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. 2018 Nov 14;19(1):629.
doi: 10.1186/s13063-018-2997-5.

Motivational Interviewing as a Tool to Enhance Access to Mental Health Treatment in Adolescents With Chronic Medical Conditions and Need for Psychological Support (COACH-MI): Study Protocol for a Clusterrandomised Controlled Trial

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Free PMC article

Motivational Interviewing as a Tool to Enhance Access to Mental Health Treatment in Adolescents With Chronic Medical Conditions and Need for Psychological Support (COACH-MI): Study Protocol for a Clusterrandomised Controlled Trial

Christina Reinauer et al. Trials. .
Free PMC article

Abstract

Background: This cluster-randomised monocentric controlled trial focuses on improving the uptake symptoms of mental health care in adolescents with chronic medical conditions who have been identified by screening to have depression or anxiety. The study aims to determine the efficacy of motivational interviewing (MI) delivered by trained physicians to increase 12- to 20-year-old adolescents' utilisation of psychological health care for symptoms of anxiety or depression.

Methods/design: In this single-centre approach, n = 1,000 adolescents will be screened (using PHQ-9 and GAD-7), and adolescents with results indicative of anxiety or depressive symptoms (n = 162) will be advised to seek psychological health care in clusters from treating physicians in specialised outpatient departments. Participants who screen positive will receive either two sessions of MI or treatment as usual (TAU; regarded as the typical daily clinical practice), which is focused on recommending them to seek psychological health care for further evaluation. MI efficacy will be compared to the current TAU as the control condition. The primary outcome is the utilisation rate of psychological health care after counselling by an MI-trained physician vs. an untrained physician. Additionally, reasons for not claiming psychological support and changes in disease-related parameters will be evaluated in a 6-month follow-up session.

Discussion: This trial will evaluate the feasibility of MI as a way to improve the utilisation of mental health-care services by adolescents who need further support other than that provided by standard care for chronic diseases. Physicians offering MI to adolescents may serve as a model for optimising health-care management in daily clinical practice, which may improve adolescents' long-term well-being by improving adherence to medical treatment and preventing negative lifelong consequences into adulthood.

Trial registration: German Trials Register (DRKS), DRKS00014043 . Registered on 26 April 2018. Düsseldorf University study ID: 2017114504.

Keywords: Adolescents; adherence to medical treatment; anxiety; chronic condition; depression; motivational interviewing.

Conflict of interest statement

Ethics approval and consent to participate

The study will be conducted in accordance with the principles of good clinical practice, the Declaration of Helsinki [42] and all current ethical standards. Written informed consent will be obtained from study participants and their legal representatives or guardians prior to enrolment. Consent can be withdrawn at any time during the trial without giving reasons. The study protocols have been approved by the ethics committee of the University of Düsseldorf (COACH-MI study, reference 6244R). The ethics committee, trial registry and trial participants will be informed of any protocol modifications. The COACH consortium will be advised by an external data and safety monitoring board. We will report the progress of the project to the Federal Ministry of Education and Research (BMBF). No physical risks are anticipated with study participation; however, participants and parents will be provided travel insurance for the second counselling appointment with MI-educated physicians.

The study intervention is considered safe and will be monitored using the SAE reporting system. All ongoing or newly developed SAEs will be immediately reported to the principal investigator and to the data safety and monitoring board, and routine reports will be delivered at 6-month intervals. The most likely patient safety concern is that a former unknown suicidality or severe depression may be uncovered by the screening or subsequent advice (during a TAU or MI session). As a standard procedure for responding to suicidal ideations (PHQ-9 question 9), physicians are advised to use the Columbia Suicide Severity Rating Scale (C-SSRS) [43] as a standard tool for evaluating suicidality. Red flags (see above) will trigger an immediate psychological evaluation. If a substantiated concern arises for active suicidal thoughts or major depression, the patient will be referred to the psychiatric unit for immediate evaluation or treatment. These participants will be dropped from the study.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of study design. ITT intention to treat, MI motivational interviewing, TAU treatment as usual
Fig. 2
Fig. 2
SPIRIT schedule of enrolment, intervention and assessments

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