eSMART-MH: Electronic Self-management Resource Training for Mental Health

Sponsor

Case Western Reserve University (Other)

Overall Status

Completed

CT.gov ID

NCT01304862

Collaborator

(none)

Enrollment

Location

Arms

28.9

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Depression Generalized Anxiety Disorder	Behavioral: eSMART-MH intervention Behavioral: Educational videos about healthy living	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Electronic Self-management Resource Training for Mental Health

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Engagement in Mental Health Treatment: Medical Adherence Medication Module (MAMMM) [12 weeks]
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.

Secondary Outcome Measures

Mental Illness Stigma: Alienation Subscale [12 weeks]
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.
Mental Health Literacy: In Our Own Voice Knowledge Measure (IOOVKM) [12 weeks]
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.
Patient Activation: Patient Activation Measure (PAM) [12 weeks]
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.
Effective Communication: Patients' Self-Competence Subscale (PSC) [12 weeks]
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.
Symptom Severity: Hospital Anxiety and Depression Scale (HADS) [12 weeks]
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.
Feasibility and Acceptability of Intervention [12 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Frances Payne Bolton School of Nursing	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

Case Western Reserve University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Melissa D. Pinto-Foltz, KL2 SCHOLAR, Case Western Reserve University

ClinicalTrials.gov Identifier:

NCT01304862

Other Study ID Numbers:

KL2RR024990

First Posted:

Feb 28, 2011

Last Update Posted:

Mar 2, 2022

Last Verified:

Feb 1, 2022

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Mar 2, 2022