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Background: Relations among psychological variables are assumed to be complex and to vary over time. Personalized networks can model multivariate complex interactions. The development of time-varying networks allows to model the variation of parameters over time. Objectives: We aimed to determine the value of time-varying networks for clinical practice. Methods: We applied time-varying mixed graphical models (TV-MGM) and time-varying vector autoregressive models (TV-VAR) to intensive longitudinal data of nine participants with depressive symptoms (n = 6) or anxiety (n = 3). Results: Most of the participants showed temporal changes in network topology within the assessment period of 30 days. Time-varying networks of participants with small, medium, and large time variability in edge parameters clearly show the different temporal evolvements of dynamic interactions between variables. The case example indicates clinical utility but also limitations to the application of time-varying networks in clinical practice. Conclusion: Time-varying network models provide a data-driven and exploratory approach that could complement current diagnostic standards by reflecting interacting, often mutually reinforcing processes of mental health problems and by accounting for variation over time. They can be used to generate hypotheses for further confirmatory and clinical testing.
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OBJECTIVE: Research suggests that some therapists achieve better outcomes than others. However, an overlooked area of study is how institution differences impact patient outcomes independent of therapist variance. This study aimed to examine the role of institution and therapist differences in adult outpatient psychotherapy. METHOD: The study included 1428 patients who were treated by 196 therapists at 10 clinics. Two- and three-level hierarchical linear regression models were employed to investigate the effects of therapists and institutions on three dependent patient variables: (1) symptom change, (2) treatment duration, and (3) dropout. Level three explanatory variables were tested. RESULTS: The results showed that therapist effects (TE) were significant for all three types of treatment outcome (7.8%-18.2%). When a third level (institution) was added to the model, the differences between therapists decreased, and significant institution effects (IE) were found: 6.3% for symptom change, 10.6% for treatment duration, and 6.5% for dropout. The exploratory analyses found no predictors able to explain the systematic variation at the institution level. DISCUSSION: TE on psychotherapy outcomes remain a relevant factor but may have been overestimated in previous studies due to not properly distinguishing them from differences at the institution level.
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OBJECTIVE: The causes of the long-term persistence of symptoms after a severe acute respiratory syndrome coronavirus 2 infection (i.e., post-COVID syndrome) remain elusive. Although previous research identified demographic and medical risk factors for the development of post-COVID, the present prospective study is the first to investigate the role of psychological factors. METHODS: The interview and survey data of polymerase chain reaction-positive participants ( n = 137; 70.8% female) were assessed in the acute, subacute (3 months after symptom onset), and chronic phases (6 months after symptom onset) of COVID. RESULTS: After controlling for medical (body mass index, disease score) and demographic factors (sex, age), psychosomatic symptom burden (measured by the Somatic Symptom Disorder-B Criteria Scale) predicted higher odds and magnitude of COVID-related symptom impairment in the post-COVID phases. Fear of COVID-related health consequences (measured by the Fear of COVID Scale) also predicted higher odds of reporting any COVID symptoms in the subacute and chronic phases, whereas it only predicted a higher magnitude of COVID-related symptom impairment in the subacute phase. In subsequent exploratory analyses, we found that other psychological factors were associated with an overall increase (i.e., chronic stress and depression) or decrease (i.e., trait positive affect) in the odds and magnitude of COVID-related symptom impairment. CONCLUSIONS: We conclude that psychological factors can fuel or temper the experience in post-COVID syndrome, opening new possibilities for psychological interventions. TRIAL REGISTRATION: The study protocol was preregistered in the Open Science Framework ( https://osf.io/k9j7t ).
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COVID-19 , Humanos , Femenino , Masculino , COVID-19/epidemiología , SARS-CoV-2 , Estudios Prospectivos , Factores de Riesgo , Encuestas y CuestionariosRESUMEN
BACKGROUND: Research has shown that patients with somatoform disorders (SFD) have difficulty using medical reassurance (i.e. normal results from diagnostic testing) to revise concerns about being seriously ill. In this brief report, we investigated whether deficits in adequately interpreting the likelihood of a medical disease may contribute to this difficulty, and whether patients' concerns are altered by different likelihood framings. METHODS: Patients with SFD (N = 60), patients with major depression (N = 32), and healthy volunteers (N = 37) were presented with varying likelihoods for the presence of a serious medical disease and were asked how concerned they are about it. The likelihood itself was varied, as was the format in which it was presented (i.e. negative framing focusing on the presence of a disease v. positive framing emphasizing its absence; use of natural frequencies v. percentages). RESULTS: Patients with SFD reported significantly more concern than depressed patients and healthy people in response to low likelihoods (i.e. 1: 100 000 to 1:10), while the groups were similarly concerned for likelihoods ⩾1:5. Across samples, the same mathematical likelihood caused significantly different levels of concern depending on how it was framed, with the lowest degree of concern for a positive framing approach and higher concern for natural frequencies (e.g. 1:100) than for percentages (e.g. 1%). CONCLUSIONS: The results suggest a specific deficit of patients with SFD in interpreting low likelihoods for the presence of a medical disease. Positive framing approaches and the use of percentages rather than natural frequencies can lower the degree of concern.
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Trastorno Depresivo Mayor , Humanos , Trastorno Depresivo Mayor/epidemiología , Depresión , Probabilidad , Trastornos Somatomorfos/diagnósticoRESUMEN
OBJECTIVE: Placebos being prescribed with full honesty and disclosure (i.e., open-label placebo [OLP]) have been shown to reduce symptom burden in a variety of conditions. With regard to allergic rhinitis, previous research provided inconclusive evidence for the effects of OLP, possibly related to a separate focus on either symptom severity or symptom frequency. Overcoming this limitation of previous research, the present study aimed to examine the effects of OLP on both the severity and frequency of allergic symptoms. METHODS: In a randomized-controlled trial, patients with allergic rhinitis ( N = 74) were randomized to OLP or treatment as usual (TAU). Because of the COVID-19 pandemic, OLP was administered remotely in a virtual clinical encounter. Participants took placebo tablets for 14 days. The primary outcomes were the severity and frequency of allergic symptoms. The secondary end point was allergy-related impairment. RESULTS: OLP did not significantly improve symptom severity over TAU ( F (1,71) = 3.280, p = .074, η2 = 0.044) but did reduce symptom frequency ( F (1,71) = 7.272, p = .009, η2 = 0.093) and allergy-related impairment more than TAU ( F (1,71) = 6.445, p = .013, η2 = 0.083), reflecting medium to large effects. The use of other antiallergic medication did not influence the results. CONCLUSIONS: Although OLP was able to lower the frequency of allergic symptoms and allergy-related impairment substantially, its effects on symptom severity were weaker. The remote provision of OLP suggests that physical contact between patients and providers might not be necessary for OLP to work.
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Placebos , Rinitis Alérgica , Humanos , Rinitis Alérgica/psicología , Rinitis Alérgica/terapia , Resultado del Tratamiento , Efecto Placebo , Placebos/administración & dosificación , Placebos/uso terapéutico , Telemedicina , Relaciones Médico-PacienteRESUMEN
BACKGROUND: Several studies indicate that patients' presurgical expectations can influence postsurgical health outcome. PURPOSE: To estimate the potential for clinical exploitation of this association, a meta-analysis of prospective studies which assess the association between patients' presurgical expectations and postsurgical quality of life is applied to accumulate the overall effect. METHODS: We searched the databases MEDLINE, CENTRAL, and PsychINFO for English- and German-language articles published from 1980 until December 2013. Additionally, manual searches of bibliographies of retrieved articles and relevant reviews were conducted. Prospective studies measuring presurgical expectations and postsurgical quality of life in patients aging 18-65 were selected. Correlations between presurgical expectations and postsurgical quality of life were extracted or provided by the authors. RESULTS: The search yielded 21 prospective studies (including 2611 patients undergoing surgery) with a follow-up period ranging from 1 week to 13 years. The pooled correlations were 0.369 (95% confidence interval (CI), 0.264 to 0.466; P for heterogeneity <0.001; random-effects model) for overall quality of life (11 studies), 0.126 (95% CI, 0.079 to 0.172; P for heterogeneity = 0.63; random-effects model) for physical quality of life (12 studies), and 0.208 (95% CI, 0.113 to 0.299; P for heterogeneity <0.001; random-effects model) for mental quality of life (12 studies), indicating low to moderate associations between presurgery patients' expectations and postsurgery quality of life. CONCLUSIONS: These results confirm the importance of patients' expectations in the prediction of postsurgical outcomes and underline the necessity to optimize these expectations in order to improve postoperative quality of life.
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Periodo Perioperatorio/psicología , Calidad de Vida , Procedimientos Quirúrgicos Operativos/psicología , Actitud Frente a la Salud , Humanos , Evaluación del Resultado de la Atención al Paciente , Estudios ProspectivosRESUMEN
BACKGROUND: Acceptance and Commitment Therapy (ACT) for pain offers an alternative to traditional Cognitive Behavioural Therapy (CBT) approaches. ACT focuses on the enhancement of 'psychological flexibility' that enables individuals to pursue their values and goals despite pain. To assess specific treatment effect or mediators and moderators of change, questionnaires measuring ACT constructs are needed. METHODS: The Psychological Inflexibility in Pain Scale (PIPS) was translated into German and completed by 182 participants with chronic back pain (70.3 % women, age 51.0 ± 10.5 years). Item analyses and a confirmatory factor analysis were computed as well as correlations with the Chronic Pain Acceptance Questionnaire (CPAQ), which measures related, but slightly different ACT-related constructs, and self-reported disability, pain intensity and further pain-related questionnaires. RESULTS: The confirmatory factor analysis reproduced the original structure with two subscales and a good fit. The internal consistencies of the subscales were Cronbach's α = .91 (Avoidance) and α = .26 (Fusion). Average item-whole correlations of the items with the respective subscales were r = .71 (Avoidance) and r = .20 (Fusion). The highest correlations were observed for Avoidance with the CPAQ (r = -.81), the Tampa Scale of Kinesiophobia (r = .58) and the Pain Catastrophizing Scale (r = .56) and for Fusion with the CPAQ subscale Pain willingness (r = -.55). The PIPS subscale Avoidance predicted pain-related disability even after controlling for catastrophizing and fear of movement. CONCLUSIONS: The PIPS subscale Avoidance may be a valuable instrument to assess treatment processes in future RCTs. The PIPS subscale Fusion seemed more problematic in the German sample with chronic back pain. More research on the comparison between PIPS and other questionnaires assessing psychological flexibility and the usefulness of the concept 'Fusion' for chronic pain are needed.
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Adaptación Psicológica , Dolor de Espalda/psicología , Dolor Crónico/psicología , Encuestas y Cuestionarios , Adulto , Ansiedad/etiología , Catastrofización , Depresión/etiología , Personas con Discapacidad/psicología , Análisis Factorial , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dimensión del Dolor , Psicometría , Calidad de Vida , Reproducibilidad de los ResultadosRESUMEN
Placebo interventions generate mismatches between expected pain and sensory signals from which pain states are inferred. Because we lack direct access to bodily states, we can only infer whether nociceptive activity indicates tissue damage or results from noise in sensory channels. Predictive processing models propose to make optimal inferences using prior knowledge given noisy sensory data. However, these models do not provide a satisfactory explanation of how pain relief expectations are translated into physiological manifestations of placebo responses. Furthermore, they do not account for individual differences in the ability to endogenously regulate nociceptive activity in predicting placebo analgesia. The brain not only passively integrates prior pain expectations with nociceptive activity to infer pain states (perceptual inference) but also initiates various types of actions to ensure that sensory data are consistent with prior pain expectations (active inference). We argue that depending on whether the brain interprets conflicting sensory data (prediction errors) as a signal to learn from or noise to be attenuated, the brain initiates opposing types of action to facilitate learning from sensory data or, conversely, to enhance the biasing influence of prior pain expectations on pain perception. Furthermore, we discuss the role of stress, anxiety, and unpredictability of pain in influencing the weighting of prior pain expectations and sensory data and how they relate to the individual ability to regulate nociceptive activity (endogenous pain modulation). Finally, we provide suggestions for future studies to test the implications of the active inference model of placebo analgesia.
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Analgesia , Dolor , Humanos , Dolor/tratamiento farmacológico , Analgesia/métodos , Percepción del Dolor/fisiología , Encéfalo , AnsiedadRESUMEN
BACKGROUND: There is a significant research gap with respect to the long-term sustainability of psychological treatment effects in chronic pain patients. This study aimed to investigate long-term treatment effects of two psychological treatments: cognitive behavioural therapy (CBT) as a broad-spectrum approach and exposure as a specific intervention for fear-avoidant pain patients. METHODS: Patients with chronic low back pain were randomized to CBT or exposure in vivo. Long-term follow-up (LTFU) data were available for 64 patients up to 8 years after treatment, with a response rate of 73%. The primary outcomes were pain-related disability and pain intensity and secondary outcomes were emotional distress, psychological flexibility, catastrophizing and pain-related fear. The data analysis was performed with longitudinal multilevel modelling. RESULTS: Multilevel analyses showed improvements in all primary outcomes as well as all secondary outcomes from pre-treatment to LTFU for both treatments. The mean proportion of cases meeting reliable and clinical improved criteria in all primary outcome was 36% (range: 22%-46%) in the exposure group and 50% (range: 33%-60%) in the CBT group. Dropout analyses revealed significantly higher deterioration rates over time. Pre-treatment to LTFU effect sizes of the primary outcomes ranged from 0.54 to 1.59. CONCLUSIONS: Our results indicate that the effects of psychological treatments might be stable over several years. Treatment gains for exposure as a stand-alone treatment seem to be of shorter duration than a general CBT intervention. Thus, psychological treatments might offer a promising and sustainable long-term perspective for patients with chronic back pain. SIGNIFICANCE: The long-term stability of treatment effects is a highly neglected issue despite its inherent importance in the context of chronic pain. This study is the first to investigate treatment effects of cognitive behavioural therapy and in vivo exposure in chronic back pain sufferers up to 8 years after treatment. The findings contribute to an understanding of the sustainability of psychological cognitive behavioural therapy-based intervention effects.
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Dolor Crónico , Terapia Cognitivo-Conductual , Humanos , Dolor Crónico/terapia , Dolor Crónico/psicología , Estudios de Seguimiento , Terapia Cognitivo-Conductual/métodos , Dolor de Espalda/terapia , CogniciónRESUMEN
Introduction: Depressive symptoms have been linked to difficulties in revising established negative beliefs in response to novel positive information. Recent predictive processing accounts have suggested that this bias in belief updating may be related to a blunted processing of positive prediction errors at the neural level. In this proof-of-concept study, pupil dilation in response to unexpected positive emotional information was examined as a psychophysiological marker of an attenuated processing of positive prediction errors associated with depressive symptoms. Methods: Participants (N = 34) completed a modified version of the emotional Bias Against Disconfirmatory Evidence (BADE) task in which scenarios initially suggest negative interpretations that are later either confirmed or disconfirmed by additional information. Pupil dilation in response to the confirmatory and disconfirmatory information was recorded. Results: Behavioral results showed that depressive symptoms were related to difficulties in revising negative interpretations despite disconfirmatory positive information. The eye tracking results pointed to a reduced pupil response to unexpected positive information among people with elevated depressive symptoms. Discussion: Altogether, the present study demonstrates that the adapted emotional BADE task can be appropriate for examining psychophysiological aspects such as changes in pupil size along with behavioral responses. Furthermore, the results suggest that depression may be characterized by deviations in both behavioral (i.e., reduced updating of negative beliefs) and psychophysiological (i.e., decreased pupil dilation) responses to unexpected positive information. Future work should focus on a larger sample including clinically depressed patients to further explore these findings.
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With the steadily growing importance of psychotherapeutic care, there is also an increasing need for high-quality training. We analyze the literature published between 2009 and 2022 on the effectiveness of training in cognitive behavioral therapy. The review addresses current gaps in the literature by focusing on the description of specific training components and their associated costs, as well as examining therapist-level predictors of training effectiveness. Our findings confirm the effect of additional supervision on both therapist competence and patient outcomes. Instructor-led training and self-guided web-based training seem to moderately increase competence, especially when targeting specific and highly structured treatments or skills. The level of prior training and experience of a therapist appears to predict the strength of training-related gains in competence. Few studies analyzed the differential effect of certain elements of training (e.g., the amount of active learning strategies) and training costs were generally not reported. Future studies should replicate or expand the existing evidence on active ingredients and therapist-level predictors of training effectiveness. Costs should be systematically reported to enhance the comparability of different training strategies.
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Terapia Cognitivo-Conductual , Humanos , Terapia Cognitivo-Conductual/educaciónRESUMEN
BACKGROUND: We examined whether the difficulties of patients with somatoform disorders (SFDs) in integrating medical reassurance can be altered by preventing patients from devaluing reassuring information through defensive cognitive strategies. METHOD: Patients with SFD (n = 60), patients with major depression (n = 32), and healthy volunteers (n = 37) watched a videotaped doctor's report, which provided medical reassurance for gastroenterological complaints. Subsequently, participants were asked about their perception of the report. In the SFD sample, patients' appraisal of the reassuring was experimentally modulated: In one condition, doubts about the validity of the doctor's diagnostic assessment were triggered; in another condition, the devaluation of medical reassurance was blocked through underscoring the validity of the doctor's diagnostic assessment; and a control condition received no manipulation. RESULTS: As evident on all outcome variables, patients with SFD had more difficulty integrating medical reassurance than depressed and healthy people. Within the SFD sample, participants from the experimental condition blocking the devaluation of medical reassurance rated the likelihood of an undetected serious disease to be significantly lower than the other two conditions. They also reported less emotional concern and a lower desire to seek the opinion of another doctor. CONCLUSIONS: By comparing patients with SFD to both a healthy and a clinical control group, the current study suggests that the difficulty in processing reassuring medical information is a specific psychopathological feature of SFD. Furthermore, our results suggest that the integration of medical reassurance can be improved by preventing patients from devaluing reassuring information through dismissive cognitive strategies. (PsycInfo Database Record (c) 2023 APA, all rights reserved).
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Emociones , Trastornos Somatomorfos , Humanos , Trastornos Somatomorfos/diagnóstico , Trastornos Somatomorfos/psicologíaRESUMEN
BACKGROUND: Increasing the access to and improving the impact of pain treatments is of utmost importance, especially among youths with chronic pain. The engagement of patients as research partners (in contrast to research participants) provides valuable expertise to collaboratively improve treatment delivery. OBJECTIVE: This study looked at a multidisciplinary exposure treatment for youths with chronic pain through the lens of patients and caregivers with the aim to explore and validate treatment change processes, prioritize and develop ideas for improvement, and identify particularly helpful treatment elements. METHODS: Qualitative exit interviews were conducted with patients and caregivers at their discharge from 2 clinical trials (ClinicalTrials.gov NCT01974791 and NCT03699007). Six independent co-design meetings were held with patients and caregivers as research partners to establish a consensus within and between groups. The results were validated in a wrap-up meeting. RESULTS: Patients and caregivers described that exposure treatment helped them better process pain-related emotions, feel empowered, and improve their relationship with each other. The research partners developed and agreed upon 12 ideas for improvement. Major recommendations include that pain exposure treatment should be disseminated more not only among patients and caregivers but also among primary care providers and the general public to facilitate an early referral for treatment. Exposure treatment should allow flexibility in terms of duration, frequency, and delivery mode. The research partners prioritized 13 helpful treatment elements. Most of the research partners agreed that future exposure treatments should continue to empower patients to choose meaningful exposure activities, break long-term goals into smaller steps, and discuss realistic expectations at discharge. CONCLUSIONS: The results of this study have the potential to contribute to the refinement of pain treatments more broadly. At their core, they suggest that pain treatments should be disseminated more, flexible, and transparent.
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Background and aims: For the first time, the ICD-11 provides the diagnosis compulsive sexual behavior disorder (CSBD) that can be assigned for pornography use disorder (PUD). This study aimed to estimate the prevalence of PUD and associated consequences in Germany, to identify the psychotherapy demand among likely PUD (lPUD) cases and the treatment supply in different psychotherapeutic settings, to survey psychotherapists' level of expertise regarding PUD, and to identify predictors for psychotherapy demand. Methods: Four studies were conducted: 1. Online study in the general population (n = 2070; m = 48.9%, f = 50.8%, d = 0.2%), 2. Survey among practicing psychotherapists (n = 983), 3. Survey of psychotherapists in psychotherapeutic outpatient clinics (n = 185), 4. Interviews with psychotherapeutic inpatient clinics (n = 28). Results: The estimated prevalence of lPUD in the online study was 4.7% and men were 6.3 times more often affected than women. Compared to individuals without PUD, individuals with lPUD more often indicated negative consequences in performance-related areas. Among lPUD cases, 51.2% of men and 64.3% of women were interested in a specialized PUD treatment. Psychotherapists reported 1.2%-2.9% of lPUD cases among their patients. 43.2%-61.5% of psychotherapists stated to be poorly informed about PUD. Only 7% of psychotherapeutic inpatient clinics provided specific treatments to patients with PUD. While, among other factors, negative consequences attributed to lPUD were predictive for psychotherapy demand, weekly pornography consumption, subjective well-being, and religious attachment were not. Discussion and conclusions: Although PUD occurs quite often in Germany, availability of mental health care services for PUD is poor. Specific PUD treatments are urgently needed.
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Literatura Erótica , Trastornos Parafílicos , Masculino , Humanos , Femenino , Literatura Erótica/psicología , Conducta Sexual/psicología , Alemania/epidemiología , Trastornos Parafílicos/psicología , Conducta Compulsiva/psicologíaRESUMEN
After traumatic experiences, intrusive memories can flash back and evoke significant distress. Here, we investigated whether the frequency and severity of intrusions can be reduced by the provision of placebo. After the (online) exposure to the trauma-film paradigm, healthy participants (N = 112) received deceptive placebo (DP), open-label placebo (OLP), or no treatment. In the DP group, participants were led to believe to receive a dopamine-modulating drug, which was supposed to disrupt the consolidation of traumatic memories, although they in fact received the same placebo tablets as the OLP group for one week. The results show that the groups did not differ in the frequency of intrusive memories after one week. However, participants receiving OLP reported a significantly reduced intensity of intrusions as compared to DP. Across groups, negative expectations about the intensity and controllability of intrusions were associated with a higher frequency of intrusions, higher distress, higher burden, and more negative appraisal. The results suggest that expectations play an important role in the emergence of intrusive memories and that some of the disabling aspects of intrusive memories can be reduced by placebo. This may carry clinical potential because placebos are an accessible, cost-effective intervention to reduce the risk of intrusive memories.
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Memoria , Trastornos por Estrés Postraumático , Dopamina/farmacología , Voluntarios Sanos , Humanos , Memoria/fisiología , Trastornos por Estrés Postraumático/tratamiento farmacológicoRESUMEN
BACKGROUND: Expectations of painful sensations constitute a core feature of chronic pain. An important clinical question is whether such expectations are revised when disconfirming experiences are made (e.g., less pain than expected). This study examined how people adjust their pain expectations when the experience of decreasing pain is expected vs. unexpected. METHODS: In a novel randomized between-subjects design, a subclinical sample of people who frequently experience pain was provided with painful thermal stimulations. Unbeknownst to participants, the temperature applied was decreased from trial to trial. Based on the experimental instructions provided, this experience of decreasing pain was expected in one condition (expectation-confirmation; n = 34), whereas it was unexpected in another (expectation-disconfirmation; n = 39). RESULTS: Perceived pain intensity was lower in the expectation-confirmation condition than in the expectation-disconfirmation condition (p = .014, ηp2 = 0.083). The expectation-confirmation condition also showed a greater adjustment of their pain expectations than the expectation-disconfirmation condition (p = .046, ηp2 = 0.047). Across groups, large expectation violations (i.e., less pain than expected) were associated with increases in pain tolerance and the ability to cope with pain at a one-week follow-up. CONCLUSIONS: In terms of assimilation, perceived pain intensity was shaped in the direction of pain expectations. The greater adjustment of expectations in the expectation-confirming condition is consistent with a confirmation bias in pain perception. Though participants who experienced large discrepancies between expected and experienced pain were hesitant to adjust their pain expectations immediately, expectation violations increased their ability to cope with pain one week later, suggesting some beneficial longer-term effects of expectation violations.
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Adaptación Psicológica , Dolor , Humanos , Dimensión del Dolor , Percepción del DolorRESUMEN
PURPOSE: Side effects in clinical trials are frequently assessed in an unstructured fashion, using ascertainment strategies with unclear quality criteria. To improve the assessment and interpretation of general side effects, a structured approach is presented and validated (General Assessment of Side Effects, GASE). Base rates and reference data of the general population as well as quality criteria of this new side effect ascertainment method are provided. METHODS: We developed a screener assessing the most common subjective side effects of clinical trials (according to FDA statistics and others). The screener was evaluated in a general population survey including 2512 participants, 1276 of them taking drugs. RESULTS: We present reference data of the general population that help to interpret and compare future results of clinical trials assessing general side effects. Highest scores for side effects were reported from users of psychopharmacological drugs, medium scores of people taking antihypertensives, and lower scores of people taking lipid-lowering drugs, pain killers, and antidiabetics. If people take multiple drugs, more side effects are reported compared to single-class drugs. This confirms GASE's validity to assess side effects. CONCLUSION: We suggest that a structured, patient-based approach to assess general side effects could improve the detection of drug-induced side effects. The problem of clinical studies being underpowered to detect side effects could be reduced by using more reliable approaches. Our plea is for side effect ascertainment with sophisticated approaches for expected side effects, systematic screening for general side effects, and open question methods for spontaneous reports.
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Ensayos Clínicos como Asunto/métodos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Indicadores de Calidad de la Atención de Salud , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Reproducibilidad de los ResultadosRESUMEN
Metacognitive therapy (MCT) has been shown to be a promising treatment approach for obsessive-compulsive disorder (OCD). The changeability of metacognitions by (metacognitive) treatment and its relevance to treatment outcome is, however, still unclear. The current study investigates, (1) if treatment with MCT or exposure and response prevention (ERP) in a randomized-controlled pilot trial (n = 24 patients with OCD) changes OCD-specific metacognitions of thought fusion beliefs, beliefs about rituals and stop signals, and (2) if these changes are relevant for the treatment outcome in terms of patient- and therapist-rated OCD symptoms. ANOVA with pretest, posttest and follow-up scores could show that all three metacognitions significantly decreased during both treatments. Regarding thought fusion beliefs, a significant interaction effect indicated a higher decrease after MCT than ERP treatment. In hierarchical regression analyses, changes in stop signals from pre- to post-treatment significantly predicted patient-rating OCD symptoms at post-treatment and follow-up at 3 months after treatment. These changes were even predictive of post-treatment outcome after controlling for general metacognitions and dysfunctional cognitive beliefs. These findings support the assumption that metacognitions can change during both treatments and that changes in stop signals might be relevant for the treatment outcome on the symptom level in OCD.
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[This corrects the article DOI: 10.1371/journal.pone.0248367.].
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Behavior therapy of obsessive-compulsive disorder (OCD) aims to reduce avoidance, rituals, and discomfort in OCD-relevant situations. The Behavioral Avoidance Test (BAT) measures these behavior-related outcomes in individually challenging OCD-related situations. The association of the BAT with OCD severity measures and its relevance for treatment outcome is, however, still unclear. The current study investigates with a retrospective analysis of a subsample of a pilot study, (1) if reactions on the BAT are related to OCD severity measures in an OCD sample (n = 28), (2) if treatment with two variants of cognitive-behavior therapy (exposure and response prevention vs. metacognitive therapy) changes the BAT scores and (3) if these changes as well as pretreatment BAT avoidance are relevant for OCD treatment outcome as measured by the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). Participants rated avoidance, ritual, and discomfort in three individually challenging OCD-related situations before and after therapy. For one of these situations, BAT dimensions were rated by the therapist and an independent rater in addition to the patients' ratings. Correlational analyses found significant correlations between BAT discomfort and OCD severity measures like the Y-BOCS. A repeated measures ANOVA with pre- and posttest scores showed that all three BAT dimensions significantly decreased during both treatments. Hierarchical regression analyses (controlling for Y-BOCS pretest scores) revealed that changes in BAT discomfort as well as pretreatment BAT avoidance scores predicted the Y-BOCS posttest score. These findings suggest that the BAT is a distinct measure of behavior-related outcomes partly being relevant for OCD treatment outcome.