Internet- And Mobile-based Interventions Research Articles

Efficacy of an Internet- and Mobile-Based Intervention for Subclinical Anxiety and Depression (ICare Prevent) with Two Guidance Formats: Results from a Three-Armed Randomized Controlled Trial

Introduction: Limited research exists on intervention efficacy for comorbid subclinical anxiety and depressive disorders, despite their common co-occurrence. Internet- and mobile-based interventions (IMIs) are promising to reach individuals facing subclinical symptoms. Objective: This study aimed to evaluate the efficacy of a transdiagnostic and self-tailored IMI in reducing subclinical anxiety and depressive symptom severity with either individualized (IG-IMI) or automated (AG-IMI) guidance compared to a waitlist control group with care-as-usual access (WLC). Methods: Participants included 566 adults with subclinical anxiety (GAD-7 ≥ 5) and/or depressive (CES-D ≥16) symptoms, who did not meet criteria for a full-syndrome depressive or anxiety disorder. In a three-arm randomized clinical trial, participants were randomized to a cognitive behavioral 7-session IMI plus booster session with IG-IMI (n = 186) or AG-IMI (n = 189) or WLC (n = 191). Primary outcomes included observer-rated anxiety (HAM-A) and depressive (QIDS) symptom severity 8 weeks after randomization assessed by blinded raters via telephone. Follow-up outcomes at 6 and 12 months are reported. Results: Symptom severity was significantly lower with small to medium effects in IG-IMI (anxiety: d = 0.45, depression: d = 0.43) and AG-IMI (anxiety: d = 0.31, depression: d = 0.32) compared to WLC. No significant differences emerged between guidance formats in primary outcomes. There was a significant effect in HAM-A after 6 months favoring AG-IMI. On average, participants completed 85.38% of IG-IMI and 77.38% of AG-IMI. Conclusions: A transdiagnostic, self-tailored IMI can reduce subclinical anxiety and depressive symptom severity, but 12-month long-term effects were absent. Automated guidance holds promise for enhancing the scalability of IMIs in broad prevention initiatives.

Internet- and mobile-based anxiety and depression interventions for children and adolescents: efficacy and negative effects - a systematic review and meta-analysis.

Mental disorders, most commonly anxiety disorders and fourth most common depression, are prevalent in children and adolescents. Internet- and mobile-based interventions might represent a scalable approach to improve mental health care, however, evidence so far is inconclusive and systematic reports on negative effects are missing. Four data-bases were searched for randomized controlled trials evaluating internet- and mobile-based interventions (IMIs) targeting anxiety disorders or depression in children and adolescents up to 18 years exhibiting clinically relevant symptoms. Meta-analytic evaluations were conducted in comparison to active and passive control groups, furthermore, pre-defined sub-groups were explored and reported negative effects examined. Pooled estimates showed a moderate positive effect for IMIs targeting anxiety disorders compared to passive control groups (g = -0.69; CI -0.94 to -0.45; k = 8; n = 559; p ≤ 0,001), but not for depression. Pooled estimates compared to active control groups remained non-significant. Subgroup analyses were largely omitted due to an insufficient number of trials or were non-significant. Negative effects were mainly reported as drop-out rates and (non)-response rates, while additional negative effects, such as deterioration rates or the development of additional symptoms, were reported by only one third of included studies. The focus on children and adolescents with clinically relevant symptoms allowed the present findings to complement previous work, however, the limited amount of trials hindered many planned comparisons. The overview of reported negative effects highlighted that negative effects are being neglected in the majority of RCTs. Hence, in the future RCTs should include more information about potential negative effects, at best a combination of quantitative and qualitative information. Open Science Framework (osf.io/ch5nj).

What to do when the unwanted happens? Negative event management in studies on internet- and mobile-based interventions for youths and adults with two case reports

BackgroundDespite severely burdened individuals, often being excluded from research studies on internet- and mobile-based interventions (IMIs), negative events (NEs) including suicidal thoughts and behaviors (STBs) can still occur during a trial. NEs require monitoring and adequate safety measures. However, study protocols frequently lack comprehensive descriptions of procedures for managing NEs. AimsThis study aimed to illustrate the assessment, monitoring, and procedures for addressing NEs in two studies on IMIs in adults and youth using case reports, to identify strengths and weaknesses of the NE management approaches, and to derive key learnings and recommendations. MethodsTwo case reports were drawn from two distinct IMI studies. The first study, PSYCHOnlineTHERAPY, evaluates the combination of an IMI with on-site psychotherapy for anxiety and depressive disorders in adults (adult blended study). The second study evaluates a standalone, therapist-guided IMI for post-traumatic stress disorder (PTSD) in youth (youth standalone study). Potential NEs were predefined depending on the study sample. The case studies thoroughly document the systematic recording and ongoing monitoring of NEs through self-report and observer-based assessments during the interventions. The cases illustrate a variety of NE management strategies, including automated and personalized approaches, adapted to the specific nature and severity of the NEs. The NE management approaches are visualized using decision trees. ResultsIn the adult blended case study, online questionnaires detected STBs and triggered automated support information. As on-site therapy had already ended, a telephone consultation session allowed for the identification and discussion of the heightened intensity of suicidal thoughts, along with the development of specific additional help options. In the youth standalone case study, heightened tension in an adolescent with PTSD during trauma processing could be addressed in a telephone therapeutic session focusing on resource activation and emotion regulation. The referral to on-site treatment was supported. Overall, advantages of the NE management included automated procedures, multimodal assessment of a wide range of NEs, and standardized procedures tailored to different severity levels. Weaknesses included the use of single-item assessments for STBs and lack of procedures in case of deterioration or nonresponse to treatment. ConclusionThis study provides practical insights and derives key learnings and recommendations regarding the management of NEs in different IMI contexts for both adults and youth.

Mind-body internet and mobile-based interventions for depression and anxiety in adults with chronic physical conditions: A systematic review of RCTs.

This review summarizes the effectiveness of scalable mind-body internet and mobile-based interventions (IMIs) on depression and anxiety symptoms in adults living with chronic physical conditions. Six databases (MEDLINE, PsycINFO, SCOPUS, EMBASE, CINAHL, and CENTRAL) were searched for randomized controlled trials published from database inception to March 2023. Mind-body IMIs included cognitive behavioral therapy, breathwork, meditation, mindfulness, yoga or Tai-chi. To focus on interventions with a greater potential for scale, the intervention delivery needed to be online with no or limited facilitation by study personnel. The primary outcome was mean change scores for anxiety and depression (Hedges' g). In subgroup analyses, random-effects models were used to calculate pooled effect size estimates based on personnel support level, intervention techniques, chronic physical condition, and survey type. Meta-regression was conducted on age and intervention length. Fifty-six studies met inclusion criteria (sample size 7691, mean age of participants 43 years, 58% female): 30% (n = 17) neurological conditions, 12% (n = 7) cardiovascular conditions, 11% cancer (n = 6), 43% other chronic physical conditions (n = 24), and 4% (n = 2) multiple chronic conditions. Mind-body IMIs demonstrated statistically significant pooled reductions in depression (SMD = -0.33 [-0.40, -0.26], p<0.001) and anxiety (SMD = -0.26 [-0.36, -0.17], p<0.001). Heterogeneity was moderate. Scalable mind-body IMIs hold promise as interventions for managing anxiety and depression symptoms in adults with chronic physical conditions without differences seen with age or intervention length. While modest, the effect sizes are comparable to those seen with pharmacological therapy. The field would benefit from detailed reporting of participant demographics including those related to technological proficiency, as well as further evaluation of non-CBT interventions. Registration: The study is registered with PROSPERO ID #CRD42022375606.

Long-Term Outcomes and Cost-Effectiveness of an Internet-Based Self-Help Intervention for Social Anxiety Disorder in University Students: Results of a Randomized Controlled Trial

Social anxiety disorder (SAD) is widespread among university students and is associated with high costs for the society. While unguided internet- and mobile-based interventions (IMIs) may have short-term effects in reducing SAD symptoms, evidence for their long-term efficacy and cost-effectiveness is still limited. The aim of this study is to examine the 6-month outcomes of an IMI for university students with SAD. Participants were recruited via mass mails sent to enrolled students and included if they were at least 18 years old, met the diagnostic criteria of SAD in a structured clinical interview for DSM-IV axis I disorders (SCID-I), and provided written informed consent. In a prospective study designed as a two-armed randomized-controlled trial, 200 students (mean age 26.7 years) diagnosed with SAD were randomly assigned to an IMI or a waitlist control (WLC) condition. The IMI consisted of nine weekly sessions based on the cognitive-behavioral treatment model for social phobia by Clark and Wells. The primary outcome was SAD symptom severity assessed via the Social Phobia Scale (SPS) and the Social Interaction Anxiety Scale (SIAS). A health economic evaluation from a societal and healthcare perspective examined the costs related to the symptom-free status and quality-adjusted life years (QALYs) gained. Statistically significant differences in SAD symptom severity previously found at posttreatment favoring the IMI were maintained at a 6-month follow-up [SIAS (Cohen’s d = 0.59 ; 95% CI, 0.30, 0.87) and SPS (Cohen’s d = 0.83 ; 95% CI, 0.54, 1.1)]. From a societal perspective, at a willingness to pay (WTP) of €0, the intervention was found to have a 92% and 93% probability of cost-effectiveness compared with the WLC per symptom-free status and QALY gained, respectively. From a healthcare perspective, the likelihood of cost-effectiveness of the intervention was 97% per symptom-free status at a WTP of €1000 (US$1326) and 96% per QALY gained at a WTP of €6000 (US$7956). This IMI is effective in treating university students with SAD and has an acceptable likelihood of cost-effectiveness compared with WLC from a societal perspective. This intervention can be integrated into university healthcare to reach students with SAD as it is scalable, shows a high probability of cost-effectiveness, and overcomes known treatment barriers. This trial is registered with DRKS00011424.

Case report for an internet- and mobile-based intervention for internet use disorder.

Internet use disorder (IUD), characterized as the inability to control one's internet use, is associated with reduced quality of life and mental health comorbidities such as depression, substance abuse, or anxiety. Evidence-based treatment options are scarce due to the novelty of the diagnosis. Internet- and mobile-based interventions (IMI) may be an effective means to deliver psychological treatment to individuals with IUD as they address affected individuals in their online setting. This study presents a newly developed IMI for IUD disclosing treatment satisfaction and preliminary effects by exemplifying with a case report. The case of a female participant with IUD, characterized by an excessive use of social media, is analyzed. The case report follows the CARE guidelines and presents qualitative and quantitative outcomes regarding potential symptom reduction measured by the Internet Addiction Test (IAT) and Compulsive Internet Use Scale (CIUS), treatment satisfaction measured by the Client Satisfaction Questionnaire (CSQ) and feasibility by analyzing participant's written feedback during treatment. The case report shows that internet- and mobile-based interventions may be feasible in supporting an individual in reducing symptoms of IUD as well as depressive symptoms, anxiety and procrastination behavior. Treatment satisfaction was reported as good. This case report illustrates that IMIs can have the potential to be an easily accessible and possibly effective treatment option for IUD. Case studies on IMIs may provide insights into important mechanisms for symptom change. Further studies are needed to expand our understanding of this diverse disorder to provide adequate treatment. https://clinicaltrials.gov/,DRKS00015314.

An Online Mindfulness Intervention for International Students: A Randomized Controlled Feasibility Trial.

Student mobility across borders poses challenges to health systems at the university and country levels. International students suffer from stress more than their local peers, however, do not seek help or underutilize existing help offers. Some barriers to help-seeking among international students are insufficient information regarding the health offers, stigma, and language, which might be overcome via culturally adapted internet and mobile-based interventions (IMI). A randomized controlled feasibility trial with a parallel design assessed the feasibility and potential efficacy of an online mindfulness intervention adapted for international university students. Participants were randomized into either an adapted online mindfulness intervention (StudiCareM-E) (IG, n = 20) or a waitlist control group (WL, n = 20). Participants were assessed at baseline (t0) and eight-week post-randomization (t1). The feasibility of StudiCareM-E was evaluated regarding intervention adherence, client satisfaction, and potential negative effects. The potential efficacy of StudiCareM-E was measured by means of the level of mindfulness, perceived stress, depression, anxiety, presenteeism, and wellbeing. Efficacy outcomes were evaluated with regression models on the intention-to-treat (ITT) sample (n = 40), adjusting for the baseline values. Participants' formative feedback suggested improvements in the content of the IMI. There were no crucial negative effects compared to WL. Assessment dropout was 35% (IG: 50%: WL: 20%), and intervention dropout was 60%. StudiCareM-E yielded significant improvements in mindfulness (β = .34), well-being (β = .37), and anxiety (β = -.42) compared to WL. StudiCareM-E might be used among culturally diverse international student populations to improve their well-being. Future studies might carefully inspect the extent of the adaptation needs of their target group and design their interventions accordingly.

Moderators and mediators of change of an internet-based mindfulness intervention for college students: secondary analysis from a randomized controlled trial.

Existing evidence suggests internet- and mobile-based interventions (IMIs) improve depressive symptoms in college students effectively. However, there is far less knowledge about the potential mechanisms of change of mindfulness-based IMIs, which could contribute to optimizing target groups and interventions. Hence, within this secondary analysis of data from a randomized controlled trial (RCT), potential moderators and mediators of the effectiveness of the IMI StudiCare Mindfulness were investigated. Moderation and mediation analyses were based on secondary data from a RCT that examined the effectiveness of the 7-module IMI StudiCare Mindfulness in a sample of college students (intervention group: n = 217; waitlist control group: n = 127). Assessments were collected before (t0; baseline), 4 weeks after (t1; during intervention), and 8 weeks after (t2; post-intervention) randomization. Longitudinal mediation analyses using structural equation modeling were employed, with depressive symptom severity as the dependent variable. For moderation analyses, bilinear interaction models were calculated with depressive symptom severity and mindfulness at t2 as dependent variables. All data-analyses were performed on an intention-to-treat basis. Mediation analyses showed a significant, full mediation of the intervention effect on depressive symptom severity through mindfulness (indirect effect, a*b = 0.153, p < 0.01). Only the number of semesters (interaction: β = 0.24, p = 0.035) was found to moderate the intervention's effectiveness on depressive symptom severity at t2, and only baseline mindfulness (interaction: β = -0.20, p = 0.047) and baseline self-efficacy (interaction: β = -0.27, p = 0.012) were found to be significant moderators of the intervention effect on mindfulness at t2. Our results suggest a mediating role of mindfulness. Moderation analyses demonstrated that the intervention improved depressive symptom severity and mindfulness independent of most examined baseline characteristics. Future confirmatory trials will need to support these findings. The trial was registered a priori at the WHO International Clinical Trials Registry Platform via the German Clinical Studies Trial Register (TRN: DRKS00014774; registration date: 18 May 2018).

Systematic review of economic evaluations for internet- and mobile-based interventions for mental health problems

In view of the staggering disease and economic burden of mental disorders, internet and mobile-based interventions (IMIs) targeting mental disorders have often been touted to be cost-effective; however, available evidence is inconclusive and outdated. This review aimed to provide an overview of the cost-effectiveness of IMIs for mental disorders and symptoms. A systematic search was conducted for trial-based economic evaluations published before 10th May 2021. Electronic databases (including MEDLINE, PsycINFO, CENTRAL, PSYNDEX, and NHS Economic Evaluations Database) were searched for randomized controlled trials examining IMIs targeting mental disorders and symptoms and conducting a full health economic evaluation. Methodological quality and risk of bias were assessed. Cost-effectiveness was assumed at or below £30,000 per quality-adjusted life year gained. Of the 4044 studies, 36 economic evaluations were reviewed. Guided IMIs were likely to be cost-effective in depression and anxiety. The quality of most evaluations was good, albeit with some risks of bias. Heterogeneity across studies was high because of factors such as different costing methods, design, comparison groups, and outcomes used. IMIs for anxiety and depression have potential to be cost-effective. However, more research is needed into unguided (preventive) IMIs with active control conditions (e.g., treatment as usual) and longer time horizon across a wider range of disorders.Trial registration: PROSPERO Registration No. CRD42018093808.

Unveiling mechanisms of change in digital interventions for depression: Study protocol for a systematic review and individual participant data meta-analysis.

IntroductionThe efficacy and effectiveness of digital interventions for depression are both well-established. However, precise effect size estimates for mediators transmitting the effects of digital interventions are not available; and integrative insights on the specific mechanisms of change in internet- and mobile-based interventions (IMIs)—as related to key features like delivery type, accompanying support and theoretical foundation—are largely pending.ObjectiveWe will conduct a systematic review and individual participant data meta-analysis (IPD-MA) evaluating the mediators associated with therapeutic change in various IMIs for depression in adults.MethodsWe will use three electronic databases (i.e., Embase, Medline/PubMed, PsycINFO) as well as an already established database of IPD to identify relevant published and unpublished studies. We will include (1) randomized controlled trials that examine (2) mediators of (3) guided and unguided (4) IMIs with (5) various theoretical orientations for (6) adults with (7) clinically relevant symptoms of depression (8) compared to an active or passive control condition (9) with depression symptom severity as primary outcome. Study selection, data extraction, as well as quality and risk of bias (RoB) assessment will be done independently by two reviewers. Corresponding authors of eligible primary studies will be invited to share their IPD for this meta-analytic study. In a 1-stage IPD-MA, mediation analyses (e.g., on potential mediators like self-efficacy, emotion regulation or problem solving) will be performed using a multilevel structural equation modeling approach within a random-effects framework. Indirect effects will be estimated, with multiple imputation for missing data; the overall model fit will be evaluated and statistical heterogeneity will be assessed. Furthermore, we will investigate if indirect effects are moderated by different variables on participant- (e.g., age, sex/gender, symptom severity), study- (e.g., quality, studies evaluating the temporal ordering of changes in mediators and outcomes), and intervention-level (e.g., theoretical foundation, delivery type, guidance).DiscussionThis systematic review and IPD-MA will generate comprehensive information on the differential strength of mediators and associated therapeutic processes in digital interventions for depression. The findings might contribute to the empirically-informed advancement of psychotherapeutic interventions, leading to more effective interventions and improved treatment outcomes in digital mental health. Besides, with our novel approach to mediation analyses with IPD-MA, we might also add to a methodological progression of evidence-synthesis in psychotherapy process research.Study registration with Open Science Framework (OSF)https://osf.io/md7pq/.

Effectiveness, Acceptability, and Mechanisms of Change of the Internet-Based Intervention StudiCare Mindfulness for College Students: a Randomized Controlled Trial

ObjectivesCollege is an exhilarating but stressful time often associated with mental distress. The StudiCare project offers Internet- and mobile-based interventions (IMI) for college student mental health promotion. Within this framework, we evaluated the IMI StudiCare Mindfulness, and examined potential moderators and mediators of effectiveness.MethodsIn this randomized controlled trial, 150 college students with low to moderate mindfulness were randomly assigned to StudiCare Mindfulness or a waitlist control group (WL). StudiCare Mindfulness comprises 5 weekly online modules based on Acceptance Commitment Therapy and stress management. Assessments took place before (t0) and 6 weeks after (t1) randomization. Primary outcome was mindfulness. Secondary outcomes were stress, depression, anxiety, quality of life, intervention satisfaction, and adherence. Sociodemographic variables, pre-intervention symptomatology, personality traits, and attitudes towards IMI were examined as potential moderators.ResultsIntention-to-treat analyses (N = 149) showed a large effect of StudiCare Mindfulness on mindfulness (d = 1.37; 95% CI: 1.01–1.73) compared to WL at t1 (β = 1.18; 95% CI: 0.96–1.40). Effects on secondary outcomes were significant in favor of the intervention group except for physical quality of life. Mindfulness was found to mediate intervention effectiveness on depression, anxiety, and stress. Moderation analysis was non-significant except for baseline openness to experience, with lower openness associated with larger intervention effects on mindfulness.ConclusionsThis trial suggests that StudiCare Mindfulness may enhance mindfulness and reduce mental health problems. Its potential applicability as low-threshold prevention and treatment option on a population level should be subject to future trials.Trial RegistrationGerman Clinical Studies Trial Register TRN: DRKS00012559.

Digital prevention of depression for farmers? A qualitative study on participants' experiences regarding determinants of acceptance and satisfaction with a tailored guided internet intervention program

IntroductionFarmers, forest workers and gardeners have a higher risk of developing depression compared to other occupational populations. As part of the German pilot project “With us in balance”, the potential of six guided internet- and mobile-based interventions (IMIs) to prevent depression among their insurants is examined. The IMI program is tailored to various risk factors of depression, individual symptoms, and needs. Although IMIs have been shown to be effective in reducing depressive symptoms, there is little qualitative research about the acceptance of digital preventive IMIs. The aim of this qualitative study is to gain insights into participants' experiences with the guided IMIs by focusing on determinants for acceptance and satisfaction. MethodsSemi-structured interviews were conducted with 22/171 (13 %) intervention group (IG) participants of a randomized controlled trial. The interview guide was developed based on theoretical models of user acceptance (Unified Theory of Acceptance and Use of Technology) and patient satisfaction (evaluation model, discrepancy theory). The interviews were evaluated independently by two coders performing a deductive-inductive content analysis and attaining a substantial level of agreement (K = 0.73). ResultsThe qualitative analysis revealed 71 determinants for acceptance and satisfaction across ten dimensions: performance expectancy, organisation, e-coach, usability, training content and structure, training usage, training outcome, financing, social influence, and behavioural intention. The most frequently identified drivers for the IMI use include “location independence”, “positive relationship to the e-coach” (each n = 19, 86 %), “personal e-coach guidance”, “expertise of the e-coach”, “target group specific adaptation” (each n = 18, 82 %), “flexibility”, “high willingness for renewed participation” (each n = 17, 77 %), “fast and easy availability”, “training of health enhancing attitudes and behaviours” and “content with figurative expressions” (each n = 16, 73 %). DiscussionThe qualitative findings predominantly suggest the acceptance of and satisfaction with the IMI program for the prevention of depression in famers and related lines of work. Many identified positive drivers are related to the e-coach guidance, which emphasizes its importance in the preventive setting from the perspective of the participants. Nevertheless, some negative aspects have been identified which help to understand potential weaknesses of the IMI program. Participants indicated different needs in terms of IMI content and usage, which points towards the potential benefit of individualisation. The possibility of being able to use IMIs anonymously, flexibly and independently of location might be highly relevant for this specific target group.

Internet- and mobile-based trauma-focused intervention for adolescents and young adults with posttraumatic stress disorder: a study protocol of a proof-of-concept feasibility study

ABSTRACT Introduction: Although evidence-based treatments for posttraumatic stress disorder (PTSD) in adolescents and young adults exist, affected youth do not have sufficient access to these treatments due to structural and attitudinal barriers. Internet- and mobile-based interventions (IMIs) can help fill this healthcare gap, but such programmes have not yet been sufficiently evaluated in youth with PTSD. Aim: This study aims to investigate the feasibility of an IMI for youth with PTSD in a one-arm, non-randomised, prospective proof-of-concept feasibility study. Methods: We aim to recruit 32 youth between 15 and 21 years old with clinically relevant posttraumatic stress symptoms (CATS ≥ 21), who will receive access to the IMI. The IMI consists of nine sessions involving psychoeducation, emotion regulation and coping skills, written-based imaginal exposure, cognitive restructuring and relapse prevention. Participants will be guided by an eCoach, who provides weekly semi-standardised written feedback on completed sessions and adherence reminders. We will use a formal feasibility framework to assess different dimensions of feasibility: (1) recruitment capability and resulting sample characteristics, (2) data collection procedures and outcome measures, (3) acceptability of the IMI and study procedures, (4) resources and ability to manage and implement the study and IMI and (5) participants’ responses to the IMI in terms of symptom severity and satisfaction. Additionally, potential negative effects related to the intervention will be assessed. Assessments take place pre-, mid- and post-intervention and at follow-up, including semi-structured clinical telephone interviews for PTSD diagnostics at pre- and post-intervention assessment. Qualitative interviews will be conducted to investigate the youth perspectives on the IMI. Discussion: This study aims to determine the feasibility of a guided IMI for youth with PTSD to adapt the IMI as closely as possible to youth needs and to inform the design, procedure and safety management of a large-scale efficacy RCT. Trial registration: German Clinical Trials Register identifier: DRKS00023341. HIGHLIGHTS Evidence-based care for adolescents after trauma is not widely available.• This study evaluates the feasibility of a guided trauma-focused Internet intervention as a time- and location-independent low-threshold treatment option for adolescents and young adults with posttraumatic stress disorder.

Internet- and mobile-based intervention for depression in adults with chronic back pain: A health economic evaluation

BackgroundDepression and comorbid chronic back pain (CBP) lead to high personal and economic burden. Internet- and mobile-based interventions (IMI) might be a cost-effective adjunct to established interventions. MethodsA health economic evaluation was embedded into an observer-blinded, multicenter RCT (societal and health care perspective). We randomly assigned participants (≥18 years) with CBP and diagnosed depression from 82 orthopedic clinics across Germany to intervention (IG + treatment as usual [TAU]) or TAU control group (CG). The IG received a guided IMI. Primary outcomes were depression response and quality-adjusted life years (QALYs) at 6-months follow-up. Multiple imputation was used to address missing data. Incremental cost-effectiveness/cost-utility ratios (ICER/ICUR) and the probability of being cost-effective at different willingness-to-pay thresholds were calculated. Statistical uncertainty was estimated using bootstrapping techniques (N = 10,000). ResultsBetween October 2015 and July 2017 210 participants were randomly assigned to IG (n = 105) and CG (n = 105). Depression response did not differ significantly between groups. QALYs were significantly higher in the IG compared to the CG. Taking the societal perspective and assuming a commonly used willingness-to-pay of €34,000/QALY, the intervention's likelihood of being cost-effective was 64%. LimitationsThe main limitation is that the study was powered to detect clinical but not health economic differences between groups. ConclusionThe IMI is considered cost-effective (vs. CG) for individuals with depression and CBP (societal perspective). These results are promising when considering the high individual and economic burden of this patient group. Further research is needed to adequately inform political decision makers before implementation into routine care.

Comparing a mindfulness- and CBT-based guided self-help Internet- and mobile-based intervention against a waiting list control condition as treatment for adults with frequent cannabis use: a randomized controlled trial of CANreduce 3.0

BackgroundThough Internet- and mobile-based interventions (IMIs) and mindfulness-based interventions (generally delivered in-situ) appear effective for people with substance use disorders, IMIs incorporating mindfulness are largely missing, including those targeting frequent cannabis use.MethodsThis paper details the protocol for a three-arm randomized controlled trial comparing a mindfulness-based self-help IMI (arm 1) and cognitive-behavioral therapy (CBT)-based self-help IMI (arm 2) versus being on a waiting list (arm 3) in their effectiveness reducing cannabis use in frequent cannabis users. Predictors of retention, adherence and treatment outcomes will be identified and similarities between the two active intervention arms explored. Both active interventions last six weeks and consist of eight modules designed to reduce cannabis use and common mental health symptoms. With a targeted sample size of n = 210 per treatment arm, data will be collected at baseline immediately before program use is initiated; at six weeks, immediately after program completion; and at three and six months post baseline assessment to assess the retention of any gains achieved during treatment.The primary outcome will be number of days of cannabis use over the preceding 30 days. Secondary outcomes will include further measures of cannabis use and use of other substances, changes in mental health symptoms and mindfulness, client satisfaction, intervention retention and adherence, and adverse effects. Data analysis will follow ITT principles and primarily employ (generalized) linear mixed models.DiscussionThis RCT will provide important insights into the effectiveness of an IMI integrating mindfulness to reduce cannabis use in frequent cannabis users.Trial registrationInternational Standard Randomized Controlled Trial Number Registry: ISRCTN14971662; date of registration: 09/09/2021.

Clinical- and Cost Effectiveness of a Guided Internet-Based Intervention for Children (12–18 Years) of Parents With Mental Disorders (iCHIMPS): Study Protocol of a Multicentered Cluster-Randomized Controlled Trial

IntroductionChildren of parents with mental disorders have a high chance of developing a mental disorder themselves. However, this at-risk group is regularly overlooked and typically not seen by any mental health professionals. Internet- and mobile-based interventions (IMIs) can provide a means of promoting mental health for children of parents with mental disorders.ObjectiveThe introduced study will evaluate the clinical- and cost-effectiveness of the iCHIMPS IMI in promoting mental health for children of parents with mental disorders.MethodsA two-armed multicentered cluster-randomized controlled trial (cRCT) comparing the clinical- and cost-effectiveness of the iCHIMPS IMI in the intervention group (IG) to a treatment-as-usual (TAU) control group will be conducted. Recruitment will be handled at currently 21 adult mental health clinics throughout Germany. Participating families will be randomly divided into the two groups until the final sample size of 306 participating adolescents (age 12–18) has been reached. The adolescents in the intervention group will receive access to the IMI and can take part in up to eight intervention modules. Assessment will be conducted during the recruitment (baseline), 1-month, 2-months, and 6-month post-inclusion. Primary outcome is the mental health of the participating adolescents at 6-months post-inclusion as measured by the Youth Self Report score. Secondary self-report outcomes are mental wellbeing, self-efficacy, coping strategies and negative effects as well as mental health of the adolescents as reported by their parent(s). Included moderators are sociodemographic characteristics, working alliance, social support and the mental health diagnoses of the parents. Statistical analyses will be conducted on the intention-to-treat principle as well as with additional per-protocol analyses. Additionally, the cost-effectiveness as well as qualitative data concerning the adherence, acceptance, and feasibility of the IMI will be analyzed.DiscussionThe iCHIMPS cRCT examines the clinical- as well as cost-effectiveness of the iCHIMPS mental health promotion IMI for children of parents with mental disorders. This provides the opportunity to gain insights into an innovative as well as time- and location-independent form of support for this often-overlooked at-risk group. Additionally, the larger CHIMPS-NET project allows comparisons between internet-based and face-to-face interventions for a similar target group.Clinical Trial Registrationwww.ClinicalTrials.gov, identifier: DRKS00025158.

ESano - An eHealth Platform for Internet- and Mobile-based Interventions.

The prevention and treatment of mental disorders and chronic somatic diseases is a core challenge for health care systems of the 21th century. Mental- and behavioral health interventions provide the means for lowering the public health burden. However, structural deficits, reluctance to use existing services, perceived stigma and further personal and environmental reasons restrict the uptake of these evidence-based approaches. Internet- and mobile-based interventions (IMIs) might overcome some of the limitations of on-site interventions by providing an anonymous, scalable, time- and location-independent, yet evidence-based approach. In order to implement digital mental and behavioral health concepts across the life-span into practice, a technical solution to support the design, creation, and execution of IMIs is needed. However, there are various conceptual, technical as well as legal challenges to implementing a corresponding software solution in the healthcare domain. Therefore, the work at hand (1) identifies these challenges and derives a number of respective requirements, (2) introduces the eHealth platform eSano, a software project developed by an interdisciplinary team of computer scientists, psychologists, therapists, and other domain experts, with the aim to serve as a flexible basis for mental and behavioral research and health care, and (3) provides technical insights into the developed platform and its approach to address the aforementioned requirements.

The Mediation Effect of Phobic Anxiety on the Treatment Outcome of Activity and Participation across Age: Comparison between Online and Face-to-Face Rehabilitation Aftercare of an RCT.

The efficacy of internet and mobile-based interventions (IMIs) has been demonstrated with different mental health disorders, but little is known about the mediating effect of phobic anxiety on activity and participation and the differential effect of age. The current study tested a moderated mediation model with short-term change in phobic anxiety mediating between treatment (IMI vs. face-to-face, F2F) and long-term change in activity and participation, and age of patients moderating this mediation. Participants (N = 142) were recruited from psychosomatic rehabilitation clinics and randomized into the IMI psychosomatic aftercare or F2F psychosomatic aftercare. Moderated mediation analyses were conducted using R software. Results showed that the long-term treatment effects of activity and participation (βc = −0.18, p = 0.034; βc’ = −0.13, p = 0.145) were improved through the successful decrease of phobic anxiety (βa = −0.18, p = 0.047; βb = 0.37, p = 0.010). Older patients benefited equally from both IMI and F2F interventions regarding short-term treatment change in phobic anxiety, while younger participants benefited more from IMI (βAge*Treatment = 0.20, p = 0.004). IMIs targeting mental disorders can improve activity and participation along with phobic anxiety, especially in younger individuals. The needs of older patients should be considered with the development and improvement of IMIs.

Acceptance towards digital health interventions – Model validation and further development of the Unified Theory of Acceptance and Use of Technology

Internet- and mobile-based interventions (IMI) offer an effective way to complement health care. Acceptance of IMI, a key facilitator of their implementation in routine care, is often low. Based on the Unified Theory of Acceptance and Use of Technology (UTAUT), this study validates and adapts the UTAUT to digital health care.Following a systematic literature search, 10 UTAUT-grounded original studies (N = 1588) assessing patients' and health professionals' acceptance of IMI for different somatic and mental health conditions were included. All included studies assessed Performance Expectancy, Effort Expectancy, Social Influence, Facilitating Conditions and acceptance as well as age, gender, internet experience, and internet anxiety via self-report questionnaires. For the model validation primary data was obtained and analyzed using structural equation modeling.The best fitting model (RMSEA = 0.035, SRMR = 0.029) replicated the basic structure of UTAUT's core predictors of acceptance. Performance Expectancy was the strongest predictor (γ = 0.68, p < .001). Internet anxiety was identified as an additional determinant of acceptance (γ = −0.07, p < .05) and moderated the effects of Social Influence (γ = 0.07, p < .05) and Effort Expectancy (γ = −0.05, p < .05). Age, gender and experience had no moderating effects.Acceptance is a fundamental prerequisite for harnessing the full potential of IMI. The adapted UTAUT provides a powerful model identifying important factors – primarily Performance Expectancy - to increase the acceptance across patient populations and health professionals.

Engaging Parents of Lower-Socioeconomic Positions in Internet- and Mobile-Based Interventions for Youth Mental Health: A Qualitative Investigation.

Growing literature supports the use of internet- and mobile-based interventions (IMIs) targeting parenting behaviours to prevent child and adolescent mental health difficulties. However, parents of lower-socioeconomic positions (SEP) are underserved by these interventions. To avoid contributing to existing mental health inequalities, additional efforts are needed to understand the engagement needs of lower-SEP parents. This study qualitatively explored lower-SEP parents’ perspectives on how program features could facilitate their engagement in IMIs for youth mental health. We conducted semi-structured interviews with 16 lower-SEP parents of children aged 0–18 to identify important program features. Participants were mostly female (81.3%) and aged between 26 and 56 years. Transcriptions were analysed using inductive thematic analysis. Twenty-three modifiable program features important to lower-SEP parents’ engagement in IMIs were identified. These features aligned with one of three overarching themes explaining their importance to parents’ willingness to engage: (1) It will help my child; (2) I feel like I can do it; (3) It can easily fit into my life. The relative importance of program features varied based on parents’ specific social and economic challenges. These findings offer initial directions for program developers in optimising IMIs to overcome barriers to engagement for lower-SEP parents.