Study protocol: development and randomized controlled trial of a preventive blended care parenting intervention for parents with PTSD.

BACKGROUND: Children of parents with post-traumatic stress disorder (PTSD) are at increased risk of adverse psychological outcomes. An important risk mechanism is impaired parental functioning, including negative parenting behavior, perceived incompetence, and lack of social support. Several parenting interventions for trauma-exposed parents and parents with psychiatric disorders exist, but none have specifically targeted parents with PTSD. Our objective is to evaluate the effectiveness of a blended care preventive parenting intervention for parents with PTSD. METHODS: The intervention was adapted from an existing online intervention, KopOpOuders Self-Help. In co-creation with parents with PTSD and partners, the intervention was adapted into KopOpOuders-PTSD, by adding PTSD-specific content and three in-person-sessions with a mental health prevention professional. Effectiveness will be tested in a randomized controlled trial among N = 142 parents being treated for PTSD at Arkin Mental Health Care (control condition: treatment as usual, n = 71; intervention condition: treatment as usual + intervention, n = 71). Online questionnaires at pretest, posttest, and three-month follow-up and ecological momentary assessment at pretest and posttest will be used. Intervention effects on primary (parenting behavior) and secondary outcomes (perceived parenting competence, parental social support, parenting stress, child overall psychological problems and PTSD symptoms) will be analyzed using generalized linear mixed modeling. We will also analyze possible moderation effects of parental PTSD symptoms at pretest on primary and secondary outcomes. DISCUSSION: This study protocol describes the randomized controlled trial of KopOpOuders-PTSD, a blended care preventive parenting intervention for parents with PTSD. Findings can contribute to understanding of the effectiveness of parenting support in clinical practice for PTSD. TRIAL REGISTRATION: This protocol (Version 1) was registered on 11-02-2022 at ClinicalTrials.gov under identification number NCT05237999.

Effectiveness and treatment moderators of internet interventions for adult problem drinking: An individual patient data meta-analysis of 19 randomised controlled trials.

BACKGROUND: Face-to-face brief interventions for problem drinking are effective, but they have found limited implementation in routine care and the community. Internet-based interventions could overcome this treatment gap. We investigated effectiveness and moderators of treatment outcomes in internet-based interventions for adult problem drinking (iAIs). METHODS AND FINDINGS: Systematic searches were performed in medical and psychological databases to 31 December 2016. A one-stage individual patient data meta-analysis (IPDMA) was conducted with a linear mixed model complete-case approach, using baseline and first follow-up data. The primary outcome measure was mean weekly alcohol consumption in standard units (SUs, 10 grams of ethanol). Secondary outcome was treatment response (TR), defined as less than 14/21 SUs for women/men weekly. Putative participant, intervention, and study moderators were included. Robustness was verified in three sensitivity analyses: a two-stage IPDMA, a one-stage IPDMA using multiple imputation, and a missing-not-at-random (MNAR) analysis. We obtained baseline data for 14,198 adult participants (19 randomised controlled trials [RCTs], mean age 40.7 [SD = 13.2], 47.6% women). Their baseline mean weekly alcohol consumption was 38.1 SUs (SD = 26.9). Most were regular problem drinkers (80.1%, SUs 44.7, SD = 26.4) and 19.9% (SUs 11.9, SD = 4.1) were binge-only drinkers. About one third were heavy drinkers, meaning that women/men consumed, respectively, more than 35/50 SUs of alcohol at baseline (34.2%, SUs 65.9, SD = 27.1). Post-intervention data were available for 8,095 participants. Compared with controls, iAI participants showed a greater mean weekly decrease at follow-up of 5.02 SUs (95% CI -7.57 to -2.48, p < 0.001) and a higher rate of TR (odds ratio [OR] 2.20, 95% CI 1.63-2.95, p < 0.001, number needed to treat [NNT] = 4.15, 95% CI 3.06-6.62). Persons above age 55 showed higher TR than their younger counterparts (OR = 1.66, 95% CI 1.21-2.27, p = 0.002). Drinking profiles were not significantly associated with treatment outcomes. Human-supported interventions were superior to fully automated ones on both outcome measures (comparative reduction: -6.78 SUs, 95% CI -12.11 to -1.45, p = 0.013; TR: OR = 2.23, 95% CI 1.22-4.08, p = 0.009). Participants treated in iAIs based on personalised normative feedback (PNF) alone were significantly less likely to sustain low-risk drinking at follow-up than those in iAIs based on integrated therapeutic principles (OR = 0.52, 95% CI 0.29-0.93, p = 0.029). The use of waitlist control in RCTs was associated with significantly better treatment outcomes than the use of other types of control (comparative reduction: -9.27 SUs, 95% CI -13.97 to -4.57, p < 0.001; TR: OR = 3.74, 95% CI 2.13-6.53, p < 0.001). The overall quality of the RCTs was high; a major limitation included high study dropout (43%). Sensitivity analyses confirmed the robustness of our primary analyses. CONCLUSION: To our knowledge, this is the first IPDMA on internet-based interventions that has shown them to be effective in curbing various patterns of adult problem drinking in both community and healthcare settings. Waitlist control may be conducive to inflation of treatment outcomes.

Effectiveness of a web-based solution-focused brief chat treatment for depressed adolescents and young adults: randomized controlled trial.

BACKGROUND: Up to 9% of young people suffer from depression. Unfortunately, many in need of help remain untreated. The Internet offers anonymous ways to help depressed youth, especially those who are reluctant to search for help because of fear of stigma. OBJECTIVE: Our goal was to evaluate the effectiveness of an individual chat treatment based on Solution-Focused Brief Therapy (SFBT) to young individuals aged 12-22 years with depressive symptoms by comparing it to a waiting list control group. METHODS: For this study, 263 young people with depressive symptoms were randomized to the Web-based SFBT intervention, PratenOnline, or to a waiting list control condition. The chat treatment was delivered by trained professionals. Groups were compared on depressive complaints as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) after 9 weeks and 4.5 months. For the chat group only, changes in depressive symptoms at 7.5 months after baseline were explored. RESULTS: The experimental SFBT condition (n=131) showed significantly greater improvement than the waiting list condition (n=132) in depressive symptoms at 9 weeks and 4.5 months on the CES-D, with a small between group effect size at 9 weeks (d=0.18, 95% CI -0.10 to 0.47) and a large effect size at 4.5 months (d=0.79, 95% CI 0.45-1.08). The percentage of participants showing a reliable and clinically significant change in depression was significantly larger for the SFBT intervention at 4.5 months only (28.2% vs 11.4% for the waiting list, P<.001, number needed to treat=6). At 7.5 months, the SFBT group showed further improvements. However, results have to be considered carefully because of high attrition rates. CONCLUSIONS: The Web-based SFBT chat intervention of PratenOnline was more effective than a waiting list control group in reducing depressive symptoms, and effects were larger at follow-up then at post-treatment. More studies are needed to find out if outcomes will be replicated, especially for those younger than 18 year old. TRIAL REGISTRATION: Netherlands Trial Register: NTR 1696; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1696 (Archived by WebCite at http://www.webcitation.org/6DspeYWrJ).

Web-based cognitive bias modification for problem drinkers: protocol of a randomised controlled trial with a 2x2x2 factorial design.

BACKGROUND: The automatic tendency to attend to, positively evaluate and approach alcohol related stimuli has been found to play a causal role in problematic alcohol use and can be retrained by computerised Cognitive Bias Modification (CBM). In spite of CBMs potential as an internet intervention, little is known about the efficacy of web-based CBM. The study described in this protocol will test the effectiveness of web-based CBM in a double blind randomised controlled trial with a 2 (attention bias retraining: real versus placebo) x 2 (alcohol/no-go training: real versus placebo) x 2 (approach bias retraining: real versus placebo) factorial design. METHODS/DESIGN: The effectiveness of 12 sessions of CBM will be examined among problem drinkers aged 18-65 who are randomly assigned to one of the eight CBM conditions, after completing two modules of a validated cognitive behavioural intervention, DrinkingLess. The primary outcome measure is the change in alcohol use. It is expected that, for each of the CBM interventions, participants in the real CBM conditions will show a greater decrease in alcohol use than participants in the placebo conditions. Secondary outcome measures include the percentage of participants drinking within the limits for sensible drinking. Possible mediating (change in automatic biases) and moderating (working memory, inhibition) factors will be examined, as will the comparative cost-effectiveness of the various CBM strategies. DISCUSSION: This study will be the first to test the relative efficacy of various web-based CBM strategies in problem drinkers. If proven effective, CBM could be implemented as a low-cost, low-threshold adjuvant to CBT-based online interventions for problem drinkers. TRIAL REGISTRATION: Netherlands Trial register: NTR3875.

An Internet-based guided self-help intervention for panic symptoms: randomized controlled trial.

BACKGROUND: Internet-based guided self-help is efficacious for panic disorder, but it is not known whether such treatment is effective for milder panic symptoms as well. OBJECTIVE: To evaluate the effectiveness of Don't Panic Online, an Internet-based self-help course for mild panic symptoms, which is based on cognitive behavioral principles and includes guidance by email. METHODS: A pragmatic randomized controlled trial was conducted. Participants (N=126) were recruited from the general population and randomized to either the intervention group or to a waiting-list control group. Inclusion criteria were a Panic Disorder Severity Scale-Self Report (PDSS-SR) score between 5-15 and no suicide risk. Panic symptom severity was the primary outcome measure; secondary outcome measures were anxiety and depressive symptom severity. Measurements were conducted online and took place at baseline and 12 weeks after baseline (T1). At baseline, diagnoses were obtained by telephone interviews. RESULTS: Analyses of covariance (intention-to-treat) showed no significant differences in panic symptom reduction between groups. Completers-only analyses revealed a moderate effect size in favor of the intervention group (Cohen's d=0.73, P=.01). Only 27% of the intervention group finished lesson 4 or more (out of 6). Nonresponse at T1 was high for the total sample (42.1%). Diagnostic interviews showed that many participants suffered from comorbid depression and anxiety disorders. CONCLUSIONS: The Internet-based guided self-help course appears to be ineffective for individuals with panic symptoms. However, intervention completers did derive clinical benefits from the intervention. TRIAL REGISTRATION: Nederlands Trial Register: NTR1639; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=1639 (Archived by WebCite at http://www.webcitation.org/6ITZPozs9).

An Internet-based intervention to promote mental fitness for mildly depressed adults: randomized controlled trial.

BACKGROUND: Depression is a worldwide problem warranting global solutions to tackle it. Enhancing well-being has benefits in its own right and could be a good strategy for preventing depression. Providing well-being interventions via the Internet may have synergetic effects. OBJECTIVE: Psyfit ("mental fitness online") is a fully automated self-help intervention to improve well-being based on positive psychology. This study examines the clinical effects of this intervention. METHODS: We conducted a 2-armed randomized controlled trial that compared the effects of access to Psyfit for 2 months (n=143) to a waiting-list control condition (n=141). Mild to moderately depressed adults in the general population seeking self-help were recruited. Primary outcome was well-being measured by Mental Health Continuum-Short Form (MHC-SF) and WHO Well-being Index (WHO-5); secondary outcomes were depressive symptoms, anxiety, vitality, and general health measured by Center for Epidemiological Studies Depression Scale (CES-D), Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A), and Medical Outcomes Study-Short Form (MOS-SF) vitality and general health subscales, respectively. Online measurements were taken at baseline, 2 months, and 6 months after baseline. RESULTS: The dropout rate was 37.8% in the Psyfit group and 22.7% in the control group. At 2-month follow-up, Psyfit tended to be more effective in enhancing well-being (nonsignificantly for MHC-SF: Cohen's d=0.27, P=.06; significantly for WHO-5: Cohen's d=0.31, P=.01), compared to the waiting-list control group. For the secondary outcomes, small but significant effects were found for general health (Cohen's d=0.14, P=.01), vitality (d=0.22, P=.02), anxiety symptoms (Cohen's d=0.32, P=.001), and depressive symptoms (Cohen's d=0.36, P=.02). At 6-month follow-up, there were no significant effects on well-being (MHC-SF: Cohen's d=0.01, P=.90; WHO-5: Cohen's d=0.26, P=.11), whereas depressive symptoms (Cohen's d=0.35, P=.02) and anxiety symptoms (Cohen's d=0.35, P=.001) were still significantly reduced compared to the control group. There was no clear dose-response relationship between adherence and effectiveness, although some significant differences appeared across most outcomes in favor of those completing at least 1 lesson in the intervention. CONCLUSIONS: This study shows that an online well-being intervention can effectively enhance well-being (at least in the short-term and for 1 well-being measure) and can help to reduce anxiety and depression symptoms. Further research should focus on increasing adherence and motivation, reaching and serving lower-educated people, and widening the target group to include people with different levels of depressive symptoms. TRIAL REGISTRATION: Netherlands Trial Register (NTR) number: NTR2126; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2126 (archived by WebCite at http://www.webcitation.org/6IIiVrLcO).

Effectiveness of an online group course for depression in adolescents and young adults: a randomized trial.

BACKGROUND: Depression is a serious mental health problem, whose first onset is usually in adolescence. Online treatment may offer a solution for the current undertreatment of depression in youth. For adults with depressive symptoms, the effectiveness of Internet-based cognitive behavioral therapy has been demonstrated. This study is one of the first randomized controlled trials to investigate the effectiveness online depression treatment for young people with depressive complaints and the first to focus on an online group course. OBJECTIVE: To evaluate and discuss the effectiveness of a guided Web-based group course called Grip op Je Dip (Master Your Mood [MYM]), designed for young people aged 16 to 25 years with depressive symptoms, in comparison with a wait-listed control group. METHODS: We randomly assigned 244 young people with depressive symptoms to the online MYM course or to a waiting-list control condition. The primary outcome measure was treatment outcome after 3 months on the Center for Epidemiologic Studies Depression Scale. Secondary outcomes were anxiety (measured by the Hospital Anxiety and Depression Scale) and mastery (Mastery Scale). We studied the maintenance of effects in the MYM group 6 months after baseline. Missing data were imputed. RESULTS: The MYM group (n = 121) showed significantly greater improvement in depressive symptoms at 3 months than the control group (n = 123) (t(187 )= 6.62, P < .001), with a large between-group effect size of d = 0.94 (95% confidence interval [CI] 0.64-1.23). The MYM group also showed greater improvement in anxiety (t(187 )= 3.80, P < .001, d = 0.49, 95% CI 0.24-0.75) and mastery (t(187 )= 3.36, P = .001, d = 0.44, 95% CI 0.19-0.70). At 12 weeks, 56% (68/121) of the participants in the MYM group and 20% (24/123) in the control group showed reliable and clinically significant change. This between-group difference was significant (χ(2) (1 )= 35.0, P < .001) and yielded a number needed to treat of 2.7. Improvements in the MYM group were maintained at 6 months. A limitation is the infeasibility of comparing the 6-month outcomes of the MYM and control groups, as the controls had access to MYM after 3 months. CONCLUSIONS: The online group course MYM was effective in reducing depressive symptoms and anxiety and in increasing mastery in young people. These effects persisted in the MYM group at 6 months.

Development of a Dynamically Tailored mHealth Intervention (What Do You Drink) to Reduce Excessive Drinking Among Dutch Lower-Educated Students: User-Centered Design Approach.

BACKGROUND: The high prevalence and adverse consequences of excessive drinking among lower-educated adolescents and young adults are public concerns in the Netherlands. Evidence-based alcohol prevention programs targeting adolescents and young adults with a low educational background are sparse. OBJECTIVE: This study aimed to describe the planned process for the theory- and evidence-based development, implementation, and evaluation of a dynamically tailored mobile alcohol intervention, entitled What Do You Drink (WDYD), aimed at lower-educated students from secondary vocational education and training (Middelbaar Beroepsonderwijs in Dutch). METHODS: We used intervention mapping as the framework for the systematic development of WDYD. It consists of the following six steps: assessing needs (step 1), formulating intervention objectives (step 2), translating theoretical methods into practical applications (step 3), integrating these into a coherent program (step 4), anticipating future implementation and adoption (step 5), and developing an evaluation plan (step 6). RESULTS: Reducing excessive drinking among Dutch lower-educated students aged 16 to 24 years was defined as the desired behavioral outcome and subdivided into the following five program objectives: make the decision to reduce drinking, set realistic drinking goals, use effective strategies to achieve drinking goals, monitor own drinking behavior, and evaluate own drinking behavior and adjust goals. Risk awareness, motivation, social norms, and self-efficacy were identified as the most important and changeable individual determinants related to excessive drinking and, therefore, were incorporated into WDYD. Dynamic tailoring was selected as the basic intervention method for changing these determinants. A user-centered design strategy was used to enhance the fit of the intervention to the needs of students. The intervention was developed in 4 iterations, and the prototypes were subsequently tested with the students and refined. This resulted in a completely automated, standalone native app in which students received dynamically tailored feedback regarding their alcohol use and goal achievement via multiple sessions within 17 weeks based on diary data assessing their alcohol consumption, motivation, confidence, and mood. A randomized controlled trial with ecological momentary assessments will be used to examine the effects, use, and acceptability of the intervention. CONCLUSIONS: The use of intervention mapping led to the development of an innovative, evidence-based intervention to reduce excessive alcohol consumption among lower-educated Dutch adolescents and young adults. Developing an intervention based on theory and empirical evidence enables researchers and program planners to identify and retain effective intervention elements and to translate the intervention to new populations and settings. This is important, as black boxes, or poorly described interventions, have long been a criticism of the eHealth field, and effective intervention elements across mobile health alcohol interventions are still largely unknown. TRIAL REGISTRATION: Netherlands Trial Registry NTR6619; https://trialsearch.who.int/Trial2.aspx?TrialID=NTR6619.

Comparing a ses-sensitive and an all-ses implementation strategy to improve participation rates of patients with a lower socioeconomic background in a web-based intervention for depressive complaints: a cluster randomised trial in primary care.

BACKGROUND: Depression is a major public health concern, which is most pronounced in population segments with a lower social-economic status (SES). E-health interventions for depressive complaints are proven to be effective, but their reach needs to be improved, especially among people with a lower socioeconomic status (SES). Implementing e-health interventions in the primary care setting with SES-sensitive guidance from General Practice nurses (GP nurses) may be a useful strategy to increase the reach of e-health in lower SES groups. We implemented an evidence-based online intervention that targets depressive complaints in primary care. METHODS: A pragmatic cluster-randomised trial was conducted in two parallel groups where a SES sensitive (SES-sens) implementation strategy with additional face-to-face guidance by GP nurses was compared to an all-SES implementation strategy. The primary outcome was the percentage of lower SES participants in either condition. Participation was defined as completing at least 1 face-to-face session and 2 online exercises. Participation rates were evaluated using logistic mixed modelling. RESULTS: In both conditions, the participation rates of lower SES participants were quite high, but were notably lower in the SES-sens implementation condition (44%) than in the all-SES implementation condition (58%). This unexpected outcome remained statistically significant even after adjusting for potential confounders between the conditions (Odds Ratio 0.43, 95%-CI 0.22 to 0.81). Less guidance was provided by the GP nurses in the SES-sens group, contrary to the implementation instructions. CONCLUSIONS: From a public health point of view, it is good news that a substantial number of primary care patients with a lower SES level used the implemented e-health intervention. It is also positive that an all-SES implementation strategy performed well, and even outperformed a SES-sensitive strategy. However, this was an unexpected finding, warranting further research into tailoring implementation strategies of e-health interventions towards specific target groups in the primary care setting. TRIAL REGISTRATION: Netherlands Trial Register, identifier: NL6595 , registered on 12 November 2017.

Effectiveness of E-self-help interventions for curbing adult problem drinking: a meta-analysis.

BACKGROUND: Self-help interventions without professional contact to curb adult problem drinking in the community are increasingly being delivered via the Internet. OBJECTIVE: The objective of this meta-analysis was to assess the overall effectiveness of these eHealth interventions. METHODS: In all, 9 randomized controlled trials (RCTs), all from high-income countries, with 9 comparison conditions and a total of 1553 participants, were identified, and their combined effectiveness in reducing alcohol consumption was evaluated by means of a meta-analysis. RESULTS: An overall medium effect size (g = 0.44, 95% CI 0.17-0.71, random effect model) was found for the 9 studies, all of which compared no-contact interventions to control conditions. The medium effect was maintained (g = 0.39; 95% CI 0.23-0.57, random effect model) after exclusion of two outliers. Type of control group, treatment location, type of analysis, and sample size did not have differential impacts on treatment outcome. A significant difference (P = .04) emerged between single-session personalized normative feedback interventions (g = 0.27, 95% CI 0.11-0.43) and more extended e- self-help (g = 0.61, 95% CI 0.33-0.90). CONCLUSION: E-self-help interventions without professional contact are effective in curbing adult problem drinking in high-income countries. In view of the easy scalability and low dissemination costs of such interventions, we recommend exploration of whether these could broaden the scope of effective public health interventions in low- and middle-income countries as well.

Translating effective web-based self-help for problem drinking into the real world.

BACKGROUND: Drinking Less (DL) is a 24/7 free-access anonymous interactive web-based self-help intervention without therapeutic guidance for adult problem drinkers in the community. In a randomized controlled trial (referred to here as DL-RCT), DL has been shown effective in reducing risky alcohol consumption. OBJECTIVE: To assess whether the findings of DL-RCT are generalizable to a naturalistic setting (DL-RW) in terms of ability to reach the target group and alcohol treatment response. METHODS: Pretest-posttest study with 6-month follow-up. An online survey was conducted of 378 of the 1,625 people who used DL-RW from May to November 2007. Primary outcome measures were (1) problem drinking, defined as alcohol consumption in the previous 4 weeks averaging >21 or >14 standard units (male/female) per week or >or=6 or >or=4 units (m/f) on 1 or more days per week; and (2) mean weekly alcohol consumption. DL-RW and DL-RCT data were compared and pooled. Intention-to-treat (ITT) analysis was performed to analyze and compare changes in drinking from baseline to follow-up. RESULTS: In the DL-RW group, 18.8% (n = 71) were drinking successfully within the limits of the Dutch guideline for low-risk drinking (p < 0.001) 6 months after baseline (ITT). The DL-RW group also decreased its mean weekly alcohol intake by 7.4 units, t(377) = 6.67, p < 0.001, d = 0.29. Drinking reduction in DL-RW was of a similar magnitude to that in the DL-RCT condition in terms of drinking within the guideline [chi(2)(1) = 1.83, CI: 0.82-3.00, p = 0.18, RD = 0.05, OR = 1.55] and mean weekly consumption (a negligible difference of d = 0.03 in favor of DL-RW group). CONCLUSION: The results from DL-RCT and DL-RW were similar, and they demonstrate that web-based self-help without therapeutic guidance is feasible, well accepted, and effective for curbing adult problem drinking in the community.

Effectiveness of a web-based self-help smoking cessation intervention: protocol of a randomised controlled trial.

BACKGROUND: Cigarette smoking is a major risk factor for many chronic and fatal illnesses. Stopping smoking directly reduces those risks. The aim of this study is to investigate the effectiveness of a web-based interactive self-help programme for smoking cessation, known as the StopSite, by comparing it to an online self-help guide. Both interventions were based on cognitive-behavioural and self-control principles, but the former provided exercises, feedback and interactive features such as one-to-one chatrooms and a user forum, which facilitated mutual support and experience sharing. METHODS AND DESIGN: We conducted a randomised controlled trial to compare the interactive intervention with the self-help guide. The primary outcome measure was prolonged abstinence from smoking. Secondary outcomes were point-prevalence abstinence, number of cigarettes smoked, and incidence of quit attempts reported at follow-up assessments. Follow-up assessments took place three and six months after a one-month grace period for starting the intervention after baseline. Analyses were based on intention-to-treat principles using a conservative imputation method for missing data, whereby non-responders were classified as smokers. DISCUSSION: The trial should add to the body of knowledge on the effectiveness of web-based self-help smoking cessation interventions. Effective web-based programmes can potentially help large numbers of smokers to quit, thus having a major public health impact. TRIAL REGISTRATION: ISRCTN74423766.

The effects of integrative reminiscence on depressive symptomatology and mastery of older adults.

A quasi-experimental (non-randomized) study was conducted to study the effects of a new intervention The story of your life that combines integrative reminiscence with narrative therapy. The program consists of seven sessions of two hours and one follow-up session after 8 weeks. It is directed at community-dwelling people of 55 years and older with mild to moderate depressive symptoms. After the intervention the participants showed significantly less depressive symptoms and higher mastery, also in comparison with a waiting-list control group. Demographic factors and initial levels of depressive symptomatology and mastery were not found to moderate the effects. The effects were maintained at 3 months after completion of the intervention. Although the new program was positively evaluated by the majority of the participants there is room for improvement. Adaptations should be made, and evaluated in a randomised controlled trial.

Web-based self-help for problem drinkers: a pragmatic randomized trial.

AIMS: Self-help interventions for adult problem drinkers in the general population have proved effective. The question is whether this also holds for self-help interventions delivered over the internet. DESIGN: We conducted a pragmatic randomized trial with two parallel groups, using block randomization stratified for gender and with follow-up at 6 months. SETTING: The intervention and trial were conducted online in the Netherlands in 2003-2004. PARTICIPANTS: We selected 261 adult problem drinkers from the general population with a weekly alcohol consumption above 210 g of ethanol for men or 140 g for women, or consuming at least 60 g (men) or 40 g (women) at least 1 day a week over the past 3 months. Participants were randomized to either the experimental drinking less (DL) condition or to the control condition (PBA). INTERVENTION: DL is a web-based, multi-component, interactive self-help intervention for problem drinkers without therapist guidance. The recommended treatment period is 6 weeks. The intervention is based on cognitive-behavioural and self-control principles. The control group received access to an online psychoeducational brochure on alcohol use (PBA). OUTCOME MEASURES: We assessed the following outcome measures at 6-month follow-up: (i) the percentage of participants who had reduced their drinking levels to within the normative limits of the Dutch guideline for low-risk drinking; and (ii) the reduction in mean weekly alcohol consumption. FINDINGS: At follow-up, 17.2% of the intervention group participants had reduced their drinking successfully to within the guideline norms; in the control group this was 5.4% [odds ratio (OR) = 3.66; 95% confidence interval (CI) 1.3-10.8; P = 0.006; number needed to treat (NNT) = 8.5]. The intervention subjects decreased their mean weekly alcohol consumption significantly more than control subjects, with a difference of 12.0 standardized units (95% CI 5.9-18.1; P < 0.001; standardized mean difference 0.40). CONCLUSIONS: To our knowledge this is one of the first randomized controlled trials on a web-based self-help intervention without therapist guidance for self-referred problem drinkers among the adult general population. The intervention showed itself to be effective in reducing problem drinking in the community.

Predicting successful treatment outcome of web-based self-help for problem drinkers: secondary analysis from a randomized controlled trial.

BACKGROUND: Web-based self-help interventions for problem drinking are coming of age. They have shown promising results in terms of cost-effectiveness, and they offer opportunities to reach out on a broad scale to problem drinkers. The question now is whether certain groups of problem drinkers benefit more from such Web-based interventions than others. OBJECTIVE: We sought to identify baseline, client-related predictors of the effectiveness of Drinking Less, a 24/7, free-access, interactive, Web-based self-help intervention without therapist guidance for problem drinkers who want to reduce their alcohol consumption. The intervention is based on cognitive-behavioral and self-control principles. METHODS: We conducted secondary analysis of data from a pragmatic randomized trial with follow-up at 6 and 12 months. Participants (N = 261) were adult problem drinkers in the Dutch general population with a weekly alcohol consumption above 210 g of ethanol for men or 140 g for women, or consumption of at least 60 g (men) or 40 g (women) one or more days a week over the past 3 months. Six baseline participant characteristics were designated as putative predictors of treatment response: (1) gender, (2) education, (3) Internet use competence (sociodemographics), (4) mean weekly alcohol consumption, (5) prior professional help for alcohol problems (level of problem drinking), and (6) participants' expectancies of Web-based interventions for problem drinking. Intention-to-treat (ITT) analyses, using last-observation-carried-forward (LOCF) data, and regression imputation (RI) were performed to deal with loss to follow-up. Statistical tests for interaction terms were conducted and linear regression analysis was performed to investigate whether the participants' characteristics as measured at baseline predicted positive treatment responses at 6- and 12-month follow-ups. RESULTS: At 6 months, prior help for alcohol problems predicted a small, marginally significant positive treatment outcome in the RI model only (beta = .18, P = .05, R(2) = .11). At 12 months, females displayed modest predictive power in both imputation models (LOCF: beta = .22, P = .045, R(2) = .02; regression: beta = .27, P = .01, R(2) = .03). Those with higher levels of education exhibited modest predictive power in the LOCF model only (beta = .33, P = .01, R(2) = .03). CONCLUSIONS: Although female and more highly educated users appeared slightly more likely to derive benefit from the Drinking Less intervention, none of the baseline characteristics we studied persuasively predicted a favorable treatment outcome. The Web-based intervention therefore seems well suited for a heterogeneous group of problem drinkers and could hence be offered as a first-step treatment in a stepped-care approach directed at problem drinkers in the general population. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 47285230; http://www.controlled-trials.com/isrctn47285230 (Archived by WebCite at http://www.webcitation.org/5cSR2sMkp).

Outcome of cognitive behaviour therapy for minor depression in routine practice.

OBJECTIVES: To examine (1) whether the improvement in depressive symptomatology in subjects participating in psychoeducational groups for minor depression in routine practice is comparable to the improvement realized in a randomized efficacy trial; and (2) whether the level of depressive symptoms of subjects who participated in this intervention is similar after treatment to the level of depressive symptoms of the general population. DESIGN: Participants (N = 187) of 20 psychoeducational groups in routine practice in the Netherlands were examined before and after the intervention using the Centre for Epidemiological Studies - Depression scale (CES-D). METHODS: The standardized improvement from pre- to post-test in subjects was compared to the improvement found in subjects participating in a randomized trial of the same intervention. Furthermore, we compared the post-test scores to the scores of the general population. RESULTS: The improvement of depressive symptoms in routine practice was of the same magnitude as the improvement in the randomized trial. However, a considerable proportion of the participants (54.5%) still scored above the cut-off score of the CES-D at post-test, and the mean CES-D score of the participants (M = 17.0; SD = 9.8) differed significantly (p < .01) from the mean score in the general population (M = 9.7; SD = 8.6). CONCLUSION: Psychoeducational intervention can be an important help for people with depressive symptoms. The improvement in terms of depressive symptoms in routine practice does not differ from the improvement found in a randomized trial. However, participants remained considerably more depressed than the general population and this intervention is, for many, not sufficient as a form of treatment.

The mental health of visitors of web-based support forums for bereaved by suicide.

BACKGROUND: Persons bereaved by suicide are reluctant to ask for social support when they experience feelings of guilt and blame. A web-based peer forum may provide a safe and anonymous place for mutual support. AIMS: This study examined the mental health changes of visitors of two online support forums for persons bereaved by suicide and their experiences with the forum over 1 year. METHOD: Visitors of two forums completed self-report measures at baseline and at 6 and 12 months' follow-up. Repeated measures analyses were used to study changes in well-being, depressive symptoms, and complicated grief. Additionally, participants were interviewed about their experiences with the forum. RESULTS: The 270 participants were mostly female, low in well-being, with high levels of depressive symptoms and complicated grief. Suicidal risk was high for 5.9%. At 12 months, there were small to medium-sized significant improvements in well-being and depressive symptoms (p < .001) and nearly as much for grief (p = .08). About two thirds reported benefit from visiting the forum. Because of the pre-post design we cannot determine whether a causal relationship exists between the form and changes in mental health. CONCLUSION: After 1 year some positive changes but a large group was still struggling with their mental health. Interviews indicate that the forum was valued for finding recognition.

Web-based depression treatment: associations of clients' word use with adherence and outcome.

BACKGROUND: The growing number of web-based psychological treatments, based on textual communication, generates a wealth of data that can contribute to knowledge of online and face-to-face treatments. We investigated whether clients' language use predicted treatment outcomes and adherence in Master Your Mood (MYM), an online group course for young adults with depressive symptoms. METHODS: Among 234 participants from a randomised controlled trial of MYM, we tested whether their word use on course application forms predicted baseline levels of depression, anxiety and mastery, or subsequent treatment adherence. We then analysed chat session transcripts of course completers (n=67) to investigate whether word use changes predicted changes in treatment outcomes. RESULTS: Depression improvement was predicted by increasing use of 'discrepancy words' during treatment (e.g. should). At baseline, more discrepancy words predicted higher mastery level. Adherence was predicted by more words used at application, more social words and fewer discrepancy words. LIMITATIONS: Many variables were included, increasing the chance of coincidental results. This risk was constrained by examining only those word categories that have been investigated in relation to depression or adherence. CONCLUSIONS: This is the first study to link word use during treatment to outcomes of treatment that has proven to be effective in an RCT. The results suggest that paying attention to the length of problem articulation at application and to 'discrepancy words' may be wise, as these seem to be psychological markers. To expand knowledge of word use as psychological marker, research on web-based treatment should include text analysis.

Internet-based intervention to promote mental fitness in mildly depressed adults: design of a randomized controlled trial.

BACKGROUND: Investing in mental well-being is considered a supplement to current mental health service delivery in which the treatment and prevention of mental disorders are core components. It may be possible for people to enhance their well-being by boosting their "mental fitness." OBJECTIVE: Psyfit, an online, multi-component, fully automated self-help intervention, was developed with the aim of improving well-being and reducing depressive symptoms. The efficacy and cost-effectiveness of this intervention will be examined in a randomized controlled trial. METHODS: In this two-armed randomized controlled trial, a total of 290 participants will be assigned to use Psyfit (experimental condition) or to a 6-month waiting list (control condition). Adults with mild to moderate depressive symptoms interested in improving their mental fitness will be recruited from the general population through advertisements on the Internet and in newspapers. Online measurements by self-assessment will be made prior to randomization (pre-test), 2 months after baseline (post-test), and 6 months after baseline (follow-up). RESULTS: The primary outcome is well-being. Secondary outcomes are depressive symptoms, general health, vitality, and economic costs. Analysis will be conducted in accordance with the intention-to-treat principle. CONCLUSIONS: This study will examine the efficacy and cost-effectiveness of an online intervention that aims to promote well-being in people with elevated levels of depressive symptoms. If shown to be effective, the intervention could prove to be an affordable and widely accessible intervention to improve well-being in the general population. TRIAL REGISTRATION: The study is registered with the Netherlands Trial Register, part of the Dutch Cochrane Centre (NTR2126).

Effectiveness of an online group course for adolescents and young adults with depressive symptoms: study protocol for a randomized controlled trial.

BACKGROUND: Depression is a common condition whose first onset is usually in late adolescence or early adulthood. Internet-based interventions are an effective treatment approach to depression. The aim of this study is to investigate the effectiveness of a Dutch online cognitive-behavioural group course known as Master Your Mood (Grip op Je Dip) for young people reporting depressive symptoms. Secondary research questions involve maintenance of effect at 6 months, mediators, and predictors of better outcomes. METHODS: We will conduct a randomised controlled trial (RCT) in which 244 young people aged 16-25 are randomly allocated to the Grip op Je Dip (GOJD) online group course or to a waiting list control group. The participants will be recruited from the general population. The primary outcome measure will be the severity of depressive symptoms according to the Center for Epidemiological Studies Depression Scale (CES-D). Other outcomes will include anxiety (Hospital Anxiety and Depression Scale-Anxiety, HADS) and mastery (Mastery Scale). Assessments will take place in both groups at baseline and three months later. Effect maintenance will be studied in the GOJD group six months after baseline, with missing data imputed using the expectation-maximisation method. Mediators and predictors of better outcomes will also be identified. DISCUSSION: The trial should add to the body of knowledge on the effectiveness of Internet-based interventions for depression. To our knowledge, this will be the first RCT on an online group intervention in this field. TRIAL REGISTRATION: NTR1694.