An interventional study of Mobile Application and Treatment as Usual (TAU) in Schizophrenia and Schizoaffective Disorder, sponsored by Dartmouth-Hitchcock Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-13.
Sponsored by Dartmouth-Hitchcock Medical Center · Not applicable, Interventional, and Treatment
This 2-arm clinical trial piloted a mobile Self-Management of Schizophrenia (SOS) system that administers interventions targeting persistent symptoms of psychosis, social dysfunction, and medication adherence. Researchers compared an intervention arm using the SOS system and an arm receiving treatment as usual on the outcomes of change in severity of psychotic symptoms and change in social functioning.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 51 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.
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Exclusion Criteria:
Treatment as usual includes outpatient case management, linkage to services and medication monitoring.
Behavioral: Treatment as Usual (TAU)
Mobile Application system designed to improve coping with psychotic symptoms, social functioning, and medication adherence.
Behavioral: Mobile Application
Also known as: Self-Management of Schizophrenia (SOS), FOCUS
Change in Severity of Psychotic Symptoms
Severity of Psychotic Symptoms was assessed with the Psychotic Symptom Rating Scales (PSYRATS). The PSYRATS is comprised of 17 items inquiring about the specific dimensions of hallucinations and delusions, with each item being rated from 0 (absent) to 4 (severe). The PSYRATS has 2 subscales: the auditory hallucinations subscale (AHS) consisting of 11 items, and the delusions subscale (DS) consisting of 6 items. These subscale scores are added to create a total score ranging from 0-68. Higher scores indicate worse symptoms.
Time frame: Baseline, week 12
Change in Social Functioning
Social Functioning was measured using two subscales from the Social Functioning Scale (SFS): Social Engagement (5-items) and Withdrawal \& Communication (10-items). The item values range from 0 (almost never) to 3 (often). The two subscales were summed to give a score between 0-45. A higher score indicates greater social functioning.
Time frame: Baseline, week 12
Change in System Use
System use was measured by the SOS application regarding the percent of SOS prompts and self-report interactions with the system.
Time frame: 4 weeks
Usability and Satisfaction
Usability and Satisfaction was measured using the USE (Usefulness, Satisfaction, and Ease of use) Questionnaire, which was designed to measure satisfaction, usefulness, ease of use and ease of learning.
Time frame: 4 weeks
Individuals with schizophrenia or schizoaffective disorder who were receiving services were recruited through flyers in waiting rooms and bulletin boards at treatment centers, and through referrals from clinical staff. Enrollment was open from November 2015 to July 2016.
| Milestone | Treatment as Usual | Mobile Application |
|---|---|---|
| Started | 25 | 26 |
| Completed | 24 | 24 |
| Not completed | 1 | 2 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Extended hospitalization | 1 | 1 |
Severity of Psychotic Symptoms was assessed with the Psychotic Symptom Rating Scales (PSYRATS). The PSYRATS is comprised of 17 items inquiring about the specific dimensions of hallucinations and delusions, with each item being rated from 0 (absent) to 4 (severe). The PSYRATS has 2 subscales: the auditory hallucinations subscale (AHS) consisting of 11 items, and the delusions subscale (DS) consisting of 6 items. These subscale scores are added to create a total score ranging from 0-68. Higher scores indicate worse symptoms.
| units on a scale | Treatment as Usual | Mobile Application |
|---|---|---|
| baseline | 20.20 ± 3.20 | 19.88 ± 3.20 |
| 12 weeks | 21.98 ± 3.24 | 20.96 ± 3.24 |
Social Functioning was measured using two subscales from the Social Functioning Scale (SFS): Social Engagement (5-items) and Withdrawal \& Communication (10-items). The item values range from 0 (almost never) to 3 (often). The two subscales were summed to give a score between 0-45. A higher score indicates greater social functioning.
| units on a scale | Treatment as Usual | Mobile Application |
|---|---|---|
| baseline | 27.60 ± 1.15 | 25.96 ± 1.15 |
| 12 weeks | 29.28 ± 1.17 | 26.34 ± 1.17 |
System use was measured by the SOS application regarding the percent of SOS prompts and self-report interactions with the system.
No measurements were reported for this outcome.
Usability and Satisfaction was measured using the USE (Usefulness, Satisfaction, and Ease of use) Questionnaire, which was designed to measure satisfaction, usefulness, ease of use and ease of learning.
No measurements were reported for this outcome.
Collected over Assessed at the baseline and 12 week assessments for each participant.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment as Usual | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Mobile Application | 1/26 (3.8%) | 0/26 (0%) | 0/26 (0%) |
| Age, Categorical(Participants) | Treatment as Usual | Mobile Application | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 25 | 25 | 50 |
| >=65 years | 0 | 1 | 1 |
| Age, Continuous(years) | Treatment as Usual | Mobile Application | Total |
|---|---|---|---|
| Mean | 43.0 ± 12.5 | 42.5 ± 13.4 | 42.7 ± 12.8 |
| Sex: Female, Male(Participants) | Treatment as Usual | Mobile Application | Total |
|---|---|---|---|
| Female | 5 | 11 | 16 |
| Male | 20 | 15 | 35 |
| Ethnicity (NIH/OMB)(Participants) | Treatment as Usual | Mobile Application | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 1 | 3 |
| Not Hispanic or Latino | 23 | 24 | 47 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | Treatment as Usual | Mobile Application | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 1 | 3 |
| White | 22 | 24 | 46 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Beliefs about Medicines Questionnaire - General (BMQ - General)(units on a scale) | Treatment as Usual | Mobile Application | Total |
|---|---|---|---|
| Mean | 19.96 ± 4.57 | 20.32 ± 4.36 | 20.14 ± 4.46 |
| Beliefs about Medicines Questionnaire - Specific (BMQ - Specific)(units on a scale) | Treatment as Usual | Mobile Application | Total |
|---|---|---|---|
| Mean | 32.56 ± 5.24 | 32.20 ± 4.49 | 32.38 ± 4.86 |
| Schizophrenia Patient Activation Measure (SPAM)(units on a scale) | Treatment as Usual | Mobile Application | Total |
|---|---|---|---|
| Mean | 56.28 ± 5.73 | 57.48 ± 5.25 | 56.88 ± 5.49 |
3 further baseline measures are reported on the registry.
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Dartmouth-Hitchcock Medical Center