[Blended care: state of research and possibilities for implementation]. / Blended Care: Stand der Forschung und Implementierungsmöglichkeiten.

BACKGROUND: Psychotherapy is effective in treating mental disorders; however, not all patients benefit to the same extent and treatment gains are not always maintained. Blended care (BC) has the potential to improve psychotherapeutic care by combining traditional psychotherapy with online contents. OBJECTIVE: To explore the potential of BC for psychotherapeutic care and investigate its implementation possibilities. MATERIAL AND METHODS: Presentation of the effectiveness of various BC modalities, attitudes of users and decision-makers, and discussion of recommendations for its implementation. RESULTS: Indications for the effectiveness of BC in different modalities has been shown in several studies. Both therapists and patients prefer BC over a purely online intervention and want customizable contents; however, it remains unclear for which patients BC is a particularly suitable treatment option. CONCLUSION: Various combinations of BC have the potential to be an effective and financially viable treatment option. Successful implementation requires better education about BC and the provision of the necessary infrastructure.

Blended-ALMAMAR app for inpatient mental health care for refugees: study protocol for a multicenter implementation study within the I-REACH consortium (Internet based REfugee mentAl healtH Care).

BACKGROUND: Refugees are at high risk for developing mental illnesses. Due to language and cultural barriers, there is need for specifically adapted therapeutic procedures for refugees in inpatient mental health care settings. Internet-based applications in refugee mother tongues have the potential to improve the outcomes of mental health care for this vulnerable population. The key research question of the present implementation study is whether the newly developed "blended ALMAMAR" app for Arabic and Farsi speaking refugees in Germany is used and accepted by patients and professionals in routine inpatient mental health care (blended care). METHODS: We present the design of an observational, prospective multicenter implementation study in eight psychiatric hospitals. We plan to recruit 100 Farsi or Arabic speaking refugees receiving in-patient treatment due to depression, anxiety disorder, posttraumatic stress disorder or substance use disorders. These patients will get access to the "blended ALMAMAR" app during their inpatient stay in a blended-care approach. We will assess the usage (e.g., duration and frequency of use of the app) as well as subjective acceptability and usability of the intervention. To identify sociodemographic and clinical factors associated with "blended ALMAMAR" usage, we will also perform clinical and questionnaire assessments. DISCUSSION: The newly developed "blended ALMAMAR" app may help to close communication gaps for the hard-to reach and vulnerable group of refugees in inpatient mental health care. It is the first blended-care intervention that addresses severely mentally ill refugees in an inpatient psychiatric setting in Germany. TRIAL REGISTRATION: The trial was registered in the German Clinical Trials Register on November 11, 2021 (DRKS00025972) and adapted on November 14, 2023.

The Negative Effects Questionnaire: psychometric properties of an instrument for assessing negative effects in psychological treatments.

BACKGROUND: Psychological treatments provide many benefits for patients with psychiatric disorders, but research also suggests that negative effects might occur from the interventions involved. The Negative Effects Questionnaire (NEQ) has previously been developed as a way of determining the occurrence and characteristics of such incidents, consisting of 32 items and six factors. However, the NEQ has yet to be examined using modern test theory, which could help to improve the understanding of how well the instrument works psychometrically. AIMS: The current study investigated the reliability and validity of the NEQ from both a person and item perspective, establishing goodness-of-fit, item bias, and scale precision. METHOD: The NEQ was distributed to 564 patients in five clinical trials at post-treatment. Data were analysed using Rasch analysis, i.e. a modern test theory application. RESULTS: (1) the NEQ exhibits fairness in testing across sociodemographics, (2) shows comparable validity for a final and condensed scale of 20 instead of 32 items, (3) uses a rating scale that advances monotonically in steps of 0 to 4, and (4) is suitable for monitoring negative effects on an item-level. CONCLUSIONS: The NEQ is proposed as a useful instrument for investigating negative effects in psychological treatments, and its newer shorter format could facilitate its use in clinical and research settings. However, further research is needed to explore the relationship between negative effects and treatment outcome, as well as to test it in more diverse patient populations.

Avoidant Personality Disorder: a Current Review.

This review focuses on recent research on diagnostic aspects, etiology, and treatment of avoidant personality disorder (AVPD). Current studies stress the close relation between AVPD and social anxiety disorder, the influence of genetic factors in the development of AVPD, and the relative stability of symptoms. Treatment approaches should target the pervasive patterns of social inhibition, feelings of inadequacy, and hypersensitivity to negative evaluation. Empirical evidence for cognitive-behavior and schema therapy is promising. Few other therapeutic approaches have been developed, but until now, these have only been investigated in case studies. We conclude that AVPD qualifies as a neglected disorder and that more research specifically on avoidant personality disorder symptoms and its treatment is needed.

Negative effects of internet interventions: a qualitative content analysis of patients' experiences with treatments delivered online.

Internet interventions are defined as the delivery of health care-related treatments via an online or a smartphone interface, and have been shown to be a viable alternative to face-to-face treatments. However, not all patients benefit from such treatments, and it is possible that some may experience negative effects. Investigations of face-to-face treatments indicate that deterioration occurs in 5-10% of all patients. The nature and scope of other negative effects of Internet interventions is, however, largely unknown. Hence, the current study explored patients' reported negative experiences while undergoing treatments delivered via the Internet. Data from four large clinical trials (total N = 558) revealed that 9.3% of patients reported some type of negative effects. Qualitative content analysis was used to explore the patients' responses to open-ended questions regarding their negative experiences. Results yielded two broad categories and four subcategories of negative effects: patient-related negative effects (insight and symptom) and treatment-related negative effects (implementation and format). Results emphasize the importance of always considering negative effects in Internet-based interventions, and point to several ways of preventing such experiences, including regular assessment of negative events, increasing the flexibility of treatment schedules and therapist contact, as well as prolonging the treatment duration.

Clinicians' perspectives on negative effects of psychological treatments.

Negative effects of psychological treatments is a fairly unexplored area of clinical research. Previous investigations have indicated that a portion of all patients experience negative effects in terms of deterioration and various adverse events. Meanwhile, evidence suggests that many clinicians are untrained in identifying negative effects and unaware of the current research findings. The objective of the current study is thus to investigate clinicians' own perspectives and experiences of possible negative effects of psychological treatments. An invitation to participate in an anonymous online survey consisting of 14 open-ended questions was distributed via three mailing lists used by clinicians that primarily identify themselves as cognitive behavior therapists. The responses were analyzed using a qualitative method based on thematic analysis. In total, 74 participants completed the survey. A majority agreed that negative effects of psychological treatments exist and pose a problem, and many reported having experienced both deterioration and adverse events among patients in their own practice. The thematic analysis resulted in three core themes: characteristics of negative effects, causal factors, as well as methods and criteria for evaluating negative effects. The clinicians recognize that negative effects exist, but many are unaware of the current research findings and are unfamiliar with methods and criteria for identifying and preventing deterioration and adverse events. The results provide evidence for further dissemination of the present knowledge regarding negative effects, particularly during basic clinical training, as well as the need for raising awareness of the available methods for identifying and preventing negative effects.

Combining attention training with internet-based cognitive-behavioural self-help for social anxiety: a randomised controlled trial.

Guided Internet-based cognitive-behavioural self-help (ICBT) has been proven to be effective for social anxiety disorder (SAD) by several independent research groups. However, as the proportion of clinical significant change has room for improvement, new treatments should be developed and investigated. A novel treatment is attention bias modification (ABM). This study aimed at evaluating the combination of ABM and ICBT. We compared two groups, one group receiving ICBT and ABM targeting attentional avoidance and the other group receiving ICBT and control training. ABM and control training tasks were both based on the dot-probe paradigm. A total of 133 participants, diagnosed with SAD, were randomised to these two groups. The attention training group (N = 66) received 2 weeks of daily attention training followed by 9 weeks of ICBT. The control group (N = 67) received 2 weeks of daily control training, also followed by 9 weeks of ICBT. Social anxiety measures as well as the attention bias were assessed at pre-assessment, at week 2, and at post-treatment. Results showed no significant differences between the attention training group and the control group. Both groups improved substantially on social anxiety symptoms from pre- to post-assessment (dwithin = 1.39-1.41), but showed no change in attention processes (dwithin = 0.10-0.17). In this trial, the attention modification training failed to induce differential change in attention bias. Results demonstrate that the applied ABM procedure with its focus on the reduction of attentional avoidance was ineffective in the Internet-based setting. The results do not suggest that adding ABM targeting attentional avoidance to ICBT results in better outcomes than ICBT alone.

A systematic review and meta-analysis of transdiagnostic cognitive behavioural therapies for emotional disorders.

Transdiagnostic cognitive behavioural psychotherapy (TD-CBT) may facilitate the treatment of emotional disorders. Here we investigate short- and long-term efficacy of TD-CBT for emotional disorders in individual, group and internet-based settings in randomized controlled trials (PROSPERO CRD42019141512). Two independent reviewers screened results from PubMed, MEDLINE, PsycINFO, Google Scholar, medRxiv and OSF Preprints published between January 2000 and June 2023, selected studies for inclusion, extracted data and evaluated risk of bias (Cochrane risk-of-bias tool 2.0). Absolute efficacy from pre- to posttreatment and relative efficacy between TD-CBT and control treatments were investigated with random-effects models. Of 56 identified studies, 53 (6,705 participants) were included in the meta-analysis. TD-CBT had larger effects on depression (g = 0.74, 95% CI = 0.57-0.92, P < 0.001) and anxiety (g = 0.77, 95% CI = 0.56-0.97, P < 0.001) than did controls. Across treatment formats, TD-CBT was superior to waitlist and treatment-as-usual. TD-CBT showed comparable effects to disorder-specific CBT and was superior to other active treatments for depression but not for anxiety. Different treatment formats showed comparable effects. TD-CBT was superior to controls at 3, 6 and 12 months but not at 24 months follow-up. Studies were heterogeneous in design and methodological quality. This review and meta-analysis strengthens the evidence for TD-CBT as an efficacious treatment for emotional disorders in different settings.

Internet-based transdiagnostic treatment for emotional disorders in Arabic- and Farsi-speaking refugees: study protocol of a randomized controlled trial.

BACKGROUND: Refugee populations have an increased risk for mental disorders, such as depression, anxiety, and posttraumatic stress disorders. Comorbidity is common. At the same time, refugees face multiple barriers to accessing mental health treatment. Only a minority of them receive adequate help. The planned trial evaluates a low-threshold, transdiagnostic Internet-based treatment. The trial aims at establishing its efficacy and cost-effectiveness compared with no treatment. METHODS: N = 131 treatment-seeking Arabic- or Farsi-speaking patients, meeting diagnostic criteria for a depressive, anxiety, and/or posttraumatic stress disorder will be randomized to either the intervention or the waitlist control group. The intervention group receives an Internet-based treatment with weekly written guidance provided by Arabic- or Farsi-speaking professionals. The treatment is based on the Common Elements Treatment Approach (CETA), is tailored to the individual patient, and takes 6-16 weeks. The control group will wait for 3 months and then receive the Internet-based treatment. DISCUSSION: The planned trial will result in an estimate of the efficacy of a low-threshold and scalable treatment option for the most common mental disorders in refugees. TRIAL REGISTRATION: German Registry for Clinical Trials DRKS00024154. Registered on February 1, 2021.

Patient expectations in internet-based self-help for social anxiety.

A number of controlled trials have demonstrated the efficacy of Internet-based cognitive-behaviour therapy for treating social anxiety disorder (SAD). However, little is known about what makes those interventions work. The current trial focuses on patient expectations as one common mechanism of change. The study examines whether patients' expectancy predicts outcome, adherence, and dropout in an unguided Internet-based self-help programme for SAD. Data of 109 participants in a 10-week self-help programme for SAD were analysed. Social anxiety measures were administered prior to the intervention, at week 2, and after the intervention. Expectancy was assessed at week 2. Patient expectations were a significant predictor of change in social anxiety (ß = - .35 to - .40, all p < .003). Patient expectations also predicted treatment adherence (ß = .27, p = .02). Patients with higher expectations showed more adherence and better outcome. Dropout was not predicted by expectations. The effect of positive expectations on outcome was mediated by early symptom change (from week 0 to week 2). Results suggest that positive outcome expectations have a beneficial effect on outcome in Internet-based self-help for SAD. Furthermore, patient expectations as early process predictors could be used to inform therapeutic decisions such as stepping up patients to guided or face-to-face treatment options.

Who benefits from guided internet-based interventions? A systematic review of predictors and moderators of treatment outcome.

To our knowledge, no systematic review has been conducted on predictors or moderators of treatment outcome across diagnoses in guided internet-based interventions (IBIs) for adults. To identify who benefits from this specific format and therein inform future research on improving patient-treatment fit, we aimed to aggregate results of relevant studies. 2100 articles, identified by searching the databases PsycInfo, Ovid Medline, and Pubmed and through snowballing, were screened in April/May 2021 and October 2022. Risk of bias and intra- and interrater reliability were assessed. Variables were grouped by predictor category, then synthesized using vote counting based on direction of effect. N = 60 articles were included in the review. Grouping resulted in 88 predictors/moderators, of which adherence, baseline symptoms, education, age, and gender were most frequently assessed. Better adherence, treatment credibility, and working alliance emerged as conclusive predictors/moderators for better outcome, whereas higher baseline scores predicted more reliable change but higher post-treatment symptoms. Results of all other predictors/moderators were inconclusive or lacked data. Our review highlights that it is currently difficult to predict, across diagnoses, who will benefit from guided IBIs. Further rigorous research is needed to identify predictors and moderators based on a sufficient number of studies. PROSPERO registration: CRD42021242305.

Does a pre-treatment diagnostic interview affect the outcome of internet-based self-help for social anxiety disorder? a randomized controlled trial.

BACKGROUND: Numerous studies suggest that Internet-based self-help treatments are effective in treating anxiety disorders. Trials evaluating such interventions differ in their screening procedures and in the amount of clinician contact in the diagnostic assessment phase. The present study evaluates the impact of a pre-treatment diagnostic interview on the outcome of an Internet-based treatment for Social Anxiety Disorder (SAD). METHOD: One hundred and nine participants seeking treatment for SAD were randomized to either an interview-group (IG, N = 53) or to a non-interview group (NIG, N = 56). All participants took part in the same 10-week cognitive-behavioural unguided self-help programme. Before receiving access to the programme, participants of the IG underwent a structured diagnostic interview. Participants of the NIG started directly with the programme. RESULTS: Participants in both groups showed significant and substantial improvement on social anxiety measures from pre- to post-assessment (d IG = 1.30-1.63; d NIG = 1.00-1.28) and from pre- to 4-month follow-up assessment (d IG = 1.38-1.87; d NIG = 1.10-1.21). Significant between-groups effects in favour of the IG were found on secondary outcome measures of depression and general distress (d = 0.18-0.42). CONCLUSIONS: These findings suggest that Internet-based self-help is effective in treating SAD, whether or not a diagnostic interview is involved. However, the pre-treatment interview seems to facilitate change on secondary outcomes such as depression and general distress.

Psychometric Properties of the German Brief Experiential Avoidance Questionnaire (BEAQ).

The Brief Experiential Avoidance Questionnaire (BEAQ) is a 15-item short form of the Multidimensional Experiential Avoidance Questionnaire. This study aimed to investigate psychometric properties of a German translation of the BEAQ in a student and a clinical population. The BEAQ showed high internal reliability and overall acceptable convergent and discriminant validity. The BEAQ displayed adequate 7- to 13-day test-retest reliability and captured changes in experiential avoidance when experiential avoidance was targeted in treatment. Confirmatory factor analyses indicated that a bifactor structure where the BEAQ is modeled as one general and five specific factors that correspond to the Multidimensional Experiential Avoidance Questionnaire subscales fit the data adequately. All items (except Item 1 in the clinical population) loaded on the general factor and common variance was approximately equally spread across the general and specific factors. The Distress Endurance subscale was not included in this model, since it is represented by only one item, which showed poor performances and low associations to the BEAQ's total score in both samples. We recommend further research into the BEAQ's factor structure to substantiate our preliminary findings.

The unified protocol as an internet-based intervention for emotional disorders: Randomized controlled trial.

The Unified Protocol (UP) as a transdiagnostic intervention has primarily been applied in the treatment of anxiety disorders and in face-to-face-settings. The current study investigated the efficacy of a 10-week Internet-based adaptation of the UP for anxiety, depressive, and somatic symptom disorders. The trial was registered under DRKS00014820 at the German Clinical Trial Registry, DRKS. Participants (n = 129) were randomized to treatment or waitlist control. Significant treatment effects were found for symptom distress, satisfaction with life, positive/negative affect and markers of anxiety, depression, and somatic symptom burden (within-group Hedges' g = 0.32-1.38 and between-group g = 0.20-1.11). Treatment gains were maintained at 1- and 6-month-follow-up. Subgroup analyses showed comparable effects in participants with anxiety and depressive disorders. 26.6% dropped out of treatment and 35.38% did not provide post-treatment assessments. The results strengthen the application of the UP as an Internet-based treatment for alleviating symptom distress across emotional disorders. More research on the applicability for single disorders is needed and avenues to improve adherence and attrition rates should be explored.

Increasing the effectiveness of psychotherapy in routine care through blended therapy with transdiagnostic online modules (PsyTOM): study protocol for a randomized controlled trial.

BACKGROUND: In blended therapy, face-to-face psychotherapy and Internet-based interventions are combined. Blended therapy may be advantageous for patients and psychotherapists. However, most blended interventions focus on cognitive behavioral therapy or single disorders, making them less suitable for routine care settings. METHODS: In a randomized controlled trial, we will compare blended therapy and face-to-face therapy in routine care. We intend to randomize 1152 patients nested in 231 psychotherapists in a 1:1 ratio. Patients in the blended therapy group will receive access to a therapeutic online intervention (TONI). TONI contains 12 transdiagnostic online modules suited for psychodynamic, cognitive behavioral, and systemic therapy. Psychotherapists decide which modules to assign and how to integrate TONI components into the psychotherapeutic process to tailor treatment to their patients' specific needs. We will assess patients at baseline, 6 weeks, 12 weeks, and 6 months. Patients enrolled early in the trial will also complete assessments at 12 months. The primary outcomes are depression and anxiety at 6-month post-randomization, as measured by PHQ-8 and GAD-7. The secondary outcomes include satisfaction with life, level of functioning, personality traits and functioning, eating pathology, sexual problems, alcohol/drug use, satisfaction with treatment, negative effects, and mental health care utilization. In addition, we will collect several potential moderators and mediators, including therapeutic alliance, agency, and self-efficacy. Psychotherapists will also report on changes in symptom severity and therapeutic alliance. Qualitative interviews with psychotherapists and patients will shed light on the barriers and benefits of the blended intervention. Furthermore, we will assess significant others of enrolled patients in a sub-study. DISCUSSION: The integration of online modules which use a common therapeutic language and address therapeutic principles shared across therapeutic approaches into regular psychotherapy has the potential to improve the effectiveness of psychotherapy and transfer it into everyday life as well help save therapists' resources and close treatment gaps. A modular and transdiagnostic setup of the blended intervention also enables psychotherapists to tailor their treatment optimally to the needs of their patients. TRIAL REGISTRATION: German Clinical Trials Register (DRKS) DRKS00028536. Registered on 07.06.2022.

Negative effects in internet-based interventions for depression: A qualitative content analysis.

An increasing number of studies is proving the efficacy of Internet-based interventions (IBI) for treating depression. While the focus of most studies is thereby lying on the potential of IBI to alleviate emotional distress and enhance well-being, few studies are investigating possible negative effects that might be encountered by participants. The current study was therefore exploring self-reported negative effects of participants undergoing a cognitive-behavioral IBI targeting mild to moderate depression over 6 weeks. Data from the client pool of a German insurance company (n = 814, 68% female) revealed that 8.6% of the participants reported the experience of negative effects. Qualitative content analysis yielded two broad categories and five subcategories for the nature of participants' experiences of negative effects: participant-related negative effects (insight and symptom) and program-related negative effects (online format, contact, and implementation). By using both, qualitative and quantitative methods, results did not only shed light on the characteristics of negative effects but analyses also found that working alliance was a predictor for the experience of negative effects. Monitoring the occurrences of negative effects as well as working alliance throughout treatment was considered essential to help prevent negative effects and attrition among participants undergoing IBI for depression.

Differential Effects of Psychological Interventions in Online and Face-to-Face Settings on DSM-5 and ICD-11 Maladaptive Trait Domains: An Exploratory Pilot Study.

While mental health treatments have proven to be effective for a range of mental health problems, there is comparably little research on its effects on personality disorders or difficulty (PD). New dimensional conceptualizations of PD such as the ICD-11 PD model enable the cost- and time-effective dimensional assessment of severity and style of PD. Furthermore, they constitute a promising tool to investigate PD, not only as a treatment endpoint but also as a predictive or influencing factor for mental health treatments. In this study, we investigated the effects in two different mental health treatment settings [online (N = 38); face-to-face and blended [FTF/blended] (N = 35)] on the reduction of maladaptive personality traits as well as the interaction between maladaptive personality patterns and the response on primary endpoints (i.e., mental distress). Results indicate that both treatment settings have comparable within-group effects on the reduction of distress symptoms, while the treatment in the FTF/blended setting seems to have a stronger impact on the reduction of maladaptive traits. Further, reduction of maladaptive trait expressions was a reliable predictor of treatment response in the FTF/blended setting while explaining less variance in the online setting. Beyond the promising findings on the utility of maladaptive trait change as an outcome measure, we discuss possible applications as an information source for treatment decisions.

Mediators and mechanisms of change in internet- and mobile-based interventions for depression: A systematic review.

The efficacy of Internet- and mobile-based interventions (IMIs) for depression in adults is well established. Yet, comprehensive knowledge on the mediators responsible for therapeutic change in these interventions is pending. Therefore, we conducted the first systematic review on mediators in IMIs for depression, investigating mechanisms of change in interventions with different theoretical backgrounds and delivery modes (PROSPERO CRD42019130301). Two independent reviewers screened references from five databases (i.e., Cochrane Library, Embase, MEDLINE/PubMed, PsycINFO and ICTRP), selected studies for inclusion and extracted data from eligible studies. We included 26 RCTs on mediators in IMIs for depression (6820 participants), rated their risk of bias and adherence to methodological quality criteria for psychotherapy process research. Primary studies examined 64 mediators, with cognitive variables (e.g., perceived control, rumination or interpretation bias) being the largest group of both examined (m = 28) and significant mediators (m = 22); followed by a range of other mediators, including mindfulness, acceptance and behavioral activation. Our findings might contribute to the empirically-informed advancement of interventions and mental health care practices, enabling optimized treatment outcomes for patients with depression. Furthermore, we discuss implications for future research and provide methodological recommendations for forthcoming mediation studies with more pertinent designs, allowing for inferences with higher causal specificity.

For better or worse: An individual patient data meta-analysis of deterioration among participants receiving Internet-based cognitive behavior therapy.

OBJECTIVE: Psychological treatments can relieve mental distress and improve well-being, and the dissemination of evidence-based methods can help patients gain access to the right type of aid. Meanwhile, Internet-based cognitive-behavioral therapy (ICBT) has shown promising results for many psychiatric disorders. However, research on the potential for negative effects of psychological treatments has been lacking. METHOD: An individual patient data meta-analysis of 29 clinical trials of ICBT (N = 2,866) was performed using the Reliable Change Index for each primary outcome measures to distinguish deterioration rates among patients in treatment and control conditions. Statistical analyses of predictors were conducted using generalized linear mixed models. Missing data was handled by multiple imputation. RESULTS: Deterioration rates were 122 (5.8%) in treatment and 130 (17.4%) in control conditions. Relative to receiving treatment, patients in a control condition had higher odds of deteriorating, odds ratios (ORs) = 3.10, 95% confidence interval (CI) [2.21, 4.34]. Clinical severity at pretreatment was related to lower odds, OR = 0.62, 95% CI [0.50, 0.77], and OR = 0.51, 95% CI [0.51, 0.80], for treatment and control conditions. In terms of sociodemographic variables, being in a relationship, OR = 0.58, 95% CI [0.35, 0.95], having at least a university degree, OR = 0.54, 95% CI [0.33, 0.88], and being older, OR = 0.78, 95% CI, [0.62, 0.98], were also associated with lower odds of deterioration, but only for patients assigned to a treatment condition. CONCLUSION: Deterioration among patients receiving ICBT or being in a control condition can occur and should be monitored by researchers to reverse and prevent a negative treatment trend. (PsycINFO Database Record

Negative Effects of Psychological Treatments: An Exploratory Factor Analysis of the Negative Effects Questionnaire for Monitoring and Reporting Adverse and Unwanted Events.

Research conducted during the last decades has provided increasing evidence for the use of psychological treatments for a number of psychiatric disorders and somatic complaints. However, by focusing only on the positive outcomes, less attention has been given to the potential of negative effects. Despite indications of deterioration and other adverse and unwanted events during treatment, little is known about their occurrence and characteristics. Hence, in order to facilitate research of negative effects, a new instrument for monitoring and reporting their incidence and impact was developed using a consensus among researchers, self-reports by patients, and a literature review: the Negative Effects Questionnaire. Participants were recruited via a smartphone-delivered self-help treatment for social anxiety disorder and through the media (N = 653). An exploratory factor analysis was performed, resulting in a six-factor solution with 32 items, accounting for 57.64% of the variance. The derived factors were: symptoms, quality, dependency, stigma, hopelessness, and failure. Items related to unpleasant memories, stress, and anxiety were experienced by more than one-third of the participants. Further, increased or novel symptoms, as well as lack of quality in the treatment and therapeutic relationship rendered the highest self-reported negative impact. In addition, the findings were discussed in relation to prior research and other similar instruments of adverse and unwanted events, giving credence to the items that are included. The instrument is presently available in eleven different languages and can be freely downloaded and used from www.neqscale.com.