Marc Serfaty

Clinical Effectiveness of Individual Cognitive Behavioral Therapy for Depressed Older People in Primary Care A Randomized Controlled Trial

CONTEXT In older people, depressive symptoms are common, psychological adjustment to aging is complex, and associated chronic physical illness limits the use of antidepressants. Despite this, older people are rarely offered psychological interventions, and only 3 randomized controlled trials of individual cognitive behavioral therapy (CBT) in a primary care setting have been published. OBJECTIVE To determine the clinical effectiveness of CBT delivered in primary care for older people with depression. DESIGN A single-blind, randomized, controlled trial with 4- and 10-month follow-up visits. PATIENTS A total of 204 people aged 65 years or older (mean [SD] age, 74.1 [7.0] years; 79.4% female; 20.6% male) with a Geriatric Mental State diagnosis of depression were recruited from primary care. INTERVENTIONS Treatment as usual (TAU), TAU plus a talking control (TC), or TAU plus CBT. The TC and CBT were offered over 4 months. OUTCOME MEASURES Beck Depression Inventory-II (BDI-II) scores collected at baseline, end of therapy (4 months), and 10 months after the baseline visit. Subsidiary measures were the Beck Anxiety Inventory, Social Functioning Questionnaire, and Euroqol. Intent to treat using Generalized Estimating Equation and Compliance Average Causal Effect analyses were used. RESULTS Eighty percent of participants were followed up. The mean number of sessions of TC or CBT was just greater than 7. Intent-to-treat analysis found improvements of -3.07 (95% confidence interval [CI], -5.73 to -0.42) and -3.65 (95% CI, -6.18 to -1.12) in BDI-II scores in favor of CBT vs TAU and TC, respectively. Compliance Average Causal Effect analysis compared CBT with TC. A significant benefit of CBT of 0.4 points (95% CI, 0.01 to 0.72) on the BDI-II per therapy session was observed. The cognitive therapy scale showed no difference for nonspecific, but significant differences for specific factors in therapy. Ratings for CBT were high (mean [SD], 54.2 [4.1]). CONCLUSION Cognitive behavioral therapy is an effective treatment for older people with depressive disorder and appears to be associated with its specific effects. TRIAL REGISTRATION isrctn.org Identifier: ISRCTN18271323.

The ToT Study: Helping with Touch or Talk (ToT): a pilot randomised controlled trial to examine the clinical effectiveness of aromatherapy massage versus cognitive behaviour therapy for emotional distress in patients in cancer/palliative care

Distress associated with cancer often presents with symptoms of depression and/or anxiety. Cognitive Behaviour Therapy (CBT) is one of the most effective psychological treatments. Complementary therapies, especially aromatherapy massage (AM), are also popular and alleviate anxiety. No studies have directly compared these two treatments.

Development of a Cosmetic Procedure Screening Questionnaire (COPS) for Body Dysmorphic Disorder

Background: Practitioners in a cosmetic setting need a screening questionnaire to identify people with Body Dysmorphic Disorder (BDD). Method: Two groups who desired a cosmetic procedure completed the Cosmetic Procedure Screening Questionnaire (COPS): (a) a group diagnosed with BDD (n =97) and (b) a community control group (n=108). Both groups desired a cosmetic procedure. Item characteristics, reliability and factorial structure were analysed. Convergent validity with selected questionnaires was determined. Sensitivity to change during cognitive behaviour therapy was also determined in a sub-sample of BDD patients. Results: The most sensitive items discriminating between the two groups were used to form the final questionnaire. Receiver Operating Characteristics analysis was used to assess sensitivity and specificity of the COPS to discriminate between the groups and a cut-off score of 40 was chosen. Conclusions: The COPS is a sensitive and specific screening measure for BDD that can be used in cosmetic settings and as a potential research tool to predict dissatisfaction or changes in BDD symptoms after any treatment. Background: Guidelines recommend screening patients for Body Dysmorphic Disorder (BDD) prior to cosmetic surgery to identify those who may require further psychological assessment 1 but there are few validated instruments available. The aim of the current study was therefore to develop a screening questionnaire that (a) was brief, free to download and could identify people with BDD, (b) might predict either dissatisfaction with a cosmetic procedure or no change or deterioration in symptoms of BDD, and (c) may be sensitive to change after an intervention. The new scale was informed by the diagnostic criteria, expert opinion and a previous study that compared patients satisfied with cosmetic rhinoplasty with BDD patients who craved rhinoplasty but had not been able to obtain it . Method: Two groups of participants were recruited: a) Community group We recruited a community group of both genders who were either planning or very motivated to have a cosmetic procedure in the future. The questionnaire was completed by n=108 participants. b) BDD group A psychiatrist conducted an interview based on DSM-IV to diagnose BDD in a clinical setting. Ninety-seven patients with BDD seeking a cosmetic procedure were recruited. All participants completed the following: 1) Cosmetic Procedure Screening (COPS) questionnaire The questionnaire asks for the feature(s) that the person finds unattractive, the nature of the cosmetic procedures they are seeking and diagnostic criteria of BDD. The final version of COPS questionnaire comprises 9 items. Items are scored from 0 (least impaired) to 8 (most impaired). The scale and a full version of this paper is available to download from: http://www.iop.kcl.ac.uk/cadatquestionnaire. The score is achieved by summing Q 2-10. Items 2, 3 and 5 are reversed. The total ranges from 0 to 72 with a higher score reflecting greater impairment. 2) Hospital Anxiety and Depression Scale (HAD) 3) Body Image Quality of Life Inventory (BIQLI) 4) Body Image Disturbance Questionnaire (BIDQ) Results Items on the COPS that showed a significant difference between the two groups, which did not have a significant group x sex interaction and had an effect size (Cohen’s d) of at least 0.80 were retained in the item discriminatory analysis. Nine items met these criteria and were used to form the final questionnaire (see Table 1). Internal Consistency Reliability analysis resulted in an internal consistency of Cronbach’s α = 0.91 with corrected item total ranging from 0.41 to 0.86. Test-retest Reliability 67 participants in the community group repeated the COPS after 1 week. The COPS had good test–retest reliability (r = 0.87, p< 0.01). First administration (M=27.94, SD=13.89), second administration (M=30.71, SD=14.04). Convergent validity Based on the data from both groups the COPS correlated highly with the HAD depression subscale (r = 0.7, p< 0.01) and anxiety subscale (r = 0.66, p< 0.01). COPS also correlated highly with the BIQLI (r = 0.68, p<0.01). Thus higher scores on COPS are associated with lower body image quality of life. Cut-off value and ROC analysis Figure 1 represents the ROC curve for BDD patients compared with community controls. The area under the curve (AUC) for this analysis was .905 (95% CI = .862 .948) indicating that the COPS is an accurate diagnostic test. Based on the discrimination of BDD patients from the community group, a cut-off value of ≥ 40 resulted in a maximal kappa coefficient (k = 0.69, p<0.001). On the basis of this cutoff value, 88.9% of BDD patients and 80.6% of the community group were classified correctly. Sensitivity to change We examined sensitivity to change in a sub-sample of 5 patients with BDD who were undergoing cognitive behaviour therapy . Scores on the COPS were examined at baseline, 6 weeks, and 12 weeks. The mean and SD on the 9-item COPS was 52.40 (SD= 16.70) at baseline and 35.00 (SD= 22.88) at 12 weeks. A one-way repeated measures ANOVA was conducted to compare scores across these 3 treatment points. There was a significant effect across the 3 treatment points [F (1.10, 4.38)= 7.35, p = .047]. Discussion We have developed a brief (nine item) screening questionnaire (COPS) that can be used in a cosmetic procedure setting to screen patients with BDD. The scale has acceptable internal consistency, test-retest reliability, and convergent validity. It has a high sensitivity for the diagnosis of BDD in people who are likely to seek a cosmetic procedure. Individuals who score 40 or more should be referred for further assessment. The COPS was also sensitive to change in patients receiving cognitive behaviour therapy . It may therefore be used an outcome measure after any treatment (including cosmetic procedures) to determine (a) if there is any improvement in symptoms of BDD on a continuous dimension (b) whether it may predict persistence of symptoms or dissatisfaction with a cosmetic procedure (in the absence of any surgical complications). Conflict of interest: None Funding: None Ethical Approval: Brighton and Sussex Ethics Committee Acknowledgements: David Veale and Nell Ellison are supported by the National Institute for Health Research (NIHR) Specialist Biomedical Research Centre for Mental Health award to the South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry, Kings College London. References: 1. National Institute of Clinical Excellence (NICE). Obsessive-compulsive disorder: core interventions in the treatment of obsessive-compulsive disorder and body dysmorphic disorder. Clinical Guideline 31, 2005. 2. Veale D, De Haro L, Lambrou C. Cosmetic rhinoplasty in body dysmorphic disorder. British Journal of Plastic Surgery 2003; 56: 546-551. 3. Veale, D., & Neziroglu, F. (2010). Body Dysmorphic Disorder: a treatment manual. Chichester: John Wiley & Sons. 4. Veale D, Gournay K, Dryden W, Boocock A, Shah F, Willson R, et al. Body dysmorphic disorder: A cognitive behavioural model and pilot randomised controlled trial. Behaviour Research and Therapy 1996; 34: 717-729. Figure 1. Receiver operating characteristics plot of COPS scores of BDD patients compared with community controls.

A randomized double-blind placebo-controlled trial of treatment as usual plus exogenous slow-release melatonin (6 mg) or placebo for sleep disturbance and depressed mood.

Sleep disturbance is common in major depressive disorder (MDD), and is often characterized by early-morning waking. Melatonin is a hypnotic and synchronizes circadian rhythms. It may also be an antidepressant. The melatonin agonists, ramelteon and agomelatine, have hypnotic and antidepressant properties, but there is a dearth of trials investigating the use of melatonin in MDD. This randomized, controlled trial aimed to determine whether exogenous melatonin is a sleep promoter and antidepressant. Thirty-three participants with a Diagnostic and Statistical Manual of Mental Disorders (fourth edition) diagnosis of MDD and early-morning waking were selected for a 4-week, randomized, double-blind trial of slow-release melatonin (6 mg; vs. placebo) given at bedtime over 4 weeks. Sleep was measured subjectively using sleep diaries and the Leeds Sleep Evaluation Questionnaire and objectively using wrist actigraphy. Of the 33 participants, 31 completed the trial. General Linear Modelling showed significant improvements in depression and sleep over time, but this was not specific to melatonin. However, there was a trend towards an improvement in mood with melatonin, and no adverse side effects were observed. In conclusion, melatonin may be beneficial for treating MDD, it seems to be safe and well tolerated, but its potential for treating depression in people who do not wish to take antidepressants requires further evaluation.

Manualised Individual Cognitive Behavioural Therapy for mood disorders in people with mild to moderate intellectual disability: A feasibility randomised controlled trial

BACKGROUND Evaluation of complex interventions, including standardisation of the intervention, types of outcomes selected and measures of change, is a fairly novel concept in the field of intellectual disabilities. Our aim was to explore these issues in a feasibility study of Manualised Individual Cognitive Behaviour Treatment (M-iCBT) compared to the treatment as usual alone (TAU). METHODS Service users with mild to moderate intellectual disability experiencing a mood disorder or symptoms of depression and/or anxiety (mini PAS-ADD total score >10 or 7 respectively) were randomly assigned to either. RESULTS In total, 32 participants were randomly assigned to 16 sessions of M-iCBT (n=16) in addition to TAU or TAU alone (n=16). We explored recruitment and accrual rates, willingness to participate, acceptability of the intervention and suitability of assessment tools. Mean change (95% CI) in the Beck Depression Inventory-Youth (BDI-Y) score from baseline to the 16 week endpoint (primary variable) was 0.10 (95% CI: -8.56, 8.76) and in the Beck Anxiety Inventory-Youth (BAI-Y) 2.42 (95% CI: -5.27, 10.12) in favour of TAU. However, there was a clear trend in favour of CBT in depressed participants with or without anxiety. LIMITATIONS The intervention targeted both depression and anxiety following a transdiagnostic model. This may have impacted the anticipated size of change in the primary outcome. The precise impact of cognitive limitations on ability to use therapy effectively is not fully understood. CONCLUSIONS This study demonstrates that it is feasible to carry out a pragmatic randomised controlled trial of M-iCBT for people with mild to moderate intellectual disability. However, uncertainties about its clinical and cost effectiveness can only be fully answered by further examination of its superiority against other treatments.

Cost-effectiveness of cognitive behaviour therapy versus talking and usual care for depressed older people in primary care

BackgroundWhilst evidence suggests cognitive behaviour therapy (CBT) may be effective for depressed older people in a primary care setting, few studies have examined its cost-effectiveness. The aim of this study was to compare the cost-effectiveness of cognitive behaviour therapy (CBT), a talking control (TC) and treatment as usual (TAU), delivered in a primary care setting, for older people with depression.MethodsCost data generated from a single blind randomised controlled trial of 204 people aged 65 years or more were offered only Treatment as Usual, or TAU plus up to twelve sessions of CBT or a talking control is presented. The Beck Depression Inventory II (BDI-II) was the main outcome measure for depression. Direct treatment costs were compared with reductions in depression scores. Cost-effectiveness analysis was conducted using non-parametric bootstrapping. The primary analysis focussed on the cost-effectiveness of CBT compared with TAU at 10 months follow up.ResultsComplete cost data were available for 198 patients at 4 and 10 month follow up. There were no significant differences between groups in baseline costs. The majority of health service contacts at follow up were made with general practitioners. Fewer contacts with mental health services were recorded in patients allocated to CBT, though these differences were not significant. Overall total per patient costs (including intervention costs) were significantly higher in the CBT group compared with the TAU group at 10 month follow up (difference £427, 95% CI: £56 - £787, p < 0.001). Reductions in BDI-II scores were significantly greater in the CBT group (difference 3.6 points, 95% CI: 0.7-6.5 points, p = 0.018). CBT is associated with an incremental cost of £120 per additional point reduction in BDI score and a 90% probability of being considered cost-effective if purchasers are willing to pay up to £270 per point reduction in the BDI-II score.ConclusionsCBT is significantly more costly than TAU alone or TAU plus TC, but more clinically effective. Based on current estimates, CBT is likely to be recommended as a cost-effective treatment option for this patient group if the value placed on a unit reduction in BDI-II is greater than £115.Trial Registrationisrctn.org Identifier: ISRCTN18271323

Acceptance and commitment therapy for adults with advanced cancer (CanACT): study protocol for a feasibility randomised controlled trial.

BackgroundOne-third of people with cancer experience psychological distress and may suppress distressing thoughts, emotions, and concerns, leading to further problems. Conventional psychological treatments reduce distress by problem solving, but in advanced cancer, when ill health is progressive and death may be approaching, physical and psychological difficulties are complex and have no simple solutions. Acceptance and Commitment Therapy encourages acknowledgement and acceptance of mental experiences, increasing people’s ability to work with problems that cannot be solved. Previous pilot work in advanced cancer confirms that distress can be associated with an avoidance of experiencing uncomfortable thoughts and emotions.Methods/DesignThis feasibility randomised controlled trial of Acceptance Commitment Therapy aims to establish parameters for a larger trial. Fifty-four participants with advanced cancer will be randomly allocated to up to eight sessions (each 1 hour) of Acceptance Commitment Therapy or a talking control. Participants will be recruited from those attending outpatient services and hospice day care at three specialist palliative care units in North and East London, United Kingdom. The primary outcome is a measure of functioning in four areas of life (physical, social/family, emotional, and general activity) using the Functional Assessment of Cancer Therapies - General questionnaire at 3 months after randomisation. Secondary outcomes are (i) acceptance using the Acceptance and Action Questionnaire; (ii) psychological distress using the Kessler Psychological Distress Scale; (iii) physical functioning using a timed walk and sit-to-stand test; and (iv) quality of life measures including the Euroqol-5 Dimensions and ICECAP Supportive Care measures. Qualitative data will be collected at 3 months to explore the participants’ experiences of the trial and therapy. Data will be collected on the costs of care.DiscussionData generated on the recruitment, retention, and experience of the interventions and the usefulness of the outcome measures will inform the adaptations required and whether changes in function are consistent with existing data when planning for a sufficiently powered randomised controlled trial.Trial registrationISRCTN13841211 (registered 22 July 2015).

Event-related potentials and cognitive processing of affectively toned words in depression

Abstract Background: Depressed subjects and euthymic controls demonstrate differences in cognitive processing and brain electrophysiology. Contingent negative variation (CNV) and postimperative negative variation (PINV) was used to investigate the relationship between cognition and cortical event related potentials. Method: Electrophysiological responses and memory of different personality trait adjectives were measured in 15 patients with major depressive disorder and 15 euthymic controls. The words were presented acoustically to elicit event-related potentials. The subjects were asked to indicate whether the words were self-referential. Responses were measured separately for self referential and non-self referential, neutral, positively and negatively toned words. Results: Depressed patients chose more negative and fewer positive words as self-referential, though no significant differences between groups in CNV magnitude for any of the words were found. Persistence of cortical negativity after the motor...

Helping Aged Victims of Crime (the HAVoC Study): Common Crime, Older People and Mental Illness.

BACKGOUND Limited data suggest that crime may have a devastating impact on older people. Although identification and treatment may be beneficial, no well-designed studies have investigated the prevalence of mental disorder and the potential benefits of individual manualized CBT in older victims of crime. AIMS To identify mental health problems in older victims of common crime, provide preliminary data on its prevalence, and conduct a feasibility randomized controlled trial (RCT) using mixed methods. METHOD Older victims, identified through police teams, were screened for symptoms of anxiety, depression or post-traumatic stress disorder (PTSD) one (n = 581) and 3 months (n = 486) after experiencing a crime. Screen positive participants were offered diagnostic interviews. Of these, 26 participants with DSM-IV diagnoses agreed to be randomized to Treatment As Usual (TAU) or TAU plus our manualized CBT informed Victim Improvement Package (VIP). The latter provided feedback on the VIP. RESULTS Recruitment, assessment and intervention are feasible and acceptable. At 3 months 120/486 screened as cases, 33 had DSM-IV criteria for a psychiatric disorder; 26 agreed to be randomized to a pilot trial. There were trends in favour of the VIP in all measures except PTSD at 6 months post crime. CONCLUSIONS This feasibility RCT is the first step towards improving the lives of older victims of common crime. Without intervention, distress at 3 and 6 months after a crime remains high. However, the well-received VIP appeared promising for depressive and anxiety symptoms, but possibly not posttraumatic stress disorder.

FC16-04 - The clinical effectiveness of individual cognitive behaviour therapy for depressed older people in primary care and the use of a talking control (TC)

Objective To determine the clinical effectiveness of Cognitive Behaviour Therapy (CBT) delivered in primary care for older people with depression and evaluation of a talking control (TC). Methods A single-blind, randomized, controlled trial with 4- and 10-month follow-up. 204 people, aged 65 years or more, with a Geriatric Mental State diagnosis of depression were recruited from primary care. The interventions were: treatment as usual (TAU), TAU plus TC, or TAU plus CBT. The TC and CBT were offered over 4 months. The TC was to control for common effects in therapy. The Beck Depression Inventory-II (BDI-II) was the main outcome. Subsidiary measures were the Beck Anxiety Inventory, Social Functioning Questionnaire, and Euroqol. Intention to treat analysis (ITT) and Compliance Average Causal Effect (CACE) analyses was employed. The Cognitive therapy scale (CTS) evaluated common and specific factors in therapy. Results A mean of 7 sessions of TC or CBT were delivered. ITT analysis found improvements of −3.07 (95% confidence interval [CI], −5.73 to −0.42) and −3.65 (95% CI, −6.18 to −1.12) in BDI-II scores in favour of CBT vs TAU and TC respectively. CACE analysis found a benefit of 0.4 points (95% CI, 0.01 to 0.72) per therapy session of CBT over TC. Ratings for CBT on the CTS were high (mean [SD], 54.2 [4.1]) and showed no difference for nonspecific, but significant differences for specific factors in therapy. Conclusion CBT is an effective treatment for depressed older people. Improvement appears to be associated with specific factors in CBT.