New ways to cope with depression-study protocol for a randomized controlled mixed methods trial of bouldering psychotherapy (BPT) and mental model therapy (MMT).

BACKGROUND: Due to the growing gap between the demand and supply of therapeutic services for people suffering from depression, with this study, we are investigating the effectiveness and factors of influence of new approaches in group treatments for depression. Two previous studies have already identified bouldering psychotherapy (BPT) as an effective option. It combines psychotherapeutic interventions with action- and body-oriented bouldering exercises. Mental model therapy (MMT) is a new cognitive-behavioral approach for treating depression. It focuses on identifying cognitive distortions, biases in decision making, and false assumptions and aims to correct and replace them with useful mental models. We aim to investigate the effectiveness of the interventions compared with a control group (CG) and to assess the factors of influence in a mixed methods approach. METHODS: The study is being conducted as a randomized controlled intervention trial. Adult participants with unipolar depression are being randomized into three groups (BPT, MMT, or CG), and the first two groups are undergoing a 10-week treatment phase. CG follows their individual standard treatment as usual. A priori power analysis revealed that about 120 people should be included to capture a moderate effect. The primary outcome of the study is depression rated with the Montgomery and Asberg Depression Rating Scale (MADRS) before (t0), directly after (t1), and 12 months after the intervention phase (t2). Data are being collected via questionnaires, computer-assisted video interviews, and physical examinations. The primary hypotheses will be statistically analyzed by mixed model ANOVAs to compare the three groups over time. For secondary outcomes, further multivariate methods (e.g., mixed model ANOVAs and regression analyses) will be conducted. Qualitative data will be evaluated on the basis of the qualitative thematic analysis. DISCUSSION: This study is investigating psychological and physical effects of BPT and MMT and its factors of influence on outpatients suffering from depression compared with a CG in a highly naturalistic design. The study could therefore provide insight into the modes of action of group therapy for depression and help to establish new short-term group treatments. Methodological limitations of the study might be the clinical heterogeneity of the sample and confounding effects due to simultaneous individual psychotherapy. TRIAL REGISTRATION: ISRCTN, ISRCTN12347878. Registered 28 March 2022, https://www.isrctn.com/ISRCTN12347878 .

Treating depression in an outpatient setting: Predictors of patient response to bouldering psychotherapy, cognitive behavioural therapy or exercise alone.

BACKGROUND: Bouldering psychotherapy (BPT) for depression has proven effective, but nothing is known about its potential predictors of response. This study should identify predictors of response to BPT, cognitive behavioural therapy (CBT) and an active control (home-based exercise programme; EP) using a literature-based model. METHODS: In a multicentre randomised controlled trial, 233 outpatients were assigned to BPT, CBT or EP. Response (reduction of at least 46% on the Montgomery-Åsberg Depression Rating Scale [MADRS]) and remission (≤7 MADRS points) were defined as suggested by the literature. Predictors of response were identified twofold: (1) univariate analyses followed by logistic regression analyses in each group with all predictors yielding a univariate p-value <.20 and (2) a backward regression analysis with all potential predictors. Only variables that emerged as predictors in both types of analyses were interpreted. RESULTS: There was a significantly greater proportion of responders (p = .035) in the BPT than in the EP. The chance of response in the BPT was higher for patients with a higher health-related quality of life. In the EP, response was higher for patients with lower interpersonal sensitivity, suffering from their first episode and living with a partner. CONCLUSIONS: Response rates in BPT are similar to or even higher than in other outpatient psychotherapy group therapies. BPT and CBT are suitable for a wide range of patients, but patients with higher functionality could start with psychoeducation and exercise.

Bouldering psychotherapy is not inferior to cognitive behavioural therapy in the group treatment of depression: A randomized controlled trial.

OBJECTIVES: Bouldering has shown promising results in the treatment of various health problems. In previous research, bouldering psychotherapy (BPT) was shown to be superior to a waitlist control group and to physical exercise with regard to reducing symptoms of depression. The primary aim of this study was to compare group BPT with group cognitive behavioural psychotherapy (CBT) to test the hypothesis that BPT would be equally as effective as CBT. DESIGN: We conducted a randomized, controlled, assessor-blinded non-inferiority trial in which 156 outpatients meeting the criteria of a depressive episode according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) were randomly assigned to one of the two intervention groups (CBT: N = 77, BPT: N = 79). METHODS: Intervention groups were manualized and treated for 10 weeks with a maximum of 11 participants and two therapists. The primary outcome was depressive symptom severity assessed with the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Patient Health questionnaire (PHQ-9) at the beginning and end of the treatment phase as well as one year after the end of treatment. RESULT: In both groups, depressive symptoms improved significantly by an average of one severity level, moving from moderate to mild depressive symptoms after therapy (MADRS difference scores: BPT -8.06, 95% CI [-10.85, -5.27], p < .001; CBT -5.99, 95% CI [-8.55, -3.44], p < .001). The non-inferiority of BPT in comparison with CBT was established on the basis of the lower bound of the 95% confidence interval falling above all of the predefined margins. BPT was found to be effective in both the short (d = 0.89) and long term (d = 1.15). CONCLUSION: Group BPT was found to be equally as effective as group CBT. Positive effects were maintained until at least 12 months after the end of therapy. Thus, BPT is a promising approach for broadening the therapeutic field of therapies for depression. PRACTITIONER POINTS: Physical activity is effective in the treatment of depression and current guidelines explicitly recommend it as a complementary method for the treatment of depression. Nevertheless, body-related interventions are still underrepresented in current treatments for depression. Bouldering psychotherapy (BPT) combines physical activity with psychotherapeutic content. Its concept relies on proven effective factors from CBT such as exposure training, problem solving and practicing new functional behaviours and is thus an enrichment and implementation of CBT methods on the bouldering wall. The positive effect of group bouldering psychotherapy (BPT) in reducing depressive symptoms in outpatients with depression is not inferior to the effect of group cognitive behavioural therapy (CBT). Additionally the 10-weeks BPT-programme significantly improved symptoms of anxiety and interpersonal sensitivity as well as health-related quality of life, coping, body image, self-efficacy, and global self-esteem.

Is bouldering-psychotherapy a cost-effective way to treat depression when compared to group cognitive behavioral therapy - results from a randomized controlled trial.

BACKGROUND: Bouldering-Psychotherapy (BPT) has proven to effectively reduce depressive symptoms, but evidence on its cost-effectiveness is lacking. Corresponding information is paramount to support health policy decision making on a potential implementation of BPT in routine care. METHODS: Using data from the German KuS trial BPT was compared with group Cognitive Behavioral Therapy (CBT). Severity of depression symptoms at end of the intervention was operationalized via Montgomery-Asberg Depression Rating Scale (MADRS) and Patient Health Questionnaire (PHQ-9). Adopting a societal perspective, direct medical costs and productivity loss were calculated based on standardized unit costs. To determine incremental cost-effectiveness ratios (ICER) and cost-effectiveness-acceptance curves (CEAC), adjusted mean differences (AMD) in costs (gamma-distributed model) and both effect parameters (Gaussian-distributed model) were obtained from 1000 simultaneous bootstrap replications. RESULTS: BPT was related to improved effects (AMDs: MADRS -2.58; PHQ-9: - 1.35) at higher costs (AMD: +€ 754). No AMD was significant. ICERs amounted to €288 per MADRS-point and €550 per PHQ-9-point. For both effect parameters about 20% of bootstrap replications indicated dominance of BPT, and about 75% larger effects at higher costs. At hypothetical willingness to pay (WTP) thresholds of €241 (MADRS) and €615 (PHQ-9) per unit of change BPT had a 50% probability of being cost-effective. CONCLUSION: BPT is a promising alternate treatment strategy which - in absence of established WTP thresholds for improving symptoms of depression - cannot unambiguously be claimed cost-effective. Further studies defining subgroups that particularly benefit from BPT appear paramount to delineate recommendations for an efficient prospective roll-out to routine care.

Bouldering psychotherapy is effective in enhancing perceived self-efficacy in people with depression: results from a multicenter randomized controlled trial.

BACKGROUND: Recent studies have suggested that therapeutic climbing/bouldering may have positive effects on perceived self-efficacy. Nevertheless, there is still an urgent need for high-quality studies, as many existing studies have suffered from methodological problems. Therefore, the current work was aimed at investigating the effect of a manualized bouldering psychotherapy (BPT) on perceived self-efficacy in people with depression, compared with a home-based physical exercise program (EP) and state-of-the-art cognitive behavioral group therapy (CBT). METHODS: In a prospective, multicenter, randomized controlled trial, 233 people with depression were randomly assigned to one group (BPT, EP, or CBT). Perceived self-efficacy was assessed at baseline (t0) and directly after the 10-week intervention period (t1) with the GSE. In addition, depression was assessed with the PHQ-9 and the MADRS. We computed t tests, analyses of variance (ANOVAs), confounder-adjusted hierarchical regression analyses, mediation analyses, and several sensitivity analyses. RESULTS: BPT participants showed a significantly larger increase in perceived self-efficacy on the GSE compared with the EP (an increase of 3.04 vs. 1.26 points, p = .016, Cohen's d = 0.39). In the confounder-adjusted hierarchical multiple regression analysis, group allocation (BPT vs. EP) was found to be the only significant predictor of the postintervention GSE score (ß = .16, p = .014) besides the baseline GSE score (ß = .69, p < .001). No differences were found between BPT and CBT participants regarding the effect on perceived self-efficacy. Only in the CBT group, the relationship between depression at baseline and postintervention was partially mediated (23%) by perceived self-efficacy. CONCLUSIONS: Participation in the manualized BPT in a group setting leads to a clinically relevant enhancement of perceived self-efficacy in people with depression. This effect is superior to that of physical exercise alone. The results provide also initial indications that BPT is comparable to CBT in enhancing perceived self-efficacy, suggesting a strong case for a broader use of BPT as a supplement to existing health services. Future studies should focus on the modes of action of BPT and its effect on perceived self-efficacy in people with other mental or physical disorders. Trial registration ISRCTN12457760, registered partly retrospectively, 26 July 2017.

Bouldering psychotherapy is more effective in the treatment of depression than physical exercise alone: results of a multicentre randomised controlled intervention study.

BACKGROUND: Recent scientific studies have suggested that climbing/bouldering is effective in alleviating depression when the comparison group was a waitlist control group, even when physical activity and other therapeutic approaches were controlled for. In the present study, we aimed to investigate the effectiveness of a manualised psychotherapeutic bouldering intervention for depressed individuals, compared with an active control group performing physical exercise alone. METHODS: In a multicentre randomised controlled intervention trial, 133 outpatients with depression were assigned to either a bouldering psychotherapy (BPT) group or a home-based supervised exercise programme (EP). Severity of depression as the primary outcome was assessed at baseline and directly after a ten-week intervention period using the Montgomery-Åsberg Depression Rating Scale (MADRS). Secondary outcomes included anxiety, coping skills, self-esteem, body image, and interpersonal sensitivity. We applied t-tests to test for differences within the groups (t0 vs. t1) and between the BPT and the EP and a multiple regression analysis with the post-intervention MADRS score as the dependent variable. The robustness of estimates was investigated with a sensitivity analyses. RESULTS: Patients in the BPT group showed a significantly larger decrease in depression scores compared with the EP on the MADRS (drop of 8.4 vs. 3.0 points, p = .002, Cohen's d = 0.55). In the confounder-adjusted regression analyses, group allocation was found to be the only significant predictor of the post-intervention MADRS score (ß = - 5.60, p = .001) besides the baseline MADRS score. Further significant differences in change scores between the BPT and the EP were found for anxiety (p = .046, d = 0.35), body image (p = .018, d = 0.42), and global self-esteem (p = .011, d = 0.45). CONCLUSIONS: The study provides evidence that the manualised BPT is not only effective in alleviating depressive symptoms but even goes beyond the effect of mere physical exercise. Based on these findings, the BPT should be considered as a complementary therapeutic approach. TRIAL REGISTRATION: Trial identification number: ISRCTN12457760: Study KuS (Klettern und Stimmung - Climbing and Mood) combined boulder and psychotherapy against depression, registered retrospectively on July 26th, 2017.

Access to Pain Management Programs: A Multifactorial Analysis of the Pathways of Care for Chronic Pain Patients in the University Clinic Erlangen.

BACKGROUND: Different treatment options are offered for patients suffering from chronic pain, which differ in intensity and costs: 1) monodisciplinary treatment, mostly in outpatient care and 2) interdisciplinary treatment with the option of participating in pain management programs as outpatients or inpatients. The present work investigates how patients at the University Clinic Erlangen receiving monodisciplinary treatment differ from those receiving interdisciplinary treatment (research question I) as well as how patients participating in a pain management program differ from those who do not (research question II). The aim is to generate insights into whether the differences between the patient groups under various treatment modalities reflect the officially defined criteria for the indication of chronic pain management programs. METHODS: Routine data of 1,833 patients treated from January 2008 to March 2013 at the University Clinic Erlangen were analyzed. After univariate preanalyses and checks for multicollinearity, the remaining variables were used for the final multivariate model (multiple binary logistic regression) for research question I and II. RESULTS: Research question I: Patients getting interdisciplinary treatment were more often employed, had higher affective experience of pain, more often regarded their pain as treatable, had more often participated in at least one pain-associated rehabilitation treatment in the past, were younger and rarely had application for retirement in consideration. Research question II: Patients who participated in a pain management program were more often female, more often employed, described their pain as mainly located at the upper part of the body, had more concomitant symptoms, were more often diagnosed with musculoskeletal pain and rarely had a retirement request pending. CONCLUSIONS: It could be shown that patients in the analyzed pathways of care mainly differed in demographic variables, and regarding pain management programs, also in the type of pain. Differences between patients in different treatment paths reflecting the officially defined indication criteria for chronic pain management programs were detectable only to a minor extent. Clearer and operational practical guidance should help support the clinical decision to assign patients to different treatment options and close the gap between theory and practice.

Long-term effects of bouldering psychotherapy on depression: benefits can be maintained across a 12-month follow-up.

BACKGROUND: Previous studies have identified positive effects of Bouldering Psychotherapy (BPT) on symptoms of depression. The aim of the present study was to investigate the short- and long-term effects of BPT on 97 participants with depression. METHODS: BPT took place once a week over a period of 8 weeks. In a waitlist control group design, participants were assessed at baseline and after 8 weeks (end of BPT for the intervention group; start of BPT for the waitlist group), 16 weeks, and 12 months. The main outcome was severity of depression measured with the Beck Depression Inventory II (BDI-II). RESULTS: Depression scores dropped by 7.21 on the BDI-II during the first intervention period with a Cohen's d of 0.59. A regression analysis at t1 showed that group allocation (p < .001) was the only significant predictor besides the baseline depression score (p < .001). A 12-month (after t0) follow-up measurement showed that the decrease in depression severity remained stable during that time, with values of d = 0.37 for the intervention group and d = 0.43 for the waitlist group. LIMITATIONS: Limitations of the study are the assessment of symptoms via only self-report, the lack of a control group during follow-up, and different durations of the follow-up period in the two groups. CONCLUSION: Our results augment the findings of previous studies regarding the short-term effects of BPT and provide initial evidence that the positive effects of BPT on depression severity can be maintained across a period of 12 months.

A German climbing study on depression: a bouldering psychotherapeutic group intervention in outpatients compared with state-of-the-art cognitive behavioural group therapy and physical activation - study protocol for a multicentre randomised controlled trial.

BACKGROUND: Besides classical approaches for treating depression, physical activity has been demonstrated to be an effective option. Bouldering psychotherapy (BPT) combines psychotherapeutic interventions with action-oriented elements from the field of climbing. The aim of this study is to investigate the effectiveness of BPT compared with a home-based exercise program (EP - active control group, superiority trial) and state-of-the-art cognitive behavioural therapy (CBT - non-inferiority trial). METHODS: The study is being conducted as a multicentre randomised controlled intervention trial at three locations in Germany. Participants are being randomised into three groups: BPT, CBT, or EP, each with a 10-week treatment phase. A power analysis indicated that about 240 people should initially be included. The primary outcome of the study is the Montgomery and Asberg Depression Rating Scale (MADRS) directly after the intervention. Additional measurement points are located three, six, and 12 months after the end of the intervention. The data are being collected via computer-assisted telephone interviews. Statistical analyses comprise regression analyses to test for the superiority of BPT over EP. To test for the non-inferiority of BPT and CBT, a non-inferiority margin of 1.9 points in the Patient Health Questionnaire (PHQ-9) and two non-inferiority margins for the MADRS (half of the two smallest Cohen's d values from the current meta-analyses) was predefined. The mean difference between CBT and EP is being used as a supplementary equivalence margin. DISCUSSION: This is the first study to investigate the effect of a bouldering psychotherapy (BPT) on outpatients' depressive symptoms compared with mere physical activity (superiority analysis) and state-of-the-art cognitive behavioural therapy (CBT, non-inferiority analysis). Methodological strengths of the study are the elaborated, multicentred, randomised, controlled design. Assessors are blinded with regard to group allocation which leads to high objectivity. The study is conducted in a naturalistic setting, which leads to high external validity. Methodological limitations might be the clinical heterogeneity of the sample, which may dilute the intervention effects. TRIAL REGISTRATION: ISRCTN12457760 (Registration date: 26 July 2017, retrospectively registered).

Searching for success: Development of a combined patient-reported-outcome ("PRO") criterion for operationalizing success in multi-modal pain therapy.

BACKGROUND: There is a need for a way to measure success in multi-modal pain therapy that researchers and clinicians can agree upon. According to developments in health services research, operationalizing success should take patient-reported outcomes into account. We will present a success criterion for pain therapy that combines different patient-reported variables and includes validity measures. The usable criterion should be part of a statistically significant and satisfactory model identifying predictors of successful pain therapy. METHODS: Routine data from 375 patients treated with multi-modal pain therapy from 2008 to 2013 were used. The change scores of five constructs were used for the combined success criterion: pain severity, disability due to pain, depressiveness, and physical- and mental-health-related quality of life. According to the literature, an improvement of at least ½ standard deviation was required on at least four of the five constructs to count as successful. A three-step analytical approach including multiple binary logistic regression analysis was chosen to identify the predictors of therapy success with the success criterion as the dependent variable. RESULTS: A total of 58.1% of the patients were classified as successful. Convergent and predictive validity data show significant correlations between the criterion and established instruments, while discriminative validity could also be shown. A multiple binary logistic regression analysis confirmed the feasibility; a significant model (Chi(2) (8) = 52.585; p < .001) that explained 17.6% of the variance identified the following predictors of therapy success: highest pain severity in the last 4 weeks, disability due to pain, and number of physician visits in the last 6 months. CONCLUSIONS: It is possible to develop a feasible success criterion that combines several variables and includes patient-reported outcomes ("PROs") with routine data that can be used in a predictor analysis in multi-modal pain therapy. The criterion was based on basic constructs used in pain therapy and used widespread validated self-rating instruments. Thus, it should be easy to transfer this criterion to other institutions.