Trial Of Cognitive Behavioral Therapy Research Articles

Brain activity during reappraisal and associations with psychotherapy response in social anxiety and major depression: a randomized trial.

Cognitive behavioral therapy (CBT) is an effective treatment for patients with social anxiety disorder (SAD) or major depressive disorder (MDD), yet there is variability in clinical improvement. Though prior research suggests pre-treatment engagement of brain regions supporting cognitive reappraisal (e.g. dorsolateral prefrontal cortex [dlPFC]) foretells CBT response in SAD, it remains unknown if this extends to MDD or is specific to CBT. The current study examined associations between pre-treatment neural activity during reappraisal and clinical improvement in patients with SAD or MDD following a trial of CBT or supportive therapy (ST), a common-factors comparator arm. Participants were 75 treatment-seeking patients with SAD (n = 34) or MDD (n = 41) randomized to CBT (n = 40) or ST (n = 35). Before randomization, patients completed a cognitive reappraisal task during functional magnetic resonance imaging. Additionally, patients completed clinician-administered symptom measures and a self-report cognitive reappraisal measure before treatment and every 2 weeks throughout treatment. Results indicated that pre-treatment neural activity during reappraisal differentially predicted CBT and ST response. Specifically, greater trajectories of symptom improvement throughout treatment were associated with less ventrolateral prefrontal cortex (vlPFC) activity for CBT patients, but more vlPFC activity for ST patients. Also, less baseline dlPFC activity corresponded with greater trajectories of self-reported reappraisal improvement, regardless of treatment arm. If replicated, findings suggest individual differences in brain response during reappraisal may be transdiagnostically associated with treatment-dependent improvement in symptom severity, but improvement in subjective reappraisal following psychotherapy, more broadly.

Preventing postpartum insomnia: findings from a three-arm randomised controlled trial of Cognitive Behavioural Therapy for Insomnia, a responsive bassinet, and sleep hygiene.

Insomnia symptoms are common during the perinatal period and are linked to adverse outcomes. This single-blind 3-arm randomised controlled trial examined whether two interventions targeting different mechanisms prevent postpartum insomnia. Participants were nulliparous females 26-32 weeks gestation with Insomnia Severity Index (ISI) scores≥8, recruited in Australia and randomised 1:1:1 to: (a) a responsive bassinet designed to support infant sleep and reduce maternal sleep disruption until 6 months postpartum (RB), (b) therapist-assisted cognitive behavioural therapy for insomnia (CBT-I) delivered during pregnancy and postpartum, or (c) a sleep hygiene booklet (control; CTRL). Outcomes were assessed at baseline (T1), 35-36 weeks gestation (T2), and 2, 6, and 12 months postpartum (T3-T5). The primary outcome was ISI scores averaged T3-T5. Primary analyses were regressions controlling for baseline outcomes. 127 participants (age M±SD=32.62±3.49) were randomised (RB=44, CBT-I=42, CTRL= 41). Both interventions were feasible and well-accepted, with few related adverse events reported. Compared to CTRL, the average ISI across T3-T5 was lower for CBT-I (p=.014, effect size [ES]=0.56, medium) but not RB (p=.270, ES=0.25, small). Exploratory findings on maternal insomnia diagnosis, sleep disturbance, sleep-related impairment, beliefs and attitudes about sleep, depression, anxiety, as well as infant sleep outcomes were also presented. CBT-I but not RB reduced prenatal insomnia (very large effect) and prevented postpartum insomnia (medium effect). Further research is needed to examine the effects of both CBT-I and RB on other outcomes such as sleep-related wellbeing, postpartum depression, and maternal postpartum sleep duration.

Imagery-Focused Therapy for Visual Hallucinations: A Case Series.

Visual hallucinations (VH) are more common than previously thought and are linked to higher levels of distress and disability in people with a psychotic illness. Despite this, scant attention has been given to VHs in the clinical literature, and the few therapy case series of cognitive behavioural therapy (CBT) published to date have not demonstrated reliable change. In other areas of clinical research, problematic mental imagery has been found to be more strongly related to negative affect in psychological disorders than negative linguistic thinking, and imagery focused techniques have commonly been found to improve the outcomes in CBT trials. Given VHs have many similarities with visual mental imagery and many of the distressing beliefs associated with VHs targeted in CBT are maintained by accompanying mental imagery (i.e., imaging a hallucinated figure attacking them), it seems plausible that an imagery-focused approach to treating VHs may be most effective. The current study is a multiple baseline case series (N = 11) of a 10-session imagery-focused therapy for VH in a transdiagnostic sample. The study had good attendance and feedback, no adverse events and only one [seemly unrelated] drop-out, suggesting good feasibility, safety and acceptability. The majority of clients reported reduction on both full-scale measures (administered at 3 baselines, midtherapy, posttherapy and 3-month follow-up) and weekly measures of VH severity and distress, ranging from medium to large effect sizes. The case series suggests that an imagery-focused approach to treating VHs may be beneficial, with a recommendation for more rigorous clinical trials to follow.

Predicting response to a smartphone-based cognitive-behavioral therapy for body dysmorphic disorder

BackgroundBody dysmorphic disorder (BDD) is a severe, chronic disorder if untreated. Smartphone cognitive behavioral therapy (CBT) for BDD is efficacious and can reduce key treatment barriers (e.g., lack of clinicians, cost, stigma). While promising, little is known about who is more or less likely to benefit from this approach. MethodsThis is a secondary data analysis of a randomized, waitlist-controlled trial of smartphone CBT for BDD. Participants (N = 80) were recruited nationally and randomized to receive a 12-week, coach-guided CBT for BDD app, either immediately or after a 12-week waitlist. The main outcome for this analysis was BDD severity (BDD-YBOCS) over time (baseline, week 6, week 12) during the active app use phase in each randomized group (n = 74). Secondary outcomes included treatment response (≥30 % reduction in BDD-YBOCS) and remission (total BDD-YBOCS ≤16) at end-of-treatment. ResultsImmediate (vs. delayed) CBT predicted better outcomes (symptom improvement), as did gender identity (symptom improvement), higher baseline treatment credibility and expectancy (response, remission), lower baseline BDD severity (remission), and sexual minority status (vs. heterosexual; response, remission). LimitationsLimitations include the relatively small sample, drop-out rate of 22 %, and limited gender and racial-ethnic diversity. ConclusionsThese results highlight a potential advantage of smartphone CBT in historically marginalized populations, and the importance of efforts to hasten treatment access, bolster confidence in the treatment at treatment onset, and develop stratified care models to optimize treatment allocation and efficacy.

Neural correlates of drinking reduction during a clinical trial of cognitive behavioral therapy for alcohol use disorder.

Cognitive behavioral therapy (CBT) is an effective treatment for alcohol use disorder (AUD). We hypothesized that the dorsolateral prefrontal cortex (DLPFC), a region implicated in cognitive control and goal-directed behavior, plays a role in behavior change during CBT by facilitating the regulation of craving (ROC). Treatment-seeking participants with AUD (N = 22) underwent functional magnetic resonance imaging (fMRI) scanning both before and after a 12-week, single-arm trial of CBT, using an ROC task that was previously shown to engage the DLPFC. We found that both the percentage of heavy drinking days (PHDD) and the overall self-reported alcohol craving measured during the ROC task were significantly reduced from pre- to post-CBT. However, we did not find significant changes over time in either the ability to regulate craving or regulation-related activity in any brain region. We found a significant 3-way interaction between the effects of cue-induced craving, cue-induced brain activity and timepoint of assessment (pre- or post-CBT) on PHDD in the left DLPFC. Follow-up analysis showed that cue-induced craving was associated with cue-induced activity in the left DLPFC among participants who ceased heavy drinking during CBT, both at pre-CBT and post-CBT timepoints. No such associations were present at either timepoint among participants who continued to drink heavily. These results suggest that patients in whom DLPFC functioning is more strongly related to cue-induced craving may preferentially respond to CBT.

In-person cognitive behavioural therapy vs. usual care after surgical management of extremity fractures: an unsuccessful feasibility trial

BackgroundExtremity fractures are common, and most are managed operatively; however, despite successful reduction, up to half of patients report persistent post-surgical pain. Furthermore, psychological factors such as stress, distress, anxiety, depression, catastrophizing, and fear-avoidance behaviors have been associated with the development of chronic pain. The purpose of this pilot study was to examine the feasibility of a randomized controlled trial to determine the effect of in-person cognitive behavioral therapy (CBT) vs. usual care on persistent post-surgical pain among patients with a surgically managed extremity fracture.MethodsEligible patients were randomized to either in-person CBT or usual care. We used four criteria to judge the composite measure of feasibility: 1) successful implementation of CBT at each clinical site, 2) 40 patients recruited within 6 months, 3) treatment compliance in a minimum 36 of 40 participants (90%), and 4) 32 of 40 participants (80%) achieving follow-up at one year. The primary clinical outcome was persistent post-surgical pain at one year after surgery.ResultsOnly two of the four participating sites were able to implement the CBT regimen due to difficulties with identifying certified therapists who had the capacity to accommodate additional patients into their schedule within the required timeframe (i.e., 8 weeks of their fracture). Given the challenges associated with CBT implementation, only one site was able to actively recruit patients. This site screened 86 patients and enrolled 3 patients (3.5%) over a period of three months. Participants were unable to comply with the in-person CBT, with no participants attending an in-person CBT session. Follow-up at one year could not be assessed as the pilot study was stopped early, three months into the study, due to failure to achieve the other three feasibility criteria.ConclusionOur pilot trial failed to demonstrate the feasibility of a trial of in-person CBT versus usual care to prevent persistent pain after surgical repair of traumatic long-bone fractures and re-enforces the importance of establishing feasibility before embarking on definitive trials. Protocol modifications to address the identified barriers include the delivery of our intervention as a therapist-guided, remote CBT program.Trial registrationClinicalTrials.gov (Identifier NCT03196258); Registered June 22, 2017, https://clinicaltrials.gov/ct2/show/NCT03196258

Emotion differentiation among individuals in a randomized clinical trial for alcohol use disorder: Within- and between-person associations with affect, craving, and alcohol use in daily life

Emotion differentiation refers to cognitively distinguishing among discrete, same-valenced emotions. Negative emotion differentiation (NED) is a transdiagnostic indicator of emotional functioning. The role of positive emotion differentiation (PED) in clinical disorders, including alcohol use disorder (AUD), is less understood. Further, despite consensus that emotions are highly variable, little is known about within-person fluctuations in NED/PED. The current study leveraged 84 consecutive daily smartphone surveys from participants (N = 181) in a clinical trial of cognitive behavioral therapy for AUD to investigate whether between-person differences in overall NED/PED, or within-person variability in daily NED/PED, were associated with affect intensity, craving, drinking, and heavy drinking in daily life. Subsequent analyses explored whether associations were moderated by baseline alexithymia. At the between-persons level, greater average PED, but not NED, was associated with lower heavy drinking odds. At the within-persons level, higher-than-usual PED was associated with lower negative affect and odds of any drinking. Individuals with baseline alexithymia had stronger negative within-person associations between daily NED and both any and heavy drinking. PED is a skill linked to less alcohol use between- and within-persons irrespective of baseline alexithymia, whereas greater daily NED appears especially important for reduced alcohol use among individuals with co-morbid AUD and alexithymia.

Program ACTIVE II: 6- and 12-month outcomes of a treatment approach for major depressive disorder in adults with type 2 diabetes

AimsTo evaluate the long-term effects of behavioral treatments on glycemic and psychological outcomes for patients with major depressive disorder (MDD) and type 2 diabetes (T2D). MethodsProgram ACTIVE II was a multicenter randomized controlled comparative effectiveness trial of cognitive behavioral therapy (CBT), exercise (EXER), combination treatment (CBT + EXER) and usual care (UC) for adults with MDD and T2D. ResultsPrimary outcomes: change in A1c and depressive symptoms at 6- (N = 87) and 12-months (N = 75) from baseline. In those with a baseline A1c ≥7.0 %, CBT + EXER showed lasting A1c benefit at 6- (−1.2 %; SE: 0.6; p = 0.032) and 12-months (−1.4 %; SE: 0.6; p = 0.025) compared to UC. All groups had clinically significant improvements in depressive symptoms. At 6 months, CBT + EXER had significant improvements in diabetes-related distress regimen burden (p = 0.005); and social support (CIRS, p = 0.043) compared to UC. ConclusionsThe Program ACTIVE II CBT + EXER intervention demonstrated a sustained improvement in A1c for a subgroup of study participants with a baseline A1c ≥7.0 %. However, this finding should be considered preliminary because of small sample size. All 3 behavioral intervention groups demonstrated improvements in psychosocial outcomes one-year post-intervention. These findings point to the enduring benefits of community-based interventions to extend the availability of depression treatment for T2D patients.

Can peripheral psychophysiological markers predict response to exposure-based cognitive behavioral therapy in youth with severely impairing irritability? A study protocol

BackgroundIrritability, an increased proneness to anger, is a primary reason youth present for psychiatric care. While initial evidence supports the efficacy of exposure-based cognitive behavioral therapy (CBT) for youth with clinically impairing irritability, treatment mechanisms remain unclear. Here, we propose to measure peripheral psychophysiological indicators of arousal—heart rate (HR)/electrodermal activity (EDA)—and regulation—heart rate variability (HRV)—during exposures to anger-inducing stimuli as potential predictors of treatment efficacy. The objective of this study is to evaluate whether in-situ biosensing data provides peripheral physiological indicators of in-session response to exposures.MethodsBlood volume pulse (BVP; from which HR and HRV canl be derived) and EDA will be collected ambulatorily using the Empatica EmbracePlus from 40 youth (all genders; ages 8-17) undergoing six in-person exposure treatment sessions, as part of a multiple-baseline trial of exposure-based CBT for clinically impairing irritability. Clinical ratings of irritability will be conducted at baseline, weekly throughout treatment, and at 3-month and 6-month follow-ups via the Clinical Global Impressions Scale (CGI) and the Affective Reactivity Index (ARI; clinician-, parent-, and child-report). Multilevel modeling will be used to assess within- and between-person changes in physiological arousal and regulation throughout exposure-based CBT and to determine whether individual differences are predictive of treatment response.DiscussionThis study protocol leverages a wearable biosensor (Empatica) to continuously record HR/HRV (derived from BVP) and EDA during in-person exposure sessions for youth with clinically impairing irritability. Here, the goal is to identify changes in physiological arousal (EDA, HR) and regulation (HRV) over the course of treatment in tandem with changes in clinical symptoms.Trial registrationThe participants in this study come from an overarching clinical trial (trial registration numbers: NCT02531893 first registered on 8/25/2015; last updated on 8/25/2023). The research project and all related materials were submitted and approved by the appropriate Institutional Review Board of the National Institute of Mental Health (NIMH).

Pulmonary Rehabilitation with and without a Cognitive Behavioral Intervention for Breathlessness in People Living with Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial

(1) Background: Most controlled trials of cognitive behavior therapy (CBT) in people living with chronic obstructive pulmonary disease (COPD) have targeted anxiety and depression. (2) Methods: This pragmatic randomized controlled trial explored whether a comprehensive pulmonary rehabilitation program (CPRP) with CBT for breathlessness or social group control (CPRP + SC) significantly improved health outcomes. (3) Results: People with moderate-to-severe COPD were block randomized (CPRP + CBT n = 52 or CPRP + SC n = 49). Primary outcomes (Hospital Anxiety and Depression scale (HADs), six-minute walk distance (6MWD)) and secondary outcomes (breathlessness, quality of life and habitual physical activity) were assessed before and 1, 6 and 12 months post intervention. Between-group differences were calculated with mixed models for each time point to baseline (intention to treat (ITT)). Participants (n = 101, mean ± SD age 70 ± 8.5 years, 54 (53%) males, FEV1% pred 47.7 ± 16.3) were similar between groups. Post intervention, primary outcomes did not differ significantly between groups at 1 (6MWD mean difference −7.5 [95% CI −34.3 to 19.4], HADs-A −0.3 [−1.4 to 0.9], HADs-D 0.2 [−0.8 to 1.3]), 6 (6MWD −11.5 [−38.1 to 15.1], HADs-A 1.1 [0.0 to 2.2], HADs-D 0.2 [−0.9 to 1.3]), or 12 months (6MWD −3.8 [−27.2 to 19.6], HADS-A −0.4 [−1.5 to 0.6], HADs-D −0.7 [−1.7 to 0.4]). (4) Conclusions: In this cohort, combining CBT with a CPRP did not provide additional health benefits beyond those achieved by a standard CPRP.

Behavioral interventions and symptom cluster change in adults with chronic obstructive pulmonary disease and insomnia

BackgroundPeople with chronic obstructive pulmonary disease (COPD) and insomnia experience multiple co-occurring symptoms, but no studies have examined symptom cluster change over time in this population. ObjectivesThis study explored longitudinal patterns of symptom cluster profiles for adults with COPD and insomnia and evaluated whether behavioral interventions were associated with changes in symptom cluster profiles. MethodsThis study included 91 adults with COPD and insomnia who participated in a randomized trial of cognitive behavioral therapy for insomnia (CBT-I) and COPD education. The pre-specified symptom cluster included insomnia, dyspnea, fatigue, anxiety, and depression. Latent profile analysis identified participant groups with distinct symptom cluster profiles at baseline, immediately post-intervention, and at 3-month follow-up; latent transition analysis then estimated the probability of group membership change over time. Multinomial logistic regression was used to determine whether the interventions were associated with changes in symptom cluster profiles. ResultsThree groups were identified at each of three time-points: Class 1 (low symptom burden), Class 2 (intermediate), and Class 3 (high). Classes 1 and 2 showed less movement to other classes (16 % and 38 %, respectively), whereas Class 3 showed greater transition (64 %). The CBT-I intervention was significantly associated with movement to a lower symptom burden group (Class 3 to 2 or 2 to 1). ConclusionsCBT-I, with or without COPD education, shows promise as a tailored intervention to reduce symptom burden in the study population. Study findings will facilitate development of interventions to reduce the severity of multiple co-occurring symptoms in people with COPD and insomnia. Clinical Trial RegistrationRegistry: ClinicalTrials.gov; Name: A Behavioral Therapy for Insomnia Co-existing with COPD; Identifier: NCT01973647.

Abstract 13353: Sleep Health Phenotypes Predict Symptoms, Cognitive Function, and Adverse Events in Patients With Heart Failure

Introduction: Poor sleep contributes to outcomes in heart failure (HF). Phenotypes reflecting multi-dimensional sleep health may better predict outcomes and support more precise interventions than single measures, but few studies have used this approach. Aims: 1) Describe phenotypes of sleep health and 2) Evaluate whether sleep health phenotypes predict symptoms, cognitive function, and time to first hospitalization and emergency department (ED) visits among HF patients. Methods: We performed secondary analysis of a randomized controlled trial of cognitive behavioral therapy for insomnia compared with HF self-management education with HF patients. We measured sleep [rest-activity rhythms, sleep duration, and efficiency (2-week wrist actigraphy/follow-ups); insomnia; CPAP use; and daytime sleepiness (Epworth Scale)]; perceived stress; fatigue; anxiety; depression; pain; and cognitive ability (Patient-Reported Outcomes Measurement System: PROMIS) at baseline and 3, 6, and 12 months post-intervention and tracked hospitalizations and ED visits. We used K-means clustering to identify sleep phenotypes and generalized linear mixed models and Cox models to predict outcomes, adjusted for demographic factors. Results: Among 166 participants (M age = 63.2 (SD = 12.8) years; 57% female; 23% NYHA Class 3/4 HF; 35% EF less than 45%), there were 4 phenotypes [poor sleep (14%); short sleep/high sleep efficiency (39%); long sleep/low sleep efficiency (25%); and healthy sleep (21%)] at baseline. The healthy sleep group was older and had lower BMIs and less comorbidity and had better outcomes compared to all other phenotypes. In particular, this group had better fatigue (-2.43±0.87), pain (-1.86±1.05), anxiety (-1.50±0.89), stress (-1.46±0.69), and cognitive ability (1.76±0.80) than the poor sleep group. The poor sleep group had shorter time to adverse events compared to the other phenotypes (Hazard ratios of 0.41 to 0.56 for hospitalizations and 0.35 to 0.60 for ED visits). Conclusions: Multidimensional aspects of sleep predict HF outcomes and may improve on prediction with single measures. Future tailored sleep interventions focused on phenotypes may more precisely improve outcomes among HF patients than traditional approaches.

Daytime symptom trajectories among adults with stable heart failure and insomnia: evidence from a randomised controlled trial of cognitive behavioural therapy for insomnia

SummaryPeople with heart failure (HF) experience a high symptom burden and prevalent insomnia. However, little is known about daytime symptom trajectories after cognitive behavioural therapy for insomnia (CBT‐I). In this study we describe: (1) daytime symptom trajectories among adults with insomnia and stable HF over 1 year, (2) how symptom trajectories differ between CBT‐I versus HF self‐management interventions, and (3) associations between demographic, clinical, and sleep characteristics, perceived stress, health‐related quality of life (HRQoL), functional performance and daytime symptoms trajectories. We retrospectively analysed data from a randomised controlled trial of CBT‐I versus HF self‐management (NCT0266038). We measured sleep, perceived stress, HRQoL, and functional performance at baseline and symptoms at baseline, 3, 6, and 12 months. We conducted group‐based trajectory modelling, analysis of variance, chi‐square, and proportional odds models. Among 175 participants (mean [standard deviation] age 63.0 [12.9] years, 57.1% male, 76% White), we found four daytime symptom trajectories: (A) low improving symptoms (38.3%); (B) low psychological symptoms and high improving physical symptoms (22.8%); (C) high improving symptoms (24.0%); and (D) high not improving symptoms (14.9%). The CBT‐I versus the HF self‐management group had higher odds of belonging to Group A compared to other trajectories after controlling for baseline fatigue (odds ratio = 3.27, 95% confidence interval 1.39–7.68). The difference between the CBT‐I and the HF self‐management group was not statistically significant after controlling for baseline characteristics. Group D had the highest body mass index, perceived stress, and insomnia severity and the lowest cognitive ability, HRQoL, and functional performance. Research is needed to further evaluate factors contributing to symptom trajectories.

“Trajectories of treatment response in a cognitive-behavioral therapy intervention for depression and adherence in persons with HIV in South Africa”

BackgroundPeople with HIV (PHW) are at greater risk of depression than the general population. Insight into the time-to-treatment-response and predictors of response to psychotherapy may improve implementation in primary care. MethodsWe assessed depression treatment response among 80 participants in a trial of cognitive-behavioral therapy for adherence and depression (CBT-AD) for PWH with MDD and suboptimal antiretroviral therapy (ART) adherence. Participants self-reported depressive symptoms (CESD) at each therapy session. Clinicians assessed participants' depression (HAMD), along with potential predictors of response, every four months for one year. Latent class analyses examined classes of responders for the active and the post-treatment phases. Regression analyses identified predictors of class membership for each phase. ResultsDuring the active treatment phase (CESD) we identified an early response (at session 2 and with continued trajectory of improvement) and a non-response group. There were also two classes during post-treatment (HAM-D): early responders (4-month) and late responders (12-month). Distress aversion was associated with lower likelihood of early response to CBT-AD (aOR = 0.74, 95%CI[0.56–0.90], p = .009), and social support was associated with increased likelihood of early response (aOR = 2.24, 95%CI[1.07–5.46], p = .045). LimitationsSelf-reported depression during the treatment phase may have resulted from social desirability bias. ConclusionsMost participants responded to CBT-AD early during treatment (89 %) and had sustained improvements in depression by 4 months (80 %). Distress aversion was a risk factor for late response, and social support was protective. Future research is needed to assess the optimal dose of CBT-AD in resource limited settings.

Understanding the Role of Therapist Quality in Accounting for Heterogeneity of Patient Outcomes in Psychosocial Chronic Pain Treatments

A variety of evidence-based psychosocial treatments now exist for chronic pain. However, on average, effect sizes have tended to be modest and there is a high degree of heterogeneity in treatment response. In this focus article, we explore the potential role that therapist quality in delivering treatment may have in accounting for a degree of this variability in outcome. Therapist quality refers to the skillful delivery of treatment, harnessing both specific and common therapeutic factors during sessions. While recognized as important to assess and report in clinical trials by some reporting guidelines, few randomized controlled trials evaluating psychosocial treatments for chronic pain have reported on therapist factors. We reviewed the clinical trials included in three systematic reviews and meta-analyses of trials of cognitive-behavioral therapy (mainly), mindfulness-based interventions, and acceptance and commitment therapy. We found that of the 134 trials included, only nine assessed and reported therapist quality indicators, with a variety of procedures used. This is concerning as without knowledge of the quality in which treatments are delivered, the estimates of effect sizes reported may be misrepresented. We contextualize this finding by drawing on the broader psychotherapy literature which has shown that more skillful, effective therapists demonstrated ten times better patient response rates. Examination of the characteristics associated with these more effective therapists tends to indicate that skillful engagement of common factors in therapy sessions represents a distinguishing feature. We conclude by providing recommendations for assessing and reporting on therapist quality within clinical trials evaluating psychosocial treatments for chronic pain. PerspectiveTherapist quality in the delivery of psychosocial treatments for chronic pain has rarely been assessed in clinical trials. We propose that therapist quality indicators are an under-studied mechanism that potentially contributes to the heterogeneity of treatment outcomes. We provide recommendations for assessing and reporting on therapist quality in future trials.

Study protocol for ELders AT Ease (ELATE): a cluster randomised controlled trial of cognitive behaviour therapy to reduce depressive symptoms in aged care residents

BackgroundThis protocol describes a study of the effectiveness of cognitive behaviour therapy (CBT) for reducing depressive symptoms in older adults living in residential aged care (RAC) facilities in Australia. Depressive symptoms are highly prevalent in this population, yet the benefits of CBT for reducing such symptoms in RAC facilities have not been widely investigated. Elders at Ease (ELATE) is a 16-session CBT intervention designed for implementation in RAC facilities. The intervention includes cognitive, behavioural and reminiscence strategies and is delivered by mental health trainees (MHTs) in collaboration with RAC facility staff and residents’ family.Methods and analysisELATE will be evaluated using a cluster randomised trial comparing outcomes for residents who participate in the intervention with those living in usual care control facilities. The participants are RAC residents aged 65 years or above, with depressive symptoms (Patient Health Questionnaire-2 ≥ 3) and normal cognition or mild cognitive impairment (Standardised Mini Mental Status Examination ≥ 21). They are assessed at four time points: baseline prior to randomisation (T1), mid-treatment (T2; 2.5 months post randomisation), post-treatment (T3; 5 months post-randomisation) and 3-month follow-up (T4; 8 months post randomisation). The primary outcome is change in depressive symptoms between T1 and T3. Secondary outcomes are depressive symptoms at T4, anxiety, suicide ideation, sleep problems, quality of life, staff and family knowledge of late-life depression, stress levels and efficacy in caring for residents, and MHT levels of geropsychology competencies. Residents receiving the intervention are hypothesised to report a greater decrease in depressive symptoms between T1 and T3 compared to residents receiving usual care. The primary analysis is a regression, clustered over site to account for correlated readings, and independent variables are condition and depressive symptoms at T1. A cost-utility analysis is also undertaken.DiscussionELATE is a comprehensive CBT intervention for reducing depressive symptoms in RAC residents. It is designed to be implemented in collaboration with facility staff and residents’ families, individually tailored to residents with normal cognition to mild cognitive impairment and delivered by trainee therapists. ELATE offers a model that may be widely applicable across the RAC sector.Trial registrationTrial registered with the Australian and New Zealand Clinical Trial Registry (ANZCTR) Number ACTRN12619001037190, prospectively registered on 22 July 2019.

Cognitive behavioral therapy for lifestyle changes in patients with obesity and type 2 diabetes: a systematic review and meta-analysis

The aim of this systematic review and meta-analysis was to examine the contribution of cognitive behavioral therapy (CBT) to the implementation of lifestyle changes, considering health-related and behavioral outcomes. A systematic literature review was performed using multiple databases (PsycInfo, PubMed and MEDLINE). The inclusion criteria comprised randomised controlled trials of CBT for lifestyle changes in patients with obesity and/or type 2 diabetes. The quality of study reporting was assessed with the revised Cochrane Collaboration’s risk of bias tool. A meta-analysis was conducted on studies with appropriate outcomes. Nine randomised controlled trials, with a total sample size of 902 participants, met the inclusion criteria. The meta-analysis has shown a medium, significant effect size of CBT interventions for weight loss and weight maintenance, and a low, non-significant effect size of CBT interventions for reducing glycated hemoglobin (HbA1c) levels. A separate, combined, meta-analysis for all nine calculated effect sizes has yielded a medium and significant overall effect size for the model. Our review of the studies about the effectiveness of CBT in implementing lifestyle changes has, in comparison to usual control groups, proven the efficacy of CBT interventions in implementing lifestyle changes, especially for weight loss and weight maintenance.

Costs and Resource Utilization of People with Stable Heart Failure and Insomnia: Evidence from a Randomized Trial of Cognitive Behavioral Therapy for Insomnia

ABSTRACT Objectives Nearly half of patients with chronic heart failure (HF) report insomnia symptoms. The purpose of this study was to examine the impact of CBT-I versus HF self-management on healthcare costs and resource utilization among patients with stable chronic HF who participated in a clinical trial of the effects of CBT-I compared to HF self-management education (attention control) over 1 year. Methods We measured resource utilization as self-reported (medical record review) physician office visits, emergency department visits, and inpatient admissions at 3-month intervals for 1 year after enrollment. Costs were estimated by applying price weights to visits and adding self-reported out-of-pocket and indirect costs. Univariate comparisons were made of resource utilization and costs between CBT-I and the HF self-management group. A generalized linear model (GLM) was used to model costs, controlling for covariates. Results The sample included 150 patients [79 CBT-I; 71 self-management (M age = 62 + 13 years)]. The CBT-I group had 4.2 inpatient hospitalizations vs 4.6 for the self-management group (p = .40). There were 13.1 outpatient visits, in the CBT-I compared with 15.4 outpatient visits (p-value range 0.39–0.81) for the self-management group. Total costs were not significantly different in univariate or ($7,813 CBT-I vs. $7,538 self-management), p = .96) or multivariable analyses. Conclusions Among patients with both HF and insomnia, CBT-I and HF self-management were associated with similar resource utilization and total costs. Additional research is needed to estimate the value of CBT-I relative to usual care and other treatments for insomnia in patients with HF.

Outcomes of People of Color in an Efficacy Trial of Cognitive-Behavioral Treatments for Anxiety, Depression, and Related Disorders: Preliminary Evidence.

Although evidence-based psychological treatments such as cognitive behavioral therapy (CBT) have strong empirical support for reducing anxiety and depression symptoms, CBT outcome research often does not report race and ethnicity variables, or assess how well CBT works for people from historically excluded racial and ethnic groups. This study presents post hoc analyses comparing treatment retention and symptom outcomes for participants of color (n = 43) and White participants (n = 136) from a randomized controlled efficacy trial of CBT. χ2 tests and one-way ANCOVA showed no observable differences between the two samples on attrition or on clinician-rated measures of anxiety and depression at posttreatment and follow-up. Moderate to large within-group effect sizes on anxiety and depression were found for Black, Latinx, and Asian American participants at almost all time points. These preliminary findings suggest that CBT for anxiety and comorbid depression may be efficacious for Black, Asian American, and Latinx individuals.

Trials We Cannot Trust: Investigating Their Impact on Systematic Reviews and Clinical Guidelines in Spinal Pain

We previously conducted an exploration of the trustworthiness of a group of clinical trials of cognitive-behavioral therapy and exercise in spinal pain. We identified multiple concerns in 8 trials, judging them untrustworthy. In this study, we systematically explored the impact of these trials (“index trials”) on results, conclusions, and recommendations of systematic reviews and clinical practice guidelines (CPGs). We conducted forward citation tracking using Google Scholar and the citationchaser tool, searched the Guidelines International Network library and National Institute of Health and Care Excellence archive to June 2022 to identify systematic reviews and CPGs. We explored how index trials impacted their findings. Where reviews presented meta-analyses, we extracted or conducted sensitivity analyses for the outcomes of pain and disability, to explore how the exclusion of index trials affected effect estimates. We developed and applied an ’Impact Index’ to categorize the extent to which index studies impacted their results. We included 32 unique reviews and 10 CPGs. None directly raised concerns regarding the veracity of the trials. Across meta-analyses (55 comparisons), the removal of index trials reduced effect sizes by a median of 58% (Inter Quartlie Range (IQR) 40–74). 85% of comparisons were classified as highly, 3% as moderately, and 11% as minimally impacted. Nine out of 10 reviews conducting narrative synthesis drew positive conclusions regarding the intervention tested. Nine out of 10 CPGs made positive recommendations for the intervention(s) evaluated. This cohort of trials, with concerns regarding trustworthiness, has substantially impacted the results of systematic reviews and guideline recommendations. PerspectiveWe found that a group of trials of CBT for spinal pain with concerns relating to their trustworthiness has had substantial impacts on the analyses and conclusions of systematic reviews and clinical practice guidelines. This highlights the need for a greater focus on the trustworthiness of studies in evidence appraisal. Pre-registrationOur protocol was preregistered on the Open Science Framework: https://osf.io/m92ax/