Trial Of Cognitive Behavioral Therapy Research Articles

Sleeping for two: a randomized controlled trial of cognitive behavioral therapy for insomnia in pregnancy.

Insomnia and sleep problems are common in pregnancy and have potentially negative impacts on both parental and infant health. This study examined the sleeping for two adaptation of cognitive behavioral therapy for insomnia (CBT-I) in pregnancy. A parallel (1:1) randomized controlled trial evaluated CBT-I (n=32) compared to a treatment as usual (TAU) waitlist (n=32) among pregnant individuals from Alberta, Canada experiencing insomnia. Five weekly individual sessions of CBT-I pivoted from in-person delivery to telehealth due to COVID-19 pandemic physical distancing regulations. Insomnia symptom severity (primary outcome), insomnia diagnosis by structured interview, self-reported sleep problems, as well as sleep parameters measured by diary and actigraphy, were assessed pre-treatment at 12-28 weeks gestation (T1), one-week post-treatment (T2), and six months postpartum (T3). Birth information (secondary outcomes) were collected via delivery record and parent report of infant sleep (exploratory outcome) was taken at T3. Multilevel modeling using an intention-to-treat approach showed that CBT-I was associated with a decrease in insomnia symptoms and improved sleep quality across time compared to TAU. The CBT-I group had fewer diagnoses of insomnia post-treatment, but the difference did not reach statistical significance until 6-months postpartum. Participants with worse sleep quality at baseline benefitted substantially more from CBT-I vs. TAU waitlist. CBT-I delivered in pregnancy can reduce symptoms of insomnia and improve sleep quality, which could in turn minimize risk of negative consequences for birthing parent and infant health. Registry: ClinicalTrials.gov; Identifier: NCT03918057; Name: Sleeping for Two: RCT of CBT-Insomnia in Pregnancy; URL: https://www.clinicaltrials.gov/study/NCT03301727.

Sleeping for two: A randomized controlled trial of cognitive behavioural therapy for insomnia (CBT[sbnd]I) delivered in pregnancy and secondary impacts on symptoms of postpartum depression

BackgroundInsomnia in pregnancy is common and highly comorbid with depression. ObjectiveTo investigate if: 1) depressive symptoms decrease after cognitive behavioural therapy for insomnia (CBTI) delivered in pregnancy, and 2) changes in insomnia symptoms represent a mechanism linking CBT-I treatment and reduced symptoms of postpartum depression. MethodsA two-arm, single-blind, parallel groups randomized controlled trial (RCT) design was used to evaluate the impact of a 5-week CBT-I intervention adapted for pregnant people with insomnia (N = 62). Participants were eligible if they were pregnant, between 12 and 28 weeks gestation, and met diagnostic criteria for insomnia. Participants completed questionnaires assessing symptoms of insomnia and depression pre-intervention (T1), post-intervention (T2), and six months postpartum (T3). A path analysis model was used to test direct and indirect effects simultaneously. ResultsThere was a significant direct effect of CBT-I on postpartum depressive symptoms at T3. Additionally, significant indirect treatment effects on depressive symptoms at T3 emerged, through depressive symptoms at T2 and through improvements in insomnia that persisted from T2 to T3. LimitationsLimitations to the current study include limited generalizability, the non-depressed sample, and variability in treatment and assessment delivery (in-person vs. online). ConclusionsCBT-I treatment in pregnancy may indirectly reduce postpartum depressive symptoms, through sustained improvements in insomnia symptoms.

S22 - Results of Pilot Randomized Controlled Trial of Cognitive Behavioral Therapy for Insomnia to Reduce Cannabis Use

S22 - Results of Pilot Randomized Controlled Trial of Cognitive Behavioral Therapy for Insomnia to Reduce Cannabis Use

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.

An exploration into the relationship between insomnia and repetitive negative thinking among cancer survivors

Objective Insomnia and repetitive negative thinking (RNT) are both prevalent among cancer survivors, yet little work has investigated their interrelationship. To explore the hypothesis that RNT and insomnia are related, we conducted secondary analyses on data from a pilot clinical trial of cognitive behavioral therapy for insomnia (CBT-I) for cancer survivors. Methods This study analyzed survey data from 40 cancer survivors with insomnia who participated in a pilot randomized trial of CBT-I. Correlations and linear regression models were used to determine associations between aspects of RNT and related constructs (fear of cancer recurrence [FCR], cancer-specific rumination, worry, and intolerance of uncertainty) and sleep (insomnia and sleep quality), while accounting for psychiatric symptoms such as anxiety and depression. Treatment-related change in RNT was examined using a series of linear mixed models. Results Evidence for an association between RNT and insomnia among cancer survivors emerged. Higher levels of FCR and cancer-related rumination were correlated with more severe insomnia symptoms and worse sleep quality. Notably, FCR levels predicted insomnia, even after controlling for anxiety and depression. Results identified potential benefits and limitations of CBT-I in addressing RNT that should be examined more thoroughly in future research. Conclusions RNT is a potential target to consider in insomnia treatment for cancer survivors.

Preventing postpartum insomnia: findings from a three-arm randomized-controlled trial of cognitive behavioral 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 three-arm randomized-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 randomized 1:1:1 to: (1) a responsive bassinet (RB) designed to support infant sleep and reduce maternal sleep disruption until 6 months postpartum, (2) therapist-assisted cognitive behavioral therapy for insomnia (CBT-I) delivered during pregnancy and postpartum, or (3) 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. One hundred and twenty-seven participants (age M ± SD = 32.62 ± 3.49) were randomized (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 well-being, postpartum depression, and maternal postpartum sleep duration. The Study for Mother-Infant Sleep (The SMILE Project): reducing postpartum insomnia using an infant sleep intervention and a maternal sleep intervention in first-time mothers. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377927, Australian New Zealand Clinical Trials Registry: ACTRN12619001166167.

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.

People 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.

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.

“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.

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.