Objective: The structure of the relationship between ICD-11 Complex Post-traumatic Stress Disorder (C-PTSD) and dissociative symptoms requires more extensive research, especially with respect to the empirical support for a DSM-5 dissociative subtype of PTSD. The present study sought to examine 1) the structural validity of ICD-11 C-PTSD, 2) the association between latent C-PTSD factors and features of dissociation, and 3) whether patients with C-PTSD show elevated levels of dissociation when compared to PTSD and no ICD-11 PTSD disorder. Methods: A sample of traumatized psychiatric outpatients (N = 114) were diagnosed with a structured interview and subsequently administered the International Trauma Questionnaire (ITQ), the Dissociative Symptom Scale (DSS), and the Somatoform Dissociation Questionnaire, 5-items (SDQ). We used Confirmatory Factor Analysis (CFA) to replicate the established structure of C-PTSD as operationalized with the ITQ. Subsequently, a structural equation model (SEM) approach was employed to examine associations of ITQ with psychoform and somatoform dissociation as measured with the DSS and SDQ. Results: The expected factorial structure of C-PTSD was replicated in the present sample, and the domains PTSD and disturbances in self-organization were found to be related but distinct constructs. All ICD-11 C-PTSD latent factors were associated with dissociative experiences. The strongest effects were found for the symptom clusters Affective Dysregulation, Disturbances in Relationship, and Re-Experiencing. However, dissociative Gaps in Awareness and Memory and Sensory Misperception were not predicted by any ICD-11 C-PTSD latent factors. Cumulative levels of dissociative experiences appeared to differentiate ICD-11 PTSD and C-PTSD with significantly higher levels for C-PTSD. Conclusion: ICD-11 C-PTSD is strongly associated with dissociative phenomena in complex ways. Somatoform and psychoform manifestations of dissociation should be routinely assessed in patients with ICD-11 C-PTSD because such expressions may cover intense affects and painful relationship experiences. Future studies are needed to substantiate the causal and predictive relationship between ICD-11 C-PTSD and dissociation. (C) 2021 Published by Elsevier Masson SAS.

Background: The formulations of post-traumatic stress disorder (PTSD) and the newly included disorder complex PTSD (CPTSD) in the 11th edition of the International Classification of Diseases (ICD-11) have not been evaluated on a broad range of maladaptive personality traits. Objective: The aim of this study was to evaluate ICD-11 PTSD and CPTSD on maladaptive personality traits. Method: In a cross-sectional study of 106 Danish outpatients with ICD-10 PTSD, we used the International Trauma Questionnaire (ITQ) to identify patients with either ICD-11 PTSD or CPTSD (N = 84). We utilized the Personality Inventory for DSM-5 (PID-5) from the alternative model of personality disorders in DSM-5, section III, to evaluate personality trait differences between ICD-11 PTSD and CPTSD. Furthermore, PID-5 was also used to investigate relationships between personality traits and ICD-11 PTSD/CPTSD symptom clusters. The Life Event Checklist was used to assess traumatic experiences, and the MINI International Neuropsychiatric Interview was applied to assess comorbidity. Results: Patients with ICD-11 PTSD or CPTSD had elevated scores on personality traits indicative of internalizing psychopathology. However, higher impairment levels of the trait domains Negative Affectivity (d= 0.75) and Psychoticism (d = 0.80) discriminated patients with ICD-11 CPTSD from patients with PTSD. The PID-5 trait domain Detachment was moderately positively correlated to most of the ITQ symptom clusters and, the ITQ Negative Self-concept symptom cluster showed a relatively high number of significant correlations across all the PID-5 trait domains and facets. The PID-5 domain Negative Affectivity and almost all the encompassing facets were significantly correlated with DSO symptom clusters. Conclusions: The findings demonstrate the relevance of applying dimensional assessment of personality features to study the psychopathology of ICD-11 PTSD and CPTSD and potential differences. The results suggest that CPTSD is a more debilitating disorder than PTSD considering the severity of the personality features.

The newly added diagnosis complex posttraumatic stress disorder (CPTSD) in the 11th edition of the International Classification of Diseases (ICD-11) includes a domain of disturbances in self-organization (DSO), in addition to PTSD. The DSO construct appears to have definitional overlap with the dimensional personality pathology severity measure, personality functioning. This study investigated the association between personality functioning and ICD-11 CPTSD, and the associations between DSO clusters and personality functioning domains. The sample comprised 83 outpatients with ICD-11 PTSD or CPTSD. Personality functioning was operationalized with the Level of Personality Functioning Scale (LPFS) and assessed with the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Alternative Model for Personality Disorders, Module I. Results showed an average level of moderate impairment in personality functioning (i.e., Identity, Self-Direction, Empathy, and Intimacy) for the whole sample. However, the levels of impairment in personality functioning were significantly more severe in patients with ICD-11 CPTSD, compared with patients with PTSD. Furthermore, the results revealed strong significant positive associations between the personality functioning domains and the DSO symptom clusters, except for the LPFS Identity domain and the DSO Affective Dysregulation cluster. Contrary to expectations, we found a significant positive association between the PTSD symptom cluster Avoidance and the LPFS domains Identity, Self-Direction, and Intimacy. Furthermore, higher levels of impairment in the Identity and Intimacy domain were associated with an increase in DSO symptom severity. New development in assessment of personality functioning may assist clinicians in differential diagnosis of PTSD and CPTSD. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Background: Many people with refugee backgrounds suffer from trauma-related complex social and psychological problems, and compliance with standard psychological treatment tends to be low. More culturally adaptable treatment options seem to be needed. Objective: We aimed to investigate whether the music therapy method: 'trauma-focused music and imagery' (tr-MI), characterized by a particular focus on arousal and affect regulation, would be equally effective as the standard psychological talk therapies for ameliorating trauma symptoms in Danish refugees. Methods: A pragmatic, noninferiority, parallel, randomized controlled trial with six-month follow-up was carried out at three clinics for refugees in the public mental health services of the Psychiatry (DK). Seventy-four adults diagnosed with posttraumatic stress disorder (PTSD) were allocated to either music therapy sessions (tr-MI, N = 39) or psychological treatment as usual (TAU, N = 35). Western classical music, new age music, and music from the participants' own national culture were used to generate inner imagery, following a phased treatment protocol. Homework entailed listening to music. The primary outcome was the measurement of trauma symptoms by the Harvard Trauma Questionnaire, section IV (HTQ-IV); secondary measures were somatoform and psychoform dissociation (DSS-20), SDQ-20), attachment (RAAS), and well-being (WHO-5). Treatment effects reflected by primary and secondary measures were estimated using linear mixed models. Results: Tr-MI was noninferior to TAU (mean difference at follow-up HTQ-IV: 0.14, CI (-0.10; 0.38), with a - 0.3 noninferiority margin). A high dropout rate of 40% occurred in the TAU group, compared to 5% in the music therapy group. Secondary measures generated small to medium effect sizes in both groups, with significant medium effect sizes for well-being and psychoform dissociation at follow-up in tr-MI. Conclusions: Tr-MI is an innovative form of psychological treatment in refugee mental health services. Trials comparing music therapy to standardized therapy are needed to substantiate the evidence base for tr-MI therapy.

BackgroundConversion and dissociative disorders are conditions where people experience unusual neurological symptoms or changes in awareness or identity. However, symptoms and clinical signs cannot be explained by a neurological disease or other medical condition. Instead, a psychological stressor or trauma is often present. The symptoms are real and can cause significant distress or problems with functioning in everyday life for the people experiencing them.ObjectivesTo assess the beneficial and harmful effects of psychosocial interventions of conversion and dissociative disorders in adults. Search methods We conducted database searches between 16 July and 16 August 2019. We searched Cochrane Central Register of Controlled Trials (CENTRAL), MEDLI NE, Embase, and eight other databases, together with reference checking, citation searching and contact with study authors to identify additional studies. Selection criteria We included all randomised controlled trials that compared psychosocial interventions for conversion and dissociative disorders with standard care, wait list or other interventions (pharmaceutical, somatic or psychosocia I). Data collection and analysis We selected, quality assessed and extracted data from the identified studies. Two review authors independently performed ail tasks. We used standard Cochrane methodology. For continuous data, we calculated mean differences (MD) and standardised mean differences (SMD) with 95% confidence interval (Co. For dichotomous outcomes, we calculated risk ratio (RR) with 95% Cl. We assessed and downgraded the evidence according to the GRADE system for risk of bias, imprecision, indirectness, inconsistency and publication bias. Main results We included 17 studies (16 with parallel-group designs and one with a cross-over design), with 894 participants aged 18 to 80 years (female:male ratio 3:1). The data were separated into 12 comparisons based on the different interventions and comparators. Studies were pooled into the same comparison when identical interventions and comparisons were evaluated. The certainty of the evidence was downgraded as aconsequence of potential risk of bias, as many of the studies had unclear or inadequate allocation concealment. Further downgrading was performed due to imprecision, few participants and inconsistency. There were 12 comparisons for the primary outcome of reduction in physical signs. Inpatient paradoxical intention therapy compared with outpatient diazepam: inpatient paradoxical intention therapy did not reduce conversive symptoms compared with outpatient diazepam at the end of treatment (RR 1.44, 95% CI 0.91 to 2.28; 1 study, 30 participants; P = 0.12; very low-quality evidence). Inpatient treatment programme plus hypnosis compared with inpatient treatment programme: inpatient treatment programme plus hypnosis did not reduce severity of impairment compared with inpatient treatment programme at the end oftreatment (MD-0A9 (negative value better), 95% CI-1.28 to 0.30; 1 study, 45 participants; P = 0.23; very low-quality evidence). Outpatient hypnosis compared with wait list: outpatient hypnosis might reduce severity of impairment compared with wait list at the end of treatment (MD 2.10 (higher value better), 95% C11.34 to 2.86; 1 study, 49 participants; P < 0.00001; low-quality evidence). Behavioural therapy plus routine clinical care compared with routine clinical care: behavioural therapy plus routine clinical care might reduce the number of weekly seizures compared with routine clinical care alone at the end of treatment (MD-21.40 (negative value better), 95% CI-27.88 to-14.92; 1 study, 18 participants; P < 0.00001; very low-quality evidence). Cognitive behavioural therapy (CBT) compared with standard medical care: CBT did not reduce monthly seizure frequency compared to standard medical care at end of treatment (RR 1.56, 95% CI 0.39 to 6.19; 1 study, 16 participants; P = 0.53; very low-quality evidence). CBT did not reduce physical signs compared to standard medical care at the end of treatment (MD-4.75 (negative value better), 95% CI 18.73 to 9.23; 1 study, 61 participants; P = 0.51; low-quality evidence). CBT did not reduce seizure freedom compared to standard medical care at end of treatment (RR 2.33, 95% CI 0.30 to 17.88; 1 trial, 16 participants; P = 0.41; very low-quality evidence). Psychoeducational follow-up programmes compared with treatment as usual (TAU): no study measu red reduction in physical signs at end of treatment. Specialised CBT-based physiotherapy inpatient programme compared with wait list: no study measured reduction in physical signs at end of treatment. Specialised CBT-based physiotherapy outpatient intervention compared with TAU: no study measured reduction in physical signs at end of treatment. Brief psychotherapeutic intervention (psychodynamic interpersonal treatment approach) compared with standard care: brief psychotherapeutic interventions did not reduce conversion symptoms compared to standard care at end of treatment (RR 0.12, 95% Cl 0.01 to 2.00; 1 study, 19 participants; P = 0.14; very low-quality evidence). CBT plus adjunctive physical activity (APA) compared with CBT alone: CBT plus APA did not reduce overall physical impacts compared to CBT alone at end of treatment (MD 5.60 (negative value better), 95% CI-15.48 to 26.68; 1 study, 21 participants; P = 0.60; very low-quality evidence). Hypnosis compared to diazepam: hypnosis did not reduce symptoms compared to diazepam at end of treatment (RR 0.69, 9 5 /o CI 0.39 to 1.24; 1 study, 40 participants; P = 0.22; very low-quality evidence).Outpatient motivational interviewing (MI) and mindfulness-based psychotherapy compared with psychotherapy alone: psychotherapy preceded by MI might decrease seizure frequency compared with psychotherapy alone at end of treatment (MD 41.40 (negative value better), 95% C14.92 to 77.88; 1 study, 54 participants; P = 0.03; very low-quality evidence). The effect on the secondary outcomes was reported in 16/17 studies. None of the studies reported results on adverse effects. In the studies reporting on level of functioning and quality of life at end of treatment the effects ranged from small to no effect. Authors' conclusions The results of the meta-analysis and reporting of single studies suggest there is lack of evidence regarding the effects of any psychosocial intervention on conversion and dissociative disorders in adults. It is not possible to draw any conclusions about potential benefits or harms from the included studies.

OBJECTIVES:This study investigated the frequency of traumatic experiences, prevalence rates of ICD-11 post-traumatic stress disorder (PTSD) and complex PTSD (CPTSD), and overlap with ICD-10 classified disorders in outpatient psychiatry.METHOD:Overall, 165 Danish psychiatric outpatients answered the International Trauma Questionnaire, the Life Event Checklist, and the World Health Organization Well-being Index. ICD-10 diagnoses were extracted from the hospital record. Chi-square analysis, t-tests, and conditional probability analysis were used for statistical analysis.RESULTS:Nearly, all patients (94%) had experienced at least one traumatic event. CPTSD (36%) was more common than PTSD (8%) and had considerable overlap with ICD-10 affective, anxiety, PTSD, personality, adjustment and stress-reaction disorders, and behavioural and emotional disorders with onset usually occurring in childhood and adolescence. ICD-11 PTSD overlapped with ICD-10 anxiety, PTSD, adjustment and stress-reaction disorders, and behavioural and emotional disorders with onset usually occurring in childhood and adolescence. A subgroup of patients with ICD-10 PTSD (23%) did not meet criteria for ICD-11 PTSD or CPTSD.CONCLUSION:Traumatic experiences are common. ICD-11 CPTSD is a highly prevalent disorder in psychiatric outpatients. One quarter with ICD-10 PTSD did not meet criteria for either ICD-11 PTSD or CPTSD. PTSD and CPTSD had considerable overlap with ICD-10 disorders.

Conversion and dissociative disorders are conditions where people experience unusual neurological symptoms or changes in awareness or identity. However, symptoms and clinical signs cannot be explained by a neurological disease or other medical condition. Instead, a psychological stressor or trauma is often present. The symptoms are real and can cause significant distress or problems with functioning in everyday life for the people experiencing them.To assess the beneficial and harmful effects of psychosocial interventions of conversion and dissociative disorders in adults.We conducted database searches between 16 July and 16 August 2019. We searched Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and eight other databases, together with reference checking, citation searching and contact with study authors to identify additional studies. SELECTION CRITERIA: We included all randomised controlled trials that compared psychosocial interventions for conversion and dissociative disorders with standard care, wait list or other interventions (pharmaceutical, somatic or psychosocial). DATA COLLECTION AND ANALYSIS: We selected, quality assessed and extracted data from the identified studies. Two review authors independently performed all tasks. We used standard Cochrane methodology. For continuous data, we calculated mean differences (MD) and standardised mean differences (SMD) with 95% confidence interval (CI). For dichotomous outcomes, we calculated risk ratio (RR) with 95% CI. We assessed and downgraded the evidence according to the GRADE system for risk of bias, imprecision, indirectness, inconsistency and publication bias.We included 17 studies (16 with parallel-group designs and one with a cross-over design), with 894 participants aged 18 to 80 years (female:male ratio 3:1). The data were separated into 12 comparisons based on the different interventions and comparators. Studies were pooled into the same comparison when identical interventions and comparisons were evaluated. The certainty of the evidence was downgraded as a consequence of potential risk of bias, as many of the studies had unclear or inadequate allocation concealment. Further downgrading was performed due to imprecision, few participants and inconsistency. There were 12 comparisons for the primary outcome of reduction in physical signs. Inpatient paradoxical intention therapy compared with outpatient diazepam: inpatient paradoxical intention therapy did not reduce conversive symptoms compared with outpatient diazepam at the end of treatment (RR 1.44, 95% CI 0.91 to 2.28; 1 study, 30 participants; P = 0.12; very low-quality evidence). Inpatient treatment programme plus hypnosis compared with inpatient treatment programme: inpatient treatment programme plus hypnosis did not reduce severity of impairment compared with inpatient treatment programme at the end of treatment (MD -0.49 (negative value better), 95% CI -1.28 to 0.30; 1 study, 45 participants; P = 0.23; very low-quality evidence). Outpatient hypnosis compared with wait list: outpatient hypnosis might reduce severity of impairment compared with wait list at the end of treatment (MD 2.10 (higher value better), 95% CI 1.34 to 2.86; 1 study, 49 participants; P < 0.00001; low-quality evidence). Behavioural therapy plus routine clinical care compared with routine clinical care: behavioural therapy plus routine clinical care might reduce the number of weekly seizures compared with routine clinical care alone at the end of treatment (MD -21.40 (negative value better), 95% CI -27.88 to -14.92; 1 study, 18 participants; P < 0.00001; very low-quality evidence). Cognitive behavioural therapy (CBT) compared with standard medical care: CBT did not reduce monthly seizure frequency compared to standard medical care at end of treatment (RR 1.56, 95% CI 0.39 to 6.19; 1 study, 16 participants; P = 0.53; very low-quality evidence). CBT did not reduce physical signs compared to standard medical care at the end of treatment (MD -4.75 (negative value better), 95% CI -18.73 to 9.23; 1 study, 61 participants; P = 0.51; low-quality evidence). CBT did not reduce seizure freedom compared to standard medical care at end of treatment (RR 2.33, 95% CI 0.30 to 17.88; 1 trial, 16 participants; P = 0.41; very low-quality evidence). Psychoeducational follow-up programmes compared with treatment as usual (TAU): no study measured reduction in physical signs at end of treatment. Specialised CBT-based physiotherapy inpatient programme compared with wait list: no study measured reduction in physical signs at end of treatment. Specialised CBT-based physiotherapy outpatient intervention compared with TAU: no study measured reduction in physical signs at end of treatment. Brief psychotherapeutic intervention (psychodynamic interpersonal treatment approach) compared with standard care: brief psychotherapeutic interventions did not reduce conversion symptoms compared to standard care at end of treatment (RR 0.12, 95% CI 0.01 to 2.00; 1 study, 19 participants; P = 0.14; very low-quality evidence). CBT plus adjunctive physical activity (APA) compared with CBT alone: CBT plus APA did not reduce overall physical impacts compared to CBT alone at end of treatment (MD 5.60 (negative value better), 95% CI -15.48 to 26.68; 1 study, 21 participants; P = 0.60; very low-quality evidence). Hypnosis compared to diazepam: hypnosis did not reduce symptoms compared to diazepam at end of treatment (RR 0.69, 95% CI 0.39 to 1.24; 1 study, 40 participants; P = 0.22; very low-quality evidence). Outpatient motivational interviewing (MI) and mindfulness-based psychotherapy compared with psychotherapy alone: psychotherapy preceded by MI might decrease seizure frequency compared with psychotherapy alone at end of treatment (MD 41.40 (negative value better), 95% CI 4.92 to 77.88; 1 study, 54 participants; P = 0.03; very low-quality evidence). The effect on the secondary outcomes was reported in 16/17 studies. None of the studies reported results on adverse effects. In the studies reporting on level of functioning and quality of life at end of treatment the effects ranged from small to no effect.The results of the meta-analysis and reporting of single studies suggest there is lack of evidence regarding the effects of any psychosocial intervention on conversion and dissociative disorders in adults. It is not possible to draw any conclusions about potential benefits or harms from the included studies.

The purpose of this pilot study was to explore differences in the level of personality functioning, symptom severity, and personality pathology in patients with mixed sensory-motor functional neurological disorder (conversion disorder). Individuals with psychogenic nonepileptic seizures were not included. We recruited 15 patients, mean age of 33.5 years (SD, 11.4 years), 13 females and 2 males, from an outpatient clinic for psychotherapeutic treatment. We assessed the patients using the Structured Clinical Interview for DSM-4 Axis II Personality Disorders, the SCL-90-R, the Karolinska Psychodynamic Profile, and the Defense Style Questionnaire. We were able to distinguish two levels of difficulty in relation to personality functioning as distinct subgroups: 1) "neurotic" with less severe or moderate personality psychopathology and 2) "borderline" with severe personality psychopathology. Furthermore, we concluded that all patients showed severe deficits in personality functioning. The study points out the clinical relevance of identifying personality functioning as part of an assessment in the preparation of a treatment strategy.

Meta-analyses of studies on psychological treatment of refugees describe highly varying outcomes, and research on multi-facetted and personalized treatment of refugees with post-traumatic stress disorder (PTSD) is needed. Music therapy has been found to affect arousal regulation and emotional processing, and a pilot study on the music therapy method Trauma-focused Music and Imagery (TMI) with traumatized refugees resulted in significant changes of trauma symptoms, well-being and sleep quality. The aim of the trial is to test the efficacy of TMI compared to verbal psychotherapy.

Traumatized refugees seeking treatment in special units of psychiatry are in need of treatment options that can help them stabilize and cope with post-traumatic stress disorder (PTSD) in their everyday life. Guided Imagery and Music (GIM) has improved psychological health for clinical populations including trauma survivors with PTSD. Prior to the implementation of a randomized controlled study, a clinical non-controlled study was carried out to assess the feasibility and acceptability of a trauma-focused modification of GIM combined with standard treatment with medication, and to examine the suitability of chosen instruments to measure reduction of PTSD symptoms in refugees. Sixteen adult refugees with PTSD were enrolled and they all completed 16 one-hour individual sessions. Pre-post measures of PTSD symptoms, sleep quality, well-being and social function demonstrated significant changes with large effect sizes. Evaluation of the single sessions showed that participants found the therapy acceptable and helpful. All participants used music listening for self-care in their homes between sessions. The findings indicate that trauma-focused modified GIM was well accepted and has a potential as an effective treatment for refugees with PTSD. A larger randomized controlled trial to validate these findings is warranted.

Background: Meta-analyses of studies on psychological treatment of refugees describe highly varying outcomes, and research on multi-facetted and personalized treatment of refugees with post-traumatic stress disorder (PTSD) is needed. Music therapy has been found to affect arousal regulation and emotional processing, and a pilot study on the music therapy method Trauma-focused Music and Imagery (TMI) with traumatized refugees resulted in significant changes of trauma symptoms, well-being and sleep quality. The aim of the trial is to test the efficacy of TMI compared to verbal psychotherapy. Methods: A randomized controlled study with a non-inferiority design is carried out in three locations of a regional outpatient psychiatric clinic for refugees. Seventy Arabic-, Englishor Danish-speaking adult refugees (aged 18–67 years) diagnosed with PTSD are randomized to 16 sessions of either music therapy or verbal therapy (standard treatment). All participants are offered medical treatment, psychoeducation by nurses, physiotherapy or body therapy and social counseling as needed. Outcome measures are performed at baseline, post therapy and at 6 months’ follow-up. A blind assessor measures outcomes post treatment and at follow-up. Questionnaires measuring trauma symptoms (HTQ), quality of life (WHO-5), dissociative symptoms (SDQ-20, DSS-20) and adult attachment (RAAS) are applied, as well as physiological measures (salivary oxytocin, beta-endorphin and substance P) and participant evaluation of each session. Discussion: The effect of music therapy can be explained by theories on affect regulation and social engagement, and the impact of music on brain regions affected by PTSD. The study will shed light on the role of therapy for the attainment of a safe attachment style, which recently has been shown to be impaired in traumatized refugees. The inclusion of music and imagery in the treatment of traumatized refugees hopefully will inform the choice of treatment method and expand the possibilities for improving refugee health and integration. Trial registration: ClinicalTrials.gov ID number NCT03574228, registered retrospectively on 28 June 2016.

Objective To compare the benefits and harms of third-wave cognitive therapy versus mentalisation-based therapy in a small sample of depressed participants. Setting The trial was conducted at an outpatient psychiatric clinic for non-psychotic patients in Roskilde, Denmark. Participants 44 consecutive adult participants diagnosed with major depressive disorder. Interventions 18 weeks of third-wave cognitive therapy (n=22) versus 18 weeks of mentalisation-based treatment (n=22). Outcomes The primary outcome was the Hamilton Rating Scale for Depression (HDRS) at end of treatment (18 weeks). Secondary outcomes were: remission (HDRS <8), Beck's Depression Inventory, Symptom Checklist 90 Revised and The WHO-Five Well-being Index 1999. Results The trial inclusion lasted for about 2 years as planned but only 44 out of the planned 84 participants were randomised. Two mentalisation-based participants were lost to follow-up. The unadjusted analysis showed that third-wave participants compared with mentalisation-based participants did not differ significantly regarding the 18 weeks HDRS score (12.9 vs 17.0; mean difference −4.14; 95% CI −8.30 to 0.03; p=0.051). In the analysis adjusted for baseline HDRS score, the difference was favouring third-wave cognitive therapy (p=0.039). At 18 weeks, five of the third-wave participants (22.7%) were in remission versus none of the mentalisation-based participants (p=0.049). We recorded no suicide attempts or suicides during the intervention period in any of the 44 participants. No significant differences were found between the two intervention groups on the remaining secondary outcomes. Conclusions Third-wave cognitive therapy may be more effective than mentalisation-based therapy for depressive symptoms measured on the HDRS. However, more randomised clinical trials are needed to assess the effects of third-wave cognitive therapy and mentalisation-based treatment for depression. Trial registration number Registered with Clinical Trials government identifier: NCT01070134 .

BACKGROUND:Most interventions for depression have shown small or no effects. 'Third wave' cognitive therapy and mentalization-based therapy have both gained some ground as treatments of psychological problems. No randomised trial has compared the effects of these two interventions for patients with major depression.METHODS/DESIGN:We plan a randomised, parallel group, assessor-blinded superiority clinical trial. During two years we will include 84 consecutive adult participants diagnosed with major depressive disorder. The participants will be randomised to either 'third wave' cognitive therapy versus mentalization-based therapy. The primary outcome will be the Hamilton Rating Scale for Depression at cessation of treatment at 18 weeks. Secondary outcomes will be the proportion of patients with remission, Symptom Checklist 90 Revised, Beck's Depression Inventory, and The World Health Organisation-Five Well-being Index 1999.DISCUSSION:Interventions for depression have until now shown relatively small effects. Our trial results will provide knowledge about the effects of two modern psychotherapeutic interventions.TRIAL REGISTRATION:ClinicalTrials: NCT01070134.