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"Donker, T."
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Economic evaluations of Internet interventions for mental health: a systematic review
2015
Internet interventions are assumed to be cost-effective. However, it is unclear how strong this evidence is, and what the quality of this evidence is.
A comprehensive literature search (1990-2014) in Medline, EMBASE, the Cochrane Central Register of Controlled Trials, NHS Economic Evaluations Database, NHS Health Technology Assessment Database, Office of Health Economics Evaluations Database, Compendex and Inspec was conducted. We included economic evaluations alongside randomized controlled trials of Internet interventions for a range of mental health symptoms compared to a control group, consisting of a psychological or pharmaceutical intervention, treatment-as-usual (TAU), wait-list or an attention control group.
Of the 6587 abstracts identified, 16 papers met the inclusion criteria. Nine studies featured a societal perspective. Results demonstrated that guided Internet interventions for depression, anxiety, smoking cessation and alcohol consumption had favourable probabilities of being more cost-effective when compared to wait-list, TAU, group cognitive behaviour therapy (CBGT), attention control, telephone counselling or unguided Internet CBT. Unguided Internet interventions for suicide prevention, depression and smoking cessation demonstrated cost-effectiveness compared to TAU or attention control. In general, results from cost-utility analyses using more generic health outcomes (quality of life) were less favourable for unguided Internet interventions. Most studies adhered reasonably to economic guidelines.
Results of guided Internet interventions being cost-effective are promising with most studies adhering to publication standards, but more economic evaluations are needed in order to determine cost-effectiveness of Internet interventions compared to the most cost-effective treatment currently available.
Journal Article
Is guided self-help as effective as face-to-face psychotherapy for depression and anxiety disorders? A systematic review and meta-analysis of comparative outcome studies
by
Cuijpers, P.
,
Li, J.
,
van Straten, A.
in
Anxiety
,
Anxiety disorders
,
Anxiety Disorders - therapy
2010
Although guided self-help for depression and anxiety disorders has been examined in many studies, it is not clear whether it is equally effective as face-to-face treatments.MethodWe conducted a meta-analysis of randomized controlled trials in which the effects of guided self-help on depression and anxiety were compared directly with face-to-face psychotherapies for depression and anxiety disorders. A systematic search in bibliographical databases (PubMed, PsycINFO, EMBASE, Cochrane) resulted in 21 studies with 810 participants.
The overall effect size indicating the difference between guided self-help and face-to-face psychotherapy at post-test was d=-0.02, in favour of guided self-help. At follow-up (up to 1 year) no significant difference was found either. No significant difference was found between the drop-out rates in the two treatments formats.
It seems safe to conclude that guided self-help and face-to-face treatments can have comparable effects. It is time to start thinking about implementation in routine care.
Journal Article
Predictors of treatment dropout in self-guided web-based interventions for depression: an ‘individual patient data’ meta-analysis
2015
It is well known that web-based interventions can be effective treatments for depression. However, dropout rates in web-based interventions are typically high, especially in self-guided web-based interventions. Rigorous empirical evidence regarding factors influencing dropout in self-guided web-based interventions is lacking due to small study sample sizes. In this paper we examined predictors of dropout in an individual patient data meta-analysis to gain a better understanding of who may benefit from these interventions.
A comprehensive literature search for all randomized controlled trials (RCTs) of psychotherapy for adults with depression from 2006 to January 2013 was conducted. Next, we approached authors to collect the primary data of the selected studies. Predictors of dropout, such as socio-demographic, clinical, and intervention characteristics were examined.
Data from 2705 participants across ten RCTs of self-guided web-based interventions for depression were analysed. The multivariate analysis indicated that male gender [relative risk (RR) 1.08], lower educational level (primary education, RR 1.26) and co-morbid anxiety symptoms (RR 1.18) significantly increased the risk of dropping out, while for every additional 4 years of age, the risk of dropping out significantly decreased (RR 0.94).
Dropout can be predicted by several variables and is not randomly distributed. This knowledge may inform tailoring of online self-help interventions to prevent dropout in identified groups at risk.
Journal Article
Automated mobile virtual reality cognitive behavior therapy for aviophobia in a natural setting: a randomized controlled trial
2023
BackgroundAccess to evidence-based psychological treatment is a challenge worldwide. We assessed the effectiveness of a fully automated aviophobia smartphone app treatment delivered in combination with a $5 virtual reality (VR) viewer.MethodsIn total, 153 participants from the Dutch general population with aviophobia symptoms and smartphone access were randomized in a single-blind randomized controlled trial to either an automated VR cognitive behavior therapy (VR-CBT) app treatment condition (n = 77) or a wait-list control condition (n = 76). The VR-CBT app was delivered over a 6-week period in the participants' natural environment. Online self-report assessments were completed at baseline, post-treatment, at 3-month and at 12-month follow-up. The primary outcome measure was the Flight Anxiety Situations Questionnaire (FAS). Analyses were based on intent-to-treat.ResultsA significant reduction of aviophobia symptoms at post-test for the VR-CBT app compared with the control condition [p < 0.001; d = 0. 98 (95% CI 0.65–1.32)] was demonstrated. The dropout rate was 21%. Results were maintained at 3-month follow-up [within-group d = 1.14 (95% CI 0.46–1.81)] and at 12-month follow-up [within-group d = 1.12 (95% CI 0.46–1.79)]. Six participants reported adverse effects of cyber sickness symptoms.ConclusionsThis study is the first to show that fully automated mobile VR-CBT therapy delivered in a natural setting can maintain long-term effectiveness in reducing aviophobia symptoms. In doing so, it offers an accessible and scalable evidence-based treatment solution that can be applied globally at a fraction of the cost of current treatment alternatives.
Journal Article
0Phobia – towards a virtual cure for acrophobia: study protocol for a randomized controlled trial
2018
Background
Virtual reality exposure therapy (VRET) has been shown to be as effective as traditional forms of in vivo exposure therapy for the treatment of specific phobias. However, as with in vivo exposure, VRET still involves relatively high costs and limited accessibility which makes it prohibitive for a large part of the population. Innovative methods using smartphone applications (apps) may improve accessibility and scalability of VRET. The aim of this study is to evaluate 0Phobia, a gamified self-guided VRET for acrophobia that is delivered through a smartphone app in combination with rudimentary cardboard virtual reality (VR) goggles.
Methods/design
Participants (
N
= 180, aged 18–65 years) with acrophobia symptoms will be recruited from the Dutch general population and randomized to either 0Phobia (
n
= 90) or a waitlist control condition (
n
= 90). 0Phobia will be delivered over a period of 3 weeks and includes psychoeducation, VR exposure, cognitive techniques, monitoring of symptoms, and relapse prevention. The primary outcome measure will be the Acrophobia Questionnaire. Secondary outcome measures will include user-friendliness, symptoms of anxiety, depression, and mastery. Assessments will take place online at baseline, directly after the intervention (post test) and at follow-up (3 months).
Discussion
This study capitalizes on novel technology and recent scientific advances to develop an affordable and scalable treatment modality.
Trial registration
Netherlands Trial Register:
NTR6442
. Registered on 29 June 2017.
Journal Article
E-care 4 caregivers – an online intervention for nonprofessional caregivers of patients with depression: study protocol for a pilot randomized controlled trial
2016
Background
Nonprofessional caregivers are highly important in the everyday life of patients with depression. Yet, they may experience increased levels of burden, stress, depression, and anxiety. Therefore, there is a need for interventions that relieve symptoms and are accessible and time-efficient. This paper describes the protocol of a pilot study to evaluate (1) the feasibility of an online self-management intervention, E-care 4 caregivers, for the nonprofessional caregiver of patients with depression, and (2) the initial effects of E-care 4 caregivers on psychological distress, subjective burden, symptoms of anxiety and depression, and quality of life.
Methods/design
The study is a randomized controlled trial in which we are comparing the E-care 4 caregivers online intervention with a wait list control group. Eighty-four nonprofessional caregivers of patients with depression aged 18 years or older are being recruited from among the general population. Feasibility is determined by semistructured telephone interviews evaluating the subjects’ satisfaction with the intervention and by using a questionnaire on the user-friendliness of the system. The primary outcome measure used to examine the initial effects of the intervention is psychological distress. Secondary outcome measures are subjective burden, symptoms of anxiety and depression, level of mastery, and quality of life. Assessments will be done at baseline and 6 weeks later. Statistical analysis of the effects of the intervention will be carried out on the basis of the intention-to-treat principle.
Discussion
E-care 4 caregivers could potentially benefit nonprofessional caregivers, as well as patients and professionals indirectly.
Trial registration
Netherlands Trial Register identifier:
NTR5268
. Registered on 30 June 2015.
Journal Article
Implementation of Internet-based preventive interventions for depression and anxiety: role of support? The design of a randomized controlled trial
by
Riper, Heleen
,
Donker, Tara
,
van Straten, Annemieke
in
Access control
,
Anxiety
,
Anxiety disorders
2009
Background
Internet-based self-help is an effective preventive intervention for highly prevalent disorders, such as depression and anxiety. It is not clear, however, whether it is necessary to offer these interventions with professional support or if they work without any guidance. In case support is necessary, it is not clear which level of support is needed. This study examines whether an internet-based self-help intervention with a coach is more effective than the same intervention without a coach in terms of clinical outcomes, drop-out and economic costs. Moreover, we will investigate which level of support by a coach is more effective compared to other levels of support.
Methods
In this randomized controlled trial, a total of 500 subjects (18 year and older) from the general population with mild to moderate depression and/or anxiety will be assigned to one of five conditions: (1) web-based problem solving through the internet (self-examination therapy) without a coach; (2) the same as 1, but with the possibility to ask help from a coach on the initiative of the respondent (on demand, by email); (3) the same as 1, but with weekly scheduled contacts initiated by a coach (once per week, by email); (4) weekly scheduled contacts initiated by a coach, but no web-based intervention; (5) information only (through the internet). The interventions will consist of five weekly lessons. Primary outcome measures are symptoms of depression and anxiety. Secondary outcome measures are drop-out from the intervention, quality of life, and economic costs. Other secondary outcome measures that may predict outcome are also studied, e.g. client satisfaction and problem-solving skills. Measures are taken at baseline (pre-test), directly after the intervention (post-test, five weeks after baseline), 3 months later, and 12 months later. Analysis will be conducted on the intention-to-treat sample.
Discussion
This study aims to provide more insight into the clinical effectiveness, differences in drop-out rate and costs between interventions with and without support, and in particular different levels of support. This is important to know in relation to the dissemination of internet-based self-help interventions.
Trial Registration
Nederlands Trial Register (NTR): TC1355
Journal Article
Addressing missing data in randomized clinical trials: A causal inference perspective
2020
The importance of randomization in clinical trials has long been acknowledged for avoiding selection bias. Yet, bias concerns re-emerge with selective attrition. This study takes a causal inference perspective in addressing distinct scenarios of missing outcome data (MCAR, MAR and MNAR).
This study adopts a causal inference perspective in providing an overview of empirical strategies to estimate the average treatment effect, improve precision of the estimator, and to test whether the underlying identifying assumptions hold. We propose to use Random Forest Lee Bounds (RFLB) to address selective attrition and to obtain more precise average treatment effect intervals.
When assuming MCAR or MAR, the often untenable identifying assumptions with respect to causal inference can hardly be verified empirically. Instead, missing outcome data in clinical trials should be considered as potentially non-random unobserved events (i.e. MNAR). Using simulated attrition data, we show how average treatment effect intervals can be tightened considerably using RFLB, by exploiting both continuous and discrete attrition predictor variables.
Bounding approaches should be used to acknowledge selective attrition in randomized clinical trials in acknowledging the resulting uncertainty with respect to causal inference. As such, Random Forest Lee Bounds estimates are more informative than point estimates obtained assuming MCAR or MAR.
Journal Article
Effectiveness of a psycho-educational intervention for expecting parents to prevent postpartum parenting stress, depression and anxiety: a randomized controlled trial
by
Donker, Tara
,
van Straten, Annemieke
,
Beijers, Roseriet
in
Adult
,
Anxiety
,
Anxiety - epidemiology
2020
Background
The first months postpartum can be challenging for parents, leading to elevated symptoms of parenting stress, depression and anxiety. In turn, distressed parents are at higher risk for providing suboptimal quality of caregiving. As psychoeducational interventions can be effective in reducing psychological distress, the goal of this randomized controlled trial was to examine the effectiveness of low-intensity universal psychoeducational program to prevent postpartum parenting stress, and to enhance parental well-being and caregiving quality.
Method
Between 26 and 34 weeks of pregnancy, 138 pregnant women and 96 partners were randomized to the intervention or a waitlist control group. The intervention consisted of a booklet, a video, a home visit, and a telephone call. Information was provided on (1) sensitive responsiveness, adapting to the parental role, and attending to own needs; (2) crying patterns; (3) feeding (arrangements); and (4) sleeping (arrangements). The primary outcome was parenting stress postpartum. Secondary outcomes were additional measures of distress (depression and anxiety), parental well-being, and caregiving quality.
Results
Both groups showed a rise in distress after birth. No between-group differences were observed on parenting stress, nor on the secondary outcomes. The intervention was rated as useful and of added value by the parents.
Conclusion
This study offered no evidence that our universal prevention program was effective in decreasing parental distress or in increasing caregiving quality. However, parents found aspects of the intervention useful. More research is needed, including a longer period of follow-up as well as observational measures of parents’ responsiveness.
Trial registration
This trial has been registered on 15 September 2016 in the Netherlands National Trial Register, ID: NTR6065,
https://www.trialregister.nl/trial/5782
.
Journal Article