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

Primary Purpose

Depression, Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eSMART-MH intervention
Educational videos about healthy living
Sponsored by
Case Western Reserve University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Frances Payne Bolton School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Self-management intervention

Educational Videos about Healthy Living

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 25, 2011
Last Updated
February 11, 2022
Sponsor
Case Western Reserve University
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1. Study Identification

Unique Protocol Identification Number
NCT01304862
Brief Title
Electronic Self-management Resource Training for Mental Health
Acronym
eSMART-MH
Official Title
Electronic Self-management Resource Training for Mental Health
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
July 1, 2013 (Actual)
Study Completion Date
July 1, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Case Western Reserve University

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Generalized Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-management intervention
Arm Type
Experimental
Arm Title
Educational Videos about Healthy Living
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
eSMART-MH intervention
Intervention Description
Involves simulated interactions between participants and the virtual health care providers (avatars).
Intervention Type
Behavioral
Intervention Name(s)
Educational videos about healthy living
Intervention Description
20 minute screen-based educational videos on topics about healthy living--nutrition, physical activity, and sleep hygiene.
Primary Outcome Measure Information:
Title
Engagement in Mental Health Treatment: Medical Adherence Medication Module (MAMMM)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Mental Illness Stigma: Alienation Subscale
Description
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.
Time Frame
12 weeks
Title
Mental Health Literacy: In Our Own Voice Knowledge Measure (IOOVKM)
Description
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.
Time Frame
12 weeks
Title
Patient Activation: Patient Activation Measure (PAM)
Description
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.
Time Frame
12 weeks
Title
Effective Communication: Patients' Self-Competence Subscale (PSC)
Description
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.
Time Frame
12 weeks
Title
Symptom Severity: Hospital Anxiety and Depression Scale (HADS)
Description
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.
Time Frame
12 weeks
Title
Feasibility and Acceptability of Intervention
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa D Pinto-Foltz, PhD, RN
Organizational Affiliation
Case Western Reserve University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Frances Payne Bolton School of Nursing
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

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Electronic Self-management Resource Training for Mental Health

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