Processes of change in a randomized clinical trial of radically open dialectical behavior therapy (RO DBT) for adults with treatment-refractory depression.

OBJECTIVE: Radically open dialectical behavior therapy (RO DBT) is an empirically supported psychotherapy for treatment-refractory depression (TRD) that targets psychological inflexibility and interpersonal functioning within the context of maladaptive overcontrol. However, it is unknown whether change in these mechanistic processes is associated with decreased symptoms. This study tested whether change in psychological inflexibility and interpersonal functioning is associated with change in depressive symptoms in RO DBT. METHOD: Adults with TRD from The Refractory Depression: Mechanisms and Efficacy of RO DBT (RefraMED) randomized controlled trial of RO DBT, n = 250; M (SD) age = 47.2 (11.5); 65% female; 90% White, were assigned to RO DBT or treatment as usual. Psychological inflexibility and interpersonal functioning were assessed at baseline, 3 (midtreatment), 7 (posttreatment), 12, and 18 months. Mediation analyses and latent growth curve modeling (LGCM) assessed whether change in psychological inflexibility and interpersonal functioning was associated with change in depressive symptoms. RESULTS: The effect of RO DBT in decreasing depressive symptoms was mediated by changes in psychological inflexibility and interpersonal functioning at 3 (95% CI [-2.35, -0.15]; [-1.29, -0.04], respectively), 7 (95% CI [-2.80, -0.41]; [-3.39, -0.02]), and only psychological inflexibility at 18 (95% CI [-3.22, -0.62]) months. LGCM indicated only in RO DBT was a decrease in psychological inflexibility through 18 months associated with a decrease in depressive symptoms (B = 0.13, p < .001). CONCLUSIONS: This supports RO DBT theory about targeting processes related to maladaptive overcontrol. Interpersonal functioning, and in particular, psychological flexibility, may be mechanisms that decrease depressive symptoms in RO DBT for TRD. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Refractory depression - mechanisms and efficacy of radically open dialectical behaviour therapy (RefraMED): findings of a randomised trial on benefits and harms.

BACKGROUND: Individuals with depression often do not respond to medication or psychotherapy. Radically open dialectical behaviour therapy (RO DBT) is a new treatment targeting overcontrolled personality, common in refractory depression. AIMS: To compare RO DBT plus treatment as usual (TAU) for refractory depression with TAU alone (trial registration: ISRCTN 85784627). METHOD: RO DBT comprised 29 therapy sessions and 27 skills classes over 6 months. Our completed randomised trial evaluated RO DBT for refractory depression over 18 months in three British secondary care centres. Of 250 adult participants, we randomised 162 (65%) to RO DBT. The primary outcome was the Hamilton Rating Scale for Depression (HRSD), assessed masked and analysed by treatment allocated. RESULTS: After 7 months, immediately following therapy, RO DBT had significantly reduced depressive symptoms by 5.40 points on the HRSD relative to TAU (95% CI 0.94-9.85). After 12 months (primary end-point), the difference of 2.15 points on the HRSD in favour of RO DBT was not significant (95% CI -2.28 to 6.59); nor was that of 1.69 points on the HRSD at 18 months (95% CI -2.84 to 6.22). Throughout RO DBT participants reported significantly better psychological flexibility and emotional coping than controls. However, they reported eight possible serious adverse reactions compared with none in the control group. CONCLUSIONS: The RO DBT group reported significantly lower HRSD scores than the control group after 7 months, but not thereafter. The imbalance in serious adverse reactions was probably because of the controls' limited opportunities to report these.

Refractory depression - cost-effectiveness of radically open dialectical behaviour therapy: findings of economic evaluation of RefraMED trial.

BACKGROUND: Refractory depression is a major contributor to the economic burden of depression. Radically open dialectical behaviour therapy (RO DBT) is an unevaluated new treatment targeting overcontrolled personality, common in refractory depression, but it is not yet known whether the additional expense of RO DBT is good value for money.AimsTo estimate the cost-effectiveness of RO DBT plus treatment as usual (TAU) compared with TAU alone in people with refractory depression (trial registration: ISRCTN85784627). METHOD: We undertook a cost-effectiveness analysis alongside a randomised trial evaluating RO DBT plus TAU versus TAU alone for refractory depression in three UK secondary care centres. Our economic evaluation, 12 months after randomisation, adopted the perspective of the UK National Health Service (NHS) and personal social services. It evaluated cost-effectiveness by comparing the net cost of RO DBT with the net gain in quality-adjusted life-years (QALYs), estimated using the EQ-5D-3L measure of health-related quality of life. RESULTS: The additional cost of RO DBT plus TAU compared with TAU alone was £7048 and was associated with a difference of 0.032 QALYs, yielding an incremental cost-effectiveness ratio (ICER) of £220 250 per QALY. This ICER was well above the National Institute for Health and Care Excellence (NICE) upper threshold of £30 000 per QALY. A cost-effectiveness acceptability curve indicated that RO DBT had a zero probability of being cost-effective compared with TAU at the NICE £30 000 threshold. CONCLUSIONS: In its current resource-intensive form, RO DBT is not a cost-effective use of resources in the UK NHS.Declaration of interestR.H. is co-owner and director of Radically Open Ltd, the RO DBT training and dissemination company. D.K. reports grants outside the submitted work from the National Institute for Health Research (NIHR). T.L. receives royalties from New Harbinger Publishing for sales of RO DBT treatment manuals, speaking fees from Radically Open Ltd, and a grant outside the submitted work from the Medical Research Council. He was co-director of Radically Open Ltd between November 2014 and May 2015 and is married to Erica Smith-Lynch, the principal shareholder and one of two directors of Radically Open Ltd. H.O'M. reports personal fees outside the submitted work from the Charlie Waller Institute and Improving Access to Psychological Therapy. S.R. provides RO DBT supervision through her company S C Rushbrook Ltd. I.R. reports grants outside the submitted work from NIHR and Health & Care Research Wales. M. Stanton reports personal fees outside the submitted work from British Isles DBT Training, Stanton Psychological Services Ltd and Taylor & Francis. M. Swales reports personal fees outside the submitted work from British Isles DBT Training, Guilford Press, Oxford University Press and Taylor & Francis. B.W. was co-director of Radically Open Ltd between November 2014 and February 2015.

Radically open DBT: Targeting emotional loneliness in Anorexia Nervosa.

This article conceptualizes Anorexia Nervosa (AN) as a prototypical overcontrolled disorder, characterized by low receptivity and openness, low flexible control, pervasive inhibited emotional expressiveness, low emotional awareness, and low social connectedness and intimacy with others. As a result, individuals with AN often report high levels of emotional loneliness. A new evidence-based treatment, Radically Open Dialectical Behavior Therapy (RO-DBT), and its underlying neuroregulatory theory, offer a novel way of understanding how self-starvation and social signaling deficits are used as maladaptive regulation strategies to reduce negative affect. RO-DBT proposes that rather than trying to be 'emotionally regulated' or achieving equanimity, long-term psychological well-being is achieved by increasing social connectedness. RO-DBT skills, including body posture, gestures, and facial expressions, activate brain regions that increase social safety responses that function to automatically enhance the open-minded and flexible social-signaling, which are crucial for establishing long-term intimate bonds with others and becoming part of a "tribe."

What can we learn from trial decliners about improving recruitment? Qualitative study.

BACKGROUND: Trials increasingly experience problems in recruiting participants. Understanding the causes of poor recruitment is critical to developing solutions. We interviewed people who had declined a trial of an innovative psychological therapy for depression (REFRAMED) about their response to the trial invitation, in order to understand their decision and identify ways to improve recruitment. METHODS: Of 214 people who declined the trial, 35 (16 %) gave permission to be contacted about a qualitative study to explore their decision. Analysis of transcripts of semi-structured interviews was informed by grounded theory. RESULTS: We interviewed 20 informants: 14 women and six men, aged 18 to 77 years. Many interviewees had prior experience of research participation and positive views of the trial. Interviewees' decision making resembled a four-stage sequential process; in each stage they either decided not to participate in the trial or progressed to the next stage. In stage 1, interviewees assessed the invitation in the context of their experiences and attitudes; we term those who opted out at this stage 'prior decliners' as they had an established position of declining trials. In stage 2, interviewees assessed their own eligibility; those who judged themselves ineligible and opted out at this stage are termed 'self-excluders'. In stage 3, interviewees assessed their need for the trial therapy and potential to benefit; we term those who decided they did not need the trial therapy and opted out at this stage 'treatment decliners'. In stage 4, interviewees deliberated the benefits and costs of trial participation; those who opted out after judging that disadvantages outweighed advantages are termed 'trial decliners'. Across all stages, most individuals declined because they judged themselves ineligible or not in need of the trial therapy. While 'prior decliners' are unlikely to respond to any trial recruitment initiative, the factors leading others to decline are amenable to amelioration as they do not arise from a rejection of trials or a personal stance. CONCLUSIONS: To improve recruitment in similar trials, the most successful interventions are likely to address patients' assessments of their eligibility and their potential to benefit from the trial treatment, rather than reducing trial burden. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN85784627 . Registration date 10 August 2011.

Radically Open-Dialectical Behavior Therapy for Disorders of Over-Control: Signaling Matters.

Radically Open-Dialectical Behavior Therapy (RO-DBT) is a transdiagnostic treatment designed to address a spectrum of difficult-to-treat disorders sharing similar phenotypic and genotypic features associated with maladaptive over-control-such as anorexia nervosa, chronic depression, and obsessive compulsive personality disorder. Over-control has been linked to social isolation, aloof and distant relationships, cognitive rigidity, high detailedfocused processing, risk aversion, strong needs for structure, inhibited emotional expression, and hyper-perfectionism. While resting on the dialectical underpinnings of standard DBT, the therapeutic strategies, core skills, and theoretical perspectives in RO-DBT often substantially differ. For example, RO-DBT contends that emotional loneliness secondary to low openness and social-signaling deficits represents the core problem of over-control, not emotion dysregulation. RO-DBT also significantly differs from other treatment approaches, most notably by linking the communicative functions of emotional expression to the formation of close social bonds and via skills targeting social-signaling and changing neurophysiological arousal. The aim of this paper is to provide a brief overview of the core theoretical principles and unique treatment strategies underlying RO-DBT.

Radically open-dialectical behavior therapy for adult anorexia nervosa: feasibility and outcomes from an inpatient program.

BACKGROUND: Anorexia Nervosa (AN) is a highly life-threatening disorder that is extremely difficult to treat. There is evidence that family-based therapies are effective for adolescent AN, but no treatment has been proven to be clearly effective for adult AN. The methodological challenges associated with studying the disorder have resulted in recommendations that new treatments undergo preliminary testing prior to being evaluated in a randomized clinical trial. The aim of this study was to provide preliminary evidence on the effectiveness of a treatment program based on a novel adaptation of Dialectical Behavior Therapy (DBT) for adult Anorexia Nervosa (Radically Open-DBT; RO-DBT) that conceptualizes AN as a disorder of overcontrol. METHODS: Forty-seven individuals diagnosed with Anorexia Nervosa-restrictive type (AN-R; mean admission body mass index = 14.43) received the adapted DBT inpatient program (mean length of treatment = 21.7 weeks). RESULTS: Seventy-two percent completed the treatment program demonstrating substantial increases in body mass index (BMI; mean change in BMI = 3.57) corresponding to a large effect size (d = 1.91). Thirty-five percent of treatment completers were in full remission, and an additional 55% were in partial remission resulting in an overall response rate of 90%. These same individuals demonstrated significant and large improvements in eating-disorder related psychopathology symptoms (d = 1.17), eating disorder-related quality of life (d = 1.03), and reductions in psychological distress (d = 1.34). CONCLUSIONS: RO-DBT was associated with significant improvements in weight gain, reductions in eating disorder symptoms, decreases in eating-disorder related psychopathology and increases in eating disorder-related quality of life in a severely underweight sample. These findings provide preliminary support for RO-DBT in treating AN-R suggesting the importance of further evaluation examining long-term outcomes using randomized controlled trial methodology.

That "poker face" just might lose you the game! The impact of expressive suppression and mimicry on sensitivity to facial expressions of emotion.

Successful interpersonal functioning often requires both the ability to mask inner feelings and the ability to accurately recognize others' expressions--but what if effortful control of emotional expressions impacts the ability to accurately read others? In this study, we examined the influence of self-controlled expressive suppression and mimicry on facial affect sensitivity--the speed with which one can accurately identify gradually intensifying facial expressions of emotion. Muscle activity of the brow (corrugator, related to anger), upper lip (levator, related to disgust), and cheek (zygomaticus, related to happiness) were recorded using facial electromyography while participants randomized to one of three conditions (Suppress, Mimic, and No-Instruction) viewed a series of six distinct emotional expressions (happiness, sadness, fear, anger, surprise, and disgust) as they morphed from neutral to full expression. As hypothesized, individuals instructed to suppress their own facial expressions showed impairment in facial affect sensitivity. Conversely, mimicry of emotion expressions appeared to facilitate facial affect sensitivity. Results suggest that it is difficult for a person to be able to simultaneously mask inner feelings and accurately "read" the facial expressions of others, at least when these expressions are at low intensity. The combined behavioral and physiological data suggest that the strategies an individual selects to control his or her own expression of emotion have important implications for interpersonal functioning.

Cardiac Responses during Picture Viewing in Young Male Patients with Schizophrenia.

Previous research investigating the emotion recognition ability in patients with schizophrenia has mainly focused on the recognition of facial expressions. To broaden our understanding of emotional processes in patients with schizophrenia, this study aimed to investigate whether these patients experience and process other emotionally evocative stimuli differently from healthy participants. To investigate this, we measured the cardiac and subjective responses of 33 male patients (9 with and 24 without antipsychotic medication) and 40 male control subjects to emotion-eliciting pictures. Cardiac responses were chosen as an outcome measure because previous research has indicated that these are linked with attentional and emotional processes and provide a more objective measure than self-report measures alone. The differences in cardiac responses between patients and controls were limited to medicated patients: only the medicated patients showed significantly decreased cardiac orienting responses compared with control subjects, regardless of picture contents. These results indicate that medicated patients directed less attention towards emotion-eliciting pictures than controls. Decreased attentional resources while processing emotional evocative stimuli could lead to incorrect appraisals of the environment and may have detrimental emotional and social consequences, contributing to chronic stress levels and an increased risk for cardiovascular disease.

Unmyelinated and myelinated skin nerve damage in Guillain-Barré syndrome: correlation with pain and recovery.

We performed a prospective study in 32 patients with Guillain-Barré syndrome (GBS) or its variants to correlate intraepidermal nerve fiber density (IENFD) at the distal leg and lumbar region with pain, autonomic dysfunction, and outcome. In the acute phase, IENFD was reduced in 60% and 61.9% of patients at the distal leg and lumbar region, respectively. In the acute phase, 43.7% of patients complained of neuropathic pain. Their IENFD at the distal leg was significantly lower than in patients without pain (P<.001) and correlated with pain intensity (r(s)=-0.51; P=.003). Intriguingly, also patients with the pure motor variant of GBS and pain had low IENFD. At 6-month follow-up, only 3 patients complained of persisting neuropathic pain, whereas 3 patients reported late-onset pain symptoms. IENFD in the acute phase did not predict presence or intensity of pain at 6-month follow-up. IENFD in the acute phase did not correlate with clinical dysautonomia or GBS severity at nadir. However, it correlated with poorer GBS disability score at 6 months (P=.04), GBS score at nadir (P=.03), and clinically probable dysautonomia (P=.004). At 6-month follow-up, median IENFD remained significantly low both at the distal leg (P=.024) and lumbar region (P=.005). Double and triple staining confocal microscope studies showed diffuse damage of myelinated dermal nerves along with axonal degeneration, and mononuclear cell infiltration. Unmyelinated and myelinated skin nerves are diffusely affected in GBS and its variants, including the pure motor form. IENFD declines early, remains low over time, correlates with pain severity in the acute phase, and may predict long-term disability.

Diurnal cortisol patterns of young male patients with schizophrenia.

AIMS: It has been suggested that schizophrenic patients are more vulnerable to stress than healthy persons, and that stressors can trigger a psychotic episode or worsen symptoms. The biological system often studied in relation to stress is the hypothalamic-pituitary-adrenal (HPA) axis, which controls the release of cortisol. We investigated whether the diurnal basal activity of the HPA axis differed between young male patients with schizophrenia and healthy controls. METHODS: Twenty-seven male patients (mean age 22 ± 5 years) and 38 healthy male control subjects (mean age 22 ± 3 years) were included in the present study. Saliva was sampled at five time points during the day: directly after awakening, 30 min thereafter, and at 12.00 hours, 16.00 hours and 22.00 hours. RESULTS: The cortisol concentration decreased significantly more during the day in the patient group thanin the control group. Patients also showed a significantly decreased area under the curve with respect to the increase, again indicating that the cortisol concentrations decreased more during the day in patients than in controls. Both the morning increase and the area under the curve with respect to the increase were significantly negatively correlated with negative symptom severity. CONCLUSIONS: Patients with schizophrenia showed a different daytime sensitivity of the HPA axis. Our findings further suggest that an increase in negative symptom severity is related to a decreased HPA axis sensitivity.

The effect of antipsychotic medication on facial affect recognition in schizophrenia: a review.

Patients with schizophrenia suffer from impairments in facial affect recognition and social functioning. Since antipsychotic medication affects different areas in the brain, they may also affect target areas involved in emotional processing mechanisms. In this article, we review the findings of the effect of antipsychotic medication on facial affect recognition in schizophrenia. We searched PubMed for articles in English with the keywords schizophrenia, facial, affect, emotion, antipsychotic and medication, published till January 2008. Eight relevant articles were found describing original studies. No substantial improvements in facial affect recognition were found after treatment with either typical or atypical antipsychotic drugs. Facial affect recognition was not related to neuropsychological functioning, and it was unclear whether improvement of symptom severity was related to performance on the facial affect recognition tasks. It is recommended that future research should focus on measuring social skills and social functioning more directly, and by investigating the effects of additional behavioural treatments on facial affect recognition and social functioning relative to treatment with antipsychotic medication alone.

Subjective and physiological responses to emotion-eliciting pictures in male schizophrenic patients.

Several studies have shown that schizophrenic patients have difficulties in their ability to recognize emotional facial expressions, whereas other research indicated that they subjectively report the same emotional experience as healthy controls. The purpose of this study was to investigate whether the physiological responses that accompany emotions differ between schizophrenic patients and controls, which would suggest a different basic emotional processing mechanism in these patients. We presented 40 emotion-eliciting pictures to male patients (n=26) and controls (n=21), while measuring heart rate (HR), breathing rate (BR), skin conductance response (SCR) and systolic blood pressure (SBP). Each subject rated each picture for its degree of valence and arousal. Mixed-effects regression models were used to investigate the relationships between the subjective ratings and the physiological responses. In both groups, BR and SCR increased with increasing arousal ratings, suggesting sympathetic activation. The SBP of both groups increased with increases in both the valence and the arousal ratings. However, whereas the patients' HR first decreased with decreasing pleasure ratings and subsequently increased with higher arousal and valence ratings, the HR in the control group was influenced by a complex interaction between valence and arousal ratings. Thus, the schizophrenic patients showed similar relationships between subjective ratings and SCR, BR, and SBP, but a different relationship between subjective ratings and HR compared with the healthy controls.

Physiological responsivity to emotional pictures in schizophrenia.

Schizophrenic patients are known to experience difficulties in emotional information processing, yet knowledge of their physiological responsivity to emotional stimuli is limited. The purpose of this study was to investigate the physiological reactions of schizophrenic patients to emotional stimuli. We presented pictures selected from the International Affective Picture System (IAPS) to patients and controls, while assessing their subjective evaluations in terms of valence and arousal scores and measuring their responses of heart rate (HR), breathing rate (BR), skin conductance level (SCL) and diastolic (DBP) and systolic blood pressure (SBP). For the analysis of the physiological data, three emotional picture categories were formed: positive (erotic content), negative (physical injuries) and neutral (landscapes). Patients and controls did not differ in their subjective evaluations of the pictures. Also, for both patients and controls, the SCL and DBP responses to positive emotional pictures were larger as compared to negative and neutral pictures. However, the patients did show significantly increased HR responses to the positive emotional pictures as compared to controls, possibly as a result of a decreased parasympathetic activity. Only for the BR response to the positive emotional pictures did we observe significant positive correlations with the PANSS scores. These first data suggest that altered physiological responsivity to emotional pictures in schizophrenia is limited to those with positive emotional content. Further studies will need to refine the dynamics of this stimulus category in relation to clinical state and medication effects.