NCT03062267

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

Completed NA Results posted Last updated 9 November 2020

What this trial tests

NA trial testing Mobile Interventionist in Schizoaffective Disorder in 49 participants. Completed in 31 May 2020.

Timeline

1 October 2017

Primary endpoint
31 May 2020

31 May 2020

Quick facts

Lead sponsor	University of Washington
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	49
Start date	1 October 2017
Primary completion	31 May 2020
Estimated completion	31 May 2020
Sites	2 locations across United States

Drugs / interventions tested

• Mobile Interventionist

Conditions studied

• Schizoaffective Disorder — all drugs for Schizoaffective Disorder →
• Schizophrenia — all drugs for Schizophrenia →
• Bipolar Disorder — all drugs for Bipolar Disorder →
• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

University of Washington

Who can join

Adults 18 to 99, any sex, with Schizoaffective Disorder or Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Psychiatric Symptoms Primary · 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.

Score at Baseline

Group	Value	95% CI
Treatment as Usual	5.2	± 11.2
Mobile Interventionist	19.6	± 20.4

Score at 3 months

Group	Value	95% CI
Treatment as Usual	6.2	± 14.4
Mobile Interventionist	15.1	± 16.7

Score at 6 months

Group	Value	95% CI
Treatment as Usual	.6	± 1.9
Mobile Interventionist	17.9	± 19.1

Psychiatric Symptoms Primary · 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.

Score at Baseline

Group	Value	95% CI
Treatment as Usual	18.5	± 13.7
Mobile Interventionist	18.5	± 11.4

Score at 3 Months

Group	Value	95% CI
Treatment as Usual	17.2	± 11.3
Mobile Interventionist	23.4	± 12.4

Score at 6 Months

Group	Value	95% CI
Treatment as Usual	15.5	± 11.2
Mobile Interventionist	14.8	± 10.3

Recovery Secondary · 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.

Score at Baseline

Group	Value	95% CI
Treatment as Usual	91.8	± 14.6
Mobile Interventionist	89.8	± 17.3

Score at 3 Months

Group	Value	95% CI
Treatment as Usual	90.0	± 13.8
Mobile Interventionist	92.9	± 15.5

Score at 6 Months

Group	Value	95% CI
Treatment as Usual	93.8	± 13.1
Mobile Interventionist	94.4	± 14.9

Satisfaction With Treatment Secondary · 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.

Group	Value	95% CI
Treatment as Usual	28.2	± 6.2
Mobile Interventionist	30.1	± 6.1

Sponsor's own description

Testing an mHealth mobile interventionist texting program on illness management.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Augmenting Evidence-Based Care With a Texting Mobile Interventionist: A Pilot Randomized Controlled Trial.
   Ben-Zeev D, Buck B, Meller S, Hudenko WJ, et al · · 2020 · cited 23× · PMID 32631130 · DOI 10.1176/appi.ps.202000239