Electronic Self-management Resource Training for Mental Health (eSMART-MH)

The purpose of this study is to determine whether mental health treatment disengagement may be mitigated by reducing barriers to self-management and enhancing self-management skills.

Study Overview

• Status: Completed
• Conditions: Depression; Generalized Anxiety Disorder
• Intervention / Treatment: Behavioral: eSMART-MH intervention; Behavioral: Educational videos about healthy living

Detailed Description

Each year, more than four million young adults (age 18-25 years old) in the U.S. receive psychotropic medication or psychotherapy as treatment for a mental illness. One in every four of these young adults will disengage from mental health treatment before significant symptom remission is achieved. Mental health treatment disengagement may be mitigated by reducing barriers to self-management and enhancing self-management skills. Electronic self-management resource training for mental health (eSMART-MH) is an innovative use of avatars-virtual persons who tailor responses to users-to improve mental health treatment disengagement.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Frances Payne Bolton School of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Self-report of a diagnosis depression or generalized anxiety disorder greater than six months
• Young adults 18-25 years of age
• Prescribed psychotropic medication and/or psychotherapy
• Have a documented domestic telephone number
• Able to read and understand English

Exclusion Criteria:

• Participation in the eSMART-HD parent project

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self-management intervention	Behavioral: eSMART-MH intervention; Involves simulated interactions between participants and the virtual health care providers (avatars).
Active Comparator: Educational Videos about Healthy Living	Behavioral: Educational videos about healthy living; 20 minute screen-based educational videos on topics about healthy living--nutrition, physical activity, and sleep hygiene.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement in Mental Health Treatment: Medical Adherence Medication Module (MAMMM)	Medical Adherence Measure Medication Module (MAMMM) is a 7-item scale that will determine the patient's degree of engagement and initiation of mental health treatment.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental Illness Stigma: Alienation Subscale	A 6-item four point Likert type scale that asks participants to rate each item from 1 (strongly disagree) to 4 (strongly agree); a higher score indicates more mental illness stigma.	12 weeks
Mental Health Literacy: In Our Own Voice Knowledge Measure (IOOVKM)	A 12-item scale that utilizes a 7-point Likert type scale with responses ranging from 1 (strongly disagree) to 7 (strongly agree). Total scores range from 12-84, with a higher score indicating higher mental health literacy.	12 weeks
Patient Activation: Patient Activation Measure (PAM)	13-item measure that assesses the patient's perception of their knowledge, skill, and confidence in self-management behavior. Scores range from 0-100, with a higher score indicating greater patient activation.	12 weeks
Effective Communication: Patients' Self-Competence Subscale (PSC)	A 16-item five point Likert scale that asks participants to rate items from 5 (important) to 1 (unimportant); a higher score indicates greater perceived self-competence and effective communication with a health care provider.	12 weeks
Symptom Severity: Hospital Anxiety and Depression Scale (HADS)	A 14-item self-report measure that assesses anxiety and depression symptom severity. The HADS contains separate subscales (7 items each) for depression and anxiety; items are scored on a four point scale from 0-4, and a summative score is generated for each subscale. A cut score of 8 signifies an increased clinical risk for anxiety and depression.	12 weeks
Feasibility and Acceptability of Intervention	To assess feasibility, the frequency of refusals and incidence of complete intervention doses will be documented. Acceptability will be assessed by utilizing and adapted acceptability scale administered at the final time point.	12 weeks

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Investigators: Principal Investigator: Melissa D Pinto-Foltz, PhD, RN, Case Western Reserve University

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: February 25, 2011
• First Submitted That Met QC Criteria: February 25, 2011
• First Posted (Estimate): February 28, 2011

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: KL2RR024990 (U.S. NIH Grant/Contract)