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Evaluating the efficacy of an integrated motivational interviewing and multi-modal exercise intervention for youth with major depression: Healthy Body, Healthy Mind randomised controlled trial protocol.

ABSTRACT: Background:Recent meta-analytic reviews suggest exercise can reduce depression severity among adults with major depressive disorder (MDD); however, efficacy studies with depressed youth are limited. Few studies have investigated the efficacy of multi-modal exercise interventions in this population, addressed treatment engagement, or explored the differential effects of exercise on depressive symptom profiles. Objectives:This paper describes the study protocol and recruitment pattern for an assessor blinded, two-arm randomised controlled trial investigating the efficacy of an integrated motivational interviewing (MI) and multi-modal exercise intervention in youth diagnosed with MDD. Associations between depressive symptom profiles (cognitive, somatic and affective) and psychological, physiological (fitness), and biological (blood biomarker) outcomes will also be examined. Methods:Participants aged 15-25 years with current MDD were recruited. Eligible participants were randomised and stratified according to gender and depression severity to either an immediate or delayed (control) group. The immediate group received a brief MI intervention followed by a 12-week small group exercise intervention (3 times per week for 1 h), all delivered by personal trainers. The delayed control group received the same intervention 12-weeks later. Both groups were reassessed at mid-treatment or mid-control, post-treatment or post-control, and follow-up (12 weeks post-treatment). Results:68 participants were recruited and randomly allocated to an intervention group. Conclusion:This trial will increase our understanding of the efficacy of multi-modal exercise interventions for depression and the specific effects of exercise on depressive symptom profiles. It also offers a novel contribution by addressing treatment engagement in exercise efficacy trials in youth with MDD.

SUBMITTER: Nasstasia Y

PROVIDER: S-EPMC5898569 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Evaluating the efficacy of an integrated motivational interviewing and multi-modal exercise intervention for youth with major depression: Healthy Body, Healthy Mind randomised controlled trial protocol.

Nasstasia Yasmina Y Baker Amanda L AL Halpin Sean A SA Hides Leanne L Lewin Terry J TJ Kelly Brian J BJ Callister Robin R

Contemporary clinical trials communications 20171124

<h4>Background</h4>Recent meta-analytic reviews suggest exercise can reduce depression severity among adults with major depressive disorder (MDD); however, efficacy studies with depressed youth are limited. Few studies have investigated the efficacy of multi-modal exercise interventions in this population, addressed treatment engagement, or explored the differential effects of exercise on depressive symptom profiles.<h4>Objectives</h4>This paper describes the study protocol and recruitment patte ...[more]

PMID: 29696220

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Project description:BackgroundWhile widely used and endorsed, there is limited evidence supporting the benefits of activity trackers for increasing physical activity; these devices may be more effective when combined with additional strategies that promote sustained behavior change like motivational interviewing (MI) and habit development.ObjectiveThis study aims to determine the utility of wearable activity trackers alone or in combination with these behavior change strategies for promoting improvements in active and sedentary behaviors.MethodsA sample of 91 adults (48/91 female, 53%) was randomized to receive a Fitbit Charge alone or in combination with MI and habit education for 12 weeks. Active and sedentary behaviors were assessed pre and post using research-grade activity monitors (ActiGraph and activPAL), and the development of habits surrounding the use of the trackers was assessed postintervention with the Self-Reported Habit Index. During the intervention, Fitbit wear time and activity levels were monitored with the activity trackers. Linear regression analyses were used to determine the influence of the trial on outcomes of physical activity and sedentary time. The influence of habits was examined using correlation coefficients relating habits of tracker use (wearing the tracker and checking data on the tracker and associated app) to Fitbit wear time and activity levels during the intervention and at follow-up.ResultsRegression analyses revealed no significant differences by group in any of the primary outcomes (all P>.05). However, personal characteristics, including lower baseline activity levels (beta=-.49, P=.01) and lack of previous experience with pedometers (beta=-.23, P=.03) were predictive of greater improvements in moderate and vigorous physical activity. Furthermore, for individuals with higher activity levels at the baseline, MI and habit education were more effective for maintaining these activity levels when compared with receiving a Fitbit alone (eg, small increase of ~48 steps/day, d=0.01, vs large decrease of ~1830 steps/day, d=0.95). Finally, habit development was significantly related to steps/day during (r=.30, P=.004) and following the intervention (r=.27, P=.03).ConclusionsThis study suggests that activity trackers may have beneficial effects on physical activity in healthy adults, but benefits vary based on individual factors. Furthermore, this study highlights the importance of habit development surrounding the wear and use of activity trackers and the associated software to promote increases in physical activity.Trial registrationClinicalTrials.gov NCT03837366; https://clinicaltrials.gov/ct2/show/NCT03837366.

Project description:BackgroundBehavioral interventions such as psychotherapy are leading, evidence-based practices for a variety of problems (e.g., substance abuse), but the evaluation of provider fidelity to behavioral interventions is limited by the need for human judgment. The current study evaluated the accuracy of statistical text classification in replicating human-based judgments of provider fidelity in one specific psychotherapy--motivational interviewing (MI).MethodParticipants (n?=?148) came from five previously conducted randomized trials and were either primary care patients at a safety-net hospital or university students. To be eligible for the original studies, participants met criteria for either problematic drug or alcohol use. All participants received a type of brief motivational interview, an evidence-based intervention for alcohol and substance use disorders. The Motivational Interviewing Skills Code is a standard measure of MI provider fidelity based on human ratings that was used to evaluate all therapy sessions. A text classification approach called a labeled topic model was used to learn associations between human-based fidelity ratings and MI session transcripts. It was then used to generate codes for new sessions. The primary comparison was the accuracy of model-based codes with human-based codes.ResultsReceiver operating characteristic (ROC) analyses of model-based codes showed reasonably strong sensitivity and specificity with those from human raters (range of area under ROC curve (AUC) scores: 0.62 - 0.81; average AUC: 0.72). Agreement with human raters was evaluated based on talk turns as well as code tallies for an entire session. Generated codes had higher reliability with human codes for session tallies and also varied strongly by individual code.ConclusionTo scale up the evaluation of behavioral interventions, technological solutions will be required. The current study demonstrated preliminary, encouraging findings regarding the utility of statistical text classification in bridging this methodological gap.

Dataset Information

Evaluating the efficacy of an integrated motivational interviewing and multi-modal exercise intervention for youth with major depression: Healthy Body, Healthy Mind randomised controlled trial protocol.

Publications

Evaluating the efficacy of an integrated motivational interviewing and multi-modal exercise intervention for youth with major depression: Healthy Body, Healthy Mind randomised controlled trial protocol.

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