Predicting clinical outcomes in a blended care intervention for early psychosis: Acceptance and Commitment Therapy in Daily-Life (ACT-DL)

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Predicting clinical outcomes in a blended care intervention for early psychosis: Acceptance and Commitment Therapy in Daily-Life (ACT-DL)

https://doi.org/10.21203/rs.3.rs-3573840/v1

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ACT in Daily Life (ACT-DL) is a blended-care Ecological Momentary Intervention that extends ACT into the daily life of individuals, improving psychotic distress, negative symptoms, and global functioning. However, it remains unclear whether ACT-DL works equally for everyone. We investigated whether moderators (i.e., sociodemographic information, personality, and trauma history) determine clinical outcomes in individuals with early psychosis receiving ACT-DL. Seventy-one participants from the INTERACT trial, using ACT-DL, were analyzed. Outcomes included psychotic distress, negative symptoms, global functioning, and psychological flexibility. Using multivariate-multilevel models, we evaluated the effects of sociodemographics, personality, and childhood trauma across baseline, post-intervention, and six- and 12-month follow-ups. Sociodemographic characteristics and personality predicted clinical outcomes. Higher education demonstrated more substantial improvement in global functioning at 6- (B = 7.43, p = .04) and 12-FU (B = 10.74, p = .002) compared to lower education. Higher extraversion showed less improvement in negative symptoms at 12-FU (B = 1.24, p = .01) and more improvement in global functioning at post-intervention (B = 0.39, p = .046) and 6-FU (B = 1.40, p = .02) compared to lower extraversion. Higher neuroticism showed more improvement in negative symptoms at 12-FU (B = -1.59, p = .001) and higher psychological flexibility at 12-FU (B = 8.38, p = .001) compared to lower neuroticism. Our findings suggest that while ACT-DL improves clinical outcomes in individuals with early psychosis, the improvement rate is dissimilar for individuals and predictable by baseline characteristics. If replicated, these findings enable precision medicine approaches in allocating ACT-DL for early psychosis.

Biological sciences/Neuroscience

Biological sciences/Psychology

Health sciences/Diseases/Psychiatric disorders/Schizophrenia

Psychosis exists on a continuum ^1,2, ranging from subclinical psychotic experiences in the Ultra-High-Risk stage (UHR) and First Episode Psychosis (FEP) to fully developed psychotic disorders like schizophrenia ^3,4. This continuum includes individuals who may not meet the criteria for a clinical diagnosis of psychosis but who experience psychotic-like symptoms, distress, and impairment. Psychological interventions for early-stage psychosis are available and have shown promising results in reducing symptoms and distress, improving functionality, and preventing or delaying the onset of a full-blown psychotic disorder ^5,6. Blended-care interventions combining digital tools with traditional face-to-face therapy have proven effective in various mental disorders ^7–9. However, it remains unclear what factors predict individual responses to blended-care interventions for early psychosis. This lack of knowledge limits the ability to personalize interventions and create appropriate clinical guidelines about what works for whom ⁶.

One promising example of a blended-care intervention for early psychosis is the Ecological Momentary Intervention (EMI) named "Acceptance and Commitment in Daily Life" (ACT-DL). ACT-DL combines face-to-face Acceptance and Commitment Therapy (ACT) with a smartphone application (app) that assesses momentary psychological states and provides users with ACT exercises and metaphors in their daily lives outside of the therapy room ¹⁰. The efficacy of ACT-DL as an EMI was evaluated in a Randomized Controlled Trial (RCT) called INTERACT ¹¹. In the INTERACT trial, the ACT-DL intervention demonstrated improved psychotic distress compared to baseline, although no significant difference was found compared to treatment as usual (TAU). However, ACT-DL generally showed small to moderate effects in improving negative symptoms and global functioning compared to TAU ¹². While specific individuals improved, others may not have benefitted as much or may have potentially deteriorated. Moderator analysis is one way to explore individual differences in treatment response. Sociodemographic information, personality traits, and childhood trauma might be relevant moderators determining clinical outcomes in individuals with early psychosis.

Sociodemographic characteristics, including age, sex, and education, influence perceptions of, engagement with, and outcomes of psychological therapies. First, research has shown that young individuals with early psychosis generally have positive attitudes toward blended-care interventions ¹³. Male sex has also been associated with lower engagement and poorer clinical outcomes than female sex in traditional face-to-face psychological interventions and mental health apps, some of which were EMIs ^14–16. Similarly, lower education levels have been associated with higher dropout and lower use of both face-to-face and digitally delivered mental health interventions (including apps) than higher education levels ^15,17,18. Second, personality traits have been studied in relation to first-episode psychosis (FEP) and psychotherapy outcomes ^19–24. Individuals with FEP reported lower levels of extraversion and higher levels of neuroticism compared to healthy controls ^25,26. In the psychotherapy literature, high-trait neuroticism is associated with higher symptom severity and lower treatment adherence, while high-trait extraversion is associated with greater symptom improvement and treatment participation²⁷. Finally, childhood trauma has been shown to negatively impact the course and prognosis of FEP ²⁸. Individuals with FEP who have a history of childhood trauma are more likely to be classified as non-responders to treatment, and exhibit higher readmission rates and lower compliance with psychotherapy than individuals without childhood trauma ^29,30. Some studies have also indicated that childhood trauma can predict treatment efficacy, with specific interventions being more effective for individuals with a trauma history ^31,32.

To better understand who might benefit most from ACT-DL, the current study aims to explore whether inter-individual factors moderate the effects of ACT-DL on psychotic distress, negative symptoms, global functioning, and psychological flexibility over time. We will investigate the following confirmatory hypotheses: (1) individuals with a lower education level will show less improvement in negative symptoms, psychotic distress, global functioning, and psychological flexibility than individuals with higher education levels over time; (2) individuals who score higher on neuroticism or lower on extraversion will show less improvement over time in negative symptoms, psychotic distress, global functioning and psychological flexibility than individuals who score lower on neuroticism or higher on extraversion; and (3) individuals with higher levels of childhood trauma will show less improvement over time in negative symptoms, psychotic distress, global functioning and psychological flexibility than individuals with lower levels of childhood trauma. Additionally, we will perform an exploratory analysis to investigate whether age and sex moderate the effect of ACT-DL on psychotic distress, negative symptoms, global functioning, and psychological flexibility over time. Findings will provide clinical guidance for whom ACT-DL might be an appropriate blended-care intervention. All statistical analyses were apriori specified in a post-registered analysis plan (https://osf.io/xr9as/?view_only=a1ec33c65c824ca899aef08ffaec2bc6), which is a registration after data is collected but before data has been accessed and analyzed.

Participants

This study conducts secondary analyses of the INTERACT dataset (Reininghaus et al., 2019). The INTERACT dataset contains one hundred and forty-eight participants (78 UHR and 70 FEP) recruited from secondary mental health services in five regions in the Netherlands and Belgium. For inclusion, individuals needed to be between 15 and 65 years old, fluent in Dutch, and able to provide written informed consent. If UHR, participants could not use antipsychotic medication for psychotic symptoms before the study; if FEP, participants needed to have had one psychotic episode within the last three years. Exclusion criteria included a primary diagnosis of alcohol/substance abuse or dependence and severe endocrine, cardiovascular, or brain disease. The current study only included individuals randomized to the ACT-DL condition (n = 71). Refer to the protocol paper for more information on the sample and methods used in INTERACT ¹¹.

Procedures

Participants were recruited from secondary mental health services in five regions in the Netherlands and Belgium: (1) Amsterdam, (2) The Hague, (3) Maastricht/Eindhoven, (4) Vlaams-Brabant/Antwerpen and (5) Oost- & West-Vlaanderen. Participants were provided with initial information about the study by their treating clinician. The study team contacted individuals interested in participating, provided a complete explanation, and asked them to sign the informed consent form. When participants signed informed consent, the researcher conducted a full eligibility assessment. Eligible participants were randomly assigned in a 1:1 ratio to either the experimental condition (ACT-DL + TAU) or the control condition (TAU). Post-intervention and follow-up assessments were carried out by trained researchers who were blind to the participants' assigned condition. Assessments were conducted at baseline, after the 8-week intervention period, and after six-month and 12-month follow-ups. The study received ethical approval from the MERC at Maastricht University Medical Centre (MUMC), the Netherlands (reference: NL46439.068.13) and the University Clinic Leuven, Belgium (reference: B322201629214).

Intervention

The ACT-DL intervention ^10,33 consisted of eight weekly manualized ACT-sessions administered face-to-face by a trained clinician and an EMI in the form of an app. EMIs are interventions that are provided in the context of daily life ³⁴. ACT uses cognitive and behavioral techniques to improve psychological flexibility (i.e., adapting cognitive strategies to changing environmental conditions), decrease stress, and improve quality of life ³⁵. The first session involved general psychoeducation; the following six sessions focused on ACT skills, including acceptance, cognitive defusion, self-as-context, contact with the present moment, values, and committed action ^35–37. The final session was a summary of all the previous components. The EMI app prompted participants daily at eight semi-random moments for three days after each face-to-face session, starting from the second session onwards. Participants answered a brief questionnaire about their current mood, psychotic experiences, and activities, followed by an exercise or metaphor related to the ACT component covered in the previous session. Participants could also start ACT exercises from the app at any time on command. After the intervention period, access to the app was discontinued ¹¹.

Measures

Moderators

Demographic variables included sex (male or female), age in years, and education level. Education level was defined as the highest educational degree achieved and was divided into six categories: 'elementary school,' 'secondary school – general education,' 'secondary school – technical education,’ 'secondary school – vocational education,' 'Bachelor,' and 'Master.' We redefined education level into two categories: 'lower education,' including elementary and all secondary school degrees, and 'higher education,' including Bachelor's and Master's degrees.

The personality traits extraversion and neuroticism were assessed with The Eysenck Personality Questionnaire-Revised Short Form (EPQR-SF) ^38,39, a self-report questionnaire consisting of 48 items with a binary (YES or NO) answer option. Extraversion and neuroticism were assessed using the 12 items of the corresponding subscales, with higher scores reflecting higher trait levels. The internal consistency of the extraversion and neuroticism subscales have been assessed in a reliability generalization study and were found to be very good to excellent, with (α = .82) and (α = .83), respectively ⁴⁰. In our sample, internal consistency was excellent for extraversion (α = .85) and neuroticism (α = .84).

Childhood trauma was measured using the Childhood Trauma Questionnaire Short Form (CTQ-SF) ⁴¹. The CTQ-SF is a widely used 28-item self-report measure designed to assess the frequency and severity of childhood abuse and neglect, including emotional, physical, and sexual abuse and emotional and physical neglect. Items are rated on a 5-point Likert scale reflecting the frequency of the traumatic experience. Given that the different forms of trauma often occur together and strict separation of individual effects of a specific type is difficult ^42–44, we computed a CTQ total score from the sum of all subscale scores (range: 25 to 125). We ran descriptive analyses using the describe function to visually check the variability of childhood trauma responses. Data were positively skewed, indicating that more individuals had lower trauma scores than individuals with high trauma. We used the categories' no-low trauma' (CTQ ≤ 51), 'moderate trauma' (51 < CTQ ≤ 68), and 'severe trauma' (CTQ > 68) based on cut-off scores of the individual trauma type subscales ⁴¹. The internal consistency in our sample was excellent (α = .90).

Clinical outcomes

Psychotic distress was measured using the Comprehensive Assessment of At-Risk Mental States (CAARMS) positive symptom subscales ⁴⁵. This semi-structured interview assesses the intensity, frequency, and emotional distress of various positive symptoms to determine if an individual meets the criteria for UHR or FEP. The CAARMS has good psychometric properties and is widely adopted as a high-quality tool for assessing changes in psychotic distress in early psychosis ^46,47. A psychotic distress total score was calculated by summing scores from the four CAARMS positive symptom scales (unusual thought disorder, non-bizarre ideas, perceptual abnormalities, and speech disorder), each ranging from 0 to 100, with 0 meaning 'not distressed at all' and 100 meaning 'extremely distressed.' Missing distress scores were excluded from the calculation as they indicate a lack of distress for that symptom.

Negative symptoms were assessed with the Brief Negative Symptom Scale (BNSS) ⁴⁸. The BNSS captures the five negative symptoms reached by the NIMH consensus ⁴⁹ (Avolition, Blunted affect, Anhedonia, Alogia, and Asociality) and measures an individual's ability to experience normal distress (Distress subscale). These six subscales have 13 items each, rated using a 7-point Likert Scale ranging from 0 'No impairment' to 6: 'Severe deficit'. A total score was calculated by summing the subscale scores (range from 0 to 78), with higher scores indicating more severe negative symptoms. The BNSS has good convergent and discriminant validity, is sensitive to change, and has good internal consistency ⁵⁰. The within-person (ω = .90) and between-person (ω = .93) consistency was excellent in our sample.

Global functioning was assessed using the single-item Social and Occupational Functioning Assessment Scale (SOFAS) ⁵¹. The SOFAS focuses exclusively on the individual's social and occupational functioning level and is not directly influenced by the overall severity of the individual's psychological symptoms. The SOFAS is rated on one continuous scale ranging from 1 'Severe malfunctioning in a wide range of activities' to 100 'Superior functioning in a wide range of activities'.

Clinical process outcome

Psychological flexibility was measured using the Flexibiliteits Index Test (FIT-60), a reliable and validated self-report instrument sensitive to change^52,53. The FIT-60 comprises six subscales: 'Acceptance,’ 'Defusion,’ 'Self as context,’ 'Attention for here and now,’ 'Values', and 'Commitment.' Each subscale consists of 10 items scored on a 7-point Likert scale ranging from 0 'Strongly disagree' to 6 'Strongly agree'. A total score was calculated by summing the scores from the different skills, with higher scores meaning more psychological flexibility. Within-person and between-person consistency in our sample was excellent (ω = .92 and ω = .97, respectively).

Data analysis

All statistical analyses were performed in R (version 4.2.2) and specified in the post-registered analysis plan (https://osf.io/dx2rp), which is a registration after data is collected but before data has been accessed and analyzed.

Analyses were conducted in R (version 4.2.2) according to intention to treat principles ¹². Given the hierarchical structure of the data, multilevel modeling was used to examine the effects of inter-individual factors on clinical outcomes over time. Multivariate multilevel models were estimated for the clinical outcomes (psychotic distress, negative symptoms, and global functioning), and univariate multilevel models were estimated for the clinical process outcome (psychological flexibility). Scores at post-intervention, six-month, and 12-month follow-up were the dependent variables. Separate models were estimated for each moderator (age, sex, education, neuroticism, extraversion, childhood trauma), resulting in six multivariate and six univariate models. Time was added as a categorical moderator in each model with 0 = baseline, 1 = post-intervention, 2 = 6-month follow-up, and 3 = twelve-month follow-up. Age and sex were added as covariates in the models assessing the moderating effects of education level, personality traits, and childhood trauma. In other words, independent variables included moderator values, time, baseline scores (grand-mean centered), and the baseline score × moderator value × time interaction. Continuous moderators (age, extraversion, neuroticism) were grand-mean centered to reduce multicollinearity and facilitate intercept interpretation. Categorial moderators were coded as follows: sex (0 = male, 1 = female), education level (0 = lower education, 1 = higher education), and childhood trauma (0 = no-low trauma, 1 = mild trauma, 2 = high trauma). Models allowed for random intercepts and random slopes per timepoint. All models were estimated with the nmle package ⁵⁴ using restricted maximum likelihood (REML) estimations. REML estimations allow for the use of all available data under the assumption that data are missing at random and that all variables associated with the missing values are included in the model. As established in the primary RCT analyses ¹², there was no association between baseline variables and missingness of psychotic distress.

An omnibus-test of no difference was performed at all three time points (Wald-type test with df = 3 and α = 0.05) to determine whether each moderator had a significant overall effect on clinical outcomes. Time-specific contrasts were considered only if a moderator had a significant overall effect (each tested at α = 0.05). This approach precludes adjusting for multiple testing at the level of time-specific contrasts ¹².

Table 1 presents the results of the omnibus-test of no difference (df = 3) for the overall effect of each moderator on the clinical outcomes. Table 2 shows descriptive statistics, adjusted mean differences with 95% confidence intervals, and p-values for moderators at each timepoint (post-intervention, six-month, and 12-month follow-up) compared to baseline. Results are interpreted in terms of an improvement in clinical outcomes.

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Sociodemographics

The omnibus-tests investigating the effects of education level were significant for global functioning (𝛘² = 10.16, p = .017) but not the other clinical outcomes (𝛘²s ≤ 4.66, ps ≥ .198). Follow-up contrasts showed significantly greater improvement in global functioning at six-month follow-up (B = 7.43, SE = 3.62, p = .040) and 12-month follow-up (B = 10.74, SE = 3.45, p = .002) for individuals with high education compared to individuals with low education (Figure 1a). There was a similar pattern at post-intervention, although the difference did not reach statistical significance (B = 6.12, SE = 3.15, p = .053).

For exploratory analyses, only the omnibus-test investigating the effects of sex on psychotic distress was significant (𝛘² = 11.52, p = .009). Follow-up contrasts showed significantly greater improvement for females compared to males in psychotic distress at 12-month follow-up (B = -61.00, SE = 23.69, p = .010) (Figure 1b). There were no significant differences at any other time point.

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Personality traits

The omnibus-tests investigating the effects of extraversion were significant for negative symptoms (𝛘² = 15.09, p = .002) and global functioning (𝛘² = 10.06, p = .018) but not the other clinical outcomes (𝛘²s ≤ 7.53, ps ≥ .057). For negative symptoms, follow-up contrasts did not show a significant difference at post-intervention (B = 0.79, SE = 0.45, p = .080) and six-month follow-up (B = 0.15, SE = 0.52, p = .799), but people with lower compared to higher trait extraversion showed a greater improvement at 12-month follow-up (B = 1.24, SE = 0.48, p = .011) (Figure 2a). For global functioning, there was a significantly greater improvement for people with higher compared to lower trait extraversion at post-intervention (B = .39, SE = 0.53, p = .046) and six-month follow-up (B = 1.40, SE = 0.59, p = .018), but this was not retained at the follow-up assessments (p = .933) (Figure 2b).

The omnibus-tests investigating the effects of neuroticism were significant for negative symptoms (𝛘² = 11,28, p = .010) and psychological flexibility (𝛘² = 14.22, p = .003). Follow-up contrasts showed significantly greater improvement in negative symptoms (B = -1.59, SE = 0.49, p = .001) and psychological flexibility (B = 8.38, SE = 2.43, p = .001) at 12-month follow-up for people with higher compared to lower trait neuroticism (Figure 2c-d). There were no significant differences at any other time point.

[Include Figure 2 about here]

Childhood trauma

The omnibus-tests investigating the effects of childhood trauma were significant only for individuals with high childhood trauma compared to none-to-low childhood trauma on psychological flexibility (𝛘² = 7.88, p = .049). However, follow-up contrasts did not show significant differences at any time point (ps ≥ .184) (Figure 3).

[Include Figure 3 about here]

The present study examined if inter-individual factors moderated treatment responses in individuals experiencing early-stage psychosis who utilized the blended-care intervention ACT-DL⁵⁵. We found that none of the moderators we examined negatively affected the effect of ACT-DL on clinical outcomes, meaning that ACT-DL may be an appropriate intervention for a wide range of individuals with early psychosis. While ACT-DL was generally effective, some moderators significantly influenced the improvement rate, with the most reliable effects for education and personality traits.

For demographics, individuals with a higher educational background consistently showed more significant improvement in global functioning than those with a lower educational background over time. This partially confirms our hypothesis that individuals with higher education would benefit more from ACT-DL. Possible explanations for this effect are that individuals with high education show more engagement with therapy ^56,57 and tend to be more 'tech-savvy' ¹⁸. Higher technological literacy might have affected how individuals used ACT-DL, resulting in a possible dose effect. Earlier findings by Batink et al. (2016) strengthen this idea; they found a weak association between the dose of ACT-DL and clinical outcomes (including psychological flexibility), where the dose was defined as the self-reported number of executed exercises during the ACT-DL and time spent on those exercises ³³. Our exploratory analyses showed that ACT-DL generally works equally well for males and females and that age did not significantly affect improvement rates.

For personality traits, our results revealed that both extraversion and neuroticism impacted responses to ACT-DL, albeit not always in keeping with our hypotheses. Consistent with our expectations, individuals with higher trait extraversion initially experienced a more rapid enhancement in their global functioning. However, at 12-month follow-up, higher and lower trait extraversion individuals converged to similar levels of global functioning. Contrary to our expectations, we found that individuals with lower trait extraversion and higher trait neuroticism significantly improved negative symptoms and psychological flexibility. The pattern of results showed a steady decline in negative symptoms for individuals with low trait extraversion and high trait neuroticism over time, alongside a steady increase in psychological flexibility, whereas the comparison groups exhibited stable symptom levels from baseline to 12-month follow-up. These effects could be explained by the possibility that individuals with lower extraversion or higher neuroticism begin treatment with more severe symptoms and lower psychological skills, allowing them more room for growth. Prior research supports this idea, linking lower extraversion to decreased social skills and higher neuroticism to more severe negative symptoms^27,58. A potential regression to the mean due to a broader margin for improvement could offer one explanation for these observations.

Additionally, it is worth considering that individuals with high trait neuroticism, defined by heightened attention to criticism, feelings of inadequacy, and a perceived lack of control, might experience greater benefits from ACT-DL. This is because ACT emphasizes accepting negative emotions and enhancing values-based behaviors, directly addressing these vulnerabilities ⁵⁹. Importantly, we found evidence that childhood trauma did not have any moderating effects on clinical outcomes, proving ACT-DL to be a safe and effective treatment for individuals with a history of childhood trauma.

Our study opens multiple avenues for future research. Given that only 59% of our participants completed the full intervention ¹², methods to boost therapy engagement are pivotal to maximizing clinical outcomes. One possible solution is to provide personalized feedback on an individual's ecological-momentary-assessment data (EMA) in an interactive way. For example, embedding an overview page within the app that provides weekly statistics on the user's EMA data and ACT-exercises might increase engagement with the intervention. Prior research supports this idea and found that personalized feedback is a strong motivator for using EMA tools and enhances uptake and adherence without altering the intervention's core principles ^60–62). Another solution is to enhance ACT-DL's efficacy at the individual level. Bacon et al. (2014) conducted qualitative research in which participants identified the distinct benefits of various ACT components. Mindfulness and Defusion, Acceptance, and Values were linked to stress reduction, providing life direction and meaning, and mitigating distress from unwanted private events, respectively. These findings suggest that different ACT components uniquely impact distinct facets of an individual's mental health. Future research should explore whether specific ACT-DL components distinctly influence particular symptoms or psychological processes. Such understanding would allow therapists to tailor the ACT-DL intervention to the individual's unique problem areas (e.g., psychotic distress). While our study provides valuable insights into the effects of moderators on treatment outcomes, several limitations warrant consideration. First, this study aimed to determine if specific moderators affected treatment outcomes in individuals who received ACT-DL. To maintain sufficient power for our confirmatory hypotheses, we narrowed our analysis exclusively to the ACT-DL group, refraining from comparisons with a control group. For a more definitive attribution of the observed changes to the intervention, future controlled studies conducted on larger samples are essential to validate our findings. Second, our sample comprised both FEP and UHR participants. While both categories signify early psychosis and are temporally and phenomenologically continuous, they represent different illness stages. Given that individuals with FEP had symptoms that reached the criteria for formal diagnosis and UHR did not, it is possible that both groups responded differently to ACT-DL. However, subgroup analysis in the primary study revealed no discernible differences between the UHR and FEP groups, and due to the study's randomization ^11,12, these and other potential confounding variables were evenly distributed across conditions. Third, throughout the treatment period, which includes the six- and 12-month follow-ups, FEP individuals may have been prescribed antipsychotics if deemed clinically necessary. While this was also true for the control condition, and even though we observed significant differences in treatment outcomes between the ACT-DL and control groups ¹², it remains unknown whether the longer-term effects identified in this study can be attributed exclusively to the ACT-DL intervention. In conclusion, this study highlights the importance of inter-individual factors as moderators of ACT-DL on clinical outcomes. Responses to ACT-DL were generally promising.

These limitations notwithstanding, this study highlights the importance of inter-individual factors as moderators of ACT-DL on clinical outcomes. We found evidence that education level, neuroticism, and extraversion predicted improvement rates of ACT-DL in individuals with early psychosis. Future research should replicate these findings in more extensive and diverse samples and explore strategies to enhance the effectiveness of ACT-DL for a broader range of individuals.

Required Statements

Financial support

RB is funded by the European Union's Horizon 2020 Research and Innovation Programme under grant agreement 945263 (IMMERSE). This work was further supported by an ERC Consolidator Grant (ERC-2012-StG, project 309767-INTERACT) and FWO Odysseus Grant (No. G0F8416N) awarded to IMG as well as a NWO VENI Grant (No. 451-13-022) and DFG Heisenberg professorship (No. 389624707) awarded to UR. JRB was supported by a Marie Marie Skłodowska-Curie fellowship (101063326). GK is supported by the Research Foundation Flanders (12ZZM21N/1204924N). TV was supported by a Postdoctoral Fellowship grant from Research Foundation Flanders (FWO 1243620N).

Ethical standards

The study received ethical approval from the MERC at Maastricht University Medical Centre (MUMC), the Netherlands (reference: NL46439.068.13) and the University Clinic Leuven, Belgium (reference: B322201629214). Written consent was obtained from each participant prior to assessment and randomization, as detailed in the study protocol (version 12, 18 May 2018). The trial was prospectively registered in the Netherlands Trial Register (NTR4252).

Competing interests

The authors declare none.

Data Availability Statement

Deidentified data are available upon request through a data access system, Data Curation for Open Science (DROPS), administered via REDCap at the Center for Contextual Psychiatry, KU Leuven. Interested researchers can submit an abstract, which is subject to review by the research team to ensure there is no overlap with existing projects. Following abstract approval, a variable access request is submitted, and researchers are required to preregister their analysis plan. A dataset containing only variables required for the proposed analysis is then released to the researchers by a data manager, along with a time- and date-stamped receipt of data access.

Author Note

The authors have no competing interests to declare relevant to this article's content.

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Predicting clinical outcomes in a blended care intervention for early psychosis: Acceptance and Commitment Therapy in Daily-Life (ACT-DL)

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