Comparing Mobile Health (mHealth) and Clinic-Based Self-Management Interventions for Serious Mental Illness

Schizophrenia Clinical Trial

Official title:

Comparing Mobile Health (mHealth) and Clinic-Based Self-Management Interventions for Serious Mental Illness: Patient Engagement, Satisfaction, and Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02421965
• Other study ID #: STUDY00028548
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2017

Study information

• Verified date: November 2018
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Mental Disorders
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Behavioral:
• FOCUS (Smartphone Application)
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.
• WRAP (Wellness Recovery Action Planning)
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.

Locations

Country	Name	City	State
United States	Thresholds Psychiatric Rehabilitation Centers	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient willingness to enroll / initiate the intervention (WRAP / FOCUS)	Patient willingness to enroll will be measured by proportion of individuals in each arm who commence the intervention after allocation. It is an important indicator of whether patients find the intervention appealing. Data will be obtained from electronic tracking records / FOCUS software.	1st day of - attendance of WRAP session OR usage of FOCUS application
Primary	Patient Engagement	Patient engagement will be measured by weeks of WRAP sessions attended / weeks FOCUS was used, during the 12-week intervention period. Data for WRAP sessions will be obtained from Thresholds electronic tracking record. Data for FOCUS usage will be captured automatically on FOCUS software.	3 months
Primary	Patient Satisfaction	Patient satisfaction will be assessed by a 5-item questionnaire on a 7-point scale.	3 months
Primary	Change in the Severity of Symptoms	Change in the Severity of Symptoms will measured using Symptom Checklist-9 scale, Beck Depression Inventory-2 (BDI-2) scale and Psychotic Symptom Rating Scale (PSYRATS). Symptom Checklist-9 (SCL-9) is a nine-item questionnaire to assess psychiatric functioning. BDI-2 is a widely used 21-item self-report scale to measure depressive symptom severity. PSYRATS is a fine-grained measure of psychotic symptoms that consists of 17 self-report items that evaluate dimensional symptom severity.	Baseline, 3 months (post-treatment), 6 months (follow-up)
Primary	Recovery	Recovery of patient will be measured using the Recovery Assessment Scale (RAS). RAS has 24 items that assess 5 factors related to recovery including Hope, Goal Directedness, and Domination by Symptoms.	Baseline, 3 months (post-treatment), 6 months (follow-up)
Primary	Change in the Quality of Life	Quality of Life will be assessed using a 6-item Quality of Life scale of general wellbeing, interpersonal relations, participation in activities, and role functioning. Patients respond on a 7-point scale.	Baseline, 3 months (post-treatment), 6 months (follow-up)