Leveraging Single-Case Experimental Designs to Promote Personalized Psychological Treatment: Step-by-Step Implementation Protocol with Stakeholder Involvement of an Outpatient Clinic for Personalized Psychotherapy.

Our objective is to implement a single-case experimental design (SCED) infrastructure in combination with experience-sampling methods (ESM) into the standard diagnostic procedure of a German outpatient research and training clinic. Building on the idea of routine outcome monitoring, the SCED infrastructure introduces intensive longitudinal data collection, individual effectiveness measures, and the opportunity for systematic manipulation to push personalization efforts further. It aims to empower psychotherapists and patients to evaluate their own treatment (idiographic perspective) and to enable researchers to analyze open questions of personalized psychotherapy (nomothetic perspective). Organized around the principles of agile research, we plan to develop, implement, and evaluate the SCED infrastructure in six successive studies with continuous stakeholder involvement: In the project development phase, the business model for the SCED infrastructure is developed that describes its vision in consideration of the context (Study 1). Also, the infrastructure's prototype is specified, encompassing the SCED procedure, ESM protocol, and ESM survey (Study 2 and 3). During the optimization phase, feasibility and acceptability are tested and the infrastructure is adapted accordingly (Study 4). The evaluation phase includes a pilot implementation study to assess implementation outcomes (Study 5), followed by actual implementation using a within-institution A-B design (Study 6). The sustainability phase involves continuous monitoring and improvement. We discuss to what extent the generated data could be used to address current questions of personalized psychotherapy research. Anticipated barriers and limitations during the implementation processes are outlined.

Same same, but different: effects of likelihood framing on concerns about a medical disease in patients with somatoform disorders, major depression, and healthy people.

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.

How the integration of normal medical test results can be improved in patients with somatoform disorders-An experimental study.

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).

Using clinical patient characteristics to predict treatment outcome of cognitive behavior therapies for individuals with medically unexplained symptoms: A systematic review and meta-analysis.

OBJECTIVE: For individuals with medically unexplained symptoms (MUS), cognitive behavioral therapy (CBT) is the best-evaluated treatment. This systematic review and meta-analyses identify clinical patient characteristics associated with the treatment outcome of CBT for MUS. METHODS: A systematic literature search (PubMed, PsycInfo, Web of Science) resulted in 53 eligible studies; of these 32 studies could be included in meta-analyses. Pooled correlation coefficients between predictors and treatment outcome were calculated with a random-effects model. Moderator analyses were conducted to examine differences between subgroups of MUS and different levels of methodological study quality. RESULTS: Meta-analyses demonstrated that individuals with higher symptom intensity (r = 0.38; p < 0.001), lower physical functioning (r = -0.29; p < 0.001), lower emotional and social functioning (r = -0.37; p < 0.001), more potential symptom-related incentives (r = -0.15; p = 0.001), or longer symptom duration (r = 0.10; p = 0.033) at the beginning of treatment reported less change of symptom severity until the end of therapy or higher end-of-treatment symptom severity. The pooled effect sizes did not differ between certain subgroups of MUS or between different levels of methodological quality. CONCLUSION: Our findings indicated that clinical characteristics of MUS patients are associated with treatment outcome of CBT. We discuss how the results can be used to optimize and personalize future treatments for MUS.

Network Analysis of Persistent Somatic Symptoms in Two Clinical Patient Samples.

OBJECTIVE: Previous attempts to group persistent somatic symptoms (PSSs) with factor-analytic approaches have obtained heterogeneous results. An alternative approach that seems to be more suitable is the network theory. Compared with factor analysis, which focuses on the underlying factor of symptoms, network analysis focuses on the dynamic relationships and interactions among different symptoms. The main aim of this study is to apply the network approach to examine the heterogeneous structure of PSS within two clinical samples. METHODS: The first data set consisted of n = 254 outpatients who were part of a multicenter study. The second data set included n = 574 inpatients, both with somatoform disorders. Somatic symptom severity was assessed with the Screening of Somatoform Disorder (SOMS-7T). RESULTS: Results indicate that there are five main symptom groups that were found in both samples: neurological, gastrointestinal, urogenital, cardiovascular, and musculoskeletal symptoms. Although patterns of symptoms with high connection to each other look quite similar in both networks, the order of the most central symptoms (e.g., symptoms with a high connection to other symptoms in the network) differs. CONCLUSIONS: This work is the first to estimate the structure of PSS using network analysis. A next step could be first to replicate our findings before translating them into clinical practice. Second, results may be useful for generating hypotheses to be tested in future studies, and the results open new opportunities for a better understanding for etiology, prevention, and intervention research.

Symptom change trajectories in patients with persistent somatic symptoms and their association to long-term treatment outcome.

OBJECTIVE: This study investigated symptom change trajectory for patients with persistent somatic symptoms (PSS) during psychotherapy and the association of these patterns with pre-treatment characteristics and long-term outcome. METHODS: Growth mixture modeling was used to identify trajectory curves in a sample of N = 210 outpatients diagnosed with PSS and treated either with conventional cognitive behavioral therapy (CBT) or CBT enriched with emotion regulation training (ENCERT). RESULTS: We identified three subgroups of patients with similar symptom change patterns over the course of treatment (a "no change," "strong response," and "slow change" subgroup). Higher initial anxiety symptoms were significantly associated with the no change and strong response subgroups; symptom-related disability in daily routine with no changes. Patients with a strong response had the highest proportion of reliable improvement at termination and at six-month-follow-up. CONCLUSION: Our results indicate that, instead of one common change pattern, patients with PSS respond differently to treatment. Due to the high association of symptom curves with long-term outcome, the identification and prediction of an individual's trajectory could provide important information for clinicians to identify non-responding patients that are at risk for failure. Selecting personalized treatment interventions could increase the effectiveness of psychotherapy.Trial registration: ClinicalTrials.gov identifier: NCT01908855..

Predicting optimal treatment outcomes using the Personalized Advantage Index for patients with persistent somatic symptoms.

Objective: Because individual patients with persistent somatic symptoms (PSS) respond differently to treatments, a better understanding of the factors that predict therapy outcomes are of high importance. Aggregating a wide selection of information into the treatment-decision process is a challenge for clinicians. Using the Personalized Advantage Index (PAI) this study aims to deal with this. Methods: Data from a multicentre RCT comparing CBT (N = 128) versus CBT enriched with emotion regulation training (ENCERT) (N = 126) for patients diagnosed with somatic symptom disorder were used to identify based on two machine learning approaches predictors of therapy outcomes. The identified predictors were used to calculate the PAI. Results: Five treatment unspecific predictors (pre-treatment somatic symptom severity, depression, symptom disability, health-related quality of life, age) and five treatment specific moderators (global functioning, early childhood traumatic events, gender, health anxiety, emotion regulation skills) were identified. Individuals assigned to their PAI-indicated optimal treatment had significantly lower somatic symptom severity at the end of therapy compared to those randomised to their non-optimal condition. Conclusion: Allowing patients to choose a personalised treatment seems to be meaningful. This could help to improve outcomes for PSS and reduce its high costs to the health care system.

Cognitive and emotional variables predicting treatment outcome of cognitive behavior therapies for patients with medically unexplained symptoms: A meta-analysis.

OBJECTIVE: Cognitive behavior therapy (CBT) is the best-evaluated psychological approach to treat patients with medically unexplained symptoms (MUS). We still need a better understanding of what characterizes patients with MUS who benefit more or less from CBT. This systematic review aimed to identify patients' cognitive-emotional characteristics predicting the outcome of CBT for MUS. METHODS: A systematic literature search (PubMed, PsycINFO, Web of Science) revealed 37 eligible studies, 23 of these provided data for meta-analyses. Mean correlation coefficients between predictor variables and the outcomes (symptom intensity, physical or social-emotional functioning) were calculated using a random-effects model. Differences between syndromes of MUS were investigated with moderator analyses. RESULTS: Meta-analyses showed that patients with a comorbid mood disorder (r = 0.32, p < .01) or anxiety disorder (r = 0.18, p < .01), symptom catastrophizing and worries (r = 0.34, p < .01), tendencies of somatosensory amplification (r = 0.46, p = .04), and low symptom acceptance or self-efficacy (r = 0.25, p < .01) have a less favorable CBT outcome. Moderator analyses revealed that these associations between predictors and treatment outcome are pronounced in patients with chronic fatigue syndrome and irritable bowel syndrome. CONCLUSIONS: Our results show that pre-treatment differences in patients' cognitive-emotional characteristics predict patients' outcome in CBT. Patient-tailored CBT could be a promising approach to address MUS patients' widely varying needs more effectively. PROTOCOL REGISTRATION: The protocol of this systematic review and meta-analysis was registered in the PROSPERO registry (CRD 42018098649).

Cognitive Behaviour Therapy Complemented with Emotion Regulation Training for Patients with Persistent Physical Symptoms: A Randomised Clinical Trial.

INTRODUCTION: Persistent medically unexplained symptoms (MUS) are a major burden for health care. Cognitive behaviour therapy (CBT) is efficacious for patients with MUS, with small to medium effects. The current study investigates whether therapy outcomes of a CBT for MUS patients can be improved by complementing it with emotion regulation training. METHODS: In a multicentre trial 255 patients with at least three persisting MUS were randomised to 20 sessions of either conventional CBT (n = 128) or CBT complemented with emotion regulation training (ENCERT; n = 127). Somatic symptom severity and secondary outcomes were assessed at pre-treatment, therapy session 8, end of therapy, and 6-month follow-up. RESULTS: Linear mixed-effect models revealed medium to large effects in both study arms for almost all outcomes at the end of therapy and 6-month follow-up. ENCERT and CBT did not differ in their effect on the primary outcome (d = 0.20, 95% CI: -0.04 to 0.44). Significant time × group cross-level interactions suggested ENCERT to be of more benefit than conventional CBT for a few secondary outcomes. Moderator analyses revealed higher effects of ENCERT in patients with co-morbid mental disorders. DISCUSSION/CONCLUSIONS: Current findings are based on a representative sample. Results demonstrate that both CBT and ENCERT can achieve strong effects on primary and secondary outcomes in MUS patients. Our results do not indicate that adding a training in emotion regulation skills generally improves the effect of CBT across all patients with MUS. Large effect sizes of both treatments and potential specific benefits of ENCERT for patients with co-morbid mental disorders are discussed.

The role of therapist and patient in-session behavior for treatment outcome in exposure-based cognitive behavioral therapy for panic disorder with agoraphobia.

OBJECTIVE: There is a very limited amount of research on the relationship between therapist and patient in-session behavior and treatment outcome in cognitive behavioral therapy (CBT) for panic disorder with agoraphobia (PD/AG). Additionally, the findings tend to be inconclusive. This study investigates the association between therapist competence, adherence, patient interpersonal behavior, and therapeutic alliance and outcome in a low-control CBT setting by using comprehensive measures. METHODS: Twenty-six patients with PD/AG received 12 sessions of exposure-based CBT. With regard to the outcome, treatments were classified either as problematic or nonproblematic by means of distinct criteria. Two raters evaluated the in-session behavior. RESULTS: Patient interpersonal behavior was significantly associated with outcome at follow-up (r = 0.49). At posttreatment, the correlation did not reach significance ( r = 0.34). Competence, adherence, and alliance were not outcome associated. CONCLUSION: The findings emphasize the need for therapists to pay particular attention to patients' interpersonal behavior during treatment.

[CBASP as an Inpatient Concept for Treatment-Resistant Chronic Depression: A Pilot Study of the Relationship between Adverse Effects and Treatment Outcome]. / CBASP als stationäres Behandlungskonzept der therapieresistenten chronischen Depression: Eine Pilotstudie zum Zusammenhang von Nebenwirkungen und Therapieerfolg.

BACKGROUND: Inpatient psychotherapy might trigger adverse effects among others due to short but intensive treatment. Thus, in this pilot study, certain adverse effects of the multidisciplinary inpatient Cognitive Behavioral Analysis System of Psychotherapy (CBASP) for treatment-resistant chronically depressed patients as well as their relationship to treatment outcome (response-, remission-, and relapse-rates) are examined. MATERIAL AND METHODS: 50 patients with treatment-resistant and chronic depression completed the structured 12-weeks inpatient treatment program. Adverse effects were assessed by 1) deterioration of depressive symptoms (measured by the Hamilton Depression Rating Scale, HDRS) at discharge and 2) a self-report questionnaire measuring Adverse Effects of Inpatient Psychotherapy (ADEFIP), which were filled out 6 to 12 months after discharge by the patients. RESULTS: After 12 weeks of treatment, 84% could be classified as responder, of whom 44% fulfilled the remission criterion. 16% were Non-Responder. According to HDRS, none of the patients showed objective deterioration of the depressive symptoms. Six months after discharge, 40% of the responders suffered from relapse. Concerning the ADEFIP, 66% of the patients reported transient deterioration of symptoms. These patients were less likely to achieve remission. Over 50% reported interpersonal conflicts with treatment team members or other patients without any relation to outcome. Finally, more than half of the patients reported significant changes in social relationships after discharge. These patients were less likely to relapse. Overall, 94% of the patients reported at least one of the in this study assessed adverse effects. CONCLUSIONS: Despite some limitations, this pilot study suggests that the CBASP inpatient program could indeed cause adverse effects. However, only subjective transient deterioration appeared to have a negative impact on the individual treatment outcome in the short-term. Results encourage further research concerning adverse treatment effects in the context of short- and long-term treatment outcome investigating how relevant adverse effects are.

Readiness to change as a moderator of therapy outcome in patients with somatoform disorders.

OBJECTIVE: A considerable amount of patients with somatoform disorders do not benefit from psychotherapy as much as expected. Our aim was to explore whether readiness to change moderates the relationship between the intensity of symptoms and therapy outcome in the early stages of psychotherapy. METHOD: 144 patients with somatoform disorders received an outpatient cognitive-behavioural intervention. Symptom intensity was measured with the Screening for Somatoform Disorders (SOMS-7). For readiness to change, a German modification of the Pain Stages of Change Questionnaire (PSOCQ) was used, which comprises four subscales (FF-STABS). Regression analyses were carried out, with baseline symptoms and the readiness to change subscales as predictors and symptom reduction as the outcome variable. RESULTS: Moderation analyses revealed significant interaction effects between baseline symptoms and the precontemplation subscale, as well as between baseline symptoms and the action subscale. For preparation and maintenance, no significant interaction effects were found. CONCLUSIONS: The results suggest that readiness to change is a variable that can be used to differentiate between patients, with low precontemplation and action scores indicating a better chance for positive outcome, even with high initial impairment. Rather than using readiness to change sum scores, the sub-aspects of this construct should be the subject of future research.

[Dialectical Behavioral Therapy for Male Adolescents with Borderline Symptomatology]. / Dialektisch-Behaviorale Therapie für männliche Jugendliche mit Symptomen einer Borderline-Persönlichkeitsstörung.

Dialectical Behavioral Therapy for Male Adolescents with Borderline Symptomatology The efficacy of Dialectical Behavior Therapy for adolescents (DBT-A) in patients with borderline symptomatology has mainly been shown in female adolescents. However, male adolescents with borderline symptoms are characterized by more aggressive, disruptive, and antisocial behavior. Therefore, the efficacy of the DBT-A has to be investigated in male adolescents. The DBT-A manual was adopted for male adolescents in an inpatient setting. The program has been investigated using a pre-post design in seven male adolescents (on average 14 years of age) with an average of five borderline symptoms according to DSM-IV. Criteria for outcome are symptoms of psychopathology, emotion regulation, aggressive, and self-injurious behavior. After treatment a reduction in aggressive behavior (pre-post effect size d = 1.18) and an improvement in adaptive emotion regulation (d = 0.65) were shown. No improvement could be shown in general symptoms of psychopathology (d = 0.02). The results of these case studies of DBT-A in male adolescents are promising. However, further RCTs with larger sample sizes and a control group will be required.

[Long-term outcome of disorder-specific group therapy for multisomatoform disorders: a 3-year follow-up study]. / Langzeitverlauf nach störungsorientierten Kurzgruppeninterventionen bei somatoformen Störungen mit multiplen Körperbeschwerden: Eine 3-Jahres-Katamnese

Little is known about the long-term effectiveness of disorder-specific group interventions for somatoform disorders. In total 128 patients with somatoform disorders who had participated in 2 different 8-week outpatient group programs (cognitive-behavioral therapy or progressive muscle relaxation) were questioned at baseline and at the end of treatment. On average, there was a follow-up after 6 months and after 3 -years (3-year follow-up response rate: 63.3%). Both interventions were combined for long-term analysis as there were no substantial differences. In 2.5% of cases a possible medical cause was found for complaints originally considered as somatoform. A short disorder-specific group intervention achieved small effect sizes (range: 0.14-0.40; ITT-sample range: 0.06-0.33) in the long term; about 30% of patients can be considered responders. Further efforts are needed to improve the treatment of patients with somatoform disorders.

[Readiness for behavioural change in somatoform disorders]. / Stadien der Bewältigung bei Patienten mit somatoformen Symptomen.

The readiness for behavioural change in patients with somatoform symptoms constitutes an important construct in psychotherapy research. However, no psychometric instrument is available yet for assessing this construct. This study, therefore, attempts to adapt a questionnaire for the assessment of the "readiness for behavioural change" in patients with chronic pain (FQ-STAPM) to patients with somatoform symptoms. Various psychometric test criteria of the questionnaire are examined. The sample consists of n=103 in- and outpatients with multiple somatoform symptoms. Item characteristics, reliability (internal consistency), and construct validity for three of the four adapted scales are acceptable. Furthermore, the four-factor-structure of the FQ-STAPM can be confirmed. Moderate changes on the adapted scales of the FQ-STAPM are detected in a longitudinal design. The results corroborate the applicability of the instrument in patients with somatoform symptoms.