Rapid Lentiviral Vector Producer Cell Line Generation Using a Single DNA Construct.

Stable suspension producer cell lines for the production of vesicular stomatitis virus envelope glycoprotein (VSVg)-pseudotyped lentiviral vectors represent an attractive alternative to current widely used production methods based on transient transfection of adherent 293T cells with multiple plasmids. We report here a method to rapidly generate such producer cell lines from 293T cells by stable transfection of a single DNA construct encoding all lentiviral vector components. The resulting suspension cell lines yield titers as high as can be achieved with transient transfection, can be readily scaled up in single-use stirred-tank bioreactors, and are genetically and functionally stable in extended cell culture. By removing the requirement for efficient transient transfection during upstream processing of lentiviral vectors and switching to an inherently scalable suspension cell culture format, we believe that this approach will result in significantly higher batch yields than are possible with current manufacturing processes and enable better patient access to medicines based on lentiviral vectors.

Therapist written goodbye letters: evidence for therapeutic benefits in the treatment of anorexia nervosa.

BACKGROUND: Despite their use in clinical practice, there is little evidence to support the use of therapist written goodbye letters as therapeutic tools. However, preliminary evidence suggests that goodbye letters may have benefits in the treatment of anorexia nervosa (AN). AIMS: This study aimed to examine whether therapist written goodbye letters were associated with improvements in body mass index (BMI) and eating disorder symptomology in patients with AN after treatment. METHOD: Participants were adults with AN (n = 41) who received The Maudsley Model of Anorexia Treatment for Adults (MANTRA) in a clinical trial evaluating two AN out-patient treatments. As part of MANTRA, therapists wrote goodbye letters to patients. A rating scheme was developed to rate letters for structure and quality. Linear regression analyses were used to examine associations between goodbye letter scores and outcomes after treatment. RESULTS: Higher quality letters and letters that adopted a more affirming stance were associated with greater improvements in BMI at 12 months. Neither the overall quality nor the style of goodbye letters were associated with improvements in BMI at 24 months or reductions in eating disorder symptomology at either 12 or 24 months. CONCLUSIONS: The results highlight the potential importance of paying attention to the overall quality of therapist written goodbye letters in the treatment of AN, and adopting an affirming stance.

Advancing implementation frameworks with a mixed methods case study in child behavioral health.

Despite a growing policy push for the provision of services based on evidence, evidence-based treatments for children and youth with mental health challenges have poor uptake, yielding limited benefit. With a view to improving implementation in child behavioral health, we investigated a complementary implementation approach informed by three implementation frameworks in the context of implementing motivational interviewing in four child and youth behavioral health agencies: the Active Implementation Frameworks (AIF) (process), the Consolidated Framework for Implementation Research (factors), and the Implementation Outcomes Framework (evaluation). The study design was mixed methods with embedded interrupted time series and motivational interviewing (MI) fidelity was the primary outcome. Focus groups and field notes informed perspectives on the implementation approach, and a questionnaire explored the salience of Consolidated Framework for Implementation Research (CFIR) factors. Findings validate the process guidance provided by the AIF and highlight CIFR factors related to implementation success. Novel CFIR factors, not elsewhere reported in the literature, are identified that could potentially extend the framework if validated in future research. Introducing fidelity measurement in practice proved challenging and was not sustained beyond the study. A complementary implementation approach was successful in implementing MI in child behavioral health agencies. In contrast with the typical train and hope approach to implementation, practice change did not occur immediately post-training but emerged over a 7 month period of consultation and practice following a discrete interactive training period. The saliency of CFIR constructs aligned with findings from studies conducted in other contexts, demonstrating external validity and highlighting common factors that can focus planning and measurement.

The effectiveness of consultation for clinicians learning to deliver motivational interviewing with fidelity.

Despite the emerging literature documenting gains in clinician competence following consultation, little empirical work has examined consultation as an implementation strategy. To this end, the present study examined consultation in the context of implementing motivational interviewing in four community child and youth mental health organizations. We used qualitative methods with a dual goal: to describe the consultation process and to explore trainees' perspectives on consultation. Participants included 22 clinicians and 9 supervisors who received monthly, group, phone-based consultation for seven months following training in motivational interviewing. Analyses showed that consultation was perceived as effective because it helped to "keep motivational interviewing alive," fulfilled a profound learning function through collaboration and connection with others, and served as protected time for reflection on practice change. Our findings contribute to a body of knowledge about consultation elements that appear to be effective when implementing research-supported interventions in child and youth mental health.

Mass spectrometry analysis reveals differences in the host cell protein species found in pseudotyped lentiviral vectors.

Lentiviral vectors (LVs) have been successfully used in clinical trials showing long term therapeutic benefits. Studying the role of cellular proteins in lentivirus HIV-1 life cycle can help understand virus assembly and budding, leading to improvement of LV production for gene therapy. Lentiviral vectors were purified using size exclusion chromatography (SEC). The cellular protein composition of LVs produced by two different methods was compared: the transient transfection system pseudotyped with the VSV-G envelope, currently used in clinical trials, and a stable producer cell system using a non-toxic envelope derived from cat endogenous retrovirus RD114, RDpro. Proteins of LVs purified by size exclusion chromatography were identified by tandem mass spectrometry (MS/MS). A smaller number of cellular protein species were detected in stably produced vectors compared to transiently produced vector samples. This may be due to the presence of co-purified VSV-G vesicles in transiently produced vectors. AHNAK (Desmoyokin) was unique to RDpro-Env vectors. The potential role in LV particle production of selected proteins identified by MS analysis including AHNAK was assessed using shRNA gene knockdown technique. Down-regulation of the selected host proteins AHNAK, ALIX, and TSG101 in vector producer cells did not result in a significant difference in vector production.

Written case formulations in the treatment of anorexia nervosa: Evidence for therapeutic benefits.

OBJECTIVE: Case formulation is a core component of many psychotherapies and formulation letters may provide an opportunity to enhance the therapeutic alliance and improve treatment outcomes. This study aimed to determine if formulation letters predict treatment satisfaction, session attendance, and symptom reductions in anorexia nervosa (AN). It was hypothesized that higher quality formulation letters would predict greater treatment satisfaction, a greater number of attended sessions, and greater improvement in eating disorder symptoms. METHOD: Patients were adult outpatients with AN (n = 46) who received Maudsley Anorexia Nervosa Treatment for Adults (MANTRA) in the context of a clinical trial. A Case Formulation Rating Scheme was used to rate letters for adherence to the MANTRA model and use of a collaborative, reflective, affirming stance. Analyses included linear regression and mixed models. RESULTS: Formulation letters that paid attention to the development of the AN predicted greater treatment acceptability ratings (p = 0.002). More reflective and respectful letters predicted greater reductions in Eating Disorder Examination scores (p = 0.003). DISCUSSION: Results highlight the potential significance of a particular style of written formulation as part of treatment for AN. Future research should examine applicability to other psychiatric disorders. © 2016 Wiley Periodicals, Inc.(Int J Eat Disord 2016; 49:874-882).

Two-year follow-up of the MOSAIC trial: A multicenter randomized controlled trial comparing two psychological treatments in adult outpatients with broadly defined anorexia nervosa.

OBJECTIVE: This study reports follow-up data from a multicenter randomized controlled trial (n = 142) comparing the Maudsley Model of Anorexia Nervosa Treatment for Adults (MANTRA) with Specialist Supportive Clinical Management (SSCM) in outpatients with broadly defined anorexia nervosa (AN). At 12 months postrandomization, all patients had statistically significant improvements in body mass index (BMI), eating disorder (ED) symptomatology and other outcomes with no differences between groups. MANTRA was more acceptable to patients. The present study assessed whether gains were maintained at 24 months postrandomization. METHODS: Follow-up data at 24 months were obtained from 73.2% of participants. Outcome measures included BMI, ED symptomatology, distress, impairment, and additional service utilization during the study period. Outcomes were analyzed using linear mixed models. RESULTS: There were few differences between groups. In both treatment groups, improvements in BMI, ED symptomatology, distress levels, and clinical impairment were maintained or increased further. Estimated mean BMI change from baseline to 24 months was 2.16 kg/m(2) for SSCM and 2.25 kg/m(2) for MANTRA (effect sizes of 1.75 and 1.83, respectively). Most participants (83%) did not require any additional intensive treatments (e.g., hospitalization). Two SSCM patients became overweight through binge-eating. DISCUSSION: Both treatments have value as outpatient interventions for patients with AN. © 2016 Crown copyright. International Journal of Eating Disorders. (Int J Eat Disord 2016; 49:793-800).

Process evaluation of the MOSAIC trial: treatment experience of two psychological therapies for out-patient treatment of Anorexia Nervosa.

BACKGROUND: This study is part of a series of process evaluations within the MOSAIC Trial (Maudsley Outpatient Study of Treatments for Anorexia Nervosa and Related Conditions). This randomised controlled trial (RCT) compared two psychological treatments, the Maudsley Model for Treatment of Adults with Anorexia Nervosa (MANTRA) and Specialist Supportive Clinical Management (SSCM) for adult outpatients with Anorexia Nervosa. The present process study integrates quantitative (treatment acceptability and credibility) and qualitative (written) feedback to evaluate patients' treatment experiences. METHOD: All 142 MOSAIC participants were asked to (a) rate treatment acceptability and credibility on visual analogue scales (VAS) at six and 12 months post-randomisation, and (b) provide written feedback regarding their views on their treatment at 12 months. Transcripts were first analysed thematically and then rated according to the global valence of feedback (positive, mixed/negative). RESULTS: 114/142 (80.3 %) MOSAIC participants provided VAS data and 82 (57.7 %) provided written feedback. At 12 months, MANTRA patients gave significantly higher acceptability and credibility ratings compared to SSCM patients. A significantly higher proportion of MANTRA patients provided written feedback. MANTRA patients also tended to write in more detail and to give globally more positive feedback when compared to individuals receiving SSCM. Qualitative themes suggest that patients experienced the two treatments differently in terms of characteristics and outcomes. CONCLUSIONS: This study highlights the benefits of incorporating qualitative and quantitative data into RCT process evaluations. MANTRA patients were more willing to express their views on treatment and generally felt more positively about this than those receiving SSCM.

The Maudsley Outpatient Study of Treatments for Anorexia Nervosa and Related Conditions (MOSAIC): Comparison of the Maudsley Model of Anorexia Nervosa Treatment for Adults (MANTRA) with specialist supportive clinical management (SSCM) in outpatients with broadly defined anorexia nervosa: A randomized controlled trial.

OBJECTIVE: Anorexia nervosa (AN) in adults has poor outcomes, and treatment evidence is limited. This study evaluated the efficacy and acceptability of a novel, targeted psychological therapy for AN (Maudsley Model of Anorexia Nervosa Treatment for Adults; MANTRA) compared with Specialist Supportive Clinical Management (SSCM). METHOD: One hundred forty-two outpatients with broadly defined AN (body mass index [BMI] ≤ 18.5 kg/m²) were randomly allocated to receive 20 to 30 weekly sessions (depending on clinical severity) plus add-ons (4 follow-up sessions, optional sessions with dietician and with carers) of MANTRA (n = 72) or SSCM (n = 70). Assessments were administered blind to treatment condition at baseline, 6 months, and 12 months after randomization. The primary outcome was BMI at 12 months. Secondary outcomes included eating disorders symptomatology, other psychopathology, neuro-cognitive and social cognition, and acceptability. Additional service utilization was also assessed. Outcomes were analyzed using linear mixed models. RESULTS: Both treatments resulted in significant improvements in BMI and reductions in eating disorders symptomatology, distress levels, and clinical impairment over time, with no statistically significant difference between groups at either 6 or 12 months. Improvements in neuro-cognitive and social-cognitive measures over time were less consistent. One SSCM patient died. Compared with SSCM, MANTRA patients rated their treatment as significantly more acceptable and credible at 12 months. There was no significant difference between groups in additional service consumption. CONCLUSIONS: Both treatments appear to have value as first-line outpatient interventions for patients with broadly defined AN. Longer term outcomes remain to be evaluated.

The Effects of Movement on Hemorrhage When QuikClot® Combat Gauze™ Is Used in a Hypothermic Hemodiluted Porcine Model.

BACKGROUND: The purpose of this study was to compare the effectiveness of QuikClot(®) Combat Gauze™ (QCG) to a control wound dressing to withstand movement in a porcine model with hemodilution and hypothermia. DESIGN: This was a prospective study with a between-subjects experimental design. Twenty-six Yorkshire swine were randomly assigned to two groups: QCG (n = 13) or a control dressing (n = 13). METHODS: The subjects were exsanguinated to 30% of the blood volume; hypothermia was induced for 10 minutes. The hemostatic agent, QCG, was placed into the wound, followed by standard wound packing. If hemostasis was achieved, 5L of crystalloid solution were rapidly administered intravenously, and the wound was again observed for rebleeding. If no bleeding occurred, the extremity on the side of the injury was systematically moved through flexion, extension, abduction, and adduction sequentially 10 times or until rebleeding occurred. RESULTS: An independent t test indicated there were significant differences in the number of movements before rebleeding between the QCG group (mean ± standard deviation [SD], 32.92 ± 14.062) and the control group (mean ± SD, 6.15 ± 15.021) (p < .0001). CONCLUSION: QCG produces a robust clot that can withstand more movement than a control dressing.

Neuro- and social-cognitive clustering highlights distinct profiles in adults with anorexia nervosa.

OBJECTIVE: This study aimed to explore the neuro- and social-cognitive profile of a consecutive series of adult outpatients with anorexia nervosa (AN) when compared with widely available age and gender matched historical control data. The relationship between performance profiles, clinical characteristics, service utilization, and treatment adherence was also investigated. METHOD: Consecutively recruited outpatients with a broad diagnosis of AN (restricting subtype AN-R: n = 44, binge-purge subtype AN-BP: n = 33 or Eating Disorder Not Otherwise Specified-AN subtype EDNOS-AN: n = 23) completed a comprehensive set of neurocognitive (set-shifting, central coherence) and social-cognitive measures (Emotional Theory of Mind). Data were subjected to hierarchical cluster analysis and a discriminant function analysis. RESULTS: Three separate, meaningful clusters emerged. Cluster 1 (n = 45) showed overall average to high average neuro- and social- cognitive performance, Cluster 2 (n = 38) showed mixed performance characterized by distinct strengths and weaknesses, and Cluster 3 (n = 17) showed poor overall performance (Autism Spectrum disorder (ASD) like cluster). The three clusters did not differ in terms of eating disorder symptoms, comorbid features or service utilization and treatment adherence. A discriminant function analysis confirmed that the clusters were best characterized by performance in perseveration and set-shifting measures. DISCUSSION: The findings suggest that considerable neuro- and social-cognitive heterogeneity exists in patients with AN, with a subset showing ASD-like features. The value of this method of profiling in predicting longer term patient outcomes and in guiding development of etiologically targeted treatments remains to be seen.

Effects of intraosseous transfusion of whole blood on hemolysis and transfusion time in a swine model of hemorrhagic shock: a pilot study.

This prospective, experimental, mixed study determined whether there were differences in intraosseous (IO) and intravenous (IV) whole blood transfusion relative to hemolysis and transfusion time. Swine were assigned to the IV group (n = 6) with an 18-gauge catheter in the auricular vein or the IO group (n = 7) with a 15-gauge 10 needle in the proximal humerus. Following baseline specimen collection, 900 mL of blood was collected from each animal. The collected blood was autologously transfused by the IV or IO route using a pressure infusion bag inflated to 300 mm Hg, with immediate posttransfusion specimen collection. Hemolysis was defined by the amount of plasma free hemoglobin. Multivariate analysis of variance revealed no significant differences between groups relative to posttransfusion free hemoglobin or transfusion time (P = .065). The IV group's mean free hemoglobin level was 10.23 +/- 10.52 micromol/L; the IO group, 7.2 +/- 5.82 micromol/L. The IV group's mean transfusion time was 13.48 +/- 4.1 minutes; the IO group, 28.70 +/- 19.51 minutes. Intraosseous transfusion does not significantly increase hemolysis or transfusion time compared with IV transfusion. Clinically, it can take up to twice as long to transfuse 900 mL of blood IO compared with IV.

The effects of using a human patient simulator compared to a CD-ROM in teaching critical thinking and performance.

BACKGROUND: Military healthcare personnel, including nurse anesthetists, must have the knowledge and skills to care for the extensive, severe injuries incurred on the battlefield. No studies have compared the 2 teaching strategies of using the human patient simulator (HPS) and a CD-ROM in caring for combat injuries relative to critical thinking and performance using nurse anesthesia participants. METHODS: A prospective, pretest-posttest experimental, mixed design (within and between) was used to determine if there were statistically significant differences in HPS and CD-ROM educational strategies relative to caring for patients who have trauma. Two instruments were used: critical thinking, which consisted of multiple-choice questions; and a combat performance instrument that measured ability to care for patients. RESULTS: A repeated analysis of variance and a least significant difference post-hoc test were used to analyze the data. The HPS group performed better than the CD-ROM and control groups relative to performance (P=.000) but not on critical thinking (P=.239). There was no difference between the CD-ROM and control group (P=.171) on the combat performance instrument. CONCLUSION: In this study, the HPS method of instruction was a more effective method of teaching than the CD-ROM approach.

To change or not to change a multiple choice answer.

It is a common belief that changing answers on multiple-choice examinations is detrimental, and such action usually results in changing from right to wrong. Over the past 60 years, studies have shown that changing answers on multiple-choice examinations is generally beneficial. The misconception regarding answer changing behavior may be perpetuated by faculty despite evidence to the contrary. As a part of the US Army Graduate Program in Anesthesia Nursing process improvement program, the investigators examined answer changing behaviors of nursing anesthesia students. The results of this evaluation supported conclusions from previous studies in that the odds of students changing from wrong to right was 72% and from right to wrong was 20%. Students should be informed about the benefits of changing answers on multiple-choice examinations.

Improvements in symptoms following neuronavigated repetitive transcranial magnetic stimulation (rTMS) in severe and enduring anorexia nervosa: findings from two case studies.

BACKGROUND: Advances in the treatment of anorexia nervosa (AN) are most likely to arise from targeted, brain-directed treatments, such as repetitive transcranial magnetic stimulation (rTMS). We describe findings from two individuals with treatment-resistant AN who received 19-20 sessions of neuronavigated, high frequency rTMS, applied to the left dorsolateral prefrontal cortex. METHOD: Within-session measures assessed changes pre-rTMS, post-rTMS in subjective eating disorder (ED) experiences. Weight, ED symptoms and mood were assessed pre-treatment, post-treatment and at 1 month follow-up. RESULTS: In both cases, there was improvement in ED symptomatology and mood after 19-20 sessions of neuronavigated rTMS, and these changes persisted or continued to improve at follow-up. Within sessions, Patient A demonstrated a consistent reduction in subjective ED experiences, and Patient B a reduction in some ED related experiences. CONCLUSIONS: These findings suggest that rTMS has potential as an adjunct to the treatment of AN and deserves further study.

The MOSAIC study - comparison of the Maudsley Model of Treatment for Adults with Anorexia Nervosa (MANTRA) with Specialist Supportive Clinical Management (SSCM) in outpatients with anorexia nervosa or eating disorder not otherwise specified, anorexia nervosa type: study protocol for a randomized controlled trial.

BACKGROUND: Anorexia nervosa (AN) is a biologically based serious mental disorder with high levels of mortality and disability, physical and psychological morbidity and impaired quality of life. AN is one of the leading causes of disease burden in terms of years of life lost through death or disability in young women. Psychotherapeutic interventions are the treatment of choice for AN, but the results of psychotherapy depend critically on the stage of the illness. The treatment response in adults with a chronic form of the illness is poor and drop-out from treatment is high. Despite the seriousness of the disorder the evidence-base for psychological treatment of adults with AN is extremely limited and there is no leading treatment. There is therefore an urgent need to develop more effective treatments for adults with AN. The aim of the Maudsley Outpatient Study of Treatments for Anorexia Nervosa and Related Conditions (MOSAIC) is to evaluate the efficacy and cost effectiveness of two outpatient treatments for adults with AN, Specialist Supportive Clinical Management (SSCM) and the Maudsley Model of Treatment for Adults with Anorexia Nervosa (MANTRA). METHODS/DESIGN: 138 patients meeting the inclusion criteria are randomly assigned to one of the two treatment groups (MANTRA or SSCM). All participants receive 20 once-weekly individual therapy sessions (with 10 extra weekly sessions for those who are severely ill) and four follow-up sessions with monthly spacing thereafter. There is also optional access to a dietician and extra sessions involving a family member or a close other. Body weight, eating disorder- related symptoms, neurocognitive and psychosocial measures, and service use data are measured during the course of treatment and across a one year follow up period. The primary outcome measure is body mass index (BMI) taken at twelve months after randomization. DISCUSSION: This multi-center study provides a large sample size, broad inclusion criteria and a follow-up period. However, the study has to contend with difficulties directly related to running a large multi-center randomized controlled trial and the psychopathology of AN. These issues are discussed.

The effects of a human patient simulator vs. a CD-ROM on performance.

OBJECTIVES: Military health care personnel need to have skills relative to caring for patients on the battlefield. No studies have compared the two teaching strategies of using the human patient simulator (HPS) and a CD-ROM in caring for combat injuries. The objective of this study was to determine if there were statistically significant differences in HPS and CD-ROM educational strategies relative to caring for patients who have trauma. METHODS: A pretest/post-test prospective experimental design was used. Anesthesia students were randomly assigned to one of three groups: HPS, CD-ROM, or a control group. A valid and reliable instrument, Combat Performance, was used to evaluate the participant's ability to give care to trauma patients. RESULTS: A repeated analysis of variance and a least significant difference post hoc test were used to analyze the data. The HPS group performed better than the CD-ROM and control groups relative to performance (p = 0.001). There was no difference between the CD-ROM and control group (p = 0.171). DISCUSSION: We speculate that the HPS group performed better than the CD-ROM group because of the realism. CONCLUSION: In this study, the HPS method of instruction was a more effective method of teaching than the CD-ROM approach.

An experimental exploration of social problem solving and its associated processes in anorexia nervosa.

People with Anorexia Nervosa (AN) have well-documented socio-emotional and neurocognitive impairments. As yet, little is known about their ability to solve problems in social situations, although a link with cognitive avoidance has been suggested. This study explored social problem-solving (SPS), using an experimental task. Secondly, the role of cognitive avoidance in SPS was investigated. Individuals with AN (n=31) and healthy controls (HC; n=39) completed the Social Problem Resolution Task which consists of problem scenarios involving awkward everyday social situations. Participants were asked to generate both the optimal solution and their personal solution. Solutions were rated in terms of how socially sensitive and practically effective they were. AN patients produced relatively poorer personal solutions compared to optimal solutions than HC participants and had higher scores on a measure of cognitive avoidance than the HC group. In AN patients, cognitive avoidance was partially associated with poor SPS. These findings suggest that whilst people with AN have no difficulty in generating socially sensitive and effective solutions to problems, but may have difficulty applying this knowledge to themselves.

Psychosocial barriers to engagement with an eating disorder service: a qualitative analysis of failure to attend.

Patient non-attendance and failure to engage with health services may be costly to the individual in terms of the delays in obtaining appropriate treatment and the unnecessary suffering and discomfort this may entail. Non-attendance is also costly to health services because of administrative and clinical time lost and the opportunity costs of not treating other patients. Patients who have been referred to eating disorders clinics by general practitioners appear to have high rates of non-attendance or dropping out immediately after assessment. The reasons behind their failure to engage are poorly understood. After undertaking a comprehensive audit in a major eating disorder unit in London we undertook a qualitative study of non-attenders in order to obtain the reasons behind non-engagement. We found that while participants tend to open their explanations with practical difficulties (e.g., child-minding) or service- related factors, what commonly emerged from their narratives were profound social-psychological problems and the ambivalence of confronting or losing a relationship with food that was both comforting and debilitating. Some participants described a world of imprisonment which precluded the likelihood of firm engagement with services. We suggest that such people may require better identification and outreach provision.

A randomized controlled trial of cognitive behavior therapy tailored to psychological adaptation to an implantable cardioverter defibrillator.

OBJECTIVES: To evaluate a eight-session cognitive behavior therapy (CBT) intervention tailored to adaptation in implantable cardioverter defibrillator (ICD) patients; and to test for treatment group by gender interaction effects. METHODS: Patients receiving their first ICD implant were randomized to CBT or usual cardiac care. Primary outcomes measured at baseline, 6-month, and 12-month follow-ups were symptoms of anxiety and depression (Hospital Anxiety and Depression Scale), posttraumatic stress disorder symptoms (Impact of Events Scale-Revised), and phobic anxiety (Crown-Crisp Experiential Index). Secondary outcomes were quality of life (Short Form-36 Physical Component Summary and Short Form-36 Mental Component Summary) and ICD shocks or antitachycardia pacing therapies. RESULTS: Of 292 eligible patients, 193 consented and were randomized to CBT (n = 96) or usual cardiac care (n = 97). Eighty percent were male; mean age was 64.4 years (standard deviation = 14.3); and 70% received an ICD for secondary prevention. No baseline differences were observed between the treatment conditions; however, women scored worse than men on all psychological and quality of life variables (p < .05). Eighty-three percent completed follow-up. Repeated-measures analyses of covariance revealed significantly greater improvement with CBT on posttraumatic stress disorder total and avoidance symptoms for men and women combined (p < .05) and significantly greater improvement in depressive symptoms and Short Form-36 Mental Component Summary only in women (p < .01). No differences were observed between treatment conditions on ICD therapies over follow-up. CONCLUSION: A CBT intervention to assist adaptation to an ICD enhanced psychological functioning over the first year post implant.