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

Sponsor

Dartmouth-Hitchcock Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02421965

Collaborator

Patient-Centered Outcomes Research Institute (Other)

174

Enrollment

Location

Arms

Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizoaffective Disorder Bipolar Disorder Major Depressive Disorder	Behavioral: FOCUS (Smartphone Application) Behavioral: WRAP (Wellness Recovery Action Planning)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

174 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Jul 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FOCUS (Smartphone Application) FOCUS is a smartphone application system designed to improve illness self-management and facilitate recovery in individuals with serious mental illness. It delivers both system initiated (i.e. pre-programmed) and patient initiated (i.e. on demand) real-time assessment to individuals in their own environment.	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.
Active Comparator: WRAP (Wellness Recovery Action Planning) WRAP is a clinic-based intervention designed to improve illness self-management and facilitate recovery in individuals with serious mental illness. It is conducted in group sessions that are delivered by trained facilitators with lived experience, using lecture, group discussion, and exercises.	Behavioral: 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.

Arm

Intervention/Treatment

Experimental: FOCUS (Smartphone Application)

FOCUS is a smartphone application system designed to improve illness self-management and facilitate recovery in individuals with serious mental illness. It delivers both system initiated (i.e. pre-programmed) and patient initiated (i.e. on demand) real-time assessment to individuals in their own environment.

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.

Active Comparator: WRAP (Wellness Recovery Action Planning)

WRAP is a clinic-based intervention designed to improve illness self-management and facilitate recovery in individuals with serious mental illness. It is conducted in group sessions that are delivered by trained facilitators with lived experience, using lecture, group discussion, and exercises.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

Patient willingness to enroll / initiate the intervention (WRAP / FOCUS) [1st day of - attendance of WRAP session OR usage of FOCUS application]
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.
Patient Engagement [3 months]
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.
Patient Satisfaction [3 months]
Patient satisfaction will be assessed by a 5-item questionnaire on a 7-point scale.
Change in the Severity of Symptoms [Baseline, 3 months (post-treatment), 6 months (follow-up)]
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.
Recovery [Baseline, 3 months (post-treatment), 6 months (follow-up)]
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.
Change in the Quality of Life [Baseline, 3 months (post-treatment), 6 months (follow-up)]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.