Transfer of manualized CBT for social phobia into clinical practice (SOPHO-PRAX) : a study protocol for a cluster-randomized controlled trial

Background: Cognitive-behavioral therapy (CBT) is generally known to be efficacious in the treatment of social phobia when applied in RCT's, namely when the treatment manual is based on the Clark-Wells approach. However, little is known about the efficacy of manualized treatments in routine clinical practice (Phase IV of psychotherapy research). The present study (SOPHO-PRAX) is a continuation of a large multi-centre randomized clinical trial (SOPHO-NET) and analyses the extent to which additional training practitioners in manualized procedures enhances treatment effect. Methods: N = 36 private practitioners will be included in three treatment centres and randomly designated to either training in manualized CBT or no specific training. The treatment effects of the therapies conducted by both groups of therapists will be compared. A total of 162 patients (N = 116 completers; N = 58 per condition) will be enrolled. Liebowitz Social Anxiety Scale (LSAS) will serve as primary outcome measure. Remission from social phobia is defined as LSAS total [less than or equal to] 30 points. Data will be collected at treatment begin, after 8, 15, and 25 sessions (50 mins. each), at treatment completion, as well at 6 and 12 months post-treatment. Discussion: The present CBT trial combines elements of randomized-controlled trials and naturalistic studies in an innovative way. It will directly inform about the incremental effects of procedures established in a controlled trial into clinical practice. Study results are relevant to health care decisions and policy. They may serve to improve quality of treatment, and shorten the timeframe between the development and widespread dissemination of effective methods, thereby reducing health cost expenditures. The results of this study will not only inform about the degree to which the new methods lead to an improvement of treatment course and outcome, but also about whether the effects of routine psychotherapeutic treatment are comparable to those of the controlled, strictly manualized treatments of the SOPHO-NET study. Trial Registration: ClinicalTrials.gov identifier: NCT01388231. This study was funded by the German Federal Ministry of Education and Research (SOPHO-NET: BMBF 01GV0607; SOPHO-PRAX: BMBF 01GV1001)

Persistence of Symptoms in Primary Somatoform Vertigo and Dizziness A Disorder "Lost" in Health Care?

The aim of this study was to perform a 3-year follow-up of primary somatoform vertigo and dizziness (SVD) regarding health care use and treatment. Ninety-two patients with dizziness underwent detailed vestibular neurophysiological testing and a Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Psychometric assessments comprised the Vertigo Symptom Scale, the Vertigo Handicap Questionnaire, the SCL-90-R, and the Short-Form-36 Health Survey. At the 3-year follow-up, 65 patients with primary SVD (anxiety, n = 29; depression, n = 14; somatoform disorders, n = 22) were reassessed (70.7% response). The patients improved in symptom severity (p < 0.05), handicap (p < 0.01), and physical quality of life (QoL; p < 0.05) but showed no change in emotional distress. A total of 63.1% (of n = 65) had ongoing SVD. A total of 69.2% (of n = 65) received different forms of treatments. A total of 46.1% (of n = 65) searched redundant medical diagnostic procedures. The patients with decreased coping capacity over time obtained the best prognosis. Primary SVD is an ineffectively treated disorder. Recommendations for specific complaint-oriented psychotherapy programs were given

Regulation of emotions in the community: suppression and reappraisal strategies and its psychometric properties

Objective: The German Version of the Emotion Regulation Questionnaire (ERQ) has recently been published. The questionnaire investigates two common emotion regulation strategies (10 items) on two scales (suppression, reappraisal). Major aims of the study were to assess the reliability and factor structure of the ERQ, to determine population based norms and to investigate relations of suppression and reappraisal to anxiety, depression and demographic characteristics

Regulation of emotions in the community: suppression and reappraisal strategies and its psychometric properties

Objective: The German Version of the Emotion Regulation Questionnaire (ERQ) has recently been published. The questionnaire investigates two common emotion regulation strategies (10 items) on two scales (suppression, reappraisal). Major aims of the study were to assess the reliability and factor structure of the ERQ, to determine population based norms and to investigate relations of suppression and reappraisal to anxiety, depression and demographic characteristics

Persistence of Symptoms in Primary Somatoform Vertigo and Dizziness A Disorder "Lost" in Health Care?

The aim of this study was to perform a 3-year follow-up of primary somatoform vertigo and dizziness (SVD) regarding health care use and treatment. Ninety-two patients with dizziness underwent detailed vestibular neurophysiological testing and a Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. Psychometric assessments comprised the Vertigo Symptom Scale, the Vertigo Handicap Questionnaire, the SCL-90-R, and the Short-Form-36 Health Survey. At the 3-year follow-up, 65 patients with primary SVD (anxiety, n = 29; depression, n = 14; somatoform disorders, n = 22) were reassessed (70.7% response). The patients improved in symptom severity (p < 0.05), handicap (p < 0.01), and physical quality of life (QoL; p < 0.05) but showed no change in emotional distress. A total of 63.1% (of n = 65) had ongoing SVD. A total of 69.2% (of n = 65) received different forms of treatments. A total of 46.1% (of n = 65) searched redundant medical diagnostic procedures. The patients with decreased coping capacity over time obtained the best prognosis. Primary SVD is an ineffectively treated disorder. Recommendations for specific complaint-oriented psychotherapy programs were given

To what extent are psychological variables considered in the study of risk and protective factors for suicidal thoughts and behaviours in individuals with cancer? A systematic review of 70 years of research

Psychological variables substantially shape the risk of suicidal thoughts and behaviours (STBs). However, it is unclear to what extent they are considered in individuals with cancer. We synthesized the quantitative research landscape concerning psychological risk/protective factors of STBs in the (psycho-) oncological context. This pre-registered review (PROSPERO-ID CRD42022331484) systematically searched the databases PubMed/Medline, CINAHL, PsycInfo, Cochrane Library, and Web of Science (as well as the grey literature and preprints). Risk of bias (RoB) was estimated using the ROBINS-I tool. Of 11,159 retrieved records, 319 studies were eligible for inclusion. Of those, 163 (51.1%) had investigated psychological factors (affective: n = 155; social: n = 65; cognitive: n = 63; personality/individual differences: n = 37; life events: n = 6), in a combined 3,561,741 participants. The most common STBs were suicidal ideation (n = 107) or death wishes (n = 20) rather than behaviour (suicide deaths: n = 26; attempts: n = 14). Most studies had a serious RoB. Thus, a large body of research investigated STBs in cancer patients/survivors, but it rarely aligned with the theoretical or clinical developments in suicide research. We propose a conceptual model of STBs in cancer delineating moderation and mediation effects to advance the integration of the fields, and to future research and practice

Mindfulness and skills-based eHealth intervention to reduce distress in cancer-affected patients in the Reduct trial: Intervention protocol of the make it training optimized.

Introduction Cancer-affected patients experience high distress due to various burdens. One way to expand psycho-oncological support is through digital interventions. This protocol describes the development and structure of a web-based psycho-oncological intervention, the Make It Training optimized. This intervention is currently evaluated in the Reduct trial, a multicenter randomized controlled trial. Methods The Make It Training optimized was developed in six steps: A patient need and demand assessment, development and acceptability analysis of a prototype, the formation of a patient advisory council, the revision of the training, implementation into a web app, and the development of a motivation and evaluation plan. Results Through a process of establishing cancer-affected patients' needs, prototype testing, and patient involvement, the Make It Training optimized was developed by a multidisciplinary team and implemented in a web app. It consists of 16 interactive self-guided modules which can be completed within 16 weeks. Discussion Intervention protocols can increase transparency and increase the likelihood of developing effective web-based interventions. This protocol describes the process and results of developing a patient-oriented intervention. Future research should focus on the further personalization of web-based psycho-oncological interventions and the potential benefits of combining multiple psychotherapeutic approaches

Transfer of manualized Short Term Psychodynamic Psychotherapy (STPP) for social phobia into clinical practice: study protocol for a cluster-randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>Psychodynamic psychotherapy is frequently applied in the treatment of social phobia. Nevertheless, there has been a lack of studies on the transfer of manualized treatments to routine psychodynamic practice. Our study is the first one to examine the effects of additional training in a manualized Short Term Psychodynamic Psychotherapy (STPP) procedure on outcome in routine psychotherapy for social phobia. This study is an extension to a large multi-site RCT (N = 512) comparing the efficacy of STPP to Cognitive-Behavioral Therapy (CBT) of Social Phobia.</p> <p>Methods/Design</p> <p>The manualized treatment is designed for a time limited approach with 25 individual sessions of STPP over 6 months. Private practitioners will be randomized to training in manualized STPP vs. treatment as usual without a specific training (control condition). We plan to enrol a total of 105 patients (84 completers). Assessments will be conducted before treatment starts, after 8 and 15 weeks, after 25 treatment sessions, at the end of treatment, 6 months and 12 months after termination of treatment. The primary outcome measure is the Liebowitz Social Anxiety Scale. Remission from social phobia is defined scoring with 30 or less points on this scale.</p> <p>Discussion</p> <p>We will investigate how the treatment can be transferred from a controlled trial into the less structured setting of routine clinical care. This question represents Phase IV of psychotherapy research. It combines the benefits of randomized controlled and naturalistic research. The study is genuinely designed to promote faster and more widespread dissemination of effective interventions. It will answer the questions whether manualized STPP can be implemented into routine outpatient care, whether the new methods improve treatment courses and outcomes and whether treatment effects reached in routine psychotherapeutic treatments are comparable to those of the controlled, strictly manualized treatment of the main study.</p> <p>Trial Registration</p> <p>German Clinical Trials Register (DRKS) DRKS00000570</p