Mobile Enhancement of Motivation in Schizophrenia
Primary Purpose
Schizophrenia, Schizo Affective Disorder, Psychosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Enhancement of Motivation (MEMS)
Control
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
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)
Sites / Locations
- Midtown Community Mental Health Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mobile Enhancement of Motivation (MEMS)
Control
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
Goal completion
The percentage of baseline goals participants completed over the eight-week period will be assessed at the follow-up assessment.
Secondary Outcome Measures
Motivation and Pleasure Scale-Self-Report (MAP-SR)
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).
Intrinsic Motivation Index
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.
Full Information
NCT ID
NCT03059771
First Posted
February 16, 2017
Last Updated
July 27, 2018
Sponsor
Indiana University
Collaborators
Indiana Clinical and Translational Sciences Institute, American Psychological Foundation, Indiana University-Purdue University Indianapolis Department of Psychology
1. Study Identification
Unique Protocol Identification Number
NCT03059771
Brief Title
Mobile Enhancement of Motivation in Schizophrenia
Official Title
Mobile Enhancement of Motivation in Schizophrenia: A Pilot Trial of a Personalized Text Message Intervention for Motivation Deficits
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 28, 2017 (Actual)
Primary Completion Date
January 16, 2018 (Actual)
Study Completion Date
January 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Indiana Clinical and Translational Sciences Institute, American Psychological Foundation, Indiana University-Purdue University Indianapolis Department of Psychology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizo Affective Disorder, Psychosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile Enhancement of Motivation (MEMS)
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Mobile Enhancement of Motivation (MEMS)
Intervention Description
The MEMS group will engage in a goal-setting session and then receive personalized text-messages to support goal attainment.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
The control group will only engage in a goal-setting session.
Primary Outcome Measure Information:
Title
Goal completion
Description
The percentage of baseline goals participants completed over the eight-week period will be assessed at the follow-up assessment.
Time Frame
follow-up (8 weeks)
Secondary Outcome Measure Information:
Title
Motivation and Pleasure Scale-Self-Report (MAP-SR)
Description
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).
Time Frame
baseline and follow-up (8 weeks)
Title
Intrinsic Motivation Index
Description
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.
Time Frame
baseline and follow-up (8 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Midtown Community Mental Health Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46208
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32790451
Citation
Luther L, Fischer MW, Johnson-Kwochka AV, Minor KS, Holden R, Lapish CL, McCormick B, Salyers MP. Mobile enhancement of motivation in schizophrenia: A pilot randomized controlled trial of a personalized text message intervention for motivation deficits. J Consult Clin Psychol. 2020 Oct;88(10):923-936. doi: 10.1037/ccp0000599. Epub 2020 Aug 13.
Results Reference
derived
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Mobile Enhancement of Motivation in Schizophrenia
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