Electronic Self-management Resource Training for Mental Health (eSMART-MH)
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|ClinicalTrials.gov Identifier: NCT01304862|
Recruitment Status : Unknown
Verified January 2011 by Case Western Reserve University.
Recruitment status was: Not yet recruiting
First Posted : February 28, 2011
Last Update Posted : February 28, 2011
|Condition or disease||Intervention/treatment||Phase|
|Depression Generalized Anxiety Disorder||Behavioral: eSMART-MH intervention Behavioral: Educational videos about healthy living||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Electronic Self-management Resource Training for Mental Health|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||December 2011|
|Estimated Study Completion Date :||December 2011|
|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.
- Engagement in Mental Health Treatment: Medical Adherence Medication Module (MAMMM) [ Time Frame: 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.
- Mental Illness Stigma: Alienation Subscale [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304862
|Contact: Melissa D Pinto-Foltz, PhD, RNfirstname.lastname@example.org|
|United States, Ohio|
|Frances Payne Bolton School of Nursing||Not yet recruiting|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Melissa D Pinto-Foltz, PhD, RN||Case Western Reserve University|