A pragmatic randomized controlled trial of group transdiagnostic cognitive-behaviour therapy for anxiety disorders in primary care: study protocol.

BACKGROUND: Anxiety disorders are the most common mental disorders in community settings, and they are associated with significant psychological distress, functional and social impairment. While cognitive behaviour therapy (CBT) is the most consistently efficacious psychological treatment for anxiety disorders, barriers preclude widespread implementation of CBT in primary care. Transdiagnostic group CBT (tCBT) focuses on cognitive and behavioural processes and intervention strategies common to different anxiety disorders, and could be a promising alternative to conventional CBT. This study aims to examine the effectiveness of a transdiagnostic group CBT for anxiety disorders program as a complement to treatment-as-usual (TAU) in primary mental health care. METHODS/DESIGN: The trial is a multicentre pragmatic randomized controlled trial with a pre-treatment, post-treatment, and follow-up at 4, 8 and 12-months design. Treatment and control groups. a) tCBT (12 weekly 2-h group sessions following a manualized treatment protocol); b) TAU for anxiety disorders. Inclusion criteria comprise meeting DSM-5 criteria for primary Panic Disorder, Agoraphobia, Social Anxiety Disorder and/or Generalized Anxiety Disorder. Patients are recruited in three regions in the province of Quebec, Canada. The primary outcome measures are the self-reported Beck Anxiety Inventory and the clinician-administered Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5); secondary outcome measures include treatment responder status based on the ADIS-5, and self-reported instruments for specific anxiety and depression symptoms, quality of life, functioning, and service utilisation. STATISTICAL ANALYSIS: Intention-to-treat analysis. A mixed effects regression model will be used to account for between- and within-subject variations in the analysis of the longitudinal effects of the intervention. DISCUSSION: This rigorous evaluation of tCBT in the real world will provide invaluable information to decision makers, health care managers, clinicians and patients regarding the effectiveness of the intervention. Widespread implementation of tCBT protocols in primary care could lead to better effectiveness, efficiency, access and equity for the large number of patients suffering from anxiety disorders that are currently not obtaining evidence-based psychotherapy. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02811458 .

Disorder-specific emotional imagery for differential and quantitative assessment of agoraphobia.

Visual emotional stimulation is supposed to elicit psycho-vegetative reactions, which are similar to as the ones elicited by exposure to actual experience. Visual stimulation paradigms have been widely used in studies on agoraphobia with and without panic disorder. However, the applied imagery has hardly ever been disorder- and subject- specific. 51 patients with an ICD-10 and DSM-IV diagnosis of agoraphobia with or without panic disorder (PDA) and matching healthy controls have been examined. Subjects were confronted with 146 picture showing characteristic agoraphobic situations (high places, narrow places, crowds, public transport facilities, or wide places) or pictures associated with acute physical emergency (panic) situations, which had been pre-selected by anxiety experts. Participants were asked to rate emotional arousal induced by the respective images on the Self- Assessment Manikin scale (SAM). Data on PDA severity (PAS) depressive symptoms (MADRS) and sociodemographic data were recorded. Saliva cortisol levels were measured before and after exposure in a second test applying the individually mostly feared stimuli combined with emotionally neutral pictures for every single patient. 117 of the PDA-specific images were rated significantly more fear-eliciting by patients than by healthy individuals. Sub-categorization into agoraphobia clusters showed differential effects of clusters with regard to gender distribution, severity of PDA and cortisol secretion during exposure. In this study disorder specific and individual characteristics of agoraphobia were assessed for use in future trials applying emotional imagery. It could be used for the differential assessment of PDA and associated neurobiological and psychological phenomena and in neuroimaging paradigms.

Circadian rhythm sleep disorder, free-running type in a sighted male with severe depression, anxiety, and agoraphobia.

Circadian rhythm sleep disorder, free-running type (CRSD, FRT) is a disorder in which the intrinsic circadian rhythm is no longer entrained to the 24-hour schedule. A unique case of CRSD, FRT in a 67-year-old sighted male is presented. The patient had a progressively delayed time in bed (TIB) each night, so that he would cycle around the 24-h clock approximately every 30 days. This was meticulously documented each night by the patient over the course of 22 years. The patient's CRSD, FRT was associated with severe depression, anxiety, and agoraphobia. The agoraphobia may have exacerbated the CRSD, FRT. Entrainment and stabilization of his circadian rhythm was accomplished after treatment that included melatonin, light therapy, and increased sleep structure.

Respiratory and cognitive mediators of treatment change in panic disorder: evidence for intervention specificity.

OBJECTIVE: There are numerous theories of panic disorder, each proposing a unique pathway of change leading to treatment success. However, little is known about whether improvements in proposed mediators are indeed associated with treatment outcomes and whether these mediators are specific to particular treatment modalities. Our purpose in this study was to analyze pathways of change in theoretically distinct interventions using longitudinal, moderated mediation analyses. METHOD: Forty-one patients with panic disorder and agoraphobia were randomly assigned to receive 4 weeks of training aimed at altering either respiration (capnometry-assisted respiratory training) or panic-related cognitions (cognitive training). Changes in respiration (PCO2, respiration rate), symptom appraisal, and a modality-nonspecific mediator (perceived control) were considered as possible mediators. RESULTS: The reductions in panic symptom severity and panic-related cognitions and the improvements in perceived control were significant and comparable in both treatment groups. Capnometry-assisted respiratory training, but not cognitive training, led to corrections from initially hypocapnic to normocapnic levels. Moderated mediation and temporal analyses suggested that in capnometry-assisted respiratory training, PCO2 unidirectionally mediated and preceded changes in symptom appraisal and perceived control and was unidirectionally associated with changes in panic symptom severity. In cognitive training, reductions in symptom appraisal were bidirectionally associated with perceived control and panic symptom severity. In addition, perceived control was bidirectionally related to panic symptom severity in both treatment conditions. CONCLUSION: The findings suggest that reductions in panic symptom severity can be achieved through different pathways, consistent with the underlying models.

A randomized, controlled trial of aerobic exercise in combination with paroxetine in the treatment of panic disorder.

OBJECTIVES: Regular aerobic exercise (running) has been shown to be superior to a pill placebo in the treatment of panic disorder. Combined drug and exercise treatment has not been investigated in randomized controlled studies to date. METHODS: This is a randomized, 10-week, controlled, parallel group, pilot study. A total of 75 outpatients with panic disorder with or without agoraphobia (DSM-IV and ICD-10) received either (1) exercise plus paroxetine 40 mg/day (n=21), (2) relaxation plus paroxetine (n=17), (3) exercise plus pill placebo (n=20), or (4) relaxation plus pill placebo (n=17). Changes in the Panic and Agoraphobia Scale (P&A), and the Clinical Global Impression Scale (CGI) underwent repeated measure analysis. RESULTS: Effects sizes were large for all groups (d=1.53-3.87), however not significantly different. Paroxetine-treated patients were significantly more improved than placebo-treated patients. On the CGI, patients in the exercise groups (plus paroxetine or placebo) had a trend toward better improvement compared to relaxation (P=0.06). Response and remission rates were higher in the paroxetine compared to pill placebo groups. CONCLUSIONS: While paroxetine was superior to placebo, aerobic exercise did not differ from relaxation training in most efficacy measures.

Reactivity to imagery and nocturnal panic attacks.

We assessed psychophysiological responses to imagery of traumatic events, panic attacks, and loss of vigilance (i.e., being hypnotized) in participants diagnosed with panic disorder. Participants were either currently experiencing nocturnal panic or daytime panics only. It was hypothesized that nocturnal panickers would exhibit heightened responsivity to imagery of their worst panic and worst trauma, as well as being hypnotized, compared to day panickers. Using established imagery procedures, heart rate, skin conductance, and frontalis electromyogram were recorded as participants imagined each scene. Nocturnal and day panickers differed in their responses to the hypnosis scene only. As predicted, nocturnal panickers endorsed more panic symptoms in response to imagery of being hypnotized. Contrary to expectation, nocturnal and daytime panickers showed no differences in physiologic reactivity or self-reported distress to worst trauma or worst panic imagery. The findings are discussed with respect to the role of fear of loss of vigilance for nocturnal panic.

EMDR for panic disorder with agoraphobia: comparison with waiting list and credible attention-placebo control conditions.

In a randomized controlled trial, eye movement desensitization and reprocessing (EMDR) for panic disorder with agoraphobia (PDA) was compared with both waiting list and credible attention-placebo control groups. EMDR was significantly better than waiting list for some outcome measures (questionnaire, diary, and interview measures of severity of anxiety, panic disorder, and agoraphobia) but not for others (panic attack frequency and anxious cognitions). However, low power and, for panic frequency, floor effects may account for these negative results. Differences between EMDR and the attention-placebo control condition were not statistically significant on any measure, and, in this case, the effect sizes were generally small (eta2 = .00-.06), suggesting the poor results for EMDR were not due to lack of power. Because there are established effective treatments such as cognitive-behavior therapy for PDA, these data, unless contradicted by future research, indicate EMDR should not be the first-line treatment for this disorder.

The observer perspective: biased imagery in social phobia, agoraphobia, and blood/injury phobia.

Clark and Wells' (1995): 'A cognitive model of social phobia'. In Social phobia: Diagnosis, assessment, and treatment (pp. 69-93), R. G. Heimberg, M. R. Liebowitz, D. A. & F. R. Hope (eds.); cognitive model of social phobia proposes that social phobics generate a negative impression of how they appear to others. This impression often occurs in the form of an image from an "observer" perspective in which social phobics can see themselves as if from another person's vantage point. This study investigated the specificity of the observer perspective among patients with social phobia, agoraphobia, and blood/injury phobia. All participants were asked to recall and imagine a recent anxiety-provoking social situation and a non-social/non-anxiety-provoking situation, and rate their perspective for each. Consistent with predictions only patients with social-evaluative concerns (social phobics and agoraphobics) reported observer perspectives for anxiety-provoking social situations. Only social phobics showed a significant shift from an observer to a field perspective across the two conditions. The clinical implications of these findings are briefly discussed.

Rate of improvement during cognitive-behavioral group treatment for panic disorder.

This study examined the rate of symptom improvement in patients receiving cognitive-behavioral group treatment for panic disorder in an outpatient clinic setting. Treatment was a standard program of 12 sessions that emphasized information, interoceptive and situational exposure, and cognitive restructuring, but also included diaphragmatic breathing and relaxation training as elements of treatment. Subjects were 37 patients selected from sequential admissions into an outpatient treatment program; all data were derived from ongoing quality assurance measures that are a standard part of clinical monitoring. Consequently, this study provides data not on the relative efficacy of cognitive-behavioral therapy (CBT), but on rate of improvement and effectiveness of CBT for panic disorder in actual clinical practice. Patients achieved significant treatment gains on all panic disorder dimensions assessed, and the largest reduction in symptoms was during the first third of the treatment program, thereby challenging the notion that CBT delivers its gains slowly over time. Information on rats of symptom improvement is valuable for providing patients with accurate expectations about potential treatment benefits and for helping to maintain motivation during initial treatment sessions.

Gauging the effectiveness of extended imipramine treatment for panic disorder with agoraphobia.

BACKGROUND: Imipramine has proven efficacy for panic disorder. This study assesses the net effectiveness of systematic, open imipramine treatment in a homogenous sample of panic disorder patients with agoraphobia. METHODS: One hundred and ten consecutive patients with DSM-III-R moderate to severe panic disorder with agoraphobia were treated with a fixed regimen of imipramine 2.25 mg/kg/day for 24 weeks. No instructions or encouragement for self-directed exposure to phobic situations or other coping strategies with panic or fear were given. Assessments were conducted at the end of the 2-week placebo run-in and at weeks 8, 16, and 24 of treatment. RESULTS: Overall, 53% had a marked and stable response. Most measures revealed that substantial improvement continued beyond week 8 of treatment. Treatment success was accompanied with significant improvements in anxiety sensitivity, dysphoric mood, and functional well-being. CONCLUSIONS: These results provide a clinically relevant reference with which to compare the effectiveness of alternative treatments in providing nearly complete symptom remission in patients with primary panic disorder with agoraphobia.

Depersonalization and derealization during panic and hypnosis in low and highly hypnotizable agoraphobics.

The primary aim of the present study was to investigate the association between spontaneous experiences of depersonalization or derealization (D-D) during panic states and hypnosis in low and highly hypnotizable phobic individuals. Secondarily, the association among level of hypnotizability, capacity for imaginative involvement, and severity of phobic complaints was also assessed. Sixty-four patients with panic disorder with agoraphobia according to the DSM-III-R (American Psychiatric Association, 1987) criteria participated in the study. Proneness to experience D-D during hypnosis was positively related to hypnotizability, but only for agoraphobic patients who had already experienced these perceptual distortions during panic episodes. Correlations of level of hypnotizability and capacity for imaginative involvement with severity of agoraphobic complaints were not significant. These findings suggest that hypnotizability may be a mediating variable between two different, although phenotypically similar, perceptual distortions experienced during panic states and hypnosis. Implications for both theory and clinical practice are discussed.

The relationship of attributional style to agoraphobia severity, depression, and treatment outcome.

The present study examined the relationship of attributional style, as measured with a revised version of the Attributional Style Questionnaire (ASQ) and measures of agoraphobia severity, depression, and treatment outcome in 73 Ss who met DSM-III criteria for agoraphobia with panic attacks and participated in one of three 13-week treatment conditions: paradoxical intention, graduated exposure, or progressive deep muscle relaxation training. Subjects completed assessments at four periods: pretreatment, midtreatment, posttreatment, and at 3 month follow-up. In addition to the three dimensions typically examined on the ASQ, this revised version also measured Ss' estimates of the perceived importance, and future likelihood for both positive and negative events. Congruent with previous research, moderate but somewhat inconsistent associations were observed between attributional style and depression both within and across assessment periods. Predictions about associations between attributional style and agoraphobic severity were not supported; however, an interaction was observed between depression and attributional style with respect to severity of agoraphobia. There was no evidence of group differences across treatment types, although there were several significant changes in attributional style across time. Attributions for health related events were also examined. Conceptual, clinical, and research issues related to the findings are discussed.

Patterns of change during cognitive behavioral treatment for panic disorder.

The present investigation examined patterns of change in basic features of panic and anxiety during cognitive behavioral treatment for panic disorder. Data were collected in the context of a study comparing the efficacy of cognitive therapy (CT) and relaxation training, both administered without exposure-based treatments of any kind. Thirty-six panic disorder patients completed 10 weeks of either CT or relaxation training. Weekly measures of panic frequency, state and trait anxiety, and associated fears were obtained. Data were examined using both multivariate techniques (which conceptualize change as incremental) and analysis of response slopes (wherein change is conceptualized as continuous). Results indicated that during the first half of treatment, relaxation training led to greater reductions in state and trait anxiety and agoraphobic fear, whereas CT demonstrated a slight advantage on change in panic frequency. During the second half of treatment, CT produced faster reductions in state anxiety and agoraphobic fears. Over the entire treatment course, CT conferred an advantage in rate of change in social fears. The data provide support for the utility of a more process-oriented approach to the examination of treatment effects.

Concepts of mental illness and medical pluralism in Harare.

The Focus Group Discussions (FGD) described in this paper are the first step of a study aiming to develop an 'emic' case-finding instrument. In keeping with the realities of primary care in Zimbabwe, nine FGD were held with 76 care providers including 30 village community workers, 22 traditional and faith healers (collectively referred to as traditional healers in this paper), 15 relatives of patients and 9 community psychiatric nurses. In addition to the general facets of concepts of mental illness, three 'etic' case vignettes were also presented. A change in behaviour or ability to care for oneself emerged as the central definition of mental illness. Both the head and the heart were regarded as playing an important role in the mediation of emotions. The types of mental illness described were intimately related to beliefs about spiritual causation. Angered ancestral spirits, evil spirits and witchcraft were seen as potent causes of mental illness. Families not only bore the burden of caring for the patient and all financial expenses involved, but were also ostracized and isolated. Both biomedical and traditional healers could help mentally ill persons by resolving different issues relating to the same illness episode. All case vignettes were recognized by the care providers in their communities though many felt that the descriptions did not reflect 'illnesses' but social problems and that accordingly, the treatment for these was social, rather than medical. The data enabled us to develop screening criteria for mental illness to be used by traditional healers and primary care nurses in the next stage of the study in which patients selected by these care providers on the grounds of suspicion of suffering from mental illness will be interviewed to elicit their explanatory models of illness and phenomenology.

Effectiveness of a meditation-based stress reduction program in the treatment of anxiety disorders.

OBJECTIVE: This study was designed to determine the effectiveness of a group stress reduction program based on mindfulness meditation for patients with anxiety disorders. METHOD: The 22 study participants were screened with a structured clinical interview and found to meet the DSM-III-R criteria for generalized anxiety disorder or panic disorder with or without agoraphobia. Assessments, including self-ratings and therapists' ratings, were obtained weekly before and during the meditation-based stress reduction and relaxation program and monthly during the 3-month follow-up period. RESULTS: Repeated measures analyses of variance documented significant reductions in anxiety and depression scores after treatment for 20 of the subjects--changes that were maintained at follow-up. The number of subjects experiencing panic symptoms was also substantially reduced. A comparison of the study subjects with a group of nonstudy participants in the program who met the initial screening criteria for entry into the study showed that both groups achieved similar reductions in anxiety scores on the SCL-90-R and on the Medical Symptom Checklist, suggesting generalizability of the study findings. CONCLUSIONS: A group mindfulness meditation training program can effectively reduce symptoms of anxiety and panic and can help maintain these reductions in patients with generalized anxiety disorder, panic disorder, or panic disorder with agoraphobia.

Skin conductance habituation in panic disorder patients.

Skin conductance habituation was compared between 38 patients meeting DSM-III criteria for Panic Disorder and 29 normal controls. Approximately half of each group was randomly assigned to be given 100 dB SPL tones and the other half 75 dB tones. All indices pointed to slowed habituation in patients compared with normals: number of trials to response habituation, total number of responses, and slope of decline of skin conductance level. Patient-normal differences were not significantly larger for 100 dB than for 75 dB. In addition, patients compared with normals had more nonspecific fluctuations, higher skin conductance levels, and a shorter response latency to the first stimulus. Stepwise discriminant analyses classified patients and normals better in the 100 dB than in the 75 dB condition, and showed that the various skin conductancy variables were largely redundant at the higher intensity.

Agoraphobia: the clinical problem.

The symptoms of agoraphobia can vary from those which a person may accept as being consistent with the everyday anxiety of living, to those which provide a barrier to the participation of an individual in any outside activities whatsoever. These symptoms, while classically presenting with the affective state of anxiety, may sometimes become manifest in such a way that cardiovascular, respiratory or other somatic pathology is suspected.