Electronic Self-management Resource Training for Mental Health

Depression Clinical Trial

— eSMART-MH  

Official title:

Electronic Self-management Resource Training for Mental Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304862
• Other study ID #: KL2RR024990
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Est. completion date: July 1, 2013

Study information

• Verified date: February 2022
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 1, 2013
• Est. primary completion date: July 1, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Generalized Anxiety Disorder

Intervention

Behavioral:
• eSMART-MH intervention
Involves simulated interactions between participants and the virtual health care providers (avatars).
• Educational videos about healthy living
20 minute screen-based educational videos on topics about healthy living--nutrition, physical activity, and sleep hygiene.

Locations

Country	Name	City	State
United States	Frances Payne Bolton School of Nursing	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Western Reserve University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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