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.

Psychological Factors Predict Higher Odds and Impairment of Post-COVID Symptoms: A Prospective Study.

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 ).

Enhancing Exposure Treatment for Youths With Chronic Pain: Co-design and Qualitative Approach.

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.

Feeling lonely during the pandemic: Towards personality-tailored risk profiles.

This is the first study to disentangle associations of within- and between-person fluctuations in loneliness and their effect on evening mood during a nationwide lockdown due to COVID-19. To contribute to the development of personality-tailored risk profiles, we additionally explored the moderating role of trait neuroticism and extraversion on the association of within- and between-person loneliness and mood. We employed an ambulatory assessment design during 21 days of nationwide lockdown in Germany (13/04/2020-03/05/2020) with two interval-based assessments. The final sample comprised 322 participants (74.5% women) aged between 15 and 82 years (M = 30.7, SD = 14.9) providing 6,084 evening assessments. Linear mixed models were used to evaluate the effects of within- and between-person fluctuations in loneliness on evening mood while controlling for unspecific effects of time, sex, and age. Moderation analysis was used to investigate the influence of neuroticism and extraversion on the relation between loneliness and mood, respectively. Results indicate that especially higher between-person loneliness (i.e. participants felt lonelier compared to the average participant) but also higher within-person loneliness (i.e. participants felt lonelier compared to their individual mean) were associated with a more unpleasant mood. Neuroticism augmented the effect of within-person loneliness, while extraversion seemed to buffer the effect of between-person loneliness on mood. Our findings underline the importance of carefully monitoring loneliness during COVID-19. The findings contribute towards the development of personality-tailored risk profiles (e.g. among newly arising risk groups for loneliness due to COVID-19). We discuss how the differential consideration of within- and between-psychological processes might help to elucidate currently mixed findings on psychological coping during the COVID-19 pandemic.

Coping under a COVID-19 lockdown: patterns of daily coping and individual differences in coping repertoires.

BACKGROUND: Polyregulation-the concurrent or sequential use of multiple strategies to regulate affect or cope with stressors-is a frequent but understudied phenomenon. OBJECTIVES: We aimed to identify patterns of daily coping and individuals' coping repertoires (i.e., range of coping patterns employed across situations) during a COVID-19 pandemic lockdown. We investigated day-level covariates (appraisals, worrying, mood) of daily coping patterns and person-level covariates (psychopathology, average mood) of coping repertoires. Design: A non-representative community sample (n = 322, 15-82 years old) participated in a 21-day ambulatory assessment study. METHODS: We applied multilevel latent class analysis.. RESULTS: We identified seven daily coping patterns and ten classes of individuals differing in the size of their coping repertoire and their propensity for polyregulation. Daily coping patterns differed in daily perceived controllability and mood (but not in daily worrying or stress). At the person level, individuals with a higher level of average coronavirus-related worrying more frequently engaged in a high degree of polyregulation. The size of individuals' coping repertoire was unrelated to psychopathology and average mood. CONCLUSION: The findings provide insights into the composition of daily coping patterns and individuals' coping repertoires during crisis periods and contribute to a new polyregulation perspective on coping.

Negative Emotion Differentiation Attenuates the Within-Person Indirect Effect of Daily Stress on Nightly Sleep Quality Through Calmness.

The ability to differentiate between negative emotional states [negative emotion differentiation (NED)] has been conceptualized as a trait that facilitates effective emotion regulation and buffers stress reactivity. In the present research, we investigated the role of NED in within-person processes of daily affect regulation and coping during times of stress (the first COVID-19-related pandemic lockdown in April 2020). Using intensive longitudinal data, we analyzed whether daily stress had an indirect effect on sleep quality through calmness in the evening, and we tested whether NED moderated this within-person indirect effect by buffering the link between daily stress and calmness in the evening. A non-representative community sample (n = 313, 15-82 years old) participated in a 21-day ambulatory assessment with twice-daily surveys. The results of multilevel mediation models showed that higher daily stress was related to within-day change in calmness from morning to evening, resulting in less calmness in the evening within persons. Less calmness in the evening, in turn, was related to poorer nightly sleep quality within persons. As expected, higher NED predicted a less negative within-person link between daily stress and calmness in the evening, thereby attenuating the indirect effect of daily stress on nightly sleep quality through calmness. This effect held when we controlled for mean negative emotions and depression. The results provide support for a diathesis-stress model of NED, and hence, for NED as a protective factor that helps to explain why some individuals remain more resilient during times of stress than others.

Behavioral Test (BAT-Back): Preliminary Evidence for a Successful Predictor of Treatment Outcome After Exposure Treatment for Chronic Low Back Pain.

OBJECTIVES: Although several questionnaires assessing fear of movement exist, it is still a challenge to identify individuals who might benefit more from exposure for chronic pain than from other psychological approaches and vice versa. Psychological approaches to chronic pain cannot advance toward the often called-for "tailored approaches" because of limited knowledge about treatment predictors. Our aim was to evaluate the additional predictive value of avoidance behavior based on behavioral observation. METHODS: This study examined pretreatment self-report and behavioral measures as predictors of treatment outcome for n=43 patients experiencing disabling chronic low back pain, who took part in a randomized controlled trial in which they received 10 to 15 sessions of exposure treatment. Only patients with elevated fear avoidance based on self-report measures were included. Data were analyzed using regression analyses and classification and regression trees. RESULTS: Regression analyses showed that higher avoidance behavior at pretreatment as measured by the Behavioral Avoidance Test-Back Pain (BAT-Back) significantly predicted reduction in global disability (with a small to medium effect), but not in specific disability. Self-report measures failed to predict treatment success for both outcome measures. Classification and regression trees divide subgroups who might benefit from exposure treatment through a BAT-Back score of >22 for Pain Disability Index. DISCUSSION: There is some preliminary evidence that pretreatment avoidance behavior might be an indicator for reduction in global disability after exposure treatments in patients experiencing disabling chronic low back pain and elevated fear avoidance. We identified preliminary cutoff scores that need further investigation.

An Experimental Analogue Study on the "Dose-Response Relationship" of Different Therapeutic Instructions for Pain Exposures: The More, The Better?

OBJECTIVE: Novel suggestions derived from the inhibitory learning model on how to optimize exposure therapy have been debated with enthusiasm in the last few years, particularly with respect to the focus on expectancy violations. However, little is known about how this new approach directly compares to the traditional habituation rationale of exposure therapy. In the present study, we examined these two competing therapeutic instructions among healthy female participants in an experimental heat pain paradigm. DESIGN AND METHODS: Participants (N= 116) received a therapeutic instruction derived from either a habituation-based approach or the inhibitory learning model (expectation violation). Participants were repeatedly exposed to painful thermal stimulations until a predefined exposure goal was reached. RESULTS: The expectation violation instruction led to faster goal attainment and higher response rates than the habituation instruction. Both instructions led to increased pain tolerance in the short and long term (one-week follow-up). CONCLUSION: Our results suggest that exposure treatments using an expectation violation instruction are especially time-effective. Although the findings from this analogue design cannot be directly generalized to populations with clinically relevant levels of chronic pain, they do point to some important theoretical and clinical implications for the treatment of pain.

Treatment Expectations Towards Different Pain Management Approaches: Two Perspectives.

PURPOSE: Accumulating evidence suggests an association between patient expectations and treatment success across various types of pain treatments. Expectations among treatment caregivers, however, are often neglected. Despite international treatment guidelines, only a small minority of chronic pain patients undergo psychological interventions. Therefore, our aim was to explore expectations among treatment receivers and caregivers especially concerning their attitudes towards psychological pain treatments. METHODS: Two hundred ten (potential) treatment receivers (n=85 individuals suffering from chronic low back pain (CLBP); n=125 healthy controls) and 237 caregivers (n=75 physicians; n=64 psychotherapists; n=98 physiotherapists) provided ratings of expected treatment success for standardized vignettes describing patients suffering from CLBP and undergoing a pharmacological, psychological, or multimodal pain management program. RESULTS: Individuals suffering from CLBP generally had lower treatment expectations than healthy controls. Both psychotherapists and physicians had higher treatment expectations from their own individual treatment approach. All participants expected the multimodal approach to be most effective. The psychological approach was expected to be more effective than the pharmacological approach - except for the physicians, who expected both treatment approaches to be equally effective. CONCLUSION: There is an urgent need to clarify, under which circumstances and how patient expectations can be altered among individuals suffering from CLBP. Our results appear to encourage the implementation of multimodal and psychological pain management approaches across various settings. We invite clinicians to reflect whether their own expectations are in line with the recommendations in international treatment guidelines.

Exposure and cognitive-behavioural therapy for chronic back pain: An RCT on treatment processes.

BACKGROUND: To improve treatment outcomes, it is essential to understand the processes involved in therapeutic change. The aim of this study was to investigate the processes involved in treatment of individuals with chronic lower back pain (CLBP) and high fear-avoidance. Graded in vivo exposure (Exposure), a specific treatment, and cognitive-behavioural therapy (CBT), a general treatment, were compared. METHODS: Our study used data from a three-arm randomized controlled trial. The sample comprised 61 CLBP patients (pain duration >3 months; sufficient level of fear-avoidance). Assessments of session-by-session processes were done weekly for a maximum 14 weeks. The primary outcome, functional disability, was assessed at pre-treatment, post-treatment and 6-months follow-up. First, two-level models were used to test for treatment-related similarities and differences in the changes in session-by-session measures (i.e., common and unique treatment processes respectively). Second, we analysed treatment processes as predictors of treatment outcome. RESULTS: Contrary to our expectations, we found no evidence of unique treatment processes. Our results indicate that Exposure and CBT share some treatment processes. Specifically, patients reported a reduction in fear of movement and improvements in their ability to relax, to distract themselves, to manage their pain, to confront feared movements, to be active and to enjoy things despite their pain. Changes in fear of movement, relaxation, distraction, confrontation, activity and pain-related self-efficacy were also related to disability reduction. CONCLUSIONS: Despite conceptual differences, Exposure and CBT may share common treatment processes. Future research needs to address, however, whether these processes need to be targeted directly or can be supported indirectly. SIGNIFICANCE: We identified several treatment processes (e.g., reduction of fear of movement, enhancement of self-efficacy), which were associated with disability reduction during the management of chronic pain and fear-avoidance. These processes appeared to be equally important for Exposure and CBT. Practitioners should optimize these processes to improve their patients' functioning.

Treatment processes during exposure and cognitive-behavioral therapy for chronic back pain: A single-case experimental design with multiple baselines.

Our aim was to evaluate isolated elements of psychological pain treatments and explore treatment effects on biological stress markers. We employed a single-case experimental design with multiple baselines. Matching pairs of twelve participants (chronic low back pain >6 months; elevated pain-related fear) were randomly assigned to graded in vivo exposure (EXP) or cognitive-behavioral therapy (CBT) in a yoked design. Primary assessments were taken during baseline (7-26 days), treatment (23-44 days) and at 6-months follow-up (11-30 days) including changes in pain symptoms, disability, pain-related fear, acceptance, body confidence, self-efficacy, and positive thoughts. Psycho-educational, behavioral, cognitive, and exposure interventions were compared to baseline. EXP exhibited immediate middle-to-large effects; CBT's small-to-middle effects were delayed. Within the EXP approach, change mainly occurred during exposure but not during psycho-educational sessions. Overall cortisol was lower in EXP than CBT at post-treatment. We recommend integrating exposure elements in the management of CLBP to increase its efficacy. Psycho-educational sessions might not be necessary or should be adapted, e.g. with stronger focus on motivational aspects. Since CBT seemed to produce delayed effects, core CBT interventions such as cognitive restructuring might be added after exposure treatment to sustain therapeutic effects.