Visual Snow Syndrome Improves With Modulation of Resting-State Functional MRI Connectivity After Mindfulness-Based Cognitive Therapy: An Open-Label Feasibility Study.

BACKGROUND: Visual snow syndrome (VSS) is associated with functional connectivity (FC) dysregulation of visual networks (VNs). We hypothesized that mindfulness-based cognitive therapy, customized for visual symptoms (MBCT-vision), can treat VSS and modulate dysfunctional VNs. METHODS: An open-label feasibility study for an 8-week MBCT-vision treatment program was conducted. Primary (symptom severity; impact on daily life) and secondary (WHO-5; CORE-10) outcomes at Week 9 and Week 20 were compared with baseline. Secondary MRI outcomes in a subcohort compared resting-state functional and diffusion MRI between baseline and Week 20. RESULTS: Twenty-one participants (14 male participants, median 30 years, range 22-56 years) recruited from January 2020 to October 2021. Two (9.5%) dropped out. Self-rated symptom severity (0-10) improved: baseline (median [interquartile range (IQR)] 7 [6-8]) vs Week 9 (5.5 [3-7], P = 0.015) and Week 20 (4 [3-6], P < 0.001), respectively. Self-rated impact of symptoms on daily life (0-10) improved: baseline (6 [5-8]) vs Week 9 (4 [2-5], P = 0.003) and Week 20 (2 [1-3], P < 0.001), respectively. WHO-5 Wellbeing (0-100) improved: baseline (median [IQR] 52 [36-56]) vs Week 9 (median 64 [47-80], P = 0.001) and Week 20 (68 [48-76], P < 0.001), respectively. CORE-10 Distress (0-40) improved: baseline (15 [12-20]) vs Week 9 (12.5 [11-16.5], P = 0.003) and Week 20 (11 [10-14], P = 0.003), respectively. Within-subject fMRI analysis found reductions between baseline and Week 20, within VN-related FC in the i) left lateral occipital cortex (size = 82 mL, familywise error [FWE]-corrected P value = 0.006) and ii) left cerebellar lobules VIIb/VIII (size = 65 mL, FWE-corrected P value = 0.02), and increases within VN-related FC in the precuneus/posterior cingulate cortex (size = 69 mL, cluster-level FWE-corrected P value = 0.02). CONCLUSIONS: MBCT-vision was a feasible treatment for VSS, improved symptoms and modulated FC of VNs. This study also showed proof-of-concept for intensive mindfulness interventions in the treatment of neurological conditions.

Trajectories of depression and anxiety symptom severity during psychological therapy for common mental health problems.

BACKGROUND: There is substantial variation in patient symptoms following psychological therapy for depression and anxiety. However, reliance on endpoint outcomes ignores additional interindividual variation during therapy. Knowing a patient's likely symptom trajectories could guide clinical decisions. We aimed to identify latent classes of patients with similar symptom trajectories over the course of psychological therapy and explore associations between baseline variables and trajectory class. METHODS: Patients received high-intensity psychological treatment for common mental health problems at National Health Service Improving Access to Psychological Therapies services in South London (N = 16 258). To identify trajectories, we performed growth mixture modelling of depression and anxiety symptoms over 11 sessions. We then ran multinomial regressions to identify baseline variables associated with trajectory class membership. RESULTS: Trajectories of depression and anxiety symptoms were highly similar and best modelled by four classes. Three classes started with moderate-severe symptoms and showed (1) no change, (2) gradual improvement, and (3) fast improvement. A final class (4) showed initially mild symptoms and minimal improvement. Within the moderate-severe baseline symptom classes, patients in the two showing improvement as opposed to no change tended not to be prescribed psychotropic medication or report a disability and were in employment. Patients showing fast improvement additionally reported lower baseline functional impairment on average. CONCLUSIONS: Multiple trajectory classes of depression and anxiety symptoms were associated with baseline characteristics. Identifying the most likely trajectory for a patient at the start of treatment could inform decisions about the suitability and continuation of therapy, ultimately improving patient outcomes.

Patient characteristics associated with retrospectively self-reported treatment outcomes following psychological therapy for anxiety or depressive disorders - a cohort of GLAD study participants.

BACKGROUND: Progress towards stratified care for anxiety and depression will require the identification of new predictors. We collected data on retrospectively self-reported therapeutic outcomes in adults who received psychological therapy in the UK in the past ten years. We aimed to replicate factors associated with traditional treatment outcome measures from the literature. METHODS: Participants were from the Genetic Links to Anxiety and Depression (GLAD) Study, a UK-based volunteer cohort study. We investigated associations between retrospectively self-reported outcomes following therapy, on a five-point scale (global rating of change; GRC) and a range of sociodemographic, clinical and therapy-related factors, using ordinal logistic regression models (n = 2890). RESULTS: Four factors were associated with therapy outcomes (adjusted odds ratios, OR). One sociodemographic factor, having university-level education, was associated with favourable outcomes (OR = 1.37, 95%CI: 1.18, 1.59). Two clinical factors, greater number of reported episodes of illness (OR = 0.95, 95%CI: 0.92, 0.97) and higher levels of personality disorder symptoms (OR = 0.89, 95%CI: 0.87, 0.91), were associated with less favourable outcomes. Finally, reported regular use of additional therapeutic activities was associated with favourable outcomes (OR = 1.39, 95%CI: 1.19, 1.63). There were no statistically significant differences between fully adjusted multivariable and unadjusted univariable odds ratios. CONCLUSION: Therapy outcome data can be collected quickly and inexpensively using retrospectively self-reported measures in large observational cohorts. Retrospectively self-reported therapy outcomes were associated with four factors previously reported in the literature. Similar data collected in larger observational cohorts may enable detection of novel associations with therapy outcomes, to generate new hypotheses, which can be followed up in prospective studies.

The Genetic Links to Anxiety and Depression (GLAD) Study: Online recruitment into the largest recontactable study of depression and anxiety.

BACKGROUND: Anxiety and depression are common, debilitating and costly. These disorders are influenced by multiple risk factors, from genes to psychological vulnerabilities and environmental stressors, but research is hampered by a lack of sufficiently large comprehensive studies. We are recruiting 40,000 individuals with lifetime depression or anxiety and broad assessment of risks to facilitate future research. METHODS: The Genetic Links to Anxiety and Depression (GLAD) Study (www.gladstudy.org.uk) recruits individuals with depression or anxiety into the NIHR Mental Health BioResource. Participants invited to join the study (via media campaigns) provide demographic, environmental and genetic data, and consent for medical record linkage and recontact. RESULTS: Online recruitment was effective; 42,531 participants consented and 27,776 completed the questionnaire by end of July 2019. Participants' questionnaire data identified very high rates of recurrent depression, severe anxiety, and comorbidity. Participants reported high rates of treatment receipt. The age profile of the sample is biased toward young adults, with higher recruitment of females and the more educated, especially at younger ages. DISCUSSION: This paper describes the study methodology and descriptive data for GLAD, which represents a large, recontactable resource that will enable future research into risks, outcomes, and treatment for anxiety and depression.

Sexual orientation differences in psychological treatment outcomes for depression and anxiety: National cohort study.

OBJECTIVE: This study investigates whether sexual minority patients have poorer treatment outcomes than heterosexual patients in England's Improving Access to Psychological Therapies (IAPT) services. These services provide evidence-based psychological interventions for people with depression or anxiety. METHOD: National routinely collected data were analyzed for a cohort who had attended at least 2 treatment sessions and were discharged between April 2013-March, 2015. Depression, anxiety and functional impairment were compared for 85,831 women (83,482 [97.2%] heterosexual; 1,285 [1.5%] lesbian; 1,064 [1.2%] bisexual) and 47,092 men (44,969 [95.5%] heterosexual; 1,734 [3.7%] gay; 389 [0.8%] bisexual). Linear and logistic models were fitted adjusting for baseline scores, and sociodemographic and treatment characteristics. RESULTS: Compared to heterosexual women, lesbian and bisexual women had higher final-session severity for depression, anxiety, and functional impairment and increased risk of not attaining reliable recovery in depression/anxiety or functioning (aORs 1.3-1.4) and reliable improvement in depression/anxiety or functioning (aORs 1.2-1.3). Compared to heterosexual and gay men, bisexual men had higher final-session severity for depression, anxiety, and functioning and increased risk of not attaining reliable recovery for depression/anxiety or functioning (aORs 1.5-1.7) and reliable improvement in depression/anxiety or functioning (aORs 1.3-1.4). Gay and heterosexual men did not differ on treatment outcomes. Racial minority lesbian/gay or bisexual patients did not have significantly different outcomes to their White lesbian/gay or bisexual counterparts. CONCLUSIONS: The reasons for treatment outcome inequities for bisexual patients and lesbian women (e.g., 30-70% increased risk of not recovering) need investigation. Health services should address these inequalities. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Comparison of Treatment Outcomes Between Lesbian, Gay, Bisexual and Heterosexual Individuals Receiving a Primary Care Psychological Intervention.

BACKGROUND: Lesbian, gay and bisexual individuals experience more anxiety and depression than heterosexual people. Little is known about their comparative treatment response to psychological interventions. AIMS: To compare sociodemographic/clinical characteristics and treatment outcomes across sexual orientation groups, for adults receiving primary care psychological interventions from Improving Access to Psychological Therapies (IAPT) services in London, adjusting for possible confounders. METHOD: Data from 188 lesbian women, 222 bisexual women, 6637 heterosexual women, 645 gay men, 75 bisexual men and 3024 heterosexual men were analysed from pre-treatment and last treatment sessions. Males and females were analysed separately. RESULTS: Before treatment, lesbian and bisexual women were more likely to report clinical levels of impairment (Work and Social Adjustment Scale) than heterosexual women; there were no significant differences in depression (PHQ-9) or anxiety (GAD-7). Bisexual men were more likely to meet depression caseness than gay men but less likely to meet anxiety caseness than gay or heterosexual men. Compared with heterosexual women, lesbian and bisexual individuals showed smaller reductions in depression and impairment, controlling for age, ethnicity, employment, baseline symptoms, number of sessions and intervention type. Bisexual women experienced significantly smaller reductions in anxiety than heterosexual women and were less likely to show recovery or reliable recovery. There were no significant differences in treatment outcomes between gay, bisexual and heterosexual men. CONCLUSIONS: Reasons for poorer outcomes in lesbian and bisexual women require investigation, for example lifetime trauma or stigma/discrimination regarding gender or sexual orientation in everyday life or within therapy services.

Clinical characteristics of patients assessed within an Improving Access to Psychological Therapies (IAPT) service: results from a naturalistic cohort study (Predicting Outcome Following Psychological Therapy; PROMPT).

BACKGROUND: A substantial number of patients do not benefit from first line psychological therapies for the treatment of depression and anxiety. Currently, there are no clear predictors of treatment outcomes for these patients. The PROMPT project aims to establish an infrastructure platform for the identification of factors that predict outcomes following psychological treatment for depression and anxiety. Here we report on the first year of recruitment and describe the characteristics of our sample to date. METHODS: One hundred and forty-seven patients awaiting treatment within an Improving Access to Psychological Therapies (IAPT) service were recruited between February 2014 and February 2015 (representing 48 % of those eligible). Baseline assessments were conducted to collect information on a variety of clinical, psychological and social variables including a diagnostic interview using the Mini International Neuropsychiatric Interview (MINI). RESULTS: Our initial findings showed that over a third of our sample were not presenting to IAPT services for the first time, and 63 % had been allocated to receive higher intensity IAPT treatments. Approximately half (46 %) were taking prescribed psychotropic medication (most frequently antidepressants). Co-morbidity was common: 72 % of the sample met criteria for 2 or more current MINI diagnoses. Our initial data also indicated that 16 % met criteria for borderline personality disorder and 69 % were at high risk of personality disorder. Sixty-one percent scored above the screening threshold for bipolarity. Over half of participants (55 %) reported experiencing at least one stressful life event in the previous 12 months, whilst 67 % reported experiencing at least one form of childhood trauma. CONCLUSIONS: Our results to date highlight the complex nature of patients seen within an urban IAPT service, with high rates of psychiatric comorbidity, personality disorder, bipolarity and childhood trauma. Whilst there are significant challenges associated with researching IAPT populations, we have also confirmed the feasibility of undertaking such research.

The impact of comorbid personality difficulties on response to IAPT treatment for depression and anxiety.

UNLABELLED: The UK's Improving Access to Psychological Therapies (IAPT) initiative provides evidence-based psychological interventions for mild to moderate common mental health problems in a primary care setting. Predictors of treatment response are unclear. This study examined the impact of personality disorder status on outcome in a large IAPT service. We hypothesised that the presence of probable personality disorder would adversely affect treatment response. METHOD: We used a prospective cohort design to study a consecutive sample of individuals (n = 1249). RESULTS: Higher scores on a screening measure for personality disorder were associated with poorer outcome on measures of depression, anxiety and social functioning, and reduced recovery rates at the end of treatment. These associations were not confounded by demographic status, initial symptom severity nor number of treatment sessions. The presence of personality difficulties independently predicted reduced absolute change on all outcome measures. CONCLUSIONS: The presence of co-morbid personality difficulties adversely affects treatment outcome among individuals attending for treatment in an IAPT service. There is a need to routinely assess for the presence of personality difficulties on all individuals referred to IAPT services. This information will provide important prognostic data and could lead to the provision of more effective, personalised treatment in IAPT.

Predicting outcome following psychological therapy in IAPT (PROMPT): a naturalistic project protocol.

BACKGROUND: Depression and anxiety are highly prevalent and represent a significant and well described public health burden. Whilst first line psychological treatments are effective for nearly half of attenders, there remain a substantial number of patients who do not benefit. The main objective of the present project is to establish an infrastructure platform for the identification of factors that predict lack of response to psychological treatment for depression and anxiety, in order to better target treatments as well as to support translational and experimental medicine research in mood and anxiety disorders. METHODS/DESIGN: Predicting outcome following psychological therapy in IAPT (PROMPT) is a naturalistic observational project that began patient recruitment in January 2014. The project is currently taking place in Southwark Psychological Therapies Service, an Improving Access to Psychological Therapies (IAPT) service currently provided by the South London and Maudsley NHS Foundation Trust (SLaM). However, the aim is to roll-out the project across other IAPT services. Participants are approached before beginning treatment and offered a baseline interview whilst they are waiting for therapy to begin. This allows us to test for relationships between predictor variables and patient outcome measures. At the baseline interview, participants complete a diagnostic interview; are asked to give blood and hair samples for relevant biomarkers, and complete psychological and social questionnaire measures. Participants then complete their psychological therapy as offered by Southwark Psychological Therapies Service. Response to psychological therapy will be measured using standard IAPT outcome data, which are routinely collected at each appointment. DISCUSSION: This project addresses a need to understand treatment response rates in primary care psychological therapy services for those with depression and/or anxiety. Measurement of a range of predictor variables allows for the detection of bio-psycho-social factors which may be relevant for treatment outcome. This will enable future clinical decision making to be based on the individual needs of the patient in an evidence-based manner. Moreover, the identification of individuals who fail to improve following therapy delivered by IAPT services could be utilised for the development of novel interventions.

Competences required for the delivery of high and low-intensity cognitive behavioural interventions for chronic fatigue, chronic fatigue syndrome/ME and irritable bowel syndrome.

BACKGROUND: Cognitive behavioural interventions are effective in the treatment of chronic fatigue, chronic fatigue syndrome (sometimes known as ME or CFS/ME) and irritable bowel syndrome (IBS). Such interventions are increasingly being provided not only in specialist settings but in primary care settings such as Improving Access to Psychological Therapies (IAPT) services. There are no existing competences for the delivery of "low-intensity" or "high-intensity" cognitive behavioural interventions for these conditions. AIMS: To develop "high-intensity" and "low-intensity" competences for cognitive behavioural interventions for chronic fatigue, CFS/ME and IBS. METHOD: The initial draft drew on a variety of sources including treatment manuals and other information from randomized controlled trials. Therapists with experience in providing cognitive behavioural interventions for CF, CFS/ME and IBS in research and clinical settings were consulted on the initial draft competences and their suggestions for minor amendments were incorporated into the final versions. RESULTS: Feedback from experienced therapists was positive. Therapists providing low intensity interventions reported that the competences were also helpful in highlighting training needs. CONCLUSIONS: These sets of competences should facilitate the training and supervision of therapists providing cognitive behavioural interventions for chronic fatigue, CFS/ME and IBS. The competences are available online (see table of contents for this issue: http://journals.cambridge.org/jid_BCP) or on request from the first author.

Mindfulness-based cognitive therapy for people with chronic fatigue syndrome still experiencing excessive fatigue after cognitive behaviour therapy: a pilot randomized study.

UNLABELLED: Cognitive behaviour therapy (CBT) is an effective treatment for chronic fatigue syndrome (CFS; sometimes known as myalgic encephalomyelitis). However, only a minority of patients fully recover after CBT; thus, methods for improving treatment outcomes are required. This pilot study concerned a mindfulness-based cognitive therapy (MBCT) intervention adapted for people with CFS who were still experiencing excessive fatigue after CBT. The study aimed to investigate the acceptability of this new intervention and the feasibility of conducting a larger-scale randomized trial in the future. Preliminary efficacy analyses were also undertaken. Participants were randomly allocated to MBCT or waiting list. Sixteen MBCT participants and 19 waiting-list participants completed the study, with the intervention being delivered in two separate groups. Acceptability, engagement and participant-rated helpfulness of the intervention were high. Analysis of covariance controlling for pre-treatment scores indicated that, at post-treatment, MBCT participants reported lower levels of fatigue (the primary clinical outcome) than the waiting-list group. Similarly, there were significant group differences in fatigue at 2-month follow-up, and when the MBCT group was followed up to 6 months post-treatment, these improvements were maintained. The MBCT group also had superior outcomes on measures of impairment, depressed mood, catastrophic thinking about fatigue, all-or-nothing behavioural responses, unhelpful beliefs about emotions, mindfulness and self-compassion. In conclusion, MBCT is a promising and acceptable additional intervention for people still experiencing excessive fatigue after CBT for CFS, which should be investigated in a larger randomized controlled trial. KEY PRACTITIONER MESSAGE: Only about 30% of people with chronic fatigue syndrome (CFS) recover after cognitive behaviour therapy (CBT); thus, methods for improving treatment outcomes are needed. This is the first pilot randomized study to demonstrate that a mindfulness-based intervention was associated with reduced fatigue and other benefits for people with CFS who were still experiencing excessive fatigue after a course of CBT. Levels of acceptability, engagement in the intervention and rated helpfulness were high. A larger-scale randomized controlled trial is required.

Rumination-focused cognitive-behavioural therapy for residual depression: phase II randomised controlled trial.

BACKGROUND: About 20% of major depressive episodes become chronic and medication-refractory and also appear to be less responsive to standard cognitive-behavioural therapy (CBT). AIMS: To test whether CBT developed from behavioural activation principles that explicitly and exclusively targets depressive rumination enhances treatment as usual (TAU) in reducing residual depression. METHOD: Forty-two consecutively recruited participants meeting criteria for medication-refractory residual depression were randomly allocated to TAU v. TAU plus up to 12 sessions of individual rumination-focused CBT. The trial has been registered (ISRCTN22782150). RESULTS: Adding rumination-focused CBT to TAU significantly improved residual symptoms and remission rates. Treatment effects were mediated by change in rumination. CONCLUSIONS: This is the first randomised controlled trial providing evidence of benefits of rumination-focused CBT in persistent depression. Although suggesting the internal validity of rumination-focused CBT for residual depression, the trial lacked an attentional control group so cannot test whether the effects were as a result of the specific content of rumination-focused CBT v. non-specific therapy effects.

Pilot study of Mindfulness-Based Cognitive Therapy for trainee clinical psychologists.

BACKGROUND: It is recommended that Mindfulness-Based Cognitive Therapy (MBCT) instructors should undertake MBCT themselves before teaching others. AIM: To investigate the impact of MBCT (modified for stress not depression) on trainee clinical psychologists. METHOD: Twenty trainees completed questionnaires pre- and post-MBCT. RESULTS: There was a significant decrease in rumination, and increases in self-compassion and mindfulness. More frequent home practice was associated with larger decreases in stress, anxiety and rumination, and larger increases in empathic concern. Only first-year trainees showed a significant decrease in stress. Content analysis of written responses indicated that the most commonly reported effects were increased acceptance of thoughts/feelings (70%), increased understanding of what it is like to be a client (60%), greater awareness of thoughts/feelings/behaviours/bodily sensations (55%) and increased understanding of oneself and one's patterns of responding (55%). Participants reported increased metacognitive awareness and decentring in relation to negative thoughts. Eighty-five percent reported an impact on their clinical work by the end of the course. CONCLUSIONS: Trainee psychologists undergoing MBCT experienced many of the psychological processes/effects that they may eventually be helping to cultivate in clients using mindfulness interventions, and also benefits in their general clinical work.

Rumination-focused cognitive behaviour therapy for residual depression: a case series.

The treatment of chronic and recurrent depression is a priority for the development of new interventions. The maintenance of residual symptoms following acute treatment for depression is a risk factor for both chronic depression and further relapse/recurrence. This open case series provides the first data on a cognitive-behavioural treatment for residual depression that explicitly targets depressive rumination. Rumination has been identified as a key factor in the onset and maintenance of depression, which is found to remain elevated following remission from depression. Fourteen consecutively recruited participants meeting criteria for medication--refractory residual depression [Paykel, E.S., Scott, J., Teasdale, J.D., Johnson, A.L., Garland, A., Moore, R. et al., 1999. Prevention of relapse in residual depression by cognitive therapy--a controlled trial. Archives of General Psychiatry 56, 829-835] were treated individually for up to 12 weekly 60-min sessions. Treatment specifically focused on switching patients from less helpful to more helpful styles of thinking through the use of functional analysis, experiential/imagery exercises and behavioural experiments. Treatment produced significant improvements in depressive symptoms, rumination and co-morbid disorders: 71% responded (50% reduction on Hamilton Depression Rating Scale) and 50% achieved full remission. Treating depressive rumination appears to yield generalised improvement in depression and co-morbidity. This study provides preliminary evidence that rumination-focused CBT may be an efficacious treatment for medication--refractory residual depression.

Correlation between trait hostility and faster reading times for sentences describing angry reactions to ambiguous situations.

The hypothesis that trait anger is associated with an increased tendency to interpret ambiguous situations as anger-provoking was investigated in a reading time study. A total of 48 healthy volunteers read a series of short narrative passages and were asked to adopt the perspective of the main character, identified at the start of each passage. Reading times for key sentences, which described the main characters' angry or nonangry reactions to ambiguous anger-provoking situations, were recorded. Trait anger and impulsivity were negatively correlated with reading time for sentences describing both types of reaction, but anger was also correlated with relatively faster processing of sentences describing angry reactions. This study suggests that those with angrier dispositions are more likely to anticipate angry reactions from others.

Angry cognitive bias, trait aggression and impulsivity in substance users.

RATIONALE: According to cognitive theory, people who are aggressive expect angry responses to ambiguous situations. Increased aggression has been reported a few days or weeks following use of MDMA (ecstasy). This may relate to low 5-HT release, and so a 5-HT challenge may increase cognitive bias towards anger differentially in MDMA users and non-users. OBJECTIVES: To investigate whether: (1) measures of anger and aggression will correlate with processing time of angry material and with generation of aggressive responses and (2) tryptophan challenge in people abstinent from MDMA and controls will affect angry cognitive bias. METHODS: Thirty-two current MDMA users abstinent for 3 weeks, 32 ex-users abstinent for longer than 1 year and 32 non-MDMA substance users were recruited. Trait measures were administered before and state measures before and 5 h after an amino acid drink, depleted or augmented with tryptophan. After the drink, subjects undertook a computer task, which involved reading ambiguous short stories. Reading times to a key sentence describing an angry or non-angry reaction were recorded and subjects wrote a continuing sentence for half the stories. RESULTS: Subjects were faster to process angry than non-angry reactions, indicating the presence of angry cognitive bias. Trait anger and aggression were correlated with processing time of angry relative to non-angry reactions, particularly in the current users. Impulsivity was correlated with non-specific speed of response. Subjects wrote more aggressive sentences after an angry reaction. Tryptophan depletion tended to increase aggressive content. Trait aggression was correlated with aggressive content following non-angry reactions. CONCLUSIONS: Evidence of angry cognitive bias was shown in this group of substance users, which was not specific to MDMA use. People high on trait aggression were more likely to expect an angry reaction to an ambiguous situation and to generate more written aggression when this did not occur.

Buspirone decreases physiological reactivity to unconditioned and conditioned aversive stimuli.

RATIONALE: Serotonergic pathways are thought to be important in mediating the effects of aversive events. OBJECTIVE: To investigate the effects of buspirone, a 5-HT(1A) partial agonist, on habituation and extinction in an aversive classical conditioning model. METHODS: Forty healthy male volunteers were randomly assigned to a single dose of buspirone (10 mg) or placebo. They filled in questionnaires of anxiety and depression at baseline and visual analogue scales of tension and anxiety before and at 60, 120 and 150 min after drug administration. Their skin conductance responses to auditory stimuli were measured on the conditioning model 2 h after drug intake. RESULTS: There were no differences between groups on depression or anxiety. Buspirone decreased the amplitude of the skin conductance response and the number of spontaneous fluctuations in both the habituation and extinction phases but had no effect on skin conductance level. Buspirone also attenuated the unconditioned response to the white noise and the response to the first tone. Visual analogue ratings of tension and anxiety decreased after buspirone. CONCLUSIONS: Buspirone decreased physiological reactivity in an aversive classical conditioning model. It had anxiolytic effects on both conditioned and unconditioned anxiety. This might be due to its multiple actions on 5-HT receptors.

Treatment of generalised anxiety disorder with a short course of psychological therapy, combined with buspirone or placebo.

BACKGROUND: Very few studies have examined the combination of drug and psychological treatment in generalised anxiety disorder (GAD). Theoretically, buspirone should be a useful drug to combine with a learning-based therapy. METHODS: Sixty patients with GAD were randomly assigned to treatment with buspirone or placebo, combined with anxiety management training or non-directive therapy for a period of 8 weeks. RESULTS: Forty-four patients with a mean Hamilton Anxiety Scale score of 28 completed treatment. There were no significant differences between treatment groups. All groups showed significant improvement after 8 weeks compared to baseline. There were no baseline differences between those who completed the trial and those who did not but patients given buspirone were more likely to drop out. CONCLUSIONS: A short course of psychological therapy, whether or not accompanied by active medication, was an effective treatment for patients diagnosed as having quite severe symptoms of GAD. CLINICAL IMPLICATIONS AND LIMITATIONS: Dropouts led to a sample size which may have been too small to detect group differences. Cognitive therapy may have been more effective.