DepressioneSMART-MHNCT01304862
Electronic Self-management Resource Training for Mental Health
A study testing eSMART-MH intervention and Educational videos about healthy living in people with Depression and Generalized Anxiety Disorder, run by Case Western Reserve University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Generalized Anxiety Disorder
- What is being tested?
- eSMART-MH intervention and Educational videos about healthy living
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to 1 Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Participation in the eSMART-HD parent project
Trial locations and contacts
1 site in 1 country.
United States1 site
Frances Payne Bolton School of Nursing
Cleveland, Ohio, 44106
About this study
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.
Read the 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.
- Conditions
- Depression, Generalized Anxiety Disorder
- Being tested
- eSMART-MH intervention, Educational videos about healthy living
- Medical subject headings
- Depression, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eSMART-MH interventionBehavioural
Involves simulated interactions between participants and the virtual health care providers (avatars).
Educational videos about healthy livingBehavioural
20 minute screen-based educational videos on topics about healthy living--nutrition, physical activity, and sleep hygiene.
| Study group | Role | What they receive |
|---|---|---|
| Self-management intervention | Experimental | Not described Receives: Behavioral: eSMART-MH intervention |
| Educational Videos about Healthy Living | Active comparator | Not described Receives: Behavioral: Educational videos about healthy living |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (6)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completion1 Jul 2013
- Study completion1 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa D. Pinto-Foltz, Case Western Reserve University
- Investigators
- Melissa D Pinto-Foltz, PhD, RN, Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304862
- Sponsor's protocol ID
- KL2RR024990
- Acronym
- eSMART-MH
- Status last verified
- Feb 2022
- First submitted
- 25 Feb 2011
- Last updated
- 2 Mar 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Self-management Resource Training for Mental Health
- ClinicalTrials.gov ID
- NCT01304862
- Acronym / sponsor ID
- eSMART-MH / KL2RR024990
- Conditions
- Depression, Generalized Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- 1 Jul 2013 (actual)
- Study completion
- 1 Jul 2013 (actual)
- First posted
- 28 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-management intervention | Experimental | Behavioral: eSMART-MH intervention |
| Educational Videos about Healthy Living | Active comparator | Behavioral: Educational videos about healthy living |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Participation in the eSMART-HD parent project
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eSMART-MH interventionInvolves simulated interactions between participants and the virtual health care providers (avatars). | Behavioural | Self-management intervention |
| Educational videos about healthy living20 minute screen-based educational videos on topics about healthy living--nutrition, physical activity, and sleep hygiene. | Behavioural | Educational Videos about Healthy Living |
Primary outcome
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.
6 secondary outcomes
Mental Illness Stigma: Alienation Subscale
Time frame: 12 weeks
Mental Health Literacy: In Our Own Voice Knowledge Measure (IOOVKM)
Time frame: 12 weeks
Patient Activation: Patient Activation Measure (PAM)
Time frame: 12 weeks
Effective Communication: Patients' Self-Competence Subscale (PSC)
Time frame: 12 weeks
Symptom Severity: Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 weeks
Feasibility and Acceptability of Intervention
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa D Pinto-Foltz, PhD, RN principal investigator
Case Western Reserve University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eSMART-MH intervention and Educational videos about healthy living in people with Depression and Generalized Anxiety Disorder, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement in Mental Health Treatment: Medical Adherence Medication Module (MAMMM) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.