Trial Of Cognitive Behavioral Therapy Research Articles

Using pupillometry to predict outcome in cognitive behavioral therapy for negative symptoms of schizophrenia.

Clinical trials of cognitive-behavioral therapy (CBT) for negative symptoms of schizophrenia have provided mixed results, perhaps because some patients are more likely to benefit than others. Patients likely to benefit may be those with greater pre-treatment motivation. To better examine the effects of motivation on treatment outcome, more objective measures of motivation are needed. Pupillary responses provide an objective biomarker of cognitive effort and motivation, with greater dilation associated with greater effort and motivation. The current study examined whether pre-treatment baseline pupil dilation predicted motivation and pleasure (MAP) negative symptom reduction in an open clinical trial of CBT for individuals with schizophrenia. Pupil dilation was recorded during the digit-span task at low (3 digits), moderate (6 digits) and high (9 digits) loads in participants with schizophrenia or schizoaffective disorder (N=31) with persistent negative symptoms prior to delivery of mobile-assisted CBT for negative symptoms (mCBTn). Greater pre-treatment pupil dilation during low, but not moderate or high, loads of the digit-span task significantly predicted greater reduction in MAP negative symptoms. However, while MAP negative symptoms improved throughout treatment, pupil dilation did not significantly change throughout treatment for any digit-span loads. Pupil dilation may provide a much-needed prognostic biomarker of patients most likely to benefit from CBT for MAP symptoms, but did not change with change in MAP symptoms.

A Randomized Controlled Trial of Cognitive Behavioral Therapy for Insomnia During Early Recovery from Alcohol Use Disorder Among Veterans.

1) To determine the efficacy of Cognitive Behavioral Therapy for Insomnia (CBT-I) for improving insomnia, alcohol-related outcomes, and daytime functioning at post-treatment and at 3- and 6-month follow-up, in a largely African American Veteran sample; 2) Evaluate whether improvement in insomnia is associated with a reduction in alcohol-related outcomes post-treatment. An RCT of CBT-I (n = 31) compared to Quasi-Desensitization therapy (QDT, n = 32), eight weekly in-person sessions, with assessments at baseline, end of treatment (8 weeks), and 3- and 6-months post-treatment. Primary outcomes were the Insomnia Severity Index (ISI) total score, and Percent Days Abstinent (PDA). Secondary outcomes were sleep diary variables, drinks per day, percentage non-heavy drinking days, Penn Alcohol Craving Scale, PCS and MCS scale (from the SF-12), BDI and STAI-Trait subscale total scores. Post-treatment data were obtained from 88.9% of participants. Although CBT-I improved insomnia with effect sizes (E.S.) larger than the meta-analytic estimates, QDT was equally efficacious in improving insomnia (E.S. = -1.63 vs. -1.50), improving abstinence (E.S. = 1.54 vs. 1.91) and next-day functioning (E.S. = -0.26 vs. -0.17). Across treatment groups, remission from insomnia was associated with a lower post-treatment alcohol craving score (2.79, 95% CI 1.14, 4.44 vs. 9.51, 95% CI 6.06, 12.95 in non-responders), an effect that persisted for 6 months after treatment. CBT-I and QDT are equally effective for treating insomnia during early recovery from AUD. Reduced alcohol craving may be a mechanism by which a remission from insomnia improves drinking outcomes.

Cognitive Behavioral Therapy Reduces Unhelpful Thinking Among People with Musculoskeletal Symptoms: A Meta-Analysis

Background Greater unhelpful thinking is associated with greater musculoskeletal discomfort and incapability. Cognitive-behavioral therapy (CBT) fosters healthy thinking to help alleviate symptoms. Questions In a meta-analysis of randomized control trials (RCT) of CBT for unhelpful thinking among people with musculoskeletal symptoms, we asked: 1) Does CBT reduce unhelpful thinking and feelings of distress, and improve capability, in individuals with musculoskeletal symptoms? 2) Are outcomes affected by CBT delivery methods? Methods Following QUOROM guidelines, we searched databases using keywords of pain catastrophizing, kinesiophobia, cognitive-behavioral therapy, musculoskeletal and variations. Inclusion criteria were RCT's testing CBT among people with musculoskeletal symptoms. Study quality was assessed with Cochrane Review of Bias 2. Meta-analysis of means and standard deviations was performed. Results CBT led to modest reductions in catastrophic thinking (−0.44 CI: −0.76 to −0.12; P = .01, kinesiophobia (−0.60 CI: −1.07 to −0.14; P = .01) and anxiety symptoms (−0.23 CI: −0.36 to −0.09; P < .01) over six months compared to usual care. There were no improvements in levels capability (−0.28 CI: −0.56 to 0.01; P = .05). CBT led by mental health professionals reduced catastrophic thinking more than CBT led by other clinicians (QB Test = 4.73 P = .03). There were no differences between online and in-person sessions, group versus individual therapy, or surgical versus non-surgical interventions. Conclusion The evidence that CBT delivered by various clinicians in various settings fosters healthier thinking in people presenting for care of musculoskeletal symptoms, supports comprehensive care of musculoskeletal illness. More research is needed to develop indications and interventions that also improve levels of capability. Level-I, meta-analysis of RCT's

Implementing LGBTQ-affirmative cognitive-behavioral therapy: implementation strategies across five clinical trials.

LGBTQ-affirmative cognitive-behavioral therapy (CBT) is an evidence-based treatment for reducing transdiagnostic mental and behavioral health concerns among LGBTQ individuals. Preserving the effects of this intervention as it is translated into practice can maximize public health benefits. This study systematically identifies and evaluates implementation strategies for LGBTQ-affirmative CBT. First, we identified and operationalized implementation strategies used across five trials of LGBTQ-affirmative CBT using the Pragmatic Implementation Reporting Tool. Second, we evaluated the relative importance of these strategies via a quantitative assessment (N = 31 unique trial implementers). Survey responses were analyzed descriptively within each trial. Across all trials, we organized strategies as (1) high priority, (2) moderate priority, and (3) optional (if resources are available) for implementing LGBTQ-affirmative CBT. Within each trial, we identified 20 or more implementation strategies that were used, many of which overlapped across trials. We identified nine high priority strategies (e.g., working with clients to engage them in LGBTQ-affirmative CBT), nine moderate priority strategies (e.g., conducting ongoing training in LGBTQ-affirmative CBT), and nine optional/resource dependent strategies (e.g., showing visual indicators of LGBTQ affirmation within the physical spaces where LGBTQ-affirmative CBT is delivered). LGBTQ-affirmative CBT is a complex intervention requiring a package of implementation strategies. Our findings provide guidance for implementers in settings with different levels of resources regarding the highest priority strategies that may be needed to preserve the effectiveness of LGBTQ-affirmative CBT as it is translated into real-world settings.

Phenotypes of sleep health among adults with chronic heart failure in a randomized controlled trial of cognitive behavioral therapy for insomnia

BackgroundPoor sleep contributes to adverse health in heart failure. However, studies are limited to isolated sleep characteristics. PurposesTo evaluate changes in sleep health phenotypes after cognitive behavioral therapy for insomnia or attention control and associations between sleep health phenotypes, symptoms, stress, functional performance, and emergency department visits and hospitalizations. MethodsSecondary analysis of a randomized controlled trial of cognitive behavioral therapy for insomnia among adults with heart failure. We measured sleep (rest-activity rhythms, sleep duration, quality, and efficiency, insomnia severity, daytime sleepiness), symptoms, cognitive ability, vigilance, and 6-minute walk distance at baseline and 3-, 6-, and 12-month postintervention and collected hospitalizations and emergency department visits. We used K-means cluster analysis and generalized linear mixed models, generalized estimating equations, and Cox proportional hazard models. ResultsAmong 166 participants (M age=63.2 (SD=12.6) years; 57% male; 23% New York Heart Association Class III/IV), there were four sleep health phenotypes (“Unstable Sleep” (15%); “Short Sleep” (39%); “Low Sleep Efficiency” (25%); and “Good Sleep” (21%)) at baseline. The healthiest phenotype was associated with the lowest fatigue. The proportions of participants in the healthiest sleep group increased from pre- to post-treatment. Low sleepiness (p = .0188) and a robust circadian quotient (p = .007) predicted transition to the healthiest phenotype. The poorest sleep phenotype at baseline predicted time to hospitalizations and emergency department visits (hazard ratios 0.35-0.60) after adjusting for covariates. ConclusionSleep phenotypes predict heart failure outcomes. Tailored interventions targeting phenotypes may be more effective than approaches that focus on single sleep characteristics.

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.

Exploring the perceptions of people diagnosed with schizophrenia and their family members to inform the cultural adaptation of cognitive behavioural therapy for psychosis in Saudi Arabia: a qualitative study

Abstract Cognitive behavioural therapy (CBT) is one of the best-evidenced psychosocial interventions for psychosis and is recommended by the National Institute for Health and Care Excellence and the American Psychiatric Association. CBT was developed and derived from Western cultural values, which may not be appropriate for non-Western cultures. Trials of CBT in Western countries have indicated that participants from ethnic minority groups demonstrate low rates of engagement, retention, and recruitment. This indicates that the principles underlying CBT may conflict with individual beliefs and cultural values in non-Western countries. Therefore, we interviewed 15 people diagnosed with schizophrenia and 15 with their family members to explore the beliefs and attitudes of people diagnosed with schizophrenia and their family members concerning the proposed CBT intervention for psychosis in the Saudi context. The findings revealed that most participants accepted the proposed intervention. Important factors that influenced participants’ engagement and motivation in the CBT intervention were related to the therapist’s qualities (sex, empathy, and competence), family involvement, religion, and the number and format of CBT sessions for psychosis. Key learning aims (1) To explore the beliefs and attitudes of people diagnosed with schizophrenia concerning the proposed CBT intervention for psychosis and how to improve it to make it more appropriate for their needs and cultures. (2) To explore the beliefs and attitudes of family members of people diagnosed with schizophrenia concerning the proposed CBT intervention for psychosis and how to improve it to make it more appropriate to their needs and culture.

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.