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

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT03062267
• Collaborator: (none)
• Enrollment: 49
• Locations: 2
• Arms: 2
• Actual Duration (Months): 32
• Patients Per Site: 24.5
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

Testing an mHealth mobile interventionist texting program on illness management.

Condition or Disease	Intervention/Treatment	Phase
Schizoaffective Disorder; Schizophrenia; Bipolar Disorder; Major Depressive Disorder	Other: Mobile Interventionist	N/A

Detailed Description

The ultimate objective is to evaluate a validated mHealth intervention that can be realistically integrated into community mental health settings to increase the availability, reach, and broad impact of illness management approaches for people with serious mental illness (SMI).

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effectiveness of a Mobile Texting Intervention for People With Serious Mental Illness
• Actual Study Start Date: Oct 1, 2017
• Actual Primary Completion Date: May 31, 2020
• Actual Study Completion Date: May 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Treatment as Usual Treatment as usual for 3 months.
Experimental: Mobile Interventionist Participants will exchange text messages with a mobile interventionist throughout the day for 3 months.	Other: Mobile Interventionist; A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)

Outcome Measures

Primary Outcome Measures

1. Psychiatric Symptoms [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.

2. Psychiatric Symptoms [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.

Secondary Outcome Measures

1. Recovery [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.

Other Outcome Measures

1. Satisfaction With Treatment [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Chart diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder;

2. 18 years or older;

3. A rating of "3" or higher on one of three Patient Activation items;

4. Ownership of a mobile phone with call/text plan (research staff will offer assistance in accessing the Federal Lifeline Assistance Program to people who do not have a mobile phone and/or call/text plan if they are otherwise eligible);

5. Receiving community based treatment services.

Exclusion Criteria:

1. Hearing, vision, or motor impairment that make it impossible to operate a mobile phone (determined using the individual's device for screening);

2. English reading level below 4th grade (determined using the reading section from the Wide Range Achievement Test - 4th Edition (WRAT-4).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thresholds	Chicago	Illinois	United States	60290
2	Frontier Behavioral Health	Spokane	Washington	United States	99207

Sponsors and Collaborators

• University of Washington

Investigators

• Principal Investigator: Dror Ben-Zeev, PhD, University of Washington

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 9, 2020

More Information

Publications

None provided.

• Responsible Party: Dror Ben-Zeev, Professor, School of Medicine: Psychiatry and Behavioral Sciences, University of Washington
• ClinicalTrials.gov Identifier: NCT03062267
• Other Study ID Numbers: STUDY00001274
• First Posted: Feb 23, 2017
• Last Update Posted: Nov 9, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dror Ben-Zeev, Professor, School of Medicine: Psychiatry and Behavioral Sciences, University of Washington: mhealth; texting intervention; mobile health; mobile mental health
• Additional relevant MeSH terms: Disease; Schizophrenia; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder; Psychotic Disorders; Mental Disorders

Study Results

Participant Flow

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

Arm/Group Title	Treatment as Usual	Mobile Interventionist
Arm/Group Description	Treatment as usual for 3 months.	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)
Period Title: Overall Study
STARTED	12	37
COMPLETED	10	32
NOT COMPLETED	2	5

Baseline Characteristics

Arm/Group Title	Treatment as Usual	Mobile Interventionist	Total
Arm/Group Description	Treatment as usual for 3 months.	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 of all reporting groups
Overall Participants	12	37	49
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.3 (12.0)	45.4 (11.1)	44.8 (11.2)
Sex/Gender, Customized (Count of Participants)
Female	7 58.3%	15 40.5%	22 44.9%
Male	5 41.7%	22 59.5%	27 55.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 25%	3 8.1%	6 12.2%
Not Hispanic or Latino	9 75%	33 89.2%	42 85.7%
Unknown or Not Reported	0 0%	1 2.7%	1 2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	1 2.7%	1 2%
Native Hawaiian or Other Pacific Islander	0 0%	1 2.7%	1 2%
Black or African American	2 16.7%	10 27%	12 24.5%
White	7 58.3%	17 45.9%	24 49%
More than one race	2 16.7%	6 16.2%	8 16.3%
Unknown or Not Reported	1 8.3%	2 5.4%	3 6.1%
Region of Enrollment (participants) [Number]
United States	12 100%	37 100%	49 100%

Outcome Measures

1. Primary Outcome

Title	Psychiatric Symptoms
Description	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.
Time Frame	Change from baseline to 3 months and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment as Usual	Mobile Interventionist
Arm/Group Description	Treatment as usual for 3 months.	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)
Measure Participants	12	37
Score at Baseline	5.2 (11.2)	19.6 (20.4)
Score at 3 months	6.2 (14.4)	15.1 (16.7)
Score at 6 months	.6 (1.9)	17.9 (19.1)

2. Primary Outcome

Title	Psychiatric Symptoms
Description	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.
Time Frame	Change from baseline to 3 months and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment as Usual	Mobile Interventionist
Arm/Group Description	Treatment as usual for 3 months.	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)
Measure Participants	12	37
Score at Baseline	18.5 (13.7)	18.5 (11.4)
Score at 3 Months	17.2 (11.3)	23.4 (12.4)
Score at 6 Months	15.5 (11.2)	14.8 (10.3)

3. Secondary Outcome

Title	Recovery
Description	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.
Time Frame	Change from baseline to 3 months and 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment as Usual	Mobile Interventionist
Arm/Group Description	Treatment as usual for 3 months.	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)
Measure Participants	12	37
Score at Baseline	91.8 (14.6)	89.8 (17.3)
Score at 3 Months	90.0 (13.8)	92.9 (15.5)
Score at 6 Months	93.8 (13.1)	94.4 (14.9)

4. Other Pre-specified Outcome

Title	Satisfaction With Treatment
Description	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.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment as Usual	Mobile Interventionist
Arm/Group Description	Treatment as usual for 3 months.	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)
Measure Participants	12	37
Mean (Standard Deviation) [score on a scale]	28.2 (6.2)	30.1 (6.1)

Adverse Events

Time Frame	6 months.
Arm/Group Title	Treatment as Usual		Mobile Interventionist
Arm/Group Description	Treatment as usual for 3 months.		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)
All Cause Mortality
	Treatment as Usual		Mobile Interventionist
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/37 (0%)
Serious Adverse Events
	Treatment as Usual		Mobile Interventionist
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/37 (0%)
Other (Not Including Serious) Adverse Events
	Treatment as Usual		Mobile Interventionist
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/37 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.