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The Self-help Online against Suicidal thoughts (SOS) trial: study protocol for a randomized controlled trial.

ABSTRACT: Suicidal thoughts are common, causing distress for millions of people all over the world. However, people with suicidal thoughts might not access support due to financial restraints, stigma or a lack of available treatment offers. Self-help programs provided online could overcome these barriers, and previous efforts show promising results in terms of reducing suicidal thoughts. This study aims to examine the effectiveness of an online self-help intervention in reducing suicidal thoughts among people at risk of suicide. The Danish Self-help Online against Suicidal thoughts (SOS) trial is a partial replication of a previously conducted Dutch trial.A randomized, waiting-list controlled trial with 1:1 allocation ratio will be carried out. A total of 438 people with suicidal thoughts will be recruited from the Danish suicide hotline, The Lifeline's, website and allocated to the intervention condition (N?=?219) or the control condition (N?=?219). The intervention condition consists of a 6-week, Internet-based self-help therapy intervention. The format of the intervention is self-help, but the participants can be guided by the trial manager. The control condition consists of a waiting-list assignment for 32 weeks. The primary outcomes are frequency and intensity of suicidal thoughts. Secondary outcome measures include depressive symptoms, hopelessness, worrying, quality of life, costs related to health care utilization and production loss. Number of deliberate self-harm episodes, suicides and deaths will, as well as the participant's evaluation of the intervention and the experience of negative effects, be investigated. Assessments will be conducted over the intervention website through self-report questionnaires at baseline, 2 weeks, 4 weeks, 6 weeks and 32 weeks (6 months post intervention).If we find the intervention to be linked to reductions in suicidal thoughts, this will strengthen the evidence that online self-help interventions are relevant tools for people with suicidal thoughts.ClinicalTrials.gov, NCT02872610 . Registered on 9 August 2016.

SUBMITTER: Muhlmann C

PROVIDER: S-EPMC5273797 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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The Self-help Online against Suicidal thoughts (SOS) trial: study protocol for a randomized controlled trial.

Mühlmann Charlotte C Madsen Trine T Hjorthøj Carsten C Kerkhof Ad A Nordentoft Merete M Erlangsen Annette A

Trials 20170128 1

<h4>Background</h4>Suicidal thoughts are common, causing distress for millions of people all over the world. However, people with suicidal thoughts might not access support due to financial restraints, stigma or a lack of available treatment offers. Self-help programs provided online could overcome these barriers, and previous efforts show promising results in terms of reducing suicidal thoughts. This study aims to examine the effectiveness of an online self-help intervention in reducing suicida ...[more]

PMID: 28129783

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Project description:BackgroundNon-suicidal self-injury (NSSI) is a clinically significant behavior affecting approximately 18% of adolescents and young adults worldwide. The importance of NSSI is supported by its association with a broad spectrum of mental disorders. Despite its high relevance, evidence-based, specific, time-, and cost-effective treatment approaches are scarce. Cognitive behavioral therapy (CBT) seems effective in reducing the frequency of NSSI in adolescents and young adults. However, young people are often reluctant to seek professional help and effective interventions adressing NSSI are not sufficiently available across all regions of Germany. Research indicates that the majority of youth with risk behavior (including NSSI) prefer technology-based interventions. To date, effective interventions for adolescents and young adults with NSSI that are deliverd online are not available.MethodsThe present project aims to develop and evaluate an online intervention for adolescents and young adults with NSSI based on the content of a recently evaluated face-to-face short-term program that includes elements of CBT and dialectical behavior therapy (DBT): "The Cutting Down Programme" (CDP). The efficacy of the new online CDP intervention will be tested in a randomized controlled trial (RCT) in which n = 700 youths engaging in repetitive NSSI will participate in either an online psychoeducation (n = 350) or online CDP (n = 350). Within a postline assessment four months after baseline (end of treatment; T1), and follow-up evaluations 12 and 18 months after baseline (follow-ups; T2 and T3), NSSI and comorbid symptoms as well as quality of life will be assessed. It is hypothesized that participants receiving online CDP report a greater reduction in the frequency of NSSI within the last three months at T2 (primary endpoint) compared to those receiving online psychoeducation. Exploratory analyses will focus on predictors of treatment outcome.DiscussionWe report on the development and evaluation of an online intervention for adolescents and young adults engaging in NSSI based on the CDP. If supported by empirical evidence, an online-based intervention for NSSI might help to overcome the limited availability of adequate interventions for youth.Trial registrationGerman Clinical Trials Register, DRKS00014623 . Registered on 22 May 2018.

Project description:BackgroundAviophobia (the fear of flying) can greatly impact the daily life functioning of people with the condition. Traditional exposure-based treatment is hampered by the limited availability of airplane practice situations, which is a result of economical and practical concerns. Easily accessible and low-cost virtual reality exposure therapy may address these challenges.ObjectiveThe purpose of our study is to investigate the effectiveness of ZeroPhobia: Aviophobia (a self-help mobile app-based treatment) in reducing flight anxiety symptoms and depressive and anxiety symptoms. We will also investigate the effects of usage intensity, the sense of immersion, inherent absorption ability, and perceived user-friendliness on the treatment effect.MethodsParticipants (N=114) who are aged 18-64 years and experience at least mild symptoms of aviophobia will be recruited from the general Dutch population and randomized into a treatment group or waitlist control group. By using their own phones and rudimentary mobile virtual reality headsets, participants will receive six modules of psychoeducation and cognitive behavioral therapy, which will include six levels of virtual reality exposure therapy over a period of 6 weeks. Assessments will be conducted at baseline, posttest (ie, after 6 weeks), and 3- and 12-month follow-ups. The primary outcome measure of our study is the Flight Anxiety Situations Questionnaire. The secondary outcome measures include anxiety and depression measures and additional covariates (including usage intensity, the degree of immersion, etc). We will test treatment effectiveness by conducting an intention-to-treat analysis and estimating average treatment effects on the treated. The mechanisms of treatment effect will also be explored.ResultsThe study was funded on September 25, 2018. Ethical approval was received on October 11, 2019. Recruitment closed on May 7, 2020.ConclusionsOur study will further the scientific understanding and clinical implications of technology's current ability to aid in providing effective, accessible treatment for the fear of flying.Trial registrationNetherlands Trial Registry NL70238.029.19; https://www.trialregister.nl/trial/8257.International registered report identifier (irrid)DERR1-10.2196/22008.

Project description:BACKGROUND:Despite an initial steep decrease in alcohol misuse among Estonians through structural intervention means and the scaling up of alcohol counselling in the mid-2000's, most of the country's alcohol misuse indicators remain clearly higher than European averages. Consequently, an online self-help program was launched as part of an initial behavioral intervention initiative to foster progress in alcohol prevention on a population level. METHODS:A two-arm randomized controlled trial (RCT) has been designed to compare the efficacy of a culturally-adapted minimal-guidance online self-help program, the 8-week "Selge" online program against a control condition that consists of a self-administered test of alcohol use and advice regarding usual treatment in Estonia. A target sample of 600 individuals will be recruited and randomly assigned to either condition. The program will contain 10 modules based on principles of cognitive behavioural therapy (CBT) and motivational interviewing (MI). Participants in the control group will have access to the full treatment after they complete their final follow-up assessment. The primary outcome will be change in the Alcohol Use Disorders Identification Test (AUDIT) score between the 6-month follow-up and baseline assessments. Secondary outcomes will include the number of standard drinks consumed and alcohol-free days, drinking motives and motivation for change, as well as changes in mental health. Assessments will be completed at baseline, at the end of treatment, and at 6 months follow-up. Data analysis will follow the intention-to-treat principle and employ (generalised) linear mixed models. DISCUSSION:The "Selge" program is the first and only internet program for the intervention of alcohol misuse in Estonia. If proven effective, it will foster progress in the intervention of alcohol misuse in the Estonian population and be implemented as a standard program amidst the continuum of intervention and care. TRIAL REGISTRATION:Current Controlled Trials ISRCTN48753339 registered 04/06/2019 retrospectively.

Project description:BackgroundSocial anxiety symptoms are highly prevalent among adolescents and are associated with poor quality of life and low psychosocial functioning. If untreated, social anxiety often persists into adulthood and increases the risk for comorbid disorders. Therefore, early interventions for social anxiety to prevent negative long-term consequences are critical. However, adolescents rarely seek help and often avoid face-to-face psychotherapeutic interventions due to the perceived lack of autonomy and anonymity. Thus, online interventions represent a promising opportunity to reach adolescents who have social anxiety but do not seek help yet.ObjectiveThis study aims to evaluate the efficacy, moderators, and mediators of an online intervention developed to reduce social anxiety in adolescents.MethodsA total of 222 adolescents aged 11-17 years with subclinical social anxiety (N=166) or with a diagnosis of social anxiety disorder (N=56) are randomly assigned to the online intervention or a care-as-usual control group. The 8-week guided online intervention is based on the Cognitive Model of Social Phobia and evidence-based online interventions for social anxiety adapted to the specific needs of adolescents. The care-as-usual group will be given access to the online intervention after the follow-up assessment. Participants are assessed at baseline, at 4 and 8 weeks post intervention, and at 3-month follow-up assessment on the primary outcome, that is, social anxiety, on secondary outcomes (eg, level of functioning, fear and avoidance, general anxiety, depression, quality of life, self-esteem, and negative effects of the intervention), on potential moderators (eg, therapy motivation, therapy expectancy, and satisfaction with the intervention), and potential mediators (eg, therapeutic alliance and adherence to the intervention). Data will be analyzed based on an intention-to-treat approach and both groups (intervention and care-as-usual) will be compared at each assessment time point. Furthermore, potential mechanisms of change and generalization of intervention effects on daily life are assessed using an ecological momentary assessment procedure that includes items on maintaining mechanisms of social anxiety, social context, and affect. Participants are prompted 3 times a day during the first 8 weeks of the study and again for 2 weeks following the follow-up assessment.ResultsRecruitment is ongoing; initial results are expected in 2024.ConclusionsResults are discussed considering the potential of online interventions as a low-threshold prevention and treatment option for adolescents with social anxiety and in light of current advances in dynamic modeling of change processes and mechanisms in early intervention and psychotherapy in adolescents.Trial registrationClinicalTrials.gov NCT04782102; https://clinicaltrials.gov/ct2/show/NCT04782102.International registered report identifier (irrid)DERR1-10.2196/44346.

Project description:BackgroundAlcohol misuse and emotional problems (ie, depression and anxiety) are highly comorbid among Canadian young adults. However, there is a lack of integrated, accessible, and evidence-based treatment options for these young adults.ObjectiveThe main goal of this study is to develop and test the efficacy of an integrated, online self-help program designed to target both alcohol misuse and emotional problems.MethodsA two-arm randomized controlled trial design will be used to compare the efficacy of the online integrated treatment to a psychoeducational control group. A target sample of 214 participants will be recruited and randomly assigned to either condition. The integrated treatment will last 8 weeks, and participants will work through 12 modules. Modules will incorporate content based on principles of cognitive behavioral therapy and motivational interviewing. Participants in the control group will receive links to psychoeducational resources and will have access to the full treatment after follow-up. The primary outcome will be the number of Canadian standard drinks consumed in the week leading up the assessment. Secondary outcomes of interest include symptoms of depression, anxiety, alcohol-related problems, quality of life, and use of other drugs. Assessments will be completed at 3 time-points: at baseline, at the end of treatment (ie, 8 weeks), and at follow-up (ie, 24 weeks). Upon completion, data will be analyzed using generalized linear mixed models.ResultsData collection began in June 2018 and will continue until January 2020. Final study results will be submitted for publication by July 2020.ConclusionsCurrently, there are no integrated treatments designed to target alcohol misuse and the range of emotional problems experienced by young adults. This research stands to provide an effective, accessible (ie, Web-based), and feasible option to treat the many struggling young adults in this country.Trial registrationClinicalTrials.gov ID NCT03406039; https://clinicaltrials.gov/ct2/show/NCT03406039 (Archived by WebCite at http://www.webcitation.org/72fDefnrh).Registered report identifierPRR1-10.2196/11298.

Dataset Information

The Self-help Online against Suicidal thoughts (SOS) trial: study protocol for a randomized controlled trial.

Publications

The Self-help Online against Suicidal thoughts (SOS) trial: study protocol for a randomized controlled trial.

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