Feasibility of behavioral activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial.

BACKGROUND: Depression impacts the lives of millions of people worldwide. Behavioral activation (BA), derived from cognitive behavioral therapy, has the potential for improving depressive symptoms in patients with depression. Studies evaluating the effectiveness of BA specifically in the context of group therapy programs in a hospital setting for patients with depression are limited. In this study, we report findings from a pilot trial evaluating group BA for major depressive disorder. OBJECTIVE: The objectives of this pilot trial are to assess the potential of a full trial of BA group therapy in a large-scale tertiary care setting and to provide preliminary information about possible results regarding mood symptoms and quality of life in adults with depression. METHODS: Using a parallel single-cohort pragmatic pilot randomized controlled trial design, we evaluated the potential of conducting a large trial of BA effectiveness among adults with depression. Participants were randomized to the intervention (BA in addition to usual care) or control (support group in addition to usual care) groups and were assessed weekly for 18 consecutive weeks. Participants randomized to intervention underwent 28 2-h group BA therapy visits administered by trained therapists and completed assessments to examine treatment outcomes. Feasibility was measured in terms of enrollment rates (min. 20%), completion rates of study (min. 80%), and completion rates of weekly measurement scales (min. 80%). The reporting of this pilot trial is in accordance with the CONSORT extension for randomized pilot and feasibility trials. RESULTS: We randomized 20 individuals of mean age of 48.8 years (standard deviation = 9.7) with a DSM-5 diagnosis of major depressive disorder to intervention (n = 10) or control (n = 10) groups. Based on our feasibility criteria, our recruitment rate was excellent (20/27; 74%), study completion was found to be a moderate (80% of the total participants in both arms completed the study; BA = 100%, control = 60%), and completeness of measurements on a weekly basis was adequate overall (82%; BA = 86%, control = 79%). CONCLUSIONS: The study has demonstrated the potential feasibility to perform a larger scale trial upon modifications to the control group to avoid the low rate of study completion (60%) in this group. TRIAL REGISTRATION: ClinicalTrials NCT02045771, Registered January 22, 2014.

Cognitive behavior therapy for menopausal symptoms (CBT-Meno): a randomized controlled trial.

OBJECTIVE: To evaluate the effectiveness of cognitive behavioral therapy for menopausal symptoms (CBT-Meno) compared with a waitlist condition (no active intervention). A randomized controlled trial was conducted with 71 perimenopausal or postmenopausal women who were seeking treatment for menopausal symptoms. METHODS: Blind assessments were conducted at baseline, 12 weeks postbaseline, and 3 months post-treatment. An intention-to-treat analysis was conducted. CBT-Meno sessions included psychoeducation, and cognitive and behavioral strategies for vasomotor and depressive symptoms, anxiety, sleep difficulties, and sexual concerns. Primary outcomes were scores on the Hot Flash Related Daily Interference Scale (HFRDIS) and Beck Depression Inventory (BDI-II). Secondary outcomes were scores assessing vasomotor and sexual concerns on the Greene Climacteric Scale (GCS-vm, GCS-sex), the Montgomery-Åsberg Depression Rating Scale (MADRS), Hamilton Anxiety Rating Scale (HAM-A), Pittsburgh Sleep Quality Index (PSQI), and the Female Sexual Function Index (FSFI). RESULTS: There were significantly greater improvements in CBT-Meno compared with waitlist in vasomotor symptom interference (HFRDIS; P < 0.001, ηP = 0.21) and "bothersomeness" (GCS-vm; P = 0.04, ηP = 0.06), depressive symptoms (BDI-II; P = 0.001, ηP = 0.15), sleep difficulties (PSQI; P = 0.001, ηP = 0.17), and sexual concerns (GCS-sex; P = 0.03, ηP = 0.07). These results were found even when controlling for menopausal staging and medication use. Gains were maintained at 3 months post-treatment. CONCLUSIONS: CBT-Meno was particularly effective in improving self-reported vasomotor symptoms, depressive symptoms, sleep difficulties, and sexual concerns. Although future studies will be needed to confirm the impact of CBT-Meno on anxiety symptoms, these results suggest that this protocol is effective in targeting commonly reported menopausal symptoms. : Video Summary: Supplemental Digiatl Content 1, http://links.lww.com/MENO/A416.

Mindfulness-based cognitive therapy as an augmentation treatment for obsessive-compulsive disorder.

A significant number of obsessive-compulsive disorder (OCD) patients continue to experience symptoms that interfere with their functioning following cognitive behavioural therapy (CBT). Providing an additional augmentation treatment following CBT could help reduce these residual symptoms. Mindfulness interventions that facilitate less reactivity to thoughts and feelings may be helpful for patients suffering from residual OCD symptoms. The purpose of the current randomized waitlist control trial was to evaluate the feasibility and impact of providing an 8-week mindfulness-based cognitive therapy (MBCT) intervention following completion of a CBT intervention to OCD patients who continued to suffer from significant symptoms. Results indicated that compared to the waitlist control group, MBCT participants reported decreases in OCD symptoms (d = 1.38), depression symptoms (d = 1.25), anxiety symptoms (d = 1.02), and obsessive beliefs (d = 1.20) along with increases in self-compassion (d = 0.77) and mindfulness skills (d = 0.77). Additionally, participants reported high levels of satisfaction with the MBCT intervention. The results suggest that the use of MBCT for OCD as an augmentation therapy is acceptable to patients who continue to suffer from OCD symptoms after completing CBT and provides some additional relief from residual symptoms. KEY PRACTITIONER MESSAGE: Mindfulness interventions teach skills that facilitate disengaging from cognitive routines and accepting internal experience, and these skills may be valuable in treating obsessive-compulsive disorder (OCD), as individuals describe getting "stuck" in repetitive thoughts and consequent rituals. The results of this study suggest that teaching mindfulness skills using an 8-week mindfulness-based cognitive therapy (MBCT) intervention provides an added benefit (decreases in OCD, depression, and anxiety symptoms) for patients with OCD who have completed a cognitive behavioural therapy intervention and continued to suffer from significant symptoms. Participation in MBCT was also associated with increases in mindfulness skills including increased ability to be nonjudgmental and nonreactive. By fostering a nonjudgmental stance towards intrusive thoughts, mindfulness may discourage suppression and avoidance of thoughts and this could lead to increased habituation and a decreased reliance on compulsions. The use of MBCT as an augmentation treatment should be further explored to elucidate whether this treatment is beneficial for preventing relapse of OCD and could be compared against further cognitive behavioural therapy to see if offering participants a different and theoretically compelling intervention, such as MBCT, would outperform "more of the same" for individuals with OCD.

Behavioral activation group therapy for reducing depressive symptoms and improving quality of life: a feasibility study.

BACKGROUND: Depression is associated with a loss of productivity and noticeable personal, social, and economic decline; it affects more than 350 million people worldwide. Behavioral activation (BA), derived from cognitive behavioral therapy, has drawn increasingly more interest as a means of treatment for major depressive disorder due to its relative cost-effectiveness and efficacy. In this study, we disseminate findings from a feasibility study evaluating barriers to implementing a group BA program for major depressive disorder. The purpose of this feasibility study is to assess both patient and clinician perceptions on components of a group-based behavioral activation (BA) program. In particular, this feasibility study provides in-depth evaluation of the acceptability of BA prior to the design and implementation of a randomized trial to investigate BA effectiveness. Findings from this study directly informed decisions regarding the design and implementation of BA during the pilot trial. Specific components of BA were assessed and modified based on the results of this study. METHODS: This qualitative study was completed through the Mood Disorders Program at St. Joseph's Healthcare Hamilton. The authors of this study used data from two focus group sessions, one consisting of an interdisciplinary group of clinicians working in the Mood Disorders Program, and the other of registered outpatients of the Mood Disorders Program with a confirmed clinical diagnosis of depression. The benefits of offering this program in a group format, mainly social skill development opportunities and the use of technology such as activity tracking device, smart phones, and tablets during the therapy sessions, are a major focus of both the clinician and patient groups. Both groups emphasized the importance of offering sustainable activation. RESULTS: Differences in opinions existed between staff and patient groups regarding the use of technology in the program, though ultimately it was agreed upon that technology could be useful as a therapeutic aid. All participants agreed that behavioral activation was essential to the development of positive habits and routines necessary for recovery from depression. Patients agreed the program looked sustainable and stressed the potential benefit for improving depressive symptoms. CONCLUSIONS: Discussions from clinician and patient-centered focus groups directly informed decisions regarding the design and implementation of BA during the pilot trial. Specific components of BA were assessed and modified based on the results of this study. These findings provide insight for clinicians providing behavioral activation programming, and will serve as a framework for the development of the Out of the Blues program, a group-based BA program to be piloted in the Mood Disorders Program at St. Joseph's Healthcare Hamilton. TRIAL REGISTRATION: Clinical Trials registration number NCT02045771.

A pragmatic pilot randomized trial to investigate the effectiveness of behavioural activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial protocol.

BACKGROUND: Depression is a common disorder with a lifetime prevalence of 16 %. Despite the availability of several treatment options for depression, many patients do not respond to treatment and develop chronic illness associated with several secondary comorbidities. Behavioural activation (BA) is a simple therapy that has the potential for improving symptoms of depression and quality of life in patients with depression. The effectiveness of BA has not, however, been tested in a group format for patients with moderate to severe depression attending a specialized mood disorders tertiary care setting. Group format has the advantage of treating more patients at the same time especially in resource-limited settings. The primary objective of this pilot study is to test the feasibility of a main trial by assessing the recruitment and retention rates, average group size, completion of data and resources needed and receive the participants' feedback on the intervention. The secondary objective is to explore the change in mood and quality of life measures in adults with depression receiving BA. METHODS/DESIGN: Using a pragmatic pilot randomized controlled trial design, we will test the feasibility of a large trial to assess the effectiveness of BA added to usual care compared to a depression support group with usual care. Participants will be randomized after obtaining informed written consent to one of two study arms. Face-to-face group therapy will be provided in a hospital setting by trained therapists. Intervention and control groups will be seen twice weekly for 10 weeks and then once weekly for further 8 weeks. Participants will be completing mood symptom scales, quality of life questionnaires and anthropometric measures and provide blood samples for future analysis of biomarkers of response to treatment. During the pilot study we will also solicit participants' feedback and experience regarding the number, frequency and contents of the sessions as well as to explore participant perceptions of barriers or benefits associated with the BA program. DISCUSSION: The pilot study will help to inform a larger trial and assist in modifying the intervention based on patients' feedback. TRIAL REGISTRATION: Clinicaltrials.gov Identifier NCT02045771. Hamilton Integrated Research Ethics Board (HiREB) number: 14-042.

Cognitive-behavioral, behavioral, and mindfulness-based therapies for menopausal depression: a review.

Menopause is a natural transition that all women go through in their lives that is often accompanied by a number of physical and emotional symptoms. Upwards of 40% of women report depression symptoms associated with menopause (Timur & Sahin, 2010) [1]. Treatments for menopausal depression include pharmacological agents such as antidepressants and hormone therapy (HT) as well as psychological approaches. This paper provides a review of cognitive-behavioral, behavioral, and mindfulness based (CBBMB) therapies in treating depression during the menopausal transition. After conducting an electronic database search, only two studies specifically using CBBMB methods were found, both had positive results. Since so few studies existed that specifically evaluated CBBMB treatments for menopausal depression (n=2), a larger net was cast. Studies that assessed depression symptoms as an outcome measure in an evaluation of CBBMB treatments for hot flashes or menopausal symptoms more broadly, were included. The review revealed that interventions targeting hot flashes or menopausal symptoms using CBBMB methods mostly proved to have had a positive impact on depression symptoms in the mild range of severity. Directions for future research are discussed including the need for more CBBMB interventions targeting depression during the menopausal transition to establish their efficacy.

High trait rumination is associated with blunted nighttime diastolic blood pressure dipping.

BACKGROUND: Blunted blood pressure (BP) dipping during nighttime sleep has been associated with an increased risk of cardiovascular events. Psychological traits have been associated with prolonged cardiovascular activation and a lack of cardiovascular recovery. This activation may extend into nighttime sleep and reduce BP dipping. PURPOSE: This study aims to evaluate the association between trait rumination and nighttime BP dipping. METHODS: Sixty women scoring either high or low on trait rumination underwent one 24-h ambulatory BP monitoring session. Self-reported wake and sleep times were used to calculate nighttime BP. RESULTS: High trait rumination was associated with less diastolic blood pressure (DBP) dipping relative to low trait rumination. Awake ambulatory BP, asleep systolic blood pressure (SBP) and DBP, and asleep SBP dipping were not associated with trait rumination. CONCLUSIONS: In a sample of young women, high trait rumination was associated with less DBP dipping, suggesting that it may be associated with prolonged cardiovascular activation that extends into nighttime sleep, blunting BP dipping.

Wanting a body that's better than average: the effect of manipulated body norms on ideal body size perception.

We examined the effect of body norms on ideal and current body size perception. In Study One, female participants were randomly assigned to one of three experimental conditions: (1) a thinner body norm, (2) a heavier body norm, or (3) no body norm. Body norms were manipulated by indicating a bogus "population average," and current and ideal body size perception were subsequently measured using a body silhouettes measure. Women had a thinner ideal body size in the thinner norm condition than in the heavier norm condition. Study Two replicated these results, but in a sample of young men and with regards to muscularity rather than thinness. Men had a more muscular ideal body size in the more muscular norm condition than in the less muscular norm condition. Current body size perception was also influenced by body norms, but only for women and after controlling for BMI.

Depressed affect is associated with poorer cardiovascular recovery in young women following a mental stressor.

BACKGROUND: Depressed mood has been prospectively associated with hypertension. Altered ANS function, as reflected in poor CV recovery, may be one mechanism that underlies this relationship. PURPOSE: The purpose of this study was to investigate the relationship between depressed mood and cardiovascular recovery following a standard mental stress task in healthy young women. METHODS: Depressed mood was assessed in 63 young women. Cardiovascular data were collected during a 5-min baseline period, 5-min public speaking stress task, and 15-min recovery period. RESULTS: Depressed mood accounted for 9.6% of the variation in HR reactivity (F(1,58) = 6.513, p = 0.013) and 4.5% of DBP recovery (F(1,58) = 4.538, p = 0.037). CONCLUSIONS: Greater depressed mood was associated with greater HR reactivity and poorer DBP recovery. This is the first study to directly investigate associations between depressed mood and CV recovery following mental stress.

The influence of trait and state rumination on cardiovascular recovery from a negative emotional stressor.

The purpose of this study was to evaluate the influence of trait and state rumination on cardiovascular recovery following a negative emotional stressor. Cardiovascular data was collected from 64 undergraduate women during a 10-min baseline period, 5-min emotional recall stress task, and a 15-min recovery period. Trait rumination was assessed using the Stress Reactive Rumination Scale and state rumination was assessed 5 and 10 min after the stressor, using a thought-report technique. Results indicated that trait and state rumination interacted such that low trait ruminators who were ruminating at 10 min after the termination of the stressor had poorer diastolic blood pressure and high-frequency heart rate variability recovery compared to low trait ruminators who were not ruminating. State rumination was not associated with cardiovascular recovery in high trait ruminators. Results suggest that rumination may play a role in the association between stress and hypertension by prolonging cardiovascular activation following stress.

Early socioeconomic status is associated with adult nighttime blood pressure dipping.

OBJECTIVE: To examine the prognostic significance of early socioeconomic status (SES) on 24-hour blood pressure (BP) during early adulthood. Low SES has been related to poor health outcomes, in particular, cardiovascular morbidity and mortality. Recent cross-sectional research has also linked low levels of SES with several cardiovascular risk factors including poor nighttime BP dipping. METHODS: A total of 174 undergraduate university students whose childhood SES was assessed by highest level of education completed by their parents underwent 24-hour ambulatory BP monitoring. RESULTS: Initial correlation analyses revealed positive associations between childhood SES and BP dipping, indicating that lower levels of childhood SES were associated with less systolic BP (SBP) (r = .29, p < .01) and diastolic BP (DBP) dipping (r = .38, p < .01). A stepwise multiple regression analyses indicated that childhood SES explained 6.9% of the variance in SBP dipping and 11.5% of the variance in DBP dipping above and beyond other lifestyle-related factors including daytime BP, body mass index, alcohol use, smoking, and current SES. CONCLUSIONS: These findings suggest that irrespective of adult achievement, childhood SES may have lasting health implications.

A high-fat meal increases cardiovascular reactivity to psychological stress in healthy young adults.

The consumption of high levels of saturated fat over the course of several weeks may lead to exaggerated cardiovascular reactivity. The consumption of a single high-fat meal has been associated with a transient impairment of vascular function. In a randomized, repeated measures, crossover study we tested whether the consumption of a single high-fat meal by healthy, normotensive participants would affect cardiovascular reactivity when compared with an isocaloric, low-fat meal. Thirty healthy participants ate a high-fat (42 g) and a low-fat (1 g) meal on 2 separate occasions, and their cardiovascular response to 2 standard laboratory stressors was measured. Systolic blood pressure, diastolic blood pressure, and total peripheral resistance were greater in participants following the consumption of the high-fat meal relative to the low-fat meal. The findings of the present study are consistent with the hypothesis that even a single high-fat meal may be associated with heightened cardiovascular reactivity to stress and offer insight into the pathways through which a high-fat diet may affect cardiovascular function.