A pragmatic randomized clinical trial of behavioral activation for depressed pregnant women.

Dimidjian, Sona; Goodman, Sherryl H.; Sherwood, Nancy E.; Simon, Gregory E.; Ludman, Evette; Gallop, Robert; Welch, Stacy Shaw; Boggs, Jennifer M.; Metcalf, Christina A.; Hubley, Samuel; Powers, J. David; Beck, Arne

doi:10.1037/ccp0000151

Cited by 99 publications

(103 citation statements)

References 65 publications

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“…At the same time, our mediation analysis suggested that patient-reported levels of behavioural activation at 3 months mediated the effects of HAP in reducing depression severity at 12 months. This suggests that behavioural activation may underlie HAP’s sustained effects and, thus, adds to existing evidence suggesting that patient-reported activation levels mediate response to behavioural activation therapy as specified by theory [ 47 , 48 ].…”

Section: Discussionsupporting

confidence: 56%

Sustained effectiveness and cost-effectiveness of the Healthy Activity Programme, a brief psychological treatment for depression delivered by lay counsellors in primary care: 12-month follow-up of a randomised controlled trial

et al. 2017

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BackgroundThe Healthy Activity Programme (HAP), a brief behavioural intervention delivered by lay counsellors, enhanced remission over 3 months among primary care attendees with depression in peri-urban and rural settings in India. We evaluated the sustainability of the effects after treatment termination, the cost-effectiveness of HAP over 12 months, and the effects of the hypothesized mediator of activation on clinical outcomes.Methods and findingsPrimary care attendees aged 18–65 years screened with moderately severe to severe depression on the Patient Health Questionnaire 9 (PHQ-9) were randomised to either HAP plus enhanced usual care (EUC) (n = 247) or EUC alone (n = 248), of whom 95% completed assessments at 3 months, and 91% at 12 months. Primary outcomes were severity on the Beck Depression Inventory–II (BDI-II) and remission on the PHQ-9. HAP participants maintained the gains they showed at the end of treatment through the 12-month follow-up (difference in mean BDI-II score between 3 and 12 months = −0.34; 95% CI −2.37, 1.69; p = 0.74), with lower symptom severity scores than participants who received EUC alone (adjusted mean difference in BDI-II score = −4.45; 95% CI −7.26, −1.63; p = 0.002) and higher rates of remission (adjusted prevalence ratio [aPR] = 1.36; 95% CI 1.15, 1.61; p < 0.009). They also fared better on most secondary outcomes, including recovery (aPR = 1.98; 95% CI 1.29, 3.03; p = 0.002), any response over time (aPR = 1.45; 95% CI 1.27, 1.66; p < 0.001), higher likelihood of reporting a minimal clinically important difference (aPR = 1.42; 95% CI 1.17, 1.71; p < 0.001), and lower likelihood of reporting suicidal behaviour (aPR = 0.71; 95% CI 0.51, 1.01; p = 0.06). HAP plus EUC also had a marginal effect on WHO Disability Assessment Schedule score at 12 months (aPR = −1.58; 95% CI −3.33, 0.17; p = 0.08); other outcomes (days unable to work, intimate partner violence toward females) did not statistically significantly differ between the two arms. Economic analyses indicated that HAP plus EUC was dominant over EUC alone, with lower costs and better outcomes; uncertainty analysis showed that from this health system perspective there was a 95% chance of HAP being cost-effective, given a willingness to pay threshold of Intl$16,060—equivalent to GDP per capita in Goa—per quality-adjusted life year gained. Patient-reported behavioural activation level at 3 months mediated the effect of the HAP intervention on the 12-month depression score (β = −2.62; 95% CI −3.28, −1.97; p < 0.001). Serious adverse events were infrequent, and prevalence was similar by arm. We were unable to assess possible episodes of remission and relapse that may have occurred between our outcome assessment time points of 3 and 12 months after randomisation. We did not account for or evaluate the effect of mediators other than behavioural activation.ConclusionsHAP’s superiority over EUC at the end of treatment was largely stable over time and was mediated by patient activation. HAP provides better outcomes at lower costs from a...

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Section: Discussionsupporting

confidence: 56%

Sustained effectiveness and cost-effectiveness of the Healthy Activity Programme, a brief psychological treatment for depression delivered by lay counsellors in primary care: 12-month follow-up of a randomised controlled trial

et al. 2017

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“…Feasibility of study Feasibility will be defined according to several metrics, including feasible recruitment, enrollment, and retention. Estimates are derived from previous longitudinal studies with pregnant women [65,[87][88][89][90]. Feasible recruitment will be defined as identifying at least 480 potentially eligible patients based upon medical record review by research staff to approach during the prenatal intake visit.…”

Section: Primary Outcomesmentioning

confidence: 99%

“…Acceptability of IPT Acceptability will first be measured by IPT session attendance. Acceptable IPT session attendance will be defined by 50% of participants randomized to IPT attending 5 or 6 (≥ 80%) of the total 6 sessions [87][88][89][90]. Acceptability will also be measured by participant ratings on a program acceptability interview adapted for the current study from the Treatment Process Questionnaire and administered by a project staff at the end of treatment assessment [66].…”

Section: Primary Outcomesmentioning

confidence: 99%

Protocol for a pilot randomized controlled feasibility study of brief interpersonal psychotherapy for addressing social-emotional needs and preventing excess gestational weight gain in adolescents

Shomaker

Gulley

Clark

et al. 2020

Pilot Feasibility Stud

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Background: Excess gestational weight gain (GWG) in pregnant adolescents is a major public health concern. Excess GWG increases risk of pregnancy complications as well as postpartum and offspring obesity and cardiometabolic disease. Prevention interventions for pregnant adults that target lifestyle modification (i.e., healthy eating/physical activity) show insufficient effectiveness. Pregnant adolescents have distinct social-emotional needs, which may contribute to excess GWG. From an interpersonal theoretical framework, conflict and low social support increase negative emotions, which in turn promote excess GWG through mechanisms such as overeating and physical inactivity.Methods: The current manuscript describes the design of a pilot randomized controlled feasibility trial of adolescent interpersonal psychotherapy (IPT) to address social-emotional needs and prevent excess GWG. Up to 50 pregnant, healthy adolescents 13-19y, 12-18 weeks gestation are recruited from an interdisciplinary adolescent maternity hospital clinic and randomized to IPT + usual care or usual care alone. IPT involves 6 individual 60-minute sessions delivered by a trained behavioral health clinician during 12-30 weeks gestation. Sessions include relationship psychoeducation, emotion identification and expression, and teaching/role-playing communication skills. Between sessions, adolescents are instructed to complete a daily journal and to have conversations to work on relationship goals. Outcomes are assessed at baseline, mid-program, post-program, and 3-months postpartum. Primary outcomes are feasibility and acceptability based upon rate of recruitment, session attendance, program acceptability ratings, and follow-up retention. Secondary outcomes are perinatal social functioning, stress, depression, and eating behaviors assessed with validated surveys and interviews; perinatal physical activity and (Continued on next page)

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“…Each therapy session is video and audio-recorded and at least 20% of sessions will be randomly selected for fidelity ratings. Skill acquisition and fidelity is assessed using the Quality of Behavioral Activation Scale (Q-BAS) for BA (66)(67)(68) and a fidelity form created for the EXP treatment by RLA in consultation with MGC and KWT. Fidelity ratings will be provided by experts in each therapy (KWT; CM) or their trainees.…”

Section: Here]mentioning

confidence: 99%

Protocol for a Randomized Controlled Trial Examining Multi-level Prediction of Response to Behavioral Activation and Exposure-based Therapy for Generalized Anxiety Disorder

Santiago

Akeman

Kirlić

et al. 2019

Preprint

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Background: Only 40 to 60% of patients with generalized anxiety disorder experience long-lasting improvement with gold-standard psychosocial interventions. Identifying neurobehavioral factors that predict treatment success might provide specific targets for more individualized interventions, fostering more optimal outcomes and bringing us closer to the goal of “personalized medicine.” Research suggests that reward and threat processing (approach/avoidance behavior) and cognitive control may be important for understanding anxiety and comorbid depressive disorders and have relevance to treatment outcomes. This study was designed to determine whether approach-avoidance behaviors and associated neural responses moderate treatment response to exposure-based versus behavioral activation therapy for generalized anxiety disorder. Methods: We are conducting a randomized, controlled trial involving two ten-week, group-based interventions – exposure-based therapy or behavioral activation therapy. These interventions focus on specific and unique aspects of threat and reward processing, respectively. Prior to and after treatment, participants are interviewed and undergo behavioral, biomarker and neuroimaging assessments, with a focus on approach and avoidance processing and decision-making. Primary analyses will utilize mixed models to examine whether hypothesized approach, avoidance, and conflict arbitration behaviors and associated neural responses at baseline moderate symptom change with treatment, as assessed using the GAD-7. Exploratory analyses will examine additional potential treatment moderators and utilize data reduction and machine learning methods. Discussion: This protocol provides a framework for how studies may be designed to move the field towards neuroscience-informed and personalized psychosocial treatments. Results will have implications for approach-avoidance processing in generalized anxiety disorder, relationships between levels of analysis (i.e., behavioral, neural), and predictors of behavioral therapy outcome. Trial registration: The study was retrospectively registered within 21 days of first participant enrollment in accordance with FDAAA 801 at the US National Institutes of Health (ClinicalTrials.gov) #NCT02807480 (registration date: June 21, 2016), pre-results.

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A pragmatic randomized clinical trial of behavioral activation for depressed pregnant women.

Cited by 99 publications

References 65 publications

Sustained effectiveness and cost-effectiveness of the Healthy Activity Programme, a brief psychological treatment for depression delivered by lay counsellors in primary care: 12-month follow-up of a randomised controlled trial

Sustained effectiveness and cost-effectiveness of the Healthy Activity Programme, a brief psychological treatment for depression delivered by lay counsellors in primary care: 12-month follow-up of a randomised controlled trial

Protocol for a pilot randomized controlled feasibility study of brief interpersonal psychotherapy for addressing social-emotional needs and preventing excess gestational weight gain in adolescents

Protocol for a Randomized Controlled Trial Examining Multi-level Prediction of Response to Behavioral Activation and Exposure-based Therapy for Generalized Anxiety Disorder

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