Internet-based interventions to their particular needs. Students' statements indicate that a scientific perspective on the intervention and instable life circumstances could be student-specific factors affecting treatment experience. General themes emerging from the data were attitudes towards individualization and authenticity as well as demands towards different functions of feedback. Discussion:Participants' experiences hint at certain intellectual and lifestyle-related characteristics of this population. Future studies should explore whether adaptions to these characteristics lead to a higher acceptance, adherence and effectiveness in the target population.

Dataset Information

Efficacy of a guided internet-based intervention (iSOMA) for somatic symptoms and related distress in university students: study protocol of a randomised controlled trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Efficacy of a guided internet-based intervention (iSOMA) for somatic symptoms and related distress in university students: study protocol of a randomised controlled trial.

Similar Datasets

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