Transdiagnostic group CBT vs. standard group CBT for depression, social anxiety disorder and agoraphobia/panic disorder: Study protocol for a pragmatic, multicenter non-inferiority randomized controlled trial.

BACKGROUND: Transdiagnostic Cognitive Behavior Therapy (TCBT) manuals delivered in individual format have been reported to be just as effective as traditional diagnosis specific CBT manuals. We have translated and modified the "The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders" (UP-CBT) for group delivery in Mental Health Service (MHS), and shown effects comparable to traditional CBT in a naturalistic study. As the use of one manual instead of several diagnosis-specific manuals could simplify logistics, reduce waiting time, and increase therapist expertise compared to diagnosis specific CBT, we aim to test the relative efficacy of group UP-CBT and diagnosis specific group CBT. METHODS/DESIGN: The study is a partially blinded, pragmatic, non-inferiority, parallel, multi-center randomized controlled trial (RCT) of UP-CBT vs diagnosis specific CBT for Unipolar Depression, Social Anxiety Disorder and Agoraphobia/Panic Disorder. In total, 248 patients are recruited from three regional MHS centers across Denmark and included in two intervention arms. The primary outcome is patient-ratings of well-being (WHO Well-being Index, WHO-5), secondary outcomes include level of depressive and anxious symptoms, personality variables, emotion regulation, reflective functioning, and social adjustment. Assessments are conducted before and after therapy and at 6 months follow-up. Weekly patient-rated outcomes and group evaluations are collected for every session. Outcome assessors, blind to treatment allocation, will perform the observer-based symptom ratings, and fidelity assessors will monitor manual adherence. DISCUSSION: The current study will be the first RCT investigating the dissemination of the UP in a MHS setting, the UP delivered in groups, and with depressive patients included. Hence the results are expected to add substantially to the evidence base for rational group psychotherapy in MHS. The planned moderator and mediator analyses could spur new hypotheses about mechanisms of change in psychotherapy and the association between patient characteristics and treatment effect. TRIAL REGISTRATION: Clinicaltrials.gov NCT02954731 . Registered 25 October 2016.

Neuropsychological test performance in social anxiety disorder.

BACKGROUND: The effect of state factors on neuropsychological performance in social anxiety disorder (SAD) has not been thoroughly investigated and the overall neuropsychological profile remains poorly understood. AIMS: The primary objective of the study was to investigate the effect of state anxiety and state emotion suppression on neuropsychological performance in SAD. METHODS: A neuropsychological test battery was administered before and after an anxiety manipulation (instruction to give a video-recorded speech) to 42 patients with SAD and to a gender and education matched group of 42 healthy controls (HCs). RESULTS: Overall, participants with SAD performed worse than HCs on processing speed, visuospatial construction, visuospatial memory, verbal learning and word fluency, of which only the decreased visuospatial construction performance was considered clinically significant. State anxiety was not associated with neuropsychological performance at baseline, whereas state emotion suppression predicted decreased visuospatial memory in HCs and decreased verbal learning in the SAD group. Both groups performed better on working memory, processing speed and spatial anticipation, and worse on verbal learning and memory following the anxiety manipulation. The increase in state anxiety was associated with the decrease in verbal learning in both groups. CONCLUSIONS: Participants with SAD showed clinically significant difficulties with visuospatial construction and may experience verbal learning difficulties when suppressing emotions and experiencing an increase in anxiety.

Cognitive and Emotion Regulation Change Processes in Cognitive Behavioural Therapy for Social Anxiety Disorder.

UNLABELLED: The objective of the study was to investigate variables, derived from both cognitive and emotion regulation conceptualizations of social anxiety disorder (SAD), as possible change processes in cognitive behaviour therapy (CBT) for SAD. Several proposed change processes were investigated: estimated probability, estimated cost, safety behaviours, acceptance of emotions, cognitive reappraisal and expressive suppression. Participants were 50 patients with SAD, receiving a standard manualized CBT program, conducted in groups or individually. All variables were measured pre-therapy, mid-therapy and post-therapy. Lower level mediation models revealed that while a change in most process measures significantly predicted clinical improvement, only changes in estimated probability and cost and acceptance of emotions showed significant indirect effects of CBT for SAD. The results are in accordance with previous studies supporting the mediating role of changes in cognitive distortions in CBT for SAD. In addition, acceptance of emotions may also be a critical component to clinical improvement in SAD during CBT, although more research is needed on which elements of acceptance are most helpful for individuals with SAD. The study's lack of a control condition limits any conclusion regarding the specificity of the findings to CBT. KEY PRACTITIONER MESSAGE: Change in estimated probability and cost, and acceptance of emotions showed an indirect effect of CBT for SAD. Cognitive distortions appear relevant to target with cognitive restructuring techniques. Finding acceptance to have an indirect effect could be interpreted as support for contemporary CBT approaches that include acceptance-based strategies.

Cluster A personality pathology in social anxiety disorder: a comparison with panic disorder.

BACKGROUND: Social anxiety disorder (SAD) has been associated with cluster A personality disorder (PD) traits, mainly paranoid and schizoid traits. AIM: The aim of the study was to further investigate cluster A personality pathology in patients with SAD. METHODS: Self-reported PD traits were investigated in a clinical sample of 161 participants with SAD and in a clinical comparison group of 145 participants with panic disorder with or without agoraphobia (PAD). RESULTS: A diagnosis of SAD was associated with more paranoid and schizotypal PD traits, and an association between depression and personality pathology could indicate a state-effect of depression on PD traits. CONCLUSIONS: Patients with SAD had more cluster A personality pathology than patients with PAD, with the most solid indication for paranoid personality pathology.

A study protocol for the randomized controlled trial SAFIR FAMILY TALK: a selective primary preventive intervention vs. service as usual for children of parents with mental illness.

BACKGROUND: Children of parents with mental illness have an increased risk of developing mental illness themselves throughout their lifespan. This is due to genetic factors but also environmental disadvantages during childhood associated with parental mental illness. Selective primary preventive interventions for the children are recommended to mitigate risk factors and strengthen protective factors, but large-scale, longitudinal studies are needed. This study aims to investigate the effect of the Family Talk Preventive Intervention in a cohort of children and their parents with mental illness. METHODS: The study is a randomized controlled trial with 286 planned families with at least one parent with any mental illness and at least one child aged 7 to 17 years. It will be carried out in the mental healthcare system in the Capital Region of Denmark. Families will be referred from hospitals and municipalities. The children and parents will be assessed at baseline and then randomized and allocated to either the Family Talk Preventive Intervention or service as usual. The intervention group will be assigned to Family Talk Preventive Intervention, a manualized programme consisting of ~ seven sessions for the family, including psychoeducation about parental mental illness and resilience in children, stimulating dialogue between family members and creating a common family narrative. The study period for both groups will be 12 months. Follow-up assessments will be conducted after 4 months and 12 months. The primary outcomes are the children's level of functioning, parental sense of competence and family functioning. DISCUSSION: Given the prevalence of transgenerational transmission of mental illness, a systematic approach to prevention is needed in the mental healthcare setting. This study provides valuable knowledge on the Family Talk Preventive Intervention with a large sample size, inclusion of any parental mental illness and examination of the primary outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT05615324. Registered on 26 October 2022. Retrospectively registered.

Pre-treatment patient variables as predictors of drop-out and treatment outcome in cognitive behavioural therapy for social phobia: A systematic review.

BACKGROUND: Although cognitive behavioural therapy (CBT) has been shown to be an efficacious treatment for social phobia (SP), many patients drop out or achieve little or no benefit from treatment. This fact is generally considered an argument for the importance of studies of predictor variables. AIMS: This paper systematically reviews pre-treatment patient variables as predictors of drop-out from and outcome of CBT for SP. METHOD: A structured literature search was conducted in PsycINFO, Embase and PubMed. RESULTS: 28 published studies with n>or=60 were located. No pre-treatment patient variables were found to predict drop-out. Consistently across studies, higher levels of pre-treatment symptomatic severity predicted higher levels of end-state symptomatic severity, but not degree of improvement. There was some evidence that comorbid depression and avoidant personality disorder before treatment negatively influenced post-treatment end-state functioning, but not consistently improvement. No other patient variables consistently predicted outcome across studies. CONCLUSIONS: Generally, the results are in line with the conclusion that more disturbed patients with SP both begin and end treatment at a higher symptomatic level but with a similar degree of improvement. There is, however, little clinically or theoretically relevant knowledge to be gained from existing studies of pre-treatment patient variables as predictors of drop-out and treatment outcome in CBT for patients with SP. The field is in need of conceptual and methodological improvements if more solid findings should be hoped for.

A randomized pilot study of mindfulness-based cognitive therapy and group cognitive-behavioral therapy for young adults with social phobia.

Twenty-six young participants, 18-25 years, with social phobia (SP) were randomly assigned to eight 2-hour sessions of group mindfulness-based cognitive therapy (MBCT) and twelve 2-hour sessions of group cognitive-behavioral therapy (CBT) in a crossover design with participants receiving treatments in reversed order. Outcome was assessed after treatments, and at 6- and 12-month follow-ups. MBCT achieved moderate-high pre-post effect sizes (d=0.78 on a composite SP measure), not significantly different from, although numerical lower than those of CBT (d=1.15). Participants in both groups further improved in the periods following their first and second treatment until 6-months follow-up (pre-follow-up ds = 1.42 and 1.62). Thus, MBCT might be a useful, low cost treatment for SP, although, probably, less efficacious than CBT.

Changes in perceived centrality of anxious events following cognitive behavioral therapy for social anxiety disorder and panic disorder.

BACKGROUND AND OBJECTIVE: The purpose of the present study was to explore the association between reductions in symptoms of psychopathology and perceived centrality of negative autobiographical memories in participants with social anxiety disorder (SAD) or panic disorder (PD). METHODS: Thirty-nine individuals with SAD or PD recalled and rated four negative autobiographical memories before and after ten sessions of cognitive behavioral therapy (CBT) over a three-month period. Twenty-eight healthy controls did the same before and after a three-month period. RESULTS: As hypothesized, results showed a decrease in perceived centrality following CBT. This decrease in perceived centrality was larger, although at the trend level, for individuals who experienced reliable change on disorder-specific symptoms. LIMITATIONS: The correlational nature of the study prevents establishing the causal relationship between changes in perceived centrality and psychopathology, and future studies should explore such mechanisms. CONCLUSIONS: The present study adds to the emerging body of literature, investigating changes in centrality of event following psychotherapy.

Negative autobiographical memories in social anxiety disorder: A comparison with panic disorder and healthy controls.

BACKGROUND AND OBJECTIVES: Empirical interest in mental imagery in social anxiety disorder (SAD) has grown over the past years but still little is known about the specificity to SAD. The present study therefore examines negative autobiographical memories in participants with social anxiety disorder (SAD), compared to patients with panic disorder (PD), and healthy controls (HCs). METHODS: A total of 107 participants retrieved four memories cued by verbal phrases associated with either social anxiety (SA) or panic anxiety (PA), with two memories for each cue category. RESULTS: PA-cued memories were experienced with stronger imagery and as more traumatic. They were also rated as more central to identity than SA-cued memories, but not among participants with SAD, who perceived SA-cued memories as equally central to their identity. When between-group effects were detected, participants with anxiety disorders differed from HCs, but not from each other. LIMITATIONS: Central limitations include reliance on self-report measures, comorbidity in the anxiety disorder groups, and lack of a neutrally cued memory comparison. CONCLUSIONS: The findings align with models of SAD suggesting that past negative social events play a central role in this disorder. Future research is suggested to further explore the function of negative memories, not only in SAD, but also in other anxiety disorders.

Internet-based CBT for social phobia and panic disorder in a specialised anxiety clinic in routine care: Results of a pilot randomised controlled trial.

Ample studies have demonstrated that internet-based cognitive behavioural therapy (iCBT) for anxiety disorders is effective and acceptable in controlled settings. Studies assessing the clinical effectiveness of iCBT for anxiety disorders among routine care populations are, however, not as numerous. The purpose of this study was to assess the effectiveness of iCBT among anxiety patients, who were on a waiting list for intensive outpatient treatment, in a specialised routine care clinic. A randomised controlled pilot trial was conducted. Recruited patients were on a waiting list and had a primary diagnosis of either social phobia or panic disorder. Participants were randomised into either receiving iCBT with minimal therapist contact (received access to the programme FearFighter® (FF) and received support from a clinician via telephone) or no treatment (stayed on the waiting list). The primary outcome was self-reported symptomatic change of anxiety on Beck Anxiety Inventory (BAI). The secondary outcomes were comorbid depression measured on Beck Depression Inventory (BDI-II) and quality of life measured with the EuroQol one-item visual-analogue scale (EQ-vas). All results were analysed by intention-to-treat analyses using a mixed-effects approach. N = 158 patients were assessed for eligibility of which N = 67 met all eligibility inclusion criteria, signed informed consent forms, and were randomised. Post-treatment assessment was completed by N = 47 (70%). In the intervention group, N = 11 (31%) completed all modules of FF. No significant differences of change of symptomatic levels were found between the intervention and control group for anxiety (BAI: mean diff. = 2.42; 95% CI - 1.03 to 5.86; p = 0.17; d = 0.06) or for depression (BDI-II: mean diff. 1.87; 95% CI - 2.25 to 6.00; p = 0.37; d = 0.02). A large and significant effect was found in self-reported quality of life in favour of the experimental group (EQ-vas: mean diff. - 20.88; 95% CI - 30.64 to - 11.11; p < 0.001; d = 0.81). This study was not able to document statistically significant clinical effect of iCBT with minimal therapist contact compared to a waiting list control group in a specialised anxiety clinic in routine care. However, a large and significant effect was seen on self-reported quality of life. Although these results offer an interesting perspective on iCBT in specialised care, they should be interpreted with caution, due to the limitations of the study. A large scale fully powered RCT is recommended.

Rumination-focused cognitive behaviour therapy vs. cognitive behaviour therapy for depression: study protocol for a randomised controlled superiority trial.

BACKGROUND: Cognitive behavioural therapy is an effective treatment for depression. However, one third of the patients do not respond satisfactorily, and relapse rates of around 30 % within the first post-treatment year were reported in a recent meta-analysis. In total, 30-50 % of remitted patients present with residual symptoms by the end of treatment. A common residual symptom is rumination, a process of recurrent negative thinking and dwelling on negative affect. Rumination has been demonstrated as a major factor in vulnerability to depression, predicting the onset, severity, and duration of future depression. Rumination-focused cognitive behavioural therapy is a psychotherapeutic treatment targeting rumination. Because rumination plays a major role in the initiation and maintenance of depression, targeting rumination with rumination-focused cognitive behavioural therapy may be more effective in treating depression and reducing relapse than standard cognitive behavioural therapy. METHOD/DESIGN: This study is a two-arm pragmatic randomised controlled superiority trial comparing the effectiveness of group-based rumination-focused cognitive behaviour therapy with the effectiveness of group-based cognitive behavioural therapy for treatment of depression. One hundred twenty-eight patients with depression will be recruited from and given treatment in an outpatient service at a psychiatric hospital in Denmark. Our primary outcome will be severity of depressive symptoms (Hamilton Rating Scale for Depression) at completion of treatment. Secondary outcomes will be level of rumination, worry, anxiety, quality of life, behavioural activation, experimental measures of cognitive flexibility, and emotional attentional bias. A 6-month follow-up is planned and will include the primary outcome measure and assessment of relapse. DISCUSSION: The clinical outcome of this trial may guide clinicians to decide on the merits of including rumination-focused cognitive behavioural therapy in the treatment of depression in outpatient services. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02278224 , registered 28 Oct. 2014.

Mechanisms of change in cognitive behaviour therapy for panic disorder: the role of panic self-efficacy and catastrophic misinterpretations.

The efficacy of cognitive behavioural therapy (CBT) for panic disorder with or without agoraphobia (PD) is well-established; however, little is known about the underlying change processes of clinical improvement during therapy. According to cognitive theories, CBT for PD primarily works by changing catastrophic misinterpretations of bodily symptoms and panic attacks. However, panic self-efficacy, i.e. the perceived ability to cope with panic attacks, has also been suggested as an important change mechanism in CBT for PD. The aim of the study was to investigate if change in catastrophic misinterpretations and panic self-efficacy mediated change in the level of anxiety during the course of thirteen sessions of group CBT for PD. Forty-five participants completed weekly self-report measures of the possible cognitive mediators and the level of anxiety throughout therapy. The results indicated that within-person change in panic self-efficacy in one session, but not in catastrophic misinterpretations, predicted within-person level of anxiety symptoms the following week. However, in a reversed analysis, prior change in level of anxiety symptoms also predicted change in panic self-efficacy the following session. These results support panic self-efficacy as a mediator of change in CBT for PD, although a reciprocal causal relationship between panic self-efficacy and level of anxiety seems to be implied.

The role of depression in perceived parenting style among patients with anxiety disorders.

Despite a long tradition of research on the relationship between parenting style and anxiety disorders, few studies have taken the effect of comorbid depression into account. This study investigated perceived parenting in 504 outpatients with panic disorder/agoraphobia, social phobia or obsessive-compulsive disorder, and in 210 psychology students. The anxiety group reported both parents as less caring and their fathers as more controlling than did the student group. However, these between-group differences disappeared when taking self-reported depressive symptoms into consideration. Also no differences in parental style were found between the three diagnostic anxiety groups, when depressive symptoms were taken into account. Self-reported depressive symptoms were more consistently associated with negatively perceived parenting style than with self-reported anxiety symptoms in both the anxiety group and the student group. Results do not support theories of parental control as a specific risk factor for anxiety disorders, but they are in accordance with prior findings showing an association between depression and perceived lack of parental care.

Cognitive-behavioural group treatment of panic disorder and agoraphobia in a psychiatric setting: A naturalistic study of effectiveness.

The purpose of the present study was to investigate the effectiveness of cognitive-behavioural group treatment of panic disorder and agoraphobia in a clinical setting. Fifty-three patients were offered treatment and assessed before, after and at follow-up 1 1/2-2 years after treatment. The study included an informal waiting-list control group of 40 patients. The investigation group achieved better outcome on most analyses with 47.2% found to be panic-free after treatment compared with 12.5% in the control group. Treatment gains were durable with 66.7% without panic attacks at follow-up. Most patients, however, still had major psychological problems after treatment. The outcomes of cognitive-behavioural group treatment of panic disorder in this study were modest compared with most controlled studies, possibly due to an unselected patient group with a high degree of agoraphobia.