- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03059771
Mobile Enhancement of Motivation in Schizophrenia
July 27, 2018 updated by: Michelle Salyers, Indiana University
Mobile Enhancement of Motivation in Schizophrenia: A Pilot Trial of a Personalized Text Message Intervention for Motivation Deficits
Motivation deficits are a strong determinant of poor functional outcomes in people with schizophrenia.
Mobile interventions are a promising approach to improving these deficits, as they can provide frequent cues and reinforcements that support goal-directed behavior.
The primary aims of this study are to conduct a pilot study using a randomized design to 1) Test the feasibility and acceptability of a personalized mobile text message intervention, Mobile Enhancement of Motivation in Schizophrenia (MEMS) and to 2) Test the preliminary effectiveness of MEMS compared to a control condition.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Objectives: Motivation deficits are one of the strongest determinants of poor functional outcomes in people with schizophrenia.
Mobile interventions are a promising approach to improving these deficits, as they can provide frequent cues and reinforcements that support goal-directed behavior.
The objective of this study is to conduct a pilot study using a randomized design to 1) Test the feasibility and acceptability of a personalized mobile text message intervention, Mobile Enhancement of Motivation in Schizophrenia (MEMS) and to 2) Test the preliminary effectiveness of MEMS compared to a control condition.
Methods: Up to forty outpatients with a schizophrenia-spectrum disorder will be recruited.
All participants will set individualized recovery goals to complete over an eight-week period; those randomized to receive MEMS will also receive three sets of personalized, interactive text messages each weekday to reinforce and cue goal completion.
Before and after the eight-week period, participants in both groups will complete validated measures of motivation.
Both groups will also report their goal attainment after eight weeks.
Results: It is anticipated that those in the MEMS group will demonstrate greater goal attainment and improvements in motivation compared to the control group.
Discussion: This project will test the initial feasibility, acceptability, and effectiveness of a novel intervention for improving one of the most debilitating aspects of schizophrenia.
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46208
- Midtown Community Mental Health Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Schizophrenia-spectrum diagnosis
- Have a text-message enabled cell-phone
- Are a current client at a participating community mental health center
- Are in a non-acute phase of illness or have no medication changes or hospitalizations in the prior 30 days
- Demonstrate a minimum of moderate motivation impairments according to the Clinical Assessment Interview for Negative Symptoms (CAINS; Kring et al., 2013)
- Have an English reading level at or above the fourth grade according to the Graded Word List (Pray & Ross, 1969)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mobile Enhancement of Motivation (MEMS)
Facilitators will first collaboratively help participants set personal recovery-goals using Collaborative Goal Technology (Clarke et al., 2006).
Participants will then receive three sets of interactive text messages each weekday for eight weeks to reinforce and cue goal completion.
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The MEMS group will engage in a goal-setting session and then receive personalized text-messages to support goal attainment.
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Active Comparator: Control
Participants will only engage in a goal-setting session where facilitators will collaboratively help participants set personal recovery-goals using Collaborative Goal Technology (Clarke et al., 2006).
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The control group will only engage in a goal-setting session.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Goal completion
Time Frame: follow-up (8 weeks)
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The percentage of baseline goals participants completed over the eight-week period will be assessed at the follow-up assessment.
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follow-up (8 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motivation and Pleasure Scale-Self-Report (MAP-SR)
Time Frame: baseline and follow-up (8 weeks)
|
The MAP-SR is a self-report measure 15-item self-report measure that assesses participant's level of motivation and pleasure in several domains, including work and recreational activities.
It has been found to be valid and reliable in a schizophrenia-spectrum sample (Llerena, et al., 2013).
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baseline and follow-up (8 weeks)
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Intrinsic Motivation Index
Time Frame: baseline and follow-up (8 weeks)
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The 3-item Intrinsic Motivation Index (Nakagami et al., 2008) from the clinician-rated Quality of Life Scale (Heinrichs et al., 1984) will be used to assess trait-like intrinsic motivation.
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baseline and follow-up (8 weeks)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 28, 2017
Primary Completion (Actual)
January 16, 2018
Study Completion (Actual)
January 16, 2018
Study Registration Dates
First Submitted
February 16, 2017
First Submitted That Met QC Criteria
February 16, 2017
First Posted (Actual)
February 23, 2017
Study Record Updates
Last Update Posted (Actual)
July 30, 2018
Last Update Submitted That Met QC Criteria
July 27, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1701070796
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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