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Trial Outcomes & Findings for Effectiveness of a Mobile Texting Intervention for People With Serious Mental Illness (NCT NCT03062267)

NCT ID: NCT03062267

Last Updated: 2020-11-09

Results Overview

Assessed with the Psychotic Symptom Rating Scales (PSYRATS). The PSYRATS inquires about the specific dimensions of hallucinations and delusions. There are 17 items and each item is 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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

49 participants

Primary outcome timeframe

Change from baseline to 3 months and 6 months

Results posted on

2020-11-09

Participant Flow

No significant events to report that occurred after participant enrollment but prior to assignment of participants to an arm.

Participant milestones

Participant milestones
Measure
Treatment as Usual
Treatment as usual for 3 months.
Mobile Interventionist
Participants will exchange text messages with a mobile interventionist throughout the day for 3 months. Mobile Interventionist: A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)
Overall Study
STARTED
12
37
Overall Study
COMPLETED
10
32
Overall Study
NOT COMPLETED
2
5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of a Mobile Texting Intervention for People With Serious Mental Illness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Treatment as Usual
n=12 Participants
Treatment as usual for 3 months.
Mobile Interventionist
n=37 Participants
Participants will exchange text messages with a mobile interventionist throughout the day for 3 months. Mobile Interventionist: A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)
Total
n=49 Participants
Total of all reporting groups
Age, Continuous
43.3 years
STANDARD_DEVIATION 12.0 • n=5 Participants
45.4 years
STANDARD_DEVIATION 11.1 • n=7 Participants
44.8 years
STANDARD_DEVIATION 11.2 • n=5 Participants
Sex/Gender, Customized
Female
7 Participants
n=5 Participants
15 Participants
n=7 Participants
22 Participants
n=5 Participants
Sex/Gender, Customized
Male
5 Participants
n=5 Participants
22 Participants
n=7 Participants
27 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=5 Participants
3 Participants
n=7 Participants
6 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
9 Participants
n=5 Participants
33 Participants
n=7 Participants
42 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=5 Participants
10 Participants
n=7 Participants
12 Participants
n=5 Participants
Race (NIH/OMB)
White
7 Participants
n=5 Participants
17 Participants
n=7 Participants
24 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=5 Participants
6 Participants
n=7 Participants
8 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
2 Participants
n=7 Participants
3 Participants
n=5 Participants
Region of Enrollment
United States
12 participants
n=5 Participants
37 participants
n=7 Participants
49 participants
n=5 Participants

PRIMARY outcome

Timeframe: Change from baseline to 3 months and 6 months

Assessed with the Psychotic Symptom Rating Scales (PSYRATS). The PSYRATS inquires about the specific dimensions of hallucinations and delusions. There are 17 items and each item is 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.

Outcome measures

Outcome measures
Measure
Treatment as Usual
n=12 Participants
Treatment as usual for 3 months.
Mobile Interventionist
n=37 Participants
Participants will exchange text messages with a mobile interventionist throughout the day for 3 months. Mobile Interventionist: A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)
Psychiatric Symptoms
Score at Baseline
5.2 score on a scale
Standard Deviation 11.2
19.6 score on a scale
Standard Deviation 20.4
Psychiatric Symptoms
Score at 3 months
6.2 score on a scale
Standard Deviation 14.4
15.1 score on a scale
Standard Deviation 16.7
Psychiatric Symptoms
Score at 6 months
.6 score on a scale
Standard Deviation 1.9
17.9 score on a scale
Standard Deviation 19.1

PRIMARY outcome

Timeframe: Change from baseline to 3 months and 6 months

Assessed with the Beck Depression Inventory (BDI). The Beck Depression Inventory is a psychometric test for measuring the severity of depression. There are 21 items, each rated from 0-3, and total scores range from 0-63. Higher scores indicate more severe depressive symptoms.

Outcome measures

Outcome measures
Measure
Treatment as Usual
n=12 Participants
Treatment as usual for 3 months.
Mobile Interventionist
n=37 Participants
Participants will exchange text messages with a mobile interventionist throughout the day for 3 months. Mobile Interventionist: A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)
Psychiatric Symptoms
Score at Baseline
18.5 score on a scale
Standard Deviation 13.7
18.5 score on a scale
Standard Deviation 11.4
Psychiatric Symptoms
Score at 3 Months
17.2 score on a scale
Standard Deviation 11.3
23.4 score on a scale
Standard Deviation 12.4
Psychiatric Symptoms
Score at 6 Months
15.5 score on a scale
Standard Deviation 11.2
14.8 score on a scale
Standard Deviation 10.3

SECONDARY outcome

Timeframe: Change from baseline to 3 months and 6 months

Assessed with the Recovery Assessment Scale (RAS). This scale measures mental health recovery. There are 24 items, each rated from 1 (disagree) to 5 (agree), and total scores range from 24-120. Higher scores indicate better recovery.

Outcome measures

Outcome measures
Measure
Treatment as Usual
n=12 Participants
Treatment as usual for 3 months.
Mobile Interventionist
n=37 Participants
Participants will exchange text messages with a mobile interventionist throughout the day for 3 months. Mobile Interventionist: A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)
Recovery
Score at Baseline
91.8 score on a scale
Standard Deviation 14.6
89.8 score on a scale
Standard Deviation 17.3
Recovery
Score at 3 Months
90.0 score on a scale
Standard Deviation 13.8
92.9 score on a scale
Standard Deviation 15.5
Recovery
Score at 6 Months
93.8 score on a scale
Standard Deviation 13.1
94.4 score on a scale
Standard Deviation 14.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Assessed with satisfaction items established from previous SMI research. This measure consists of 5 items, each rated from 1 (strongly disagree) to 7 (strongly agree), and total scores range from 5-35. Higher scores indicate more satisfaction with treatment.

Outcome measures

Outcome measures
Measure
Treatment as Usual
n=12 Participants
Treatment as usual for 3 months.
Mobile Interventionist
n=37 Participants
Participants will exchange text messages with a mobile interventionist throughout the day for 3 months. Mobile Interventionist: A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)
Satisfaction With Treatment
28.2 score on a scale
Standard Deviation 6.2
30.1 score on a scale
Standard Deviation 6.1

Adverse Events

Treatment as Usual

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Mobile Interventionist

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

University of Washington

Phone: (206) 685-9655

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place