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1.
Article in English | MEDLINE | ID: mdl-38536707

ABSTRACT

Introduction: The popularity of yoga has surged in recent years; however, yoga practitioners have remained a largely homogenous population. Research reflects that most practitioners are of a higher socioeconomic status. There are access barriers to yoga for lower income individuals, likely due to factors such as financial constraints and logistical challenges. The primary goal of this review was to synthesize literature on yoga research among low-income populations and better understand the feasibility and acceptability of such interventions. A secondary goal was to assess the consistency of metrics for reporting feasibility and acceptability across such studies using the CheckList Standardizing the Reporting of Interventions for Yoga (CLARIFY) guidelines as a framework. Third, the authors sought to propose additional standardized CLARIFY guidelines that may enhance reporting on the diversity of yoga research populations, adherence, and retention. Methods: The electronic databases PubMed, PsycINFO, Cochrane Central Register of Controlled Trials, and Google Scholar were searched in May 2022 using a prespecified search string. Articles assessing a yoga intervention in predominantly low-income adult populations were deemed eligible for inclusion. Results: The search resulted in 512 potential articles. Eleven were deemed eligible for inclusion. The included studies reported mostly positive effects of yoga on the target outcome (i.e., pain/disability, quality of life/wellness, and psychiatric symptoms). Recruitment and retention data showed generally good attendance and high study completion rates. Common study design components included recruitment embedded within preexisting medical settings, proximal yoga locations, and mitigation of yoga-related costs. Finally, the authors noted inconsistency in the reporting of adherence, retention, and other sociodemographic characteristics of participants and yoga instructors (e.g., race, ethnicity, and income). Discussion: Yoga may promote physical and mental health for low-income individuals. Important facilitators to access are noted, such as proximal study settings, as well as barriers such as the need for childcare that can be addressed in future research. In addition, several study design considerations could help address the specific needs of low-income participants in yoga research, such as compensating participants, recruiting within existing medical settings, and providing yoga-related equipment at no cost. Finally, the authors suggest specific ways to enhance reporting of study metrics related to socioeconomic diversity, by adding to the preexisting CLARIFY guidelines.

2.
J Clin Psychiatry ; 84(6)2023 10 23.
Article in English | MEDLINE | ID: mdl-37883245

ABSTRACT

Objective: To evaluate feasibility, acceptability, and preliminary efficacy of heated yoga to treat moderate-to-severe depression.Design: An 8-week randomized controlled trial (RCT) of heated yoga versus waitlist control was conducted from March 2017 to August 2019.Methods: Participants in the yoga condition were asked to attend heated yoga classes at 2 community heated yoga studios at least twice weekly. We assessed acceptability and feasibility using exit interview and attendance data, respectively. The primary intervention efficacy outcome variable was change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) score from baseline to post-intervention (week 8).Results: We randomized 80 participants and included 65 (mean [± SD] age 32.7 [± 11.7] years; 81.5% female) in the analyses (yoga n = 33, waitlist n = 32). The mean IDS-CR score at baseline was 35.6 (± 7.9) for the full sample, 36.9 (± 8.8) for yoga participants, and 34.4 (± 6.7) for waitlist participants. Participants attended an average of 10.3 (± 7.1) total classes over the 8-week intervention period. Yoga participants had a significantly greater pre- to post-intervention reduction in IDS-CR scores than waitlist participants (Cohen d = 1.04, P < .001). More yoga participants (59.3%; n = 16) than waitlist participants (6.3%; n = 2) evidenced larger treatment responses (IDS-CR ≥ 50% decrease in symptoms). Participants rated the heated yoga and its aftereffects positively in exit interviews.Conclusions: Approximately 1 heated yoga session per week (mean of 10.3 classes over 8 weeks) was associated with significantly greater reduction in depression symptoms than a waitlist control. Participants rated heated yoga positively. Taken together, results suggest feasibility, acceptability, and preliminary efficacy for patients with depression and warrant further research using active control conditions.Trial Registration: ClinicalTrials.gov identifier: NCT02607514.


Subject(s)
Depression , Yoga , Adult , Female , Humans , Male , Depression/therapy
3.
J Gen Intern Med ; 38(9): 2113-2122, 2023 07.
Article in English | MEDLINE | ID: mdl-36650329

ABSTRACT

BACKGROUND: Yoga is effective for chronic low back pain (cLBP) in civilians but understudied among Veterans. OBJECTIVE: Determine whether yoga is more effective than an educational book for improving disability and pain among Veterans with cLBP. DESIGN, SETTING, AND PARTICIPANTS: Veterans diagnosed with cLBP at a VA medical center enrolled in a randomized controlled trial from March to December of 2015. INTERVENTIONS: Twelve weekly hatha yoga classes or education using The Back Pain Helpbook. MEASURES: Co-primary outcomes were changes from baseline at 12 weeks in back-related disability on the modified Roland Morris Disability Questionnaire and pain on the Defense & Veterans Pain Rating Scale. Secondary outcomes were global improvement, patient satisfaction, pain medication use, and post-traumatic stress symptoms. An intention-to-treat approach was used in primary analyses. RESULTS: One hundred twenty Veterans (mean age, 55.5 [SD = 16.9]; 11 [9%] women; mean number of chronic conditions, 5.5) were randomized to yoga (n = 62) and education (n = 58). At 12 weeks, reductions in back-related disability in yoga (mean difference [MD] = - 3.50, 95% CI: - 5.03, - 1.97) were not significantly different than education (MD = - 2.55, 95% CI: - 4.10, - 0.99; between-group difference: - 0.95 [95% CI: - 3.14, 1.23], p = 0.39). For pain, there was no significant difference between yoga (MD = - 1.01, 95% CI: - 1.67, - 0.35) and education (MD = - 0.81, 95% CI: - 1.36, - 0.27; between-group difference: - 0.20, 95% CI: - 1.06, 0.66, p = 0.65). More yoga than education participants reported being very much or extremely improved (39% vs 19%, OR = 3.71, 95% CI: 1.37, 10.02, p = 0.01) and very satisfied with treatment (60% vs 31%, OR = 4.28, 95% CI: 1.70, 10.77, p = 0.002). No differences in pain medication use or post-traumatic stress symptoms were observed at 12 weeks. No serious adverse events were reported in either group. CONCLUSION: Twelve weekly yoga classes were not more effective than an education intervention for improving pain or disability outcomes among mostly older male Veterans with cLBP and multiple comorbid health conditions. GOV IDENTIFIER: NCT02224183.


Subject(s)
Chronic Pain , Low Back Pain , Veterans , Yoga , Humans , Male , Female , Middle Aged , Low Back Pain/therapy , Low Back Pain/diagnosis , Treatment Outcome , Chronic Pain/therapy
4.
J Psychiatr Pract ; 27(6): 486-491, 2021 11 05.
Article in English | MEDLINE | ID: mdl-34768274

ABSTRACT

Depression remains difficult to treat as a result of less than optimal efficacy and troublesome side effects of antidepressants. The authors present the case of a patient with treatment-resistant depression with melancholic features who had previously been unresponsive to electroconvulsive therapy (ECT) plus an antidepressant regimen but whose condition fully remitted with the addition of a standardized form of heated hatha yoga (HY; Bikram yoga) practiced in a room heated to 105°F. The patient was a 28-year-old woman who underwent 8 weeks of HY as part of a randomized controlled trial of HY for depression while continuing her antidepressant treatment. The patient was asked to attend a minimum of 2 weekly, 90-minute HY classes. After 8 weeks (12 classes in total), the patient no longer met the criteria for a major depressive episode with melancholic features, per Mini-International Neuropsychiatric Interview (MINI) criteria. Her depressive symptoms had improved dramatically, with Inventory of Depressive Symptomatology, Clinician-Rated (IDS-C30), and Hamilton Depression Rating Scale (HAM-D28) scores decreasing from 28 at baseline to 3, and from 28 at baseline to 4, respectively, indicating remission. This patient's ECT-resistant depression remitted with the addition of HY to her antidepressant regimen. Because of her youth and athleticism, this patient was likely well suited to this rigorous form of yoga. Further research is needed to explore HY as a potential intervention for treatment-resistant depression.


Subject(s)
Depressive Disorder, Major , Depressive Disorder, Treatment-Resistant , Electroconvulsive Therapy , Yoga , Adolescent , Adult , Antidepressive Agents/therapeutic use , Depressive Disorder, Major/drug therapy , Depressive Disorder, Treatment-Resistant/drug therapy , Electroconvulsive Therapy/adverse effects , Female , Humans , Treatment Outcome
5.
J Altern Complement Med ; 26(3): 190-197, 2020 Mar.
Article in English | MEDLINE | ID: mdl-31934793

ABSTRACT

Objective: To determine if a 12-week yoga intervention (YI) was associated with increased gamma aminobutyric acid (GABA) levels and decreased depressive symptoms in participants with major depressive disorder (MDD). Methods: Subjects were randomized to a high-dose group (HDG) of three YIs a week and a low-dose group (LDG) of two YIs a week. Thalamic GABA levels were obtained using magnetic resonance spectroscopy at Scan-1 before randomization. After the assigned 12-week intervention, Scan-2 was obtained, immediately followed by a YI and Scan-3. Beck Depression Inventory II (BDI-II) scores were obtained before Scan-1 and Scan-3. Settings/Location: Screenings and interventions occurred at the Boston University Medical Center. Imaging occurred at McLean Hospital. Subjects: Subjects met criteria for MDD. Intervention: Ninety minutes of Iyengar yoga and coherent breathing at five breaths per minute plus homework. Outcome measures: GABA levels and the BDI-II. Results: BDI-II scores improved significantly in both groups. GABA levels from Scan-1 to Scan-3 and from Scan-2 to Scan-3 were significantly increased in the LDG (n = 15) and showed a trend in the total cohort. Post hoc, participants were divided into two groups based on having an increase in GABA levels at Scan-2. Increases in Scan-2 GABA levels were observed in participants whose mean time between their last YI and Scan-2 was 3.93 ± 2.92 standard deviation (SD) days, but not in those whose mean time between their last YI and Scan-2 was 7.83 ± 6.88 SD. Conclusions: This study tentatively supports the hypothesis that one of the mechanisms through which yoga improves mood is by increasing the activity of the GABA system. The observed increase in GABA levels following a YI that was no longer observed 8 days after a YI suggests that the associated increase in GABA after a YI is time limited such that at least one YI a week may be necessary to maintain the elevated GABA levels.


Subject(s)
Breathing Exercises , Depressive Disorder, Major , Thalamus/metabolism , Yoga , gamma-Aminobutyric Acid/analysis , Adult , Anxiety , Depressive Disorder, Major/diagnostic imaging , Depressive Disorder, Major/metabolism , Depressive Disorder, Major/therapy , Female , Humans , Magnetic Resonance Imaging , Male , Middle Aged , Thalamus/chemistry , Thalamus/diagnostic imaging , Young Adult , gamma-Aminobutyric Acid/metabolism
6.
J Psychiatr Pract ; 25(6): 437-450, 2019 11.
Article in English | MEDLINE | ID: mdl-31821220

ABSTRACT

BACKGROUND: Evidence suggests that yoga may be an effective treatment for major depressive disorder (MDD). Studies evaluating the "dosing" of yoga treatment and efficacy for MDD are needed. The goal of this study was to assess the effects of an intervention combining Iyengar yoga and coherent breathing in participants with MDD and determine the optimal intervention dose. METHODS: Thirty-two participants (18 to 65 y of age) diagnosed with MDD were randomized to a high-dose group (HDG) or a low-dose group (LDG) of yoga and coherent breathing for 12 weeks. The HDG (n=15) involved three 90-minute yoga classes and four 30-minute homework sessions per week. The LDG (n=15) involved two 90-minute yoga classes and three 30-minute homework sessions per week. Participants were evaluated at baseline, week 4, week 8, and week 12 with the following instruments: Positivity Self-Test, Spielberger State Anxiety Inventory, Patient Health Questionnaire-9, Pittsburgh Sleep Quality Index, and Exercise-induced Feeling Inventory. Data were analyzed using intent-to-treat methods. RESULTS: Significant improvements in all outcome measures were found for both groups, with acute and cumulative benefits. Although the HDG showed greater improvements on all scales, between-group differences did not reach significance, possibly due to lack of power because of the small sample size. Cumulative yoga minutes were correlated with improvement in outcome measures. LIMITATION: This dosing study did not include a non-yoga control. CONCLUSIONS: Improvement in psychological symptoms correlated with cumulative yoga practice. Both interventions reduced symptoms of depression and anxiety and increased feelings of positivity. The time commitment for yoga practice needs to be weighed against benefits when designing yoga interventions.


Subject(s)
Depressive Disorder, Major/psychology , Quality of Life/psychology , Respiration , Yoga/psychology , Adolescent , Adult , Aged , Female , Humans , Male , Middle Aged , Time Factors , Treatment Outcome , Young Adult
7.
Complement Ther Med ; 46: 153-157, 2019 Oct.
Article in English | MEDLINE | ID: mdl-31519272

ABSTRACT

Yoga-based practices, derived from ancient Eastern mind-body practices, have grown in popularity in the West over the past several decades. Increasing evidence supports the antidepressant effects of yoga-based interventions (YBIs). However, despite yoga's promise as a potential treatment for depression, the literature to date is marked by substantial methodological limitations, which remain a barrier to the integration of YBIs into conventional clinical care. We highlight five key areas of study that need further investigation to fill crucial gaps in the literature-base to advance yoga research and yoga's potential as an effective evidence-based treatment for depression.


Subject(s)
Depression/psychology , Depression/therapy , Depressive Disorder/psychology , Depressive Disorder/therapy , Yoga/psychology , Evidence-Based Medicine/methods , Humans , Meditation/psychology
8.
J Altern Complement Med ; 25(8): 814-823, 2019 Aug.
Article in English | MEDLINE | ID: mdl-31290694

ABSTRACT

Objectives: There are no known studies of concurrent exposure to high temperature and yoga for the treatment of depression. This study explored acceptability and feasibility of heated (Bikram) yoga as a treatment for individuals with depressive symptoms. Design: An 8-week, open-label pilot study of heated yoga for depressive symptoms. Subjects: 28 medically healthy adults (71.4% female, mean age 36 [standard deviation 13.57]) with at least mild depressive symptoms (Hamilton Rating Scale for Depression [HRSD-17] score ≥10) who attended at least one yoga class and subsequent assessment visit. Intervention: Participants were asked to attend at least twice weekly community held Bikram Yoga classes. Assessments were performed at screening and weeks 1, 3, 5, and 8. Hypotheses were tested using a modified-intent-to-treat approach, including participants who attended at least one yoga class and subsequent assessment visit (N = 28). Results: Almost half of our subjects completed the 8-week intervention, and close to a third attended three quarters or more of the prescribed 16 classes over 8 weeks. Multilevel modeling revealed significant improvements over time in both clinician-rated HRSD-17 (p = 0.003; dGLMM = 1.43) and self-reported Beck Depression Inventory (BDI; p < 0.001, dGLMM = 1.31) depressive symptoms, as well as the four secondary outcomes: hopelessness (p = 0.024, dGLMM = 0.57), anxiety (p < 0.001, dGLMM = 0.78), cognitive/physical functioning (p < 0.001, dGLMM = 1.34), and quality of life (p = 0.007, dGLMM = 1.29). Of 23 participants with data through week 3 or later, 12 (52.2%) were treatment responders (≥50% reduction in HRSD-17 score), and 13 (56.5%) attained remission (HRSD score ≤7). More frequent attendance was significantly associated with improvement in self-rated depression symptoms, hopelessness, and quality of life. Conclusions: The acceptability and feasibility of heated yoga in this particular sample with this protocol warrants further attention. The heated yoga was associated with reduced depressive symptoms, and other improved related mental health symptoms, including anxiety, hopelessness, and quality of life.


Subject(s)
Depressive Disorder, Major/therapy , Hot Temperature/therapeutic use , Yoga , Adult , Depression/therapy , Female , Humans , Male , Middle Aged , Personality Inventory , Pilot Projects , Treatment Outcome , Young Adult
9.
Complement Ther Med ; 37: 136-142, 2018 Apr.
Article in English | MEDLINE | ID: mdl-29609926

ABSTRACT

BACKGROUND: Yoga interventions offer promise for the treatment of major depressive disorder (MDD), yet their safety and potential impact on suicidal ideation (SI) have not been well documented. This study evaluated the safety of a randomized controlled dose-finding trial of Iyengar yoga plus coherent breathing for individuals with MDD, as well as the potential effects of the intervention on SI without intent. METHODS: Participants with Beck Depression Inventory-II (BDI-II) scores ≥14 and a diagnosis of MDD (using DSM-IV criteria) were randomized to either a low dose group (LDG) or high dose group (HDG) and received a 12-week manualized intervention. The LDG included two 90-min yoga classes plus three 30-min homework sessions weekly. The HDG offered three 90-min classes plus four 30-min homework sessions weekly. RESULTS: Thirty-two individuals with MDD were randomized, of which 30 completed the protocol. At screening, SI without intent was endorsed on the BDI-II by 9 participants; after completing the intervention, 8 out of 9 reported resolution of SI. There were 17 adverse events possibly-related and 15 definitely-related to the intervention. The most common protocol-related adverse event was musculoskeletal pain, which resolved over the course of the study. CONCLUSIONS: The Iyengar yoga plus coherent breathing intervention was associated with the resolution of SI in 8 out of 9 participants, with mild side effects that were primarily musculoskeletal in nature. This preliminary evidence suggests that this intervention may reduce SI without intent and be safe for use in those with MDD.


Subject(s)
Breathing Exercises , Depressive Disorder, Major/therapy , Suicidal Ideation , Yoga , Adult , Female , Humans , Male , Middle Aged , Patient Safety , Young Adult
10.
Focus (Am Psychiatr Publ) ; 16(1): 12-18, 2018 Jan.
Article in English | MEDLINE | ID: mdl-31975895

ABSTRACT

Yoga has been in use for thousands of years in the East as a healing modality. Western practitioners are now starting to recognize the potential of yoga-based treatments. The purpose of this article is to explore the evidence-base of yoga-based treatments for depression and anxiety with the purpose of furthering the integration of yoga into conventional Western mental health treatment plans.

11.
Altern Complement Ther ; 23(6): 236-243, 2017 Dec 01.
Article in English | MEDLINE | ID: mdl-29225455

ABSTRACT

Objectives: The aims of this study were to assess the effects of an intervention of Iyengar yoga and coherent breathing at five breaths per minute on depressive symptoms and to determine optimal intervention yoga dosing for future studies in individuals with major depressive disorder (MDD). Methods: Subjects were randomized to the high-dose group (HDG) or low-dose group (LDG) for a 12-week intervention of three or two intervention classes per week, respectively. Eligible subjects were 18-64 years old with MDD, had baseline Beck Depression Inventory-II (BDI-II) scores ≥14, and were either on no antidepressant medications or on a stable dose of antidepressants for ≥3 months. The intervention included 90-min classes plus homework. Outcome measures were BDI-II scores and intervention compliance. Results: Fifteen HDG (Mage=38.4±15.1 years) and 15 LDG (Mage=34.7±10.4 years) subjects completed the intervention. BDI-II scores at screening and compliance did not differ between groups (p=0.26). BDI-II scores declined significantly from screening (24.6±1.7) to week 12 (6.0±3.8) for the HDG (-18.6±6.6; p < 0.001), and from screening (27.7±2.1) to week 12 (10.1±7.9) in the LDG (-17.7±9.3; p < 0.001). There were no significant differences between groups, based on response (i.e., >50% decrease in BDI-II scores; p=0.65) for the HDG (13/15 subjects) and LDG (11/15 subjects) or remission (i.e., number of subjects with BDI-II scores <14; p=1.00) for the HDG (14/15 subjects) and LDG (13/15 subjects) after the 12-week intervention, although a greater number of subjects in the HDG had 12-week BDI-II scores ≤10 (p=0.04). Conclusion: During this 12-week intervention of yoga plus coherent breathing, depressive symptoms declined significantly in patients with MDD in both the HDG and LDG. Both groups showed comparable compliance and clinical improvements, with more subjects in the HDG exhibiting BDI-II scores ≤10 at week 12.

12.
J Altern Complement Med ; 23(3): 201-207, 2017 Mar.
Article in English | MEDLINE | ID: mdl-28296480

ABSTRACT

OBJECTIVES: The aims of this study were to assess the effects of an intervention of Iyengar yoga and coherent breathing at five breaths per minute on depressive symptoms and to determine optimal intervention yoga dosing for future studies in individuals with major depressive disorder (MDD). METHODS: Subjects were randomized to the high-dose group (HDG) or low-dose group (LDG) for a 12-week intervention of three or two intervention classes per week, respectively. Eligible subjects were 18-64 years old with MDD, had baseline Beck Depression Inventory-II (BDI-II) scores ≥14, and were either on no antidepressant medications or on a stable dose of antidepressants for ≥3 months. The intervention included 90-min classes plus homework. Outcome measures were BDI-II scores and intervention compliance. RESULTS: Fifteen HDG (Mage = 38.4 ± 15.1 years) and 15 LDG (Mage = 34.7 ± 10.4 years) subjects completed the intervention. BDI-II scores at screening and compliance did not differ between groups (p = 0.26). BDI-II scores declined significantly from screening (24.6 ± 1.7) to week 12 (6.0 ± 3.8) for the HDG (-18.6 ± 6.6; p < 0.001), and from screening (27.7 ± 2.1) to week 12 (10.1 ± 7.9) in the LDG (-17.7 ± 9.3; p < 0.001). There were no significant differences between groups, based on response (i.e., >50% decrease in BDI-II scores; p = 0.65) for the HDG (13/15 subjects) and LDG (11/15 subjects) or remission (i.e., number of subjects with BDI-II scores <14; p = 1.00) for the HDG (14/15 subjects) and LDG (13/15 subjects) after the 12-week intervention, although a greater number of subjects in the HDG had 12-week BDI-II scores ≤10 (p = 0.04). CONCLUSION: During this 12-week intervention of yoga plus coherent breathing, depressive symptoms declined significantly in patients with MDD in both the HDG and LDG. Both groups showed comparable compliance and clinical improvements, with more subjects in the HDG exhibiting BDI-II scores ≤10 at week 12.


Subject(s)
Breathing Exercises , Depressive Disorder, Major/therapy , Yoga , Adult , Female , Humans , Male , Middle Aged , Young Adult
13.
J Clin Psychopharmacol ; 35(1): 34-42, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25427171

ABSTRACT

The anticonvulsant topiramate not only decreases ethanol consumption in alcohol dependence (AD) but also may produce several adverse events including cognitive impairment. Zonisamide is a structurally related anticonvulsant that is a promising agent for the treatment of AD and may have greater tolerability than topiramate. This study evaluated the effects of zonisamide (400 mg/d) on alcohol consumption and its neurotoxic effects in subjects with AD. A double-blind placebo-controlled clinical trial was conducted using 2 comparator anticonvulsant drugs, topiramate (300 mg/d) and levetiracetam (2000 mg/d), which does not impair cognition. Study medications were administered for 14 weeks, including a 2-week taper period. Medication adherence was facilitated using Brief Behavioral Compliance Enhancement Treatment. The neurotoxicity of the study drugs was assessed using neuropsychological tests and the AB-Neurotoxicity Scale. Compared with placebo, both zonisamide and topiramate produced significant reductions in the drinks consumed per day, percent days drinking, and percent days heavy drinking. Only the percent days heavy drinking was significantly decreased in the levetiracetam group. The topiramate cell was the only group that had a significant increase on the mental slowing subscale of the Neurotoxicity Scale compared with placebo at study weeks 11 and 12. Topiramate and zonisamide both produced modest reductions in verbal fluency and working memory. These findings indicate that zonisamide may have efficacy in the treatment of AD, with effect sizes similar to topiramate. Both of these drugs produced similar patterns of cognitive impairment, although only the topiramate group reported significant increases in mental slowing.


Subject(s)
Alcohol-Related Disorders/drug therapy , Cognition Disorders/chemically induced , Fructose/analogs & derivatives , Isoxazoles/therapeutic use , Neuropsychological Tests , Piracetam/analogs & derivatives , Adult , Aged , Alcohol Drinking/drug therapy , Alcohol Drinking/psychology , Alcohol-Related Disorders/diagnosis , Alcohol-Related Disorders/psychology , Anticonvulsants/adverse effects , Anticonvulsants/therapeutic use , Cognition Disorders/diagnosis , Cognition Disorders/psychology , Double-Blind Method , Female , Fructose/adverse effects , Fructose/therapeutic use , Humans , Isoxazoles/adverse effects , Levetiracetam , Male , Middle Aged , Piracetam/adverse effects , Piracetam/therapeutic use , Topiramate , Treatment Outcome , Young Adult , Zonisamide
14.
Clin Trials ; 10(6): 935-48, 2013.
Article in English | MEDLINE | ID: mdl-23867223

ABSTRACT

BACKGROUND: Subjects who enroll in multiple studies have been found to use deception at times to overcome restrictive screening criteria. Deception undermines subject safety as well as study integrity. Little is known about the extent to which experienced research subjects use deception and what type of information is concealed, withheld, or distorted. PURPOSE: This study examined the prevalence of deception and types of deception used by subjects enrolling in multiple studies. METHODS: Self-report of deceptive behavior used to gain entry into clinical trials was measured among a sample of 100 subjects who had participated in at least two studies in the past year. RESULTS: Three quarters of subjects reported concealing some health information from researchers in their lifetime to avoid exclusion from enrollment in a study. Health problems were concealed by 32% of the sample, use of prescribed medications by 28%, and recreational drug use by 20% of the sample. One quarter of subjects reported exaggerating symptoms in order to qualify for a study and 14% reported pretending to have a health condition in order to qualify. LIMITATIONS: Although this study finds high rates of lifetime deceptive behavior, the frequency and context of this behavior is unknown. Understanding the context and frequency of deception will inform the extent to which it jeopardizes study integrity and safety. CONCLUSION: The use of deception threatens both participant safety and the integrity of research findings. Deception may be fueled in part by undue inducements, overly restrictive criteria for entry, and increased demand for healthy controls. Screening measures designed to detect deception among study subjects would aid in both protecting subjects and ensuring the quality of research findings.


Subject(s)
Deception , Patient Selection , Research Subjects , Clinical Trials as Topic , Female , Humans , Income , Male , Middle Aged , Motivation , Self Report , Sex Factors , Unemployment
15.
J Altern Complement Med ; 16(11): 1145-52, 2010 Nov.
Article in English | MEDLINE | ID: mdl-20722471

ABSTRACT

OBJECTIVES: Yoga and exercise have beneficial effects on mood and anxiety. γ-Aminobutyric acid (GABA)-ergic activity is reduced in mood and anxiety disorders. The practice of yoga postures is associated with increased brain GABA levels. This study addresses the question of whether changes in mood, anxiety, and GABA levels are specific to yoga or related to physical activity. METHODS: Healthy subjects with no significant medical/psychiatric disorders were randomized to yoga or a metabolically matched walking intervention for 60 minutes 3 times a week for 12 weeks. Mood and anxiety scales were taken at weeks 0, 4, 8, 12, and before each magnetic resonance spectroscopy scan. Scan 1 was at baseline. Scan 2, obtained after the 12-week intervention, was followed by a 60-minute yoga or walking intervention, which was immediately followed by Scan 3. RESULTS: The yoga subjects (n = 19) reported greater improvement in mood and greater decreases in anxiety than the walking group (n = 15). There were positive correlations between improved mood and decreased anxiety and thalamic GABA levels. The yoga group had positive correlations between changes in mood scales and changes in GABA levels. CONCLUSIONS: The 12-week yoga intervention was associated with greater improvements in mood and anxiety than a metabolically matched walking exercise. This is the first study to demonstrate that increased thalamic GABA levels are associated with improved mood and decreased anxiety. It is also the first time that a behavioral intervention (i.e., yoga postures) has been associated with a positive correlation between acute increases in thalamic GABA levels and improvements in mood and anxiety scales. Given that pharmacologic agents that increase the activity of the GABA system are prescribed to improve mood and decrease anxiety, the reported correlations are in the expected direction. The possible role of GABA in mediating the beneficial effects of yoga on mood and anxiety warrants further study.


Subject(s)
Affect , Anxiety/therapy , Brain/metabolism , Walking/psychology , Yoga/psychology , gamma-Aminobutyric Acid/metabolism , Adult , Exercise/psychology , Female , Humans , Magnetic Resonance Spectroscopy , Male , Young Adult
16.
Am J Drug Alcohol Abuse ; 36(2): 102-5, 2010 Mar.
Article in English | MEDLINE | ID: mdl-20337506

ABSTRACT

OBJECTIVES: The objectives of this study are to assess the tolerability and efficacy of the anticonvulsant zonisamide in an open label trial of the treatment of alcohol dependence. METHODS: In this trial, zonisamide (400-mg daily) was administered to alcohol-dependent subjects (ADS) (n = 16) over 13 weeks. The mean daily consumption of standard alcoholic drinks and performance on a verbal fluency task, the COWAT, and on a measure of attention and visuomotor speed, the DSMT were assessed, and the occurrence of adverse events was monitored weekly. RESULTS: The mean number of drinks consumed daily was significantly reduced from baseline levels during the treatment period. Performances on the COWAT and on the DSMT were not significantly reduced by zonisamide treatment. Overall, zonisamide was well tolerated by the study subjects. CONCLUSION: These results indicate that zonisamide administration may not impair verbal fluency in ADS, and are consistent with other studies that found zonisamide administration may reduce alcohol intake.


Subject(s)
Alcohol-Related Disorders/drug therapy , Isoxazoles/adverse effects , Adult , Analysis of Variance , Anticonvulsants/administration & dosage , Anticonvulsants/adverse effects , Drug Administration Schedule , Female , Humans , Intention to Treat Analysis , Isoxazoles/administration & dosage , Male , Middle Aged , Patient Selection , Psychiatric Status Rating Scales , Surveys and Questionnaires , Treatment Outcome , Zonisamide
17.
Am J Geriatr Psychiatry ; 17(1): 13-23, 2009 Jan.
Article in English | MEDLINE | ID: mdl-18626002

ABSTRACT

OBJECTIVES: The authors investigated the relationship between brain lithium, serum lithium and age in adult subjects treated with lithium. In addition, the authors investigated the association between brain lithium and serum lithium with frontal lobe functioning and mood in a subgroup of older subjects. DESIGN: Cross-sectional assessment. SETTING: McLean Hospital's Geriatric Psychiatry Research Program and Brain Imaging Center; The Division of Psychiatry, Boston University School of Medicine. PARTICIPANTS: Twenty-six subjects, 20 to 85 years, with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-TR bipolar disorder (BD), currently treated with lithium. MEASUREMENTS: All subjects had measurements of mood (Hamilton Depression Rating Scale [HDRS] and Young Mania Rating Scale) and serum and brain lithium levels. Brain lithium levels were assessed using lithium Magnetic Resonance Spectroscopy. Ten subjects older than 50 years also had assessments of frontal lobe functioning (Stroop, Trails A and B, Wis. Card Sorting Task). RESULTS: Brain lithium levels correlated with serum lithium levels for the group as a whole. However, this relationship was not present for the group of subjects older than 50. For these older subjects elevations in brain (but not serum) lithium levels were associated with frontal lobe dysfunction and higher HDRS scores. The higher HDRS were associated with increased somatic symptoms. CONCLUSION: Frontal lobe dysfunction and elevated depression symptoms correlating with higher brain lithium levels supports conservative dosing recommendations in bipolar older adults. The absence of a predictable relationship between serum and brain lithium makes specific individual predictions about the "ideal" lithium serum level in an older adult with BD difficult.


Subject(s)
Antipsychotic Agents/therapeutic use , Bipolar Disorder/drug therapy , Lithium Compounds/therapeutic use , Adult , Affect/drug effects , Age of Onset , Aged , Aged, 80 and over , Bipolar Disorder/metabolism , Brain Chemistry , Cognition/drug effects , Female , Frontal Lobe/physiology , Humans , Lithium Compounds/blood , Lithium Compounds/metabolism , Magnetic Resonance Spectroscopy , Male , Middle Aged , Neuropsychological Tests
18.
Neuropsychopharmacology ; 33(4): 827-36, 2008 Mar.
Article in English | MEDLINE | ID: mdl-17568399

ABSTRACT

Treatment dropout is a problem of great prevalence and stands as an obstacle to recovery in cocaine-dependent (CD) individuals. Treatment attrition in CD individuals may result from impairments in cognitive control, which can be reliably measured by the Stroop color-word interference task. The present analyses contrasted baseline performance on the color-naming, word-reading, and interference subtests of the Stroop task in CD subjects who completed a cocaine treatment trial (completers: N=50) and those who dropped out of the trial before completion (non-completers: N=24). A logistic regression analysis was used to predict trial completion using three models with the following variables: the Stroop task subscale scores (Stroop model); the Hamilton depression rating scale (HDRS) scores (HDRS model); and both the Stroop task subscale scores and HDRS scores (Stroop and HDRS model). Each model was able to significantly predict group membership (completers vs non-completers) better than a model based on a simple constant (HDRS model p=0.02, Stroop model p=0.006, and Stroop and HDRS model p=0.003). Models using the Stroop preformed better than the HDRS model. These findings suggest that the Stroop task can be used to identify cocaine-dependent subjects at risk for treatment dropout. The Stroop task is a widely available, reliable, and valid instrument that can be easily employed to identify and tailor interventions of at risk individuals in the hope of improving treatment compliance.


Subject(s)
Cocaine-Related Disorders/physiopathology , Cocaine-Related Disorders/psychology , Neuropsychological Tests , Patient Compliance , Adult , Analysis of Variance , Color Perception/physiology , Female , Humans , Logistic Models , Male , Middle Aged , Predictive Value of Tests , Psychiatric Status Rating Scales , Reading , Sensitivity and Specificity
19.
J Trauma Stress ; 20(5): 763-74, 2007 Oct.
Article in English | MEDLINE | ID: mdl-17955544

ABSTRACT

Children and adolescents with maltreatment-related posttraumatic stress disorder (PTSD) exhibit smaller intracranial tissue volume than controls. Linear relationships have also been observed between intracranial tissue volume and the age of maltreatment onset. The authors explored associations among adult PTSD, early trauma, and cerebral volumes in 99 combat veterans. A bone-based estimate of cranial volume was developed to adjust for variation in body size. Posttraumatic stress disorder was not associated with smaller cerebral tissue volume, but rather with smaller cerebrospinal fluid (CSF) and cranial volumes. These findings co-occurred with expected effects of alcoholism and aging on cerebral tissue and CSF volumes. The results point to early developmental divergences between groups with and without PTSD following adult trauma.


Subject(s)
Brain/physiopathology , Cerebrospinal Fluid/metabolism , Skull/physiopathology , Stress Disorders, Post-Traumatic/physiopathology , Adolescent , California , Child , Female , Gulf War , Humans , Magnetic Resonance Imaging , Male , Massachusetts , Vietnam Conflict
20.
J Altern Complement Med ; 13(4): 419-26, 2007 May.
Article in English | MEDLINE | ID: mdl-17532734

ABSTRACT

OBJECTIVES: The aim of this study was to compare changes in brain gamma-aminobutyric (GABA) levels associated with an acute yoga session versus a reading session. It was hypothesized that an individual yoga session would be associated with an increase in brain GABA levels. DESIGN: This is a parallel-groups design. SETTINGS/LOCATION: Screenings, scan acquisitions, and interventions took place at medical school-affiliated centers. SUBJECTS: The sample comprised 8 yoga practitioners and 11 comparison subjects. INTERVENTIONS: Yoga practitioners completed a 60-minute yoga session and comparison subjects completed a 60-minute reading session. OUTCOME MEASURES: GABA-to-creatine ratios were measured in a 2-cm axial slab using magnetic resonance spectroscopic imaging immediately prior to and immediately after interventions. RESULTS: There was a 27% increase in GABA levels in the yoga practitioner group after the yoga session (0.20 mmol/kg) but no change in the comparison subject group after the reading session ( -0.001 mmol/kg) (t = -2.99, df = 7.87, p = 0.018). CONCLUSIONS: These findings demonstrate that in experienced yoga practitioners, brain GABA levels increase after a session of yoga. This suggests that the practice of yoga should be explored as a treatment for disorders with low GABA levels such as depression and anxiety disorders. Future studies should compare yoga to other forms of exercise to help determine whether yoga or exercise alone can alter GABA levels.


Subject(s)
Anxiety/metabolism , Anxiety/prevention & control , Brain/metabolism , Meditation , Yoga , gamma-Aminobutyric Acid/metabolism , Adult , Affect , Female , Humans , Magnetic Resonance Spectroscopy , Male , Mental Health , Middle Aged , Multivariate Analysis , Pilot Projects , Reproducibility of Results , Stress, Psychological/metabolism , Stress, Psychological/prevention & control
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