Trials Of Psychological Interventions Research Articles

CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials

BackgroundThe CONSORT (Consolidated Standards of Reporting Trials) Statement was developed to help biomedical researchers report randomised controlled trials (RCTs) transparently. We have developed an extension to the CONSORT 2010 Statement for social and psychological interventions (CONSORT-SPI 2018) to help behavioural and social scientists report these studies transparently.MethodsFollowing a systematic review of existing reporting guidelines, we conducted an online Delphi process to prioritise the list of potential items for the CONSORT-SPI 2018 checklist identified from the systematic review. Of 384 international participants, 321 (84%) participated in both rating rounds. We then held a consensus meeting of 31 scientists, journal editors, and research funders (March 2014) to finalise the content of the CONSORT-SPI 2018 checklist and flow diagram.ResultsCONSORT-SPI 2018 extends 9 items (14 including sub-items) from the CONSORT 2010 checklist, adds a new item (with 3 sub-items) related to stakeholder involvement in trials, and modifies the CONSORT 2010 flow diagram. This Explanation and Elaboration (E&E) document is a user manual to enhance understanding of CONSORT-SPI 2018. It discusses the meaning and rationale for each checklist item and provides examples of complete and transparent reporting.ConclusionsThe CONSORT-SPI 2018 Extension, this E&E document, and the CONSORT website (www.consort-statement.org) are helpful resources for improving the reporting of social and psychological intervention RCTs.

Reporting randomised trials of social and psychological interventions: the CONSORT-SPI 2018 Extension

BackgroundRandomised controlled trials (RCTs) are used to evaluate social and psychological interventions and inform policy decisions about them. Accurate, complete, and transparent reports of social and psychological intervention RCTs are essential for understanding their design, conduct, results, and the implications of the findings. However, the reporting of RCTs of social and psychological interventions remains suboptimal. The CONSORT Statement has improved the reporting of RCTs in biomedicine. A similar high-quality guideline is needed for the behavioural and social sciences. Our objective was to develop an official extension of the Consolidated Standards of Reporting Trials 2010 Statement (CONSORT 2010) for reporting RCTs of social and psychological interventions: CONSORT-SPI 2018.MethodsWe followed best practices in developing the reporting guideline extension. First, we conducted a systematic review of existing reporting guidelines. We then conducted an online Delphi process including 384 international participants. In March 2014, we held a 3-day consensus meeting of 31 experts to determine the content of a checklist specifically targeting social and psychological intervention RCTs. Experts discussed previous research and methodological issues of particular relevance to social and psychological intervention RCTs. They then voted on proposed modifications or extensions of items from CONSORT 2010.ResultsThe CONSORT-SPI 2018 checklist extends 9 of the 25 items from CONSORT 2010: background and objectives, trial design, participants, interventions, statistical methods, participant flow, baseline data, outcomes and estimation, and funding. In addition, participants added a new item related to stakeholder involvement, and they modified aspects of the flow diagram related to participant recruitment and retention.ConclusionsAuthors should use CONSORT-SPI 2018 to improve reporting of their social and psychological intervention RCTs. Journals should revise editorial policies and procedures to require use of reporting guidelines by authors and peer reviewers to produce manuscripts that allow readers to appraise study quality, evaluate the applicability of findings to their contexts, and replicate effective interventions.

Risk of bias in randomized controlled trials of psychological treatments for bulimia nervosa and binge eating

PurposeIn the context of Cochrane systematic reviews/meta-analyses of randomized clinical trials, risk of bias (RoB) is assessed using categorical indicators (low, unclear, or high RoB). This study sought to evaluate the indicators of the Cochrane RoB tool available for construct validity as applied to randomized clinical trials of psychological treatments for bulimia nervosa and binge eating. MethodsBayesian confirmatory factor analysis was used to test the construct validity of the measurement model underlying the set of five categorical items, and the reliability of these indicators to measure RoB. ResultsIn 48 primary randomized clinical trials, the model showed good fit indices and factor loadings higher than 0.4. ConclusionsThe results support the construct validity of the Cochrane RoB tool and the reliability of three of five items in this health intervention context.

A systematic review of psychological interventions in total hip and knee arthroplasty

BackgroundThe current practice in elective orthopaedics does not routinely include psychological interventions despite evidence that psychological factors such as personality, anxiety, depression and negative thinking styles can influence outcomes and recovery from surgery. The objective of this paper was to review the effectiveness of psychological interventions used in conjunction with total hip (THA) and knee arthroplasty (TKA), in improving patient reported joint outcomes.MethodsAn extensive literature search was conducted according to Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines. Search terms included psychology, interventions, and orthopaedics. Articles were included if they were randomised controlled trials (RCTs) of psychological interventions involving active patient participation measured with patient reported joint outcomes in patients undergoing hip or knee arthroplasty.ResultsA total of 19,489 titles were screened. Seven studies met the inclusion criteria and were included. Five of seven studies did not show improvements in patient reported outcomes after surgery. Specifically, psycho-education alone was not effective at improving patient reported joint outcomes in two out of two studies.ConclusionThe current literature does not support routine psychological interventions for TKA and THA. However, it should be noted that the literature for psychological interventions in conjunction with TKA and THA is still in its infancy. This gap in the literature is surprising, considering the importance of the role of psychological factors in recovery. Further RCTs with long term follow ups, multidisciplinary involvement, and more comprehensive and focused interventions that go beyond educating patients are needed. Future studies should account for the demand effect, include measures of psychological variables to determine whether psychological interventions are more beneficial for some patients compared to others, and compare the different modes of delivery and timing of interventions to determine the optimal nature and duration of psychological interventions for TKA and THA.

Why randomised controlled trials of psychological treatments are still essential

The movement towards evidence-based practice in psychotherapy has recently provoked a backlash. In the past few years, some authors have raised questions concerning the validity of randomised controlled trials (RCTs), which have long been regarded as a crucial linchpin for evidence-based practice. These critics have argued that data from RCTs should not be prioritised above data derived from alternative evidentiary sources, such as observational studies, uncontrolled case studies, and clinical experience. 1 Clay R More than one way to measure. Am Psychol. 2010; 41: 52 Google Scholar , 2 Guy A Thomas R Stephenson SL Loewenthal D NICE under scrutiny: the impact of the National Institute for Health and Clinical Excellence guidelines on the provision of psychotherapy in UK. J Psychol Therap Primary Care. 2012; 1: 77-102 Google Scholar Although many of the criticisms have been aimed at RCT methodology in general, some sceptics have extended them to raise questions concerning the role of RCTs in the evaluation of psychological treatments. Changing the topic does not change the facts – Authors' replyIn keeping with Rapoport's Rules of Argumentation,1 we acknowledge several points of agreement with Jonathan Shedler regarding our Comment.2 We concur that the treatments recommended in the post-traumatic stress disorder (PTSD) practice guidelines are not panaceas: even the best PTSD treatments leave many patients with clinically significant symptoms. Development of better interventions or improvement of existing ones to reach these remaining individuals is needed. Full-Text PDF Changing the topic does not change the factsIn a Comment published in The Lancet Psychiatry, Scott Lilienfeld and colleagues1 wrote that I encouraged psychotherapists to ignore new practice guidelines for post-traumatic stress disorder (PTSD) because they relied inordinately on randomised controlled trials (RCTs). I did not urge therapists to ignore the guidelines because they relied on RCTs; I urged them to ignore the guidelines because research studies—the same RCTs they laud—show that the recommended therapies do not work for most patients. Full-Text PDF

Assessment of Sexual Desire for Clinical Trials of Women With Hypoactive Sexual Desire Disorder: Measures, Desire-Related Behavior, and Assessment of Clinical Significance.

The Female Sexual Function Index-desire subscale is the standard measure for clinical trials of hypoactive sexual desire disorder (HSDD), but lacks items assessing sexually related behaviors and attitudes toward partner. Counting satisfying sexual events is criticized, but sexual behavior remains important. Mean treatment differences cannot define clinical significance; responder and remitter analyses help. We reviewed measures on sexual desire and sexual behavior relevant to HSDD, and how to assess clinical significance. We conducted a literature review of measures of sexual desire comparing expert-proposed criteria for dysfunctional desire, expert-developed scales, and scales from patient input. Commonly recognized symptoms of HSDD were identified. Results of HSDD trials and scale validation studies were evaluated to extract responder and remitter values. The utility of distribution-based measures of responders and remitters was assessed. Symptom relevance was evaluated as the proportion of symptom sets that included the item; responder and remitter cut points were determined by distribution-based methods. 12 Validated rating scales, 5 scales primarily derived from expert recommendations and 7 scales initially from patient input, and 5 sets of diagnostic criteria for conditions like HSDD were compared. Content varied highly between scales despite compliance with U.S. Food and Drug Administration recommendations for patient-reported outcomes. This disunity favors an expert-recommended scale such as the Elements of Desire Questionnaire with each of the common items, plus a measure of frequency of sexual activity, eg, item in the Patient Reported Outcomes Measurement Information System. Registrational drug trials, but not psychological treatment trials, usually give responder/remitter analyses, using dichotomized global impressions or anchor-based definitions. Distribution-based methods are more uniformly applicable to define responder and remitter status. The Female Sexual Function Index-desire subscale measures the most relevant element of sexual desire, but it would be meaningful to include 4 or 5 more sexual symptoms as end points: sexual thoughts/fantasies, frequency of sexual activity, receptivity, initiations, and possibly avoidance of sexual situations. The Elements of Desire Questionnaire and a measure of sexual frequency may suffice. Responder and remitter analyses show the clinical relevance of a treatment and enable comparisons across trials. Pyke RE, Clayton AH. Assessment of Sexual Desire for Clinical Trials of Women With Hypoactive Sexual Desire Disorder: Measures, Desire-Related Behavior, and Assessment of Clinical Significance. Sex Med Rev 2018;6:367-383.

Psychological interventions for coronary heart disease: Cochrane systematic review and meta-analysis.

Background Although psychological interventions are recommended for the management of coronary heart disease (CHD), there remains considerable uncertainty regarding their effectiveness. Design Systematic review and meta-analysis of randomised controlled trials (RCTs) of psychological interventions for CHD. Methods The Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL and PsycINFO were searched to April 2016. Retrieved papers, systematic reviews and trial registries were hand-searched. We included RCTs with at least 6 months of follow-up, comparing the direct effects of psychological interventions to usual care for patients following myocardial infarction or revascularisation or with a diagnosis of angina pectoris or CHD defined by angiography. Two authors screened titles for inclusion, extracted data and assessed risk of bias. Studies were pooled using random effects meta-analysis and meta-regression was used to explore study-level predictors. Results Thirty-five studies with 10,703 participants (median follow-up 12 months) were included. Psychological interventions led to a reduction in cardiovascular mortality (rfcelative risk 0.79, 95% confidence interval [CI] 0.63 to 0.98), although no effects were observed for total mortality, myocardial infarction or revascularisation. Psychological interventions improved depressive symptoms (standardised mean difference [SMD] -0.27, 95% CI -0.39 to -0.15), anxiety (SMD -0.24, 95% CI -0.38 to -0.09) and stress (SMD -0.56, 95% CI -0.88 to -0.24) compared with controls. Conclusions We found that psychological intervention improved psychological symptoms and reduced cardiac mortality for people with CHD. However, there remains considerable uncertainty regarding the magnitude of these effects and the specific techniques most likely to benefit people with different presentations of CHD.

Vasovagal reactions in blood donors: risks, prevention and management.

This narrative review examines current research on risk factors, prevention methods and management strategies for vasovagal reactions (VVRs) that occur during or as a result of blood donation. VVRs are important to blood collection agencies (BCAs) as they negatively impact the number of completed collections, perceptions of the safety of blood donation and rates of donor return. There has been significant progress in understanding and preventing VVRs in blood donation in recent years, with a multitude of risk factors identified. This has resulted in many BCAs implementing evidence-based strategies, such as donor age and weight restrictions. However, the profile of our most vulnerable donors and features of the donation setting that may protect these donors from experiencing a VVR have not been identified. Furthermore, an increased number of trials of physiological and psychological prevention interventions to reduce both immediate and delayed VVRs have been reported. However, a lack of methodological consistency in operationalising interventions to reduce or prevent VVRs means that the identification of effective VVR prevention strategies remains a challenge for practitioners. Furthermore, research is still required to determine how to successfully implement prevention and management strategies into standard operating procedures within collection centres. Finally, research in the management and mitigation of the effect of VVRs is currently only suggestive of what should be done to care for the donor who reacts and how to empower those donors to return. Collectively, research into these aspects of VVRs will provide support to donors and BCAs and improve the safety of blood donation.

A longitudinal investigation of the Concise Health Risk Tracking Self-Report (CHRT-SR) in suicidal patients during and after hospitalization

The Concise Health Risk Tracking Self-Report (CHRT-SR) scale is a brief self-report instrument to assess suicide risk. Initial investigations have indicated good psychometric properties in psychiatric outpatients. The aims of this paper were to examine the construct validity and factor structure of the twelve- (CHRT-SR12) and seven-item (CHRT-SR7) versions and to test if clinically expected within-person changes in suicide risk over time were measurable using the CHRT-SR in two study cohorts hospitalized for suicidal ideation or behavior: (1) patients with major depressive disorder (MDD) who participated in a psychological intervention trial, n = 65, and (2) participants with bipolar disorder or MDD in an observational study, n = 44. The CHRT-SR12 and self-report measures of hopelessness, depression, and positive psychological states were administered during admission and several times post-discharge. Both versions showed good internal consistency in inpatients and confirmed the three-factor structure (i.e., hopelessness, perceived lack of social support and active suicidal ideation and plans) found in outpatients. CHRT-SR scores had strong correlations with negative and positive affective constructs in the expected directions, and indicated decreases in suicide risk following discharge, in line with clinical expectations. The CHRT-SR12 and CHRT-SR7 are promising self-report measures for assessing suicide risk in very high-risk patient populations.

국내 심리치료 무선통제연구: 학회지 및 기간별 분석을 통한 체계적 고찰

무선통제연구 결과는 심리치료가 실제로 목표한 효과를 이끄는지 심리치료와 효과 간의 인과적 해석을 하는데 표준기준이 된다. 이에 무선통제연구결과는 심리치료의 효과성을 검증하는 기초 자료로 활용될 뿐 아니라, 공공정신건강 영역에서 효과적인 심리치료 서비스를 선별하는데 주요 지침이 된다. 본 연구는 국내에 보고된 심리치료 무선통제 연구를 학회지와 기간별(1983-2003, 2004-2006, 2007-2011, 2012- 2015)로 체계적으로 리뷰하고, ‘심리치료 무선통제연구의 질적 평가 척도’(Randomized Controlled Trial of Psychotherapy Quality Rating Scale, RCT-PQRS)를 사용하여 무선할당연구의 질을 평정하였다. 최종적으로 91편의 무선할당 연구가 본 연구에 포함되었으며, 무선통제연구를 적어도 5편 이상 출간한 ‘한국동서정신과학회지’, ‘한국심리학회지: 건강’, ‘한국심리학회지: 상담 및 심리치료’, ‘Korean Journal of Clinical Psychology’가 국내에서 심리치료 무선할당 연구를 보고한 주요 학술지로 선정되었다. 학회지와 기간별로 무선통제연구의 특성(예, 연구 참가자 특성, 심리치료 특성)과 질을 분석한 결과, 국내 심리치료 무선통제연구의 특성은 대부분 기간별로 차이를 보이지 않았다. 그러나 국내 심리치료 무선통제연구는 학회지별로 출판시기, 연구 참가자의 진단 여부와 진단 범주, 처치집단과 비교집단에 대한 처치의종류, 비교집단의 특성에서 모두 차이를 나타냈다. 또한 '한국심리학회'에서 출판된 연구들은 그렇지 않은 학회지의 연구보다 무선통제연구의 질이 더 높았다. 그리고 국내 심리치료 무선통제연구의 전반적인 질은 기간이 지남에 따라 상승하는 것으로 나타났다. 마지막으로 국내 심리치료 연구 결과를 게재하는 주요 학회지와 심리치료 연구자들이 앞으로 고려해야할 사항들을 제시하였으며, 임상가 및 공공 정신건강 정책 관련 전문가들에게 효과적인 심리치료 서비스에 대한 양질의 정보를 제공할 수 있는 방안에 대해서 논의하였다.

Psychological interventions for coronary heart disease.

Psychological interventions can form part of comprehensive cardiac rehabilitation programmes (CCR). These interventions may include stress management interventions, which aim to reduce stress, either as an end in itself or to reduce risk for further cardiac events in patients with heart disease.To determine the effectiveness of psychological interventions, in particular stress management interventions, on mortality and morbidity, psychological measures, quality of life, and modifiable cardiac risk factors, in patients with coronary heart disease (CHD).We searched CCTR to December 2001 (Issue 4, 2001), MEDLINE 1999 to December 2001 and EMBASE 1998 to the end of 2001, PsychINFO and CINAHL to December 2001. In addition, searches of reference lists of papers were made and expert advice was sought.RCTs of non-pharmacological psychological interventions, administered by trained staff, either single modality interventions or a part of CCR with minimum follow up of 6 months. Adults of all ages with CHD (prior myocardial infarction, coronary artery bypass graft or percutaneous transluminal coronary angioplasty, angina pectoris or coronary artery disease defined by angiography). Stress management (SM) trials were identified and reported in combination with other psychological interventions and separately.Studies were selected, and data were abstracted, independently by two reviewers. Authors were contacted where possible to obtain missing information.Thirty six trials with 12,841 patients were included. Of these, 18 (5242 patients) were SM trials. Quality of many trials was poor with the majority not reporting adequate concealment of allocation, and only 6 blinded outcome assessors. Combining the results of all trials showed no strong evidence of effect on total or cardiac mortality, or revascularisation. There was a reduction in the number of non-fatal reinfarctions in the intervention group (OR 0.78 (0.67, 0.90), but the two largest trials (with 4809 patients randomized) were null for this outcome, and there was statistical evidence of publication bias. Similar results were seen for the SM subgroup of trials. Provision of any psychological intervention or SM intervention caused small reductions in anxiety and depression. Few trials reported modifiable cardiac risk factors or quality of life.Overall psychological interventions showed no evidence of effect on total or cardiac mortality, but did show small reductions in anxiety and depression in patients with CHD. Similar results were seen for SM interventions when considered separately. However, the poor quality of trials, considerable heterogeneity observed between trials and evidence of significant publication bias make the pooled finding of a reduction in non-fatal myocardial infarction insecure.

Commentary: Distillation and element-based design of psychological treatments in global mental health - a commentary on Brown etal. (2017).

This commentary reflects on the "elements" approach in psychological treatment research, and its specific application to a systematic review of psychosocial interventions for youth in conflict-affected areas. We discuss three key questions for the field. First, what psychological treatment elements are necessary and/or sufficient to achieve clinically significant change for a given population? Second, how should elements be sequenced to achieve optimal outcomes? Third, what might account for the large heterogeneity observed in psychological treatment trials, other than the constituent practice elements? We conclude by describing a new research programme that aims to develop a transdiagnostic intervention targeting common mental health difficulties among school-going adolescents in India. The initial experience of this programme affirms the utility of aligning an elements approach with contextually-sensitive formative research.

Quantitative and Qualitative Research in HSDD: The Difference Between Testing Theory and Generating New Theories

Tiefer (2017) criticized our recent analysis of psychological treatment trials for HSDD (Pyke & Clayton, 2015) on what she claims to be scientific and “political” grounds. In the same letter, she alleged that we, and, by extension, the U.S. Food and Drug Administration, promoted drugs to the detriment of psychological treatment of female sexual problems. Such accusations require a serious response.

Omitted data in randomized controlled trials for anxiety and depression: A systematic review of the inclusion of sexual orientation and gender identity.

The current study examined the frequency with which randomized controlled trials (RCTs) of behavioral and psychological interventions for anxiety and depression include data pertaining to participant sexual orientation and nonbinary gender identities. Using systematic review methodology, the databases PubMed and PsycINFO were searched to identify RCTs published in 2004, 2009, and 2014. Random selections of 400 articles per database per year (2,400 articles in total) were considered for inclusion in the review. Articles meeting inclusion criteria were read and coded by the research team to identify whether the trial reported data pertaining to participant sexual orientation and nonbinary gender identities. Additional trial characteristics were also identified and indexed in our database (e.g., sample size, funding source). Of the 232 articles meeting inclusion criteria, only 1 reported participants' sexual orientation, and zero articles included nonbinary gender identities. A total of 52,769 participants were represented in the trials, 93 of which were conducted in the United States, and 43 acknowledged the National Institutes of Health as a source of funding. Despite known mental health disparities on the basis of sexual orientation and nonbinary gender identification, researchers evaluating interventions for anxiety and depression are not reporting on these important demographic characteristics. Reporting practices must change to ensure that our interventions generalize to lesbian, gay, bisexual, and transgender persons. (PsycINFO Database Record

Quality of life trajectories after diagnosis of gynecologic cancer: a theoretically based approach.

The course of quality of life after diagnosis of gynecologic cancer is not well understood. We aimed to identify subgroups of gynecologic cancer patients with distinct trajectories of quality of life outcomes in the 18-month period after diagnosis. We also aimed to determine whether these subgroups could be distinguished by predictors derived from Social-Cognitive Processing Theory. Gynecologic cancer patients randomized to usual care as part of a psychological intervention trial (NCT01951807) reported on depressed mood, quality of life, and physical impairment soon after diagnosis and at five additional assessments ending 18months after baseline. Clinical, demographic, and psychosocial predictors were assessed at baseline, and additional clinical factors were assessed between 6 and 18months after baseline. A two-group growth mixture model provided the best and most interpretable fit to the data for all three outcomes. One class revealed subclinical and improving scores for mood, quality of life, and physical function across 18months. A second class represented approximately 12% of patients with persisting depression, diminished quality of life, and greater physical disability. Membership of this high-risk subgroup was associated with holding back concerns, more intrusive thoughts, and use of pain medications at the baseline assessment (ps<.05). Trajectories of quality of life outcomes were identified in the 18-month period after diagnosis of gynecologic cancer. Potentially modifiable psychosocial risk factors were identified that can have implications for preventing quality of life disruptions and treating impaired quality of life in future research.

Effective psychological and psychosocial approaches to reduce repetition of self-harm: a systematic review, meta-analysis and meta-regression.

ObjectiveTo examine the efficacy of psychological and psychosocial interventions for reductions in repeated self-harm.DesignWe conducted a systematic review, meta-analysis and meta-regression to examine the efficacy of psychological and psychosocial interventions to reduce repeat self-harm in adults. We included a sensitivity analysis of studies with a low risk of bias for the meta-analysis. For the meta-regression, we examined whether the type, intensity (primary analyses) and other components of intervention or methodology (secondary analyses) modified the overall intervention effect.Data sourcesA comprehensive search of MEDLINE, PsycInfo and EMBASE (from 1999 to June 2016) was performed.Eligibility criteria for selecting studiesRandomised controlled trials of psychological and psychosocial interventions for adult self-harm patients.ResultsForty-five trials were included with data available from 36 (7354 participants) for the primary analysis. Meta-analysis showed a significant benefit of all psychological and psychosocial interventions combined (risk ratio 0.84; 95% CI 0.74 to 0.96; number needed to treat=33); however, sensitivity analyses showed that this benefit was non-significant when restricted to a limited number of high-quality studies. Meta-regression showed that the type of intervention did not modify the treatment effects.ConclusionsConsideration of a psychological or psychosocial intervention over and above treatment as usual is worthwhile; with the public health benefits of ensuring that this practice is widely adopted potentially worth the investment. However, the specific type and nature of the intervention that should be delivered is not yet clear. Cognitive–behavioural therapy or interventions with an interpersonal focus and targeted on the precipitants to self-harm may be the best candidates on the current evidence. Further research is required.

Cognitive behavioral therapy program for cannabis use cessation in first-episode psychosis patients: study protocol for a randomized controlled trial.

BackgroundThe high rate of cannabis use among patients with first-episode psychosis (FEP), as well as the associated negative impact on illness course and treatment outcomes, underlines the need for effective interventions in these populations. However, to date, there have been few clinical treatment trials (of pharmacological or psychological interventions) that have specifically focused on addressing comorbid cannabis use among these patients. The aim of this paper is to describe the design of a study protocol for a randomized controlled trial in which the objective is to assess the efficacy of a specific cognitive behavioral therapy program for cannabis cessation in patients with FEP compared to standard treatment (psychoeducation).Methods/designThis is a single-blind randomized study with 1 year of follow-up. Patients are to be randomly assigned to one of two treatments: (1) specific cognitive behavioral therapy for cannabis cessation composed of 1-hour sessions once a week for 16 weeks, in addition to pharmacological treatment scheduled by the psychiatrist, or (2) a control group (psychoeducation + pharmacological treatment) following the same format as the experimental group. Participants in both groups will be evaluated at baseline (pre-treatment), at 16 weeks (post-treatment), and at 3 and 6 months and 1 year of follow-up. The primary outcome will be that patients in the experimental group will have greater cannabis cessation than patients in the control group at post-treatment. The secondary outcome will be that the experimental group will have better clinical and functional outcomes than the control group.DiscussionThis study provides the description of a clinical trial design based on specific cognitive behavioral therapy for cannabis cessation in FEP patients, aiming to improve clinical and functional outcome, as well as tackling the addictive disorder.Trial registrationNCT02319746 ClinicalTrials.gov Identifier. ClinicalTrials.gov Protocol and Results Registration System (PRS) Receipt Release Date: 15 December 2014.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1507-x) contains supplementary material, which is available to authorized users.

Associations between personality disorder characteristics and treatment outcomes in people with co-occurring alcohol misuse and depression.

BackgroundPersonality disorders are highly comorbid with alcohol misuse and depressive symptomatology; however, few studies have investigated treatment outcomes in this population. The aim of this study was to examine relationships between baseline personality disorder cluster profiles and overall and treatment-related changes for those with co-occurring alcohol misuse and depression.MethodsSecondary analysis was conducted using a subset of data (N = 290) from two randomised controlled trials of psychological interventions for co-occurring alcohol misuse and depression, which did not specifically target personality disorders. Baseline dimensional personality disorder cluster scores were derived from the International Personality Disorder Examination Questionnaire (IPDEQ). Four treatment conditions were compared: a brief integrated intervention, followed by no further treatment, or nine further sessions of integrated-, alcohol-, or depression-focused treatment. Associations between IPDEQ scores and changes in alcohol use, depressive symptoms and functioning from baseline to the 6- and the 12-month follow-ups were of primary interest.ResultsPersonality disorder cluster scores moderately negatively impacted on overall change (primarily Cluster C), as well as treatment-related outcomes (primarily Cluster A), particularly changes in depressive symptoms and psychosocial functioning. Longer interventions appeared to be more effective in the longer-term (e.g., at 12-month follow-up), with integrated interventions relatively more effective than single-focused ones for individuals with higher personality disorder cluster scores.ConclusionsGreater attention needs to be paid to particular personality disorder clusters during the assessment and treatment of individuals with co-occurring alcohol misuse and depression. Integrated interventions, incorporating motivational interviewing and cognitive behaviour therapy, may provide a useful therapeutic framework. Integrated interventions also provide opportunities for adjunctive components focussing on other issues and coping strategies (e.g., to offset negative affective states), potentially tailored to the characteristics and needs of individual participants.

Psychological and Behavioral Interventions for Managing Insomnia Disorder: An Evidence Report for a Clinical Practice Guideline by the American College of Physicians

Psychological and behavioral interventions are frequently used for insomnia disorder. To assess benefits and harms of psychological and behavioral interventions for insomnia disorder in adults. Ovid MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, and PsycINFO through September 2015, supplemented with hand-searching. Randomized, controlled trials of psychological or behavioral interventions that were published in English and enrolled adults with insomnia disorder lasting 4 or more weeks. Data extraction by single investigator confirmed by a second reviewer; dual investigator assessment of risk of bias; consensus determination of strength of evidence. Sixty trials with low to moderate risk of bias compared psychological and behavioral interventions with inactive controls or other psychological and behavioral interventions. Cognitive behavioral therapy for insomnia (CBT-I) improved posttreatment global and most sleep outcomes, often compared with information or waitlist controls (moderate-strength evidence). Use of CBT-I improved several sleep outcomes in older adults (low- to moderate-strength evidence). Multicomponent behavioral therapy improved several sleep outcomes in older adults (low- to moderate-strength evidence). Stimulus control improved 1 or 2 sleep outcomes (low-strength evidence). Evidence for other comparisons and for harms was insufficient to permit conclusions. A wide variety of comparisons limited the ability to pool data. Trials did not always report global outcomes and infrequently conducted remitter or responder analysis. Comparisons were often information or waitlist groups, and publication bias was possible. Use of CBT-I improves most outcomes compared with inactive controls. Multicomponent behavioral therapy and stimulus control may improve some sleep outcomes. Evidence on other outcomes, comparisons, and long-term efficacy were limited. Agency for Healthcare Research and Quality. ( CRD42014009908).

Dimensions of dependence and their influence on the outcome of cognitive behaviour therapy for health anxiety: randomized controlled trial.

The personality trait of dependence is common in health-seeking behaviour. We therefore examined its impact in a large randomized controlled trial of psychological treatment for health anxiety. To test whether dependent personality traits were positive or negative in determining the outcome of an adapted form of cognitive behaviour therapy for health anxiety (CBT-HA) over the course of 5 years and whether dependent personality dysfunction could be viewed dimensionally in a similar way to the new ICD-11 diagnostic system for general personality disorder. Dependent personality dysfunction was assessed using a self-rated questionnaire, the Dependent Personality Questionnaire, at baseline in a randomized controlled trial of 444 patients from medical clinics with pathological health anxiety treated with a modified form of CBT-HA or standard treatment in the medical clinics, with assessment on five occasions over 5 years. Dependent personality dysfunction was assessed using four severity groups. Patients with mild and moderate dependent personality disorder treated with CBT-HA showed the greatest reduction in health anxiety compared with standard care, and those with no dependent dysfunction showed the least benefit. Patients with higher dependent traits received significantly more treatment sessions (8.6) than those with low trait levels (5.4) (p < 0.01). The results suggest that patients treated with cognitive behaviour therapy for health anxiety respond better if they have moderate dependent personality. The reasons for this may be related to better adherence to psychological treatment and greater negative effects of frequent reassurance and excessive consultation in those treated in standard care. Copyright © 2016 John Wiley & Sons, Ltd.