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Feasibility and impact of a guided symptom exposure augmented cognitive behavior therapy protocol to prevent symptoms of pharmacologically induced depression: A pilot study.

ABSTRACT: Depression is the leading cause of disability and a major cause of morbidity worldwide, with societal costs now upwards of 1 trillion dollars across the globe. Hence, extending current efforts to augment prevention outcomes is consistent with global public health interests. Although many prevention programs have been developed and have demonstrated efficacy, studies have yet to demonstrate that CBT is effective in preventing symptoms in populations at risk for developing depression induced by pharmacological substances. Using a randomized, controlled design, this pilot study reports on the feasibility and preliminary effects of a novel, guided symptom exposure augmented cognitive behavioral prevention intervention (GSE-CBT) in a sample diagnosed with Hepatitis C at risk for developing medication induced depression. Results demonstrated that the guided symptom exposure augmented CBT (GSE-CBT) was feasible in this population and was delivered with high integrity. Although not statistically different, we observed a pattern of lower depression levels in the GSE-CBT group versus those in the control group throughout. This pilot study demonstrates that a psychosocial prevention intervention is feasible for use in patients at risk for developing pharmacologically induced depression and that a guided symptom exposure augmented CBT protocol has the potential to prevent symptoms of depression that develop as a side effect to taking these medications. Results are preliminary and future studies should use larger samples and test the intervention in other populations.

SUBMITTER: McGinn LK

PROVIDER: S-EPMC6880945 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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Feasibility and impact of a guided symptom exposure augmented cognitive behavior therapy protocol to prevent symptoms of pharmacologically induced depression: A pilot study.

McGinn Lata K LK Van Meter Anna A Kronish Ian I Gashin Jessica J Burns Karen K Kil Natalie N McGinn Thomas G TG

Cognitive therapy and research 20190212 4

Depression is the leading cause of disability and a major cause of morbidity worldwide, with societal costs now upwards of 1 trillion dollars across the globe. Hence, extending current efforts to augment prevention outcomes is consistent with global public health interests. Although many prevention programs have been developed and have demonstrated efficacy, studies have yet to demonstrate that CBT is effective in preventing symptoms in populations at risk for developing depression induced by ph ...[more]

PMID: 31777409

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Project description:Up to 50% of patients undergoing hemodialysis suffer from symptoms of depression and/or anxiety. Access to traditional pharmacotherapies and psychotherapies for depression or anxiety in this patient population has been inadequate. The objective of this study was to investigate the feasibility and effectiveness of brief mindfulness meditation intervention for patients on hemodialysis with depression and anxiety symptoms.This study was a randomized, controlled, assessor-blinded trial conducted in an urban hemodialysis unit. Forty-one patients were randomly assigned to intervention (n=21) and treatment-as-usual (n=20) groups. The intervention group received an 8-week individual chairside meditation intervention lasting 10-15 minutes, three times a week during hemodialysis. Feasibility outcomes were primarily assessed: enrollment rates, intervention completion rates, and intervention tolerability. Symptoms of depression and anxiety were measured using the Patient Health Questionnaire (PHQ-9) and the General Anxiety Disorder-7 (GAD-7).Of those deemed eligible for the study, 67% enrolled (41 of 61). Of the participants randomized to the intervention group, 71% completed the study, with meditation being well tolerated (median rating of 8 of 10 in a Likert scale; interquartile range=10-5 of 10). Barriers to intervention delivery included frequent hemodialysis shift changes, interruptions by staff or alarms, space constraints, fluctuating participant medical status, and participant fatigue. Meditation was associated with subjective benefits but no statistically significant effect on depression scores (change in PHQ-9, -3.0±3.9 in the intervention group versus -2.0±4.7 in controls; P=0.45) or anxiety scores (change in GAD-7, -0.9±4.6 versus -0.8±4.8; P=0.91).On the basis of the results of this study, mindfulness meditation appears to be feasible and well tolerated in patients on hemodialysis with anxiety and depression symptoms. The study did not reveal significant effects of the interventions on depression and anxiety scores.This article contains a podcast at https://www.asn-online.org/media/podcast/CJASN/2017_10_12_CJASNPodcast_17_12_.mp3.

Project description:BackgroundMothers who identify as Black or African American are more likely to report depressed moods in late pregnancy and early postpartum and have the lowest rates of human milk feeding compared with all other racial groups in the United States. Internet interventions offer the potential to extend preventative and supportive services as they address key barriers, particularly for those navigating the complex and vulnerable early postpartum period. However, there is limited evidence on the feasibility of such interventions for preventing perinatal mental health disorders and improving human milk feeding outcomes in Black mothers.ObjectiveThis pilot study aimed to assess the feasibility and preliminary findings of a web-based cognitive behavioral therapy-based internet intervention, with and without human milk feeding education and support, to prevent perinatal depression and promote human milk feeding in Black mothers.MethodsParticipants were Black-identifying individuals between 20 and 28 weeks of pregnancy with human milk feeding intention and mild to moderate depressive symptoms (Patient Health Questionnaire scores 5-14). Participants were randomized to either Sunnyside, a 6-week cognitive behavioral therapy-based web-based intervention, or Sunnyside Plus, which included additional education and support to promote human milk feeding. Assessments occurred at baseline, third trimester (end of antenatal treatment), 6 weeks postpartum (end of postpartum treatment), and 12 weeks postpartum. The primary focus of this randomized pilot trial was the feasibility and preliminary outcomes of mental health and human milk feeding.ResultsA total of 22 tertiary-educated participants were randomized. The mean number of log-ins was 7.3 (SD 5.3) for Sunnyside and 13.8 (SD 10.5) for Sunnyside Plus. Scores of depression and anxiety measures remained below the clinical threshold for referral to treatment in both groups. All the participants initiated human milk feeding (18/18, 100%). Most participants reported at least some human milk feeding at both 6 and 12 weeks postpartum (6/7, 86%; 11/11, 100%, or 10/10, 100%, for Sunnyside and Sunnyside Plus, respectively).ConclusionsThe results suggest that tertiary-educated Black mothers at risk for perinatal depression and who intended to human milk feed were receptive to and satisfied with a web-based cognitive behavioral therapy-based internet intervention, with and without human milk feeding education and support. Preliminary findings indicate that both Sunnyside and Sunnyside Plus interventions have the potential to affect symptoms of depression, anxiety, and human milk feeding outcomes.Trial registrationClinicalTrials.gov NCT04128202; https://www.clinicaltrials.gov/ct2/show/NCT04128202.

Project description:BackgroundWhile existing psychological treatments for depression are effective for many, a significant proportion of depressed individuals do not respond to current approaches and few remain well over the long-term. Anhedonia (a loss of interest or pleasure) is a core symptom of depression which predicts a poor prognosis but has been neglected by existing treatments. Augmented Depression Therapy (ADepT) has been co-designed with service users to better target anhedonia alongside other features of depression. This mixed methods pilot trial aims to establish proof of concept for ADepT and to examine the feasibility and acceptability of a future definitive trial evaluating the clinical and cost-effectiveness of ADepT, compared to an evidence-based mainstream therapy (Cognitive Behavioural Therapy; CBT) in the acute treatment of depression, the prevention of subsequent depressive relapse, and the enhancement of wellbeing.MethodsWe aim to recruit 80 depressed participants and randomise them 1:1 to receive ADepT (15 weekly acute and 5 booster sessions in following year) or CBT (20 weekly acute sessions). Clinical and health economic assessments will take place at intake and at 6-, 12-, and 18-month follow-up. Reductions in PHQ-9 depression severity and increases in WEMWBS wellbeing at 6-month assessment (when acute treatment should be completed) are the co-primary outcomes. Quantitative and qualitative process evaluation will assess mechanism of action, implementation issues, and contextual moderating factors. To evaluate proof of concept, intake-post effect sizes and the proportion of individuals showing reliable and clinically significant change on outcome measures in each arm at each follow-up will be reported. To evaluate feasibility and acceptability, we will examine recruitment, retention, treatment completion, and data completeness rates and feedback from patients and therapists about their experience of study participation and therapy. Additionally, we will establish the cost of delivery of ADepT.DiscussionWe will proceed to definitive trial if any concerns about the safety, acceptability, feasibility, and proof of concept of ADepT and trial procedures can be rectified, and we recruit, retain, and collect follow-up data on at least 60% of the target sample.Trial registrationISCRTN85278228, registered 27/03/2017.

Project description:Importance: Reducing poststroke sedentary behavior is important for reducing recurrent stroke risk, yet interventions to achieve this are scant.Objective: To assess the feasibility of, and estimate change in sedentary behavior over time associated with, a behavioral intervention.Design: Single-arm delayed baseline with postintervention and 8-wk follow-up assessment.Setting: Community based.Participants: Ambulatory, community-dwelling people with chronic stroke and reported ?6 hr daily sitting time (N = 21).Intervention: Activating Behavior for Lasting Engagement (ABLE) was delivered by an occupational therapist 3×/wk for 4 wk. ABLE involves activity monitoring, activity scheduling, self-assessment, and collaborative problem solving.Outcomes and measures: Feasibility (participant safety, adherence, satisfaction, and reliable intervention delivery) was assessed against preestablished benchmarks. Changes over time in sedentary behavior (assessed with an ActivPAL micro3 device) and participation (Stroke Impact Scale-Participation subscale) were described.Results: ABLE was safe (0 serious adverse events), adhered to (11.95 sessions/participant), and reliably delivered (90.00%-97.50% adherence). Participant satisfaction was unmet (Client Satisfaction Questionnaire-8, M = 28.75, SD = 3.84). ABLE was associated with a mean group reduction in prolonged sitting of 54.95 min (SD = 81.10) at postintervention and 14.08 (SD = 58.95) at follow-up. ABLE was associated with a negligible mean group increase over time in participation at postintervention (M = 1.48%, SD = 8.52) and follow-up (M = 1.33%, SD = 15.38).Conclusions and relevance: The ABLE intervention is feasible and may be associated with within-group reduction in sedentary behavior over time. Further refinement is indicated.What this article adds: The ABLE intervention uses engagement in meaningful daily activities to reduce sedentary behavior after stroke. These findings suggest that ABLE can be delivered safely and consistently. Further research is required to enhance participant satisfaction and determine the effects of ABLE on stroke survivors' sedentary behavior.

Project description:BackgroundImpaired balance leading to falls is common in the older adults, and there is strong evidence that balance training reduces falls and increases independence. Reduced resources in health care will result in fewer people getting help with rehabilitation training. In this regard, the new technology augmented reality (AR) could be helpful. With AR, the older adults can receive help with instructions and get feedback on their progression in balance training. The purpose of this pilot study was to examine the feasibility of using AR-based visual-interactive tools in balance training of the older adults.MethodsSeven older adults (66-88 years old) with impaired balance trained under supervision of a physiotherapist twice a week for six weeks using AR-based visual-interactive guidance, which was facilitated through a Microsoft HoloLens holographic display. Afterwards, participants and physiotherapists were interviewed about the new technology and their experience of the training. Also, fear of falling and balance ability were measured before and after training.ResultsFive participants experienced the new technology as positive in terms of increased motivation and feedback. Experiences were mixed regarding the physical and technical aspects of the HoloLens and the design of the HoloLens application. Participants also described issues that needed to be further improved, for example, the training program was difficult and monotonous. Further, the HoloLens hardware was felt to be heavy, the application's menu was difficult to control with different hand manoeuvres, and the calibration took a long time. Suggestions for improvements were described. Results of the balance tests and self-assessment instruments indicated no improvements in balance performance after AR training.ConclusionsThe study showed that training with the new technology is, to some extent, feasible for the older adults, but needs further development. Also, the technology seemed to stimulate increased motivation, which is a prerequisite for adherence to training. However, the new technology and training requires further development and testing in a larger context.

Project description:ObjectiveAccess to effective treatments for adolescents with depression needs to improve. Few studies have evaluated behavioural activation (BA) for adolescent depression, and none remotely delivered BA. This study explored the feasibility and acceptability of therapist-guided and self-guided internet-delivered BA (I-BA) in preparation for a future randomised controlled trial (RCT).DesignA single-blinded randomised controlled feasibility trial.SettingA specialist outpatient clinic in Sweden.ParticipantsThirty-two adolescents with mild-to-moderate major depression, aged 13-17 years.InterventionsTen weeks of therapist-guided I-BA or self-guided I-BA, or treatment as usual (TAU). Both versions of I-BA included parental support. TAU included referral to usual care within child and youth psychiatry or primary care.OutcomesFeasibility measures included study take-up, participant retention, acceptability, safety and satisfaction. The primary outcome measure was the blinded assessor-rated Children's Depression Rating Scale, Revised. The primary endpoint was the 3-month follow-up.Results154 adolescents were screened and 32 were randomised to therapist-guided I-BA (n=11), self-guided I-BA (n=10) or TAU (n=11). Participant retention was acceptable, with two drop-outs in TAU. Most participants in TAU had been offered interventions by the primary endpoint. The mean number of completed chapters (total of 8) for adolescents was 7.5 in therapist-guided I-BA and 5.4 in self-guided I-BA. No serious adverse events were recorded. Satisfaction was acceptable in both I-BA groups. Following an intent-to-treat approach, the linear mixed-effects model revealed that both therapist-guided and self-guided I-BA (Cohen's d=2.43 and 2.23, respectively), but not TAU (Cohen's d=0.95), showed statistically significant changes on the primary outcome measure with large within-group effect sizes.ConclusionsBoth therapist-guided and self-guided I-BA are acceptable and potentially efficacious treatments for adolescents with depression. It is feasible to conduct a large-scale RCT to establish the efficacy and cost-effectiveness of I-BA versus TAU.Trial registration numberClinicalTrials.gov Registry (NCT04117789).

Dataset Information

Feasibility and impact of a guided symptom exposure augmented cognitive behavior therapy protocol to prevent symptoms of pharmacologically induced depression: A pilot study.

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Feasibility and impact of a guided symptom exposure augmented cognitive behavior therapy protocol to prevent symptoms of pharmacologically induced depression: A pilot study.

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