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.
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.
What is the public health significance of this article?
Psychological treatments have been found to be successful in treating various psychiatric disorders and improving well-being for many patients. However, while investigating the positive effects of different methods for alleviating mental distress less focus has been given to the potential for negative effects, which is frequently reported in pharmacological research. In response, the current study investigated the degree to which patients receiving Internet-based cognitive-behavioral therapy deteriorated and whether there are any predictors of deterioration, indicating that almost 6% fared worse during the treatment period and 17% in a control condition, with higher symptom levels before treatment, being in a relationship, having at least a university degree, and older age lowering the odds of deterioration for patients receiving treatment.
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.
•Aim: explore for whom internet-based interventions (IBIs) work, note research gaps•Higher adherence, credibility, and working alliance predict better outcomes.•Baseline scores predict mixed results (partly better, partly worse outcome).•Results for all other assessed variables inconclusive or lacking data•Prediction of who benefits from guided IBIs across diagnoses currently difficult
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.
Biases in attention processes are thought to play a crucial role in the aetiology and maintenance of Social Anxiety Disorder (SAD). The goal of the present study was to examine the efficacy of a ...programme intended to train attention towards positive cues and a programme intended to train attention towards negative cues. In a randomised, controlled, double-blind design, the impact of these two training conditions on both selective attention and social anxiety were compared to that of a control training condition. A modified dot probe task was used, and delivered via the internet. A total of 129 individuals, diagnosed with SAD, were randomly assigned to one of these three conditions and took part in a 14-day programme with daily training/control sessions. Participants in all three groups did not on average display an attentional bias prior to the training. Critically, results on change in attention bias implied that significantly differential change in selective attention to threat was not detected in the three conditions. However, symptoms of social anxiety reduced significantly from pre- to follow-up-assessment in all three conditions (dwithin = 0.63-1.24), with the procedure intended to train attention towards threat cues producing, relative to the control condition, a significantly greater reduction of social fears. There were no significant differences in social anxiety outcome between the training condition intended to induce attentional bias towards positive cues and the control condition. To our knowledge, this is the first RCT where a condition intended to induce attention bias to negative cues yielded greater emotional benefits than a control condition. Intriguingly, changes in symptoms are unlikely to be by the mechanism of change in attention processes since there was no change detected in bias per se. Implications of this finding for future research on attention bias modification in social anxiety are discussed.
ClinicalTrials.gov NCT01463137.
Internet interventions have great potential for alleviating emotional distress, promoting mental health, and enhancing well-being. Numerous clinical trials have demonstrated their efficacy for a ...number of psychiatric conditions, and interventions delivered via the Internet will likely become a common alternative to face-to-face treatment. Meanwhile, research has paid little attention to the negative effects associated with treatment, warranting further investigation of the possibility that some patients might deteriorate or encounter adverse events despite receiving best available care. Evidence from research of face-to-face treatment suggests that negative effects afflict 5–10% of all patients undergoing treatment in terms of deterioration. However, there is currently a lack of consensus on how to define and measure negative effects in psychotherapy research in general, leaving researchers without practical guidelines for monitoring and reporting negative effects in clinical trials. The current paper therefore seeks to provide recommendations that could promote the study of negative effects in Internet interventions with the aim of increasing the knowledge of its occurrence and characteristics. Ten leading experts in the field of Internet interventions were invited to participate and share their perspective on how to explore negative effects, using the Delphi technique to facilitate a dialog and reach an agreement. The authors discuss the importance of conducting research on negative effects in order to further the understanding of its incidence and different features. Suggestions on how to classify and measure negative effects in Internet interventions are proposed, involving methods from both quantitative and qualitative research. Potential mechanisms underlying negative effects are also discussed, differentiating common factors shared with face-to-face treatments from those unique to treatments delivered via the Internet. The authors conclude that negative effects are to be expected and need to be acknowledged to a greater extent, advising researchers to systematically probe for negative effects whenever conducting clinical trials involving Internet interventions, as well as to share their findings in scientific journals.
•Prior research of face-to-face treatment suggests that 5–10% of all patients experience negative effects in terms of deterioration, but other types of negative effects have been proposed to exist as well.•There is insufficient knowledge concerning the occurrence and characteristics of negative effects in Internet interventions.•Negative effects should be examined across treatment conditions in order to examine what types of negative effects exist, as well as to facilitate an analysis of causality.•A uniform classification of negative effects is proposed to ease monitoring procedures and the process of reporting the results in scientific journals.•Quantitative and qualitative measures are proposed in order to detect both deterioration and subjective experiences of negative effects during treatment.
Increasing access to treatment via smartphone apps is an important topic in Social Anxiety Disorder (SAD). ‘Challenger’ is an app promoting exposure exercises in daily life. The present study ...evaluated the additional benefit of using the app as adjunct to Internet-based unguided self-help for SAD. In a second step, we also tested how the app and the self-help programme (SH) should best be combined.
209 patients diagnosed with SAD were randomly allocated to three groups. Group 1 received the app and the self-help programme for six weeks (parallel treatment), group 2 first received SH for six weeks and then the app for six weeks (sequential treatment). Group 3 was a wait-list group. Comparisons were made at week 7 evaluating the potential add-on effect of the app (SH plus app versus SH only) and at week 14 comparing the parallel to the sequential treatment. Participants filled in questionnaires prior, during, and post treatment, and at 4- and 12- months follow-up.
Intention-to-treat analyses showed no significant effect of adding the app to Internet-based self-help. However, among participants actively using the app, adding Challenger to self-help resulted in significantly less social anxiety (d = 0.30). At week 14, decreases in social anxiety were large for both the parallel and the sequential group with no differences between the active groups (dwithin = 1.12–1.19). Changes were maintained throughout the follow-up period.
Results of the current study cautiously support the notion of adding a smartphone app to unguided self-help for SAD. Future studies should investigate how patients can be motivated to use the app more frequently.
•Adding a smartphone app to Internet-based self-help can increase efficacy.•The add-on effect is small.•Internet-based self-help plus app leads to large decreases in social anxiety.•The app supports clients in conducting exposure exercises in daily life.•Motivating clients to actively use the app is highly relevant.
Abstract
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
t
herapeutic
on
line
i
ntervention (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.
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.
•Negative effects in an Internet-based intervention for depression were assessed.•8.6% of the participants reported the experience of negative effects.•Negative effects were not necessarily related to depressive symptoms reduction.•Working alliance was a predictor for the experience of negative effects.•Monitoring negative effects throughout treatment might prevent drop-out rates.
Abstract Background and objectives The biased interpretation of ambiguous social situations is considered a maintaining factor of Social Anxiety Disorder (SAD). Studies on the modification of ...interpretation bias have shown promising results in laboratory settings. The present study aims at pilot-testing an Internet-based training that targets interpretation and judgmental bias. Method Thirty-nine individuals meeting diagnostic criteria for SAD participated in an 8-week, unguided program. Participants were presented with ambiguous social situations, were asked to choose between neutral, positive, and negative interpretations, and were required to evaluate costs of potential negative outcomes. Participants received elaborate automated feedback on their interpretations and judgments. Results There was a pre-to-post-reduction of the targeted cognitive processing biases ( d = 0.57–0.77) and of social anxiety symptoms ( d = 0.87). Furthermore, results showed changes in depression and general psychopathology ( d = 0.47–0.75). Decreases in cognitive biases and symptom changes did not correlate. The results held stable accounting for drop-outs (26%) and over a 6-week follow-up period. Forty-five percent of the completer sample showed clinical significant change and almost half of the participants (48%) no longer met diagnostic criteria for SAD. Limitations As the study lacks a control group, results lend only preliminary support to the efficacy of the intervention. Furthermore, the mechanism of change remained unclear. Conclusion First results promise a beneficial effect of the program for SAD patients. The treatment proved to be feasible and acceptable. Future research should evaluate the intervention in a randomized-controlled setting.
PDF
