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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Case Western Reserve University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01304862
First received: February 25, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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 Intervention Phase
Depression
Generalized Anxiety Disorder
Behavioral: eSMART-MH intervention
Behavioral: Educational videos about healthy living
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Electronic Self-management Resource Training for Mental Health

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Engagement in Mental Health Treatment: Medical Adherence Medication Module (MAMMM) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: February 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304862

Contacts
Contact: Melissa D Pinto-Foltz, PhD, RN 216.368.3156 melissa.pinto-foltz@case.edu

Locations
United States, Ohio
Frances Payne Bolton School of Nursing Not yet recruiting
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
  More Information

No publications provided

Responsible Party: Melissa D. Pinto-Foltz, PhD, RN, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01304862     History of Changes
Other Study ID Numbers: KL2 RR024990
Study First Received: February 25, 2011
Last Updated: February 25, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Mental Disorders
Behavioral Symptoms
Mood Disorders

ClinicalTrials.gov processed this record on August 01, 2014