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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03059771
Other study ID # 1701070796
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 28, 2017
Est. completion date January 16, 2018

Study information

Verified date July 2018
Source Indiana University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 59
Est. completion date January 16, 2018
Est. primary completion date January 16, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Behavioral:
Mobile Enhancement of Motivation (MEMS)
The MEMS group will engage in a goal-setting session and then receive personalized text-messages to support goal attainment.
Control
The control group will only engage in a goal-setting session.

Locations

Country Name City State
United States Midtown Community Mental Health Center Indianapolis Indiana

Sponsors (4)

Lead Sponsor Collaborator
Indiana University American Psychological Foundation, Indiana Clinical and Translational Sciences Institute, Indiana University-Purdue University Indianapolis Department of Psychology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Goal completion The percentage of baseline goals participants completed over the eight-week period will be assessed at the follow-up assessment. follow-up (8 weeks)
Secondary 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). baseline and follow-up (8 weeks)
Secondary 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. baseline and follow-up (8 weeks)
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