SchizophreniaNCT03059771
Mobile Enhancement of Motivation in Schizophrenia
A study testing Mobile Enhancement of Motivation (MEMS) in people with Schizophrenia and Schizo Affective Disorder, run by Indiana University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizo Affective Disorder, Psychosis
- What is being tested?
- Mobile Enhancement of Motivation (MEMS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2017to 16 Jan 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Midtown Community Mental Health Center
Indianapolis, Indiana, 46208
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia, Schizo Affective Disorder, Psychosis
- Being tested
- Mobile Enhancement of Motivation (MEMS), Control
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Enhancement of Motivation (MEMS)Behavioural
The MEMS group will engage in a goal-setting session and then receive personalized text-messages to support goal attainment.
ControlBehavioural
The control group will only engage in a goal-setting session.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Enhancement of Motivation (MEMS) | Experimental | 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. Receives: Behavioral: Mobile Enhancement of Motivation (MEMS) |
| Control | Active comparator | 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). Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Goal completion
The percentage of baseline goals participants completed over the eight-week period will be assessed at the follow-up assessment.
Measured: follow-up (8 weeks)
Secondary outcomes (2)
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).
Measured: baseline and follow-up (8 weeks)
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.
Measured: baseline and follow-up (8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start28 Feb 2017
- Primary completion16 Jan 2018
- Study completion16 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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
- Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana Clinical and Translational Sciences Institute, American Psychological Foundation, Indiana University-Purdue University Indianapolis Department of Psychology
- Responsible party
- Principal investigator, Michelle Salyers, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059771
- Sponsor's protocol ID
- 1701070796
- Status last verified
- Jul 2018
- First submitted
- 16 Feb 2017
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32790451
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Enhancement of Motivation in Schizophrenia: A Pilot Trial of a Personalized Text Message Intervention for Motivation Deficits
- ClinicalTrials.gov ID
- NCT03059771
- Acronym / sponsor ID
- 1701070796
- Conditions
- Schizophrenia, Schizo Affective Disorder, Psychosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Indiana Clinical and Translational Sciences Institute, American Psychological Foundation, Indiana University-Purdue University Indianapolis Department of Psychology
- Study start
- 28 Feb 2017 (actual)
- Primary completion
- 16 Jan 2018 (actual)
- Study completion
- 16 Jan 2018 (actual)
- First posted
- 23 Feb 2017 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile Enhancement of Motivation (MEMS) | Experimental | Behavioral: 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. |
| Control | Active comparator | Behavioral: ControlParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| 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. | Behavioural | Mobile Enhancement of Motivation (MEMS) |
| ControlThe control group will only engage in a goal-setting session. | Behavioural | Control |
Primary outcome
Goal completion
Time frame: follow-up (8 weeks)
The percentage of baseline goals participants completed over the eight-week period will be assessed at the follow-up assessment.
2 secondary outcomes
Motivation and Pleasure Scale-Self-Report (MAP-SR)
Time frame: baseline and follow-up (8 weeks)
Intrinsic Motivation Index
Time frame: baseline and follow-up (8 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 30 Jul 2018.
- Derived from this study: PubMed 32790451Luther 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Enhancement of Motivation (MEMS) in people with Schizophrenia and Schizo Affective Disorder, run by Indiana 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 6 inclusion and 0 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 30 Jul 2018. 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?
Goal completion (time frame: follow-up (8 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03059771, which also lists 1 linked publication.
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 30 Jul 2018.