scholarly journals The Appalachia Mind Health Initiative (AMHI): A pragmatic clinical trial of adjunctive internet-based Cognitive Behavior Therapy for treating major depressive disorder among primary care patients

Author(s):  
Robert M. Bossarte ◽  
Ronald C. Kessler ◽  
Andrew A. Nierenberg ◽  
Pim Cuijpers ◽  
Angel Enrique ◽  
...  

Abstract Background: Major Depressive Disorder (MDD) is a leading cause of disease morbidity. Combined treatment with antidepressant medication (ADM) plus psychotherapy yields a much higher MDD remission rate than ADM-only. But 77% of US MDD patients are nonetheless treated with ADM-only despite strong patient preferences for psychotherapy. This mismatch is due at least in part to a combination of cost considerations and limited availability of psychotherapists, although stigma and reluctance of PCPs to refer patients for psychotherapy are also involved. Internet-based Cognitive Behavior Therapy (i-CBT) addresses all of these problems. Methods: Enrolled patients (n=3,360) will be those who are beginning ADM-only treatment of MDD in primary care facilities throughout West Virginia, one of the poorest and most rural states in the country. Participating treatment providers and study staff at West Virginia University School of Medicine (WVU) will recruit patients and, after obtaining informed consent, administer a baseline self-report questionnaire (SRQ) and then randomize patients to 1 of 3 treatment arms with equal allocation: ADM-only, ADM + self-guided i-CBT, and ADM + guided i-CBT. Follow-up SRQs will be administered 2, 4, 8, 13, 16, 26, 39, and 52 weeks after randomization. The trial has two primary objectives: to evaluate aggregate comparative treatment effects across the 3 arms; and to estimate heterogeneity of treatment effects (HTE). The primary outcome will be episode remission based on a modified version of the patient-centered Remission from Depression Questionnaire (RDQ). The sample was powered to detect predictors of HTE that would increase the proportional remission rate by 20% by optimally assigning individuals as opposed to randomly assigning them into three treatment groups of equal size. Aggregate comparative treatment effects will be estimated using intent-to-treat analysis methods. Cumulative inverse probability weights will be used to deal with loss to follow-up. A wide range of self-report predictors of MDD heterogeneity of treatment effects based on previous studies will be included in the baseline SRQ. A state-of-the-art ensemble machine learning method will be used to estimate HTE.Discussion: The study is innovative in using a rich baseline assessment and in having a sample large enough to carry out a well-powered analysis of heterogeneity of treatment effects. We anticipate finding that self-guided and guided i-CBT will both improve outcomes compared to ADM-only. We also anticipate finding that the comparative advantages of adding i-CBT to ADM will vary significantly across patients. We hope to develop a stable individualized treatment rule that will allow patients and treatment providers to improve aggregate treatment outcomes by deciding collaboratively when ADM treatment should be augmented with i-CBT. Trial registration: The Appalachian Mind Health Initiative (AMHI; registry name) was prospectively registered on 10/9/19 (ClinicalTrials.gov Identifier: NCT04120285).

SLEEP ◽  
2020 ◽  
Vol 43 (Supplement_1) ◽  
pp. A349-A349
Author(s):  
E Bourchtein ◽  
K Puzino ◽  
S L Calhoun ◽  
C Criley ◽  
F He ◽  
...  

Abstract Introduction A strong body of cross-sectional evidence indicates that social determinants of health (SDH), such as race, ethnicity, socioeconomic status, and sex/gender, are linked to sleep problems, including insomnia symptoms. Few studies have examined the longitudinal association between SDH and the persistence and remission of insomnia symptoms in the transition between childhood and adolescence, a critical period for sleep health. Methods The Penn State Child Cohort is a random, population-based sample of 700 children (5-12y at baseline), of whom 421 were followed up as adolescents (12-23y at follow-up). All subjects underwent polysomnography, clinical history, physical exam, and parent- and self-reported scales at baseline and follow-up. Childhood insomnia symptoms were defined as a parent- and/or self-report of difficulty falling and/or staying asleep. All subjects or their parents identified the subject’s sex, race, and ethnicity, and reported on socioeconomic status (SES) of the household. Results Females (32.7%) and racial/ethnic minorities (25.0%) were associated with a significantly lower remission rate as compared to males (53.3%) and non-Hispanic whites (48.3%), respectively. Non-Hispanic whites of low SES were associated with a significantly lower full remission rate (26.3%) as compared to non-Hispanic whites of higher SES (42.0%), while racial/ethnic minorities were associated with the lowest full remission rates regardless of whether they were of low (9.1%) or higher (11.1%) SES. Conclusion Our novel data indicate that gender-, racial/ethnic- and socioeconomic-related disparities in insomnia not only occur as early as childhood but are important determinants of insomnia’s chronic course throughout development. Support National Institutes of Health (R01HL136587, R01HL97165, R01HL63772, UL1TR000127)


2011 ◽  
Vol 26 (S2) ◽  
pp. 700-700
Author(s):  
M. Garcia-Toro ◽  
E. Valmisa ◽  
J. Galan ◽  
S. Ros

IntroductionThe STAR*D is a pragmatic clinical trial that showed lower remission rate and higher relapse rate when more strategies were used.[1]Objectives and aimsAssess clinical improvement in symptoms related to depression, anxiety and sleep, based on the number of strategies used.MethodsDescriptive, non-interventional, prospective study including outpatients diagnosed with Major Depressive Disorder (MDD) with sub-optimal response to standard antidepressants. In those patients a change on the therapeutic strategy (switch of antidepressant, combination of antidepressants, augmentation or a combination of previous strategies) had to be considered necessary. Follow-up period was 22–26 weeks.Results364 patients were included by 58 psychiatrists, 336 were analyzed (92.3%) and 315 (86.5%) completed the follow-up.[Difference last visit vs. basal]p < 0.0001 in all measuresConclusionsThe more changes on strategies used the less improvement on clinical symptoms and remission rates.This study has been sponsored by AstraZeneca Farmaceutica Spain, SA.


1998 ◽  
Vol 26 (3) ◽  
pp. 271-282 ◽  
Author(s):  
Nigar G. Khawaja ◽  
Tian P. S. Oei

The present study used two single case studies to evaluate clinical improvement as a result of cognitive behavior therapy in panic disorder with or without agoraphobia (PDA). A special emphasis was placed on assessing the reduction in catastrophic cognitions, which are considered to be of prime importance in PDA. Multiple measures were employed, during pre and post treatment and at a six month follow-up. Data from self-report questionnaires, physiological measures and cognitive sampling during in vivo exposure were used. Convergent results demonstrated clinical improvement and supported the importance of catastrophic cognitions in the process of change for treatment outcome of PDA.


1986 ◽  
Vol 148 (6) ◽  
pp. 648-654 ◽  
Author(s):  
R. M. A. Hirschfeld ◽  
G. L. Klerman ◽  
N. C. Andreasen ◽  
P. J. Clayton ◽  
M. B. Keller

Nineteen patients with an episode of major depressive disorder who did not recover within two years of prospective follow-up were compared with an equal number who recovered within a year of the initial evaluation and remained well through the two-year follow-up date. The groups were individually matched for age, sex, primary/secondary status, and prior duration of episode. The only psycho-social variable that predicted chronicity was increased neuroticism on self-report personality inventories administered during the index evaluation. Early loss, recent life events, and recent social supports were not predictive of outcome.


2019 ◽  
Author(s):  
Igor Burstyn ◽  
Andrea Z. LaCroix ◽  
Irene Litvan ◽  
Robert B. Wallace ◽  
Harvey Checkoway

AbstractIntroductionThere is a lack of consistency in associations between workplace factors and risk of Parkinson disease (PD), and paucity of such data on women. We took a classic occupational epidemiology approach that assesses associations with occupational groups in order to derive insights about potential occupation-specific exposures that may be causal.MethodsThe Women’s Health Initiative (WHI-OS) is a prospective cohort that enrolled 91,627 postmenopausal women, 50 to 79 years of age from 10/01/93 to 12/31/98, at 40 clinical centers across the US with average follow-up of 11 years, who reported up to three paid jobs held the longest since age 18; these jobs were coded and duration of employment calculated. We defined the case by self-report of doctor-diagnosed PD (at baseline or follow-up), death attributed to PD, or medication consistent with PD.ResultsAmong 2,590 cases, we report evidence of excess risk among “counselors, social workers, and other community and social service specialists”. There was a suggestion of increase in risk among post-secondary teachers, and “building and grounds cleaning and maintenance”. There was also evidence of deficit in risk among women who worked in sales.Results with ever-employed and duration were similar, except for evidence of excess of risk among “health technologists and technicians” with more than 20 years of employment. Longer duration of life on a farm was associated with higher risk.ConclusionOur findings paint a largely reassuring picture of occupational risks for PD among US women, especially for trades largely unaffected by recent technological advances.


2009 ◽  
Vol 40 (1) ◽  
pp. 41-50 ◽  
Author(s):  
A. A. Nierenberg ◽  
M. M. Husain ◽  
M. H. Trivedi ◽  
M. Fava ◽  
D. Warden ◽  
...  

BackgroundMany patients with major depressive disorder (MDD) who experience full symptomatic remission after antidepressant treatment still have residual depressive symptoms. We describe the types and frequency of residual depressive symptoms and their relationship to subsequent depressive relapse after treatment with citalopram in the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial.MethodParticipants in primary (n=18) and psychiatric (n=23) practice settings were openly treated with citalopram using measurement-based care for up to 14 weeks and follow-up for up to 1 year. We assessed 943 (32.8% of 2876) participants who met criteria for remission to determine the proportions with individual residual symptoms and any of the nine DSM-IV criterion symptom domains to define a major depressive episode. At each visit, the 16-item Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR16) and the self-report Frequency, Intensity, and Burden of Side Effects Rating (FIBSER) scale were used to assessed depressive symptoms and side-effects respectively.ResultsMore than 90% of remitters had at least one residual depressive symptom (median=3). The most common were weight increase (71.3%) and mid-nocturnal insomnia (54.9%). The most common residual symptom domains were sleep disturbance (71.7%) and appetite/weight disturbance (35.9%). Those who remitted before 6 weeks had fewer residual symptoms at study exit than did later remitters. Residual sleep disturbance did not predict relapse during follow-up. Having a greater number of residual symptom domains was associated with a higher probability of relapse.ConclusionsPatients with remission of MDD after treatment with citalopram continue to experience selected residual depressive symptoms, which increase the risk of relapse.


2010 ◽  
Vol 24 (1) ◽  
pp. 33-40 ◽  
Author(s):  
Miroslaw Wyczesany ◽  
Jan Kaiser ◽  
Anton M. L. Coenen

The study determines the associations between self-report of ongoing emotional state and EEG patterns. A group of 31 hospitalized patients were enrolled with three types of diagnosis: major depressive disorder, manic episode of bipolar affective disorder, and nonaffective patients. The Thayer ADACL checklist, which yields two subjective dimensions, was used for the assessment of affective state: Energy Tiredness (ET) and Tension Calmness (TC). Quantitative analysis of EEG was based on EEG spectral power and laterality coefficient (LC). Only the ET scale showed relationships with the laterality coefficient. The high-energy group showed right shift of activity in frontocentral and posterior areas visible in alpha and beta range, respectively. No effect of ET estimation on prefrontal asymmetry was observed. For the TC scale, an estimation of high tension was related to right prefrontal dominance and right posterior activation in beta1 band. Also, decrease of alpha2 power together with increase of beta2 power was observed over the entire scalp.


Crisis ◽  
2010 ◽  
Vol 31 (5) ◽  
pp. 238-246 ◽  
Author(s):  
Paul W. C. Wong ◽  
Wincy S. C. Chan ◽  
Philip S. L. Beh ◽  
Fiona W. S. Yau ◽  
Paul S. F. Yip ◽  
...  

Background: Ethical issues have been raised about using the psychological autopsy approach in the study of suicide. The impact on informants of control cases who participated in case-control psychological autopsy studies has not been investigated. Aims: (1) To investigate whether informants of suicide cases recruited by two approaches (coroners’ court and public mortuaries) respond differently to the initial contact by the research team. (2) To explore the reactions, reasons for participation, and comments of both the informants of suicide and control cases to psychological autopsy interviews. (3) To investigate the impact of the interviews on informants of suicide cases about a month after the interviews. Methods: A self-report questionnaire was used for the informants of both suicide and control cases. Telephone follow-up interviews were conducted with the informants of suicide cases. Results: The majority of the informants of suicide cases, regardless of the initial route of contact, as well as the control cases were positive about being approached to take part in the study. A minority of informants of suicide and control cases found the experience of talking about their family member to be more upsetting than expected. The telephone follow-up interviews showed that none of the informants of suicide cases reported being distressed by the psychological autopsy interviews. Limitations: The acceptance rate for our original psychological autopsy study was modest. Conclusions: The findings of this study are useful for future participants and researchers in measuring the potential benefits and risks of participating in similar sensitive research. Psychological autopsy interviews may be utilized as an active engagement approach to reach out to the people bereaved by suicide, especially in places where the postvention work is underdeveloped.


2019 ◽  
Author(s):  
Thomas M Olino ◽  
Daniel Klein ◽  
John Seeley

Background: Most studies examining predictors of onset of depression focus on variable centered regression methods that focus on effects of multiple predictors. In contrast, person-centered approaches develop profiles of factors and these profiles can be examined as predictors of onset. Here, we developed profiles of adolescent psychosocial and clinical functioning among adolescents without a history of major depression. Methods: Data come from a subsample of participants from the Oregon Adolescent Depression Project who completed self-report measures of functioning in adolescence and completed diagnostic and self-report measures at follow-up assessments up to approximately 15 years after baseline. Results: We identified four profiles of psychosocial and clinical functioning: Thriving; Average Functioning; Externalizing Vulnerability and Family Stress; and Internalizing Vulnerability at the baseline assessment of participants without a history of depression at the initial assessment in mid- adolescence. Classes differed in the likelihood of onset and course of depressive disorders, experience of later anxiety and substance use disorders, and psychosocial functioning in adulthood. Moreover, the predictive utility of these classes was maintained when controlling for multiple other established risk factors for depressive disorders. Conclusions: This work highlights the utility of examining multiple factors simultaneously to understand risk for depression.


1999 ◽  
Vol 27 (3) ◽  
pp. 215-222 ◽  
Author(s):  
Peter L. Cornwall ◽  
Jan Scott

We report a subgroup analysis of 24 out of 42 subjects who were hospitalized for non-psychotic major depressive disorder and who agreed to participate in interviews at admission and 2 years afterwards (as reported previously by Domken, Scott, & Kelly, 1994; Bothwell & Scott, 1997). At 2 year follow-up, these 24 subjects were categorized according to established criteria into clients meeting criteria for full remission (FR; n=9) and those meeting criteria for partial remission (PR; n=15). The most striking findings were that, over time, PR subjects showed significant loss of self-esteem and showed greater divergence in self-ratings compared to observer ratings of their depressive symptoms, whilst the same ratings in the FR group changed in the opposite direction. We suggest that the persistence of depression in PR subjects may provide evidence to support Teasdale’s (1988) hypothesis that some individuals “get depressed about being depressed”. The research and clinical implications of the results are noted.


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