Clinical trial NCT02421965: Comparing Mobile Health (mHealth) and Clinic-Based Self-Management Interventions for Serious Mental Illness
Official title: Comparing Mobile Health (mHealth) and Clinic-Based Self-Management Interventions for Serious Mental Illness: Patient Engagement, Satisfaction, and Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Major Depressive Disorder
Keywords: Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Major Depressive Disorder
Mobile Application
Smartphone
SMI
Illness Self-Management
EHealth
E-Health
Health Technology
mHealth
m-Health
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-04-21
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is a three year research project whose aims are to evaluate the willingness of individuals with serious mental illness to initiate the two illness self-management interventions- WRAP or FOCUS, to examine and compare participant engagement, satisfaction, and outcomes (symptoms, recovery, quality of life) in the two interventions.

Detailed description: The objective of the study is to compare two illness self-management interventions for SMI: a clinic-based group protocol (Wellness Recovery Action Planning or WRAP) and an mHealth smartphone intervention (FOCUS). The study is structured as a randomized controlled trial, and data will be collected using a comprehensive mixed-methods quantitative /qualitative approach. This study will evaluate patients willingness to enroll in one of the two illness-self management interventions, patient satisfaction, engagement, symptoms, recovery and quality of life.

The specific aims of the study are to: 1) Evaluate and compare the willingness and ability of individuals with SMI to enroll in the two illness self-management interventions; 2) Examine and compare participant engagement and satisfaction with both treatments; and 3) Examine and compare patient outcomes following participation in the interventions.

Participants will be randomized to receive 12-weeks of WRAP or FOCUS. Participants allocated to the WRAP group will be provided all other materials (i.e. WRAP binder, handouts) in their first session and will meet weekly in groups with trained facilitators. Participants in the FOCUS group will be given a study smartphone device with FOCUS application and trained by the mHealth support specialist on how to use the functions of the smartphone (i.e. using a touchscreen, call, text) and different features of the FOCUS intervention.

Eligibility criteria: Inclusion Criteria:

* Chart diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder;
* 18 years or older; and
* A rating of "3" or lower on one of the three items which comprise the Domination by Symptoms factor from the Recovery Assessment Scale.

Exclusion Criteria:

* Hearing, vision, or motor impairment that make it impossible to operate a smartphone (determined using demonstration smartphone for screening);
* English reading level below 6th grade (determined using the Wide Range Achievement Test - 4th Edition); and
* Received the FOCUS or WRAP intervention in the past 3 years.

Primary outcomes:
measure: Patient willingness to enroll / initiate the intervention (WRAP / FOCUS)
timeFrame: 1st day of - attendance of WRAP session OR usage of FOCUS application
measure: Patient Engagement
timeFrame: 3 months
measure: Patient Satisfaction
timeFrame: 3 months
measure: Change in the Severity of Symptoms
timeFrame: Baseline, 3 months (post-treatment), 6 months (follow-up)
measure: Recovery
timeFrame: Baseline, 3 months (post-treatment), 6 months (follow-up)
measure: Change in the Quality of Life
timeFrame: Baseline, 3 months (post-treatment), 6 months (follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Thresholds Psychiatric Rehabilitation Centers
state: Illinois
Study officials:
affiliation: Dartmouth Psychiatric Research Center
name: Dror Ben-Zeev, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ben-Zeev D, Buck B, Chu PV, Razzano L, Pashka N, Hallgren KA. Transdiagnostic Mobile Health: Smartphone Intervention Reduces Depressive Symptoms in People With Mood and Psychotic Disorders. JMIR Ment Health. 2019 Apr 12;6(4):e13202. doi: 10.2196/13202.
citation: Ben-Zeev D, Brian RM, Jonathan G, Razzano L, Pashka N, Carpenter-Song E, Drake RE, Scherer EA. Mobile Health (mHealth) Versus Clinic-Based Group Intervention for People With Serious Mental Illness: A Randomized Controlled Trial. Psychiatr Serv. 2018 Sep 1;69(9):978-985. doi: 10.1176/appi.ps.201800063. Epub 2018 May 25.