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

Dartmouth Health

Status: Completed

Conditions: Major Depressive Disorder; Schizophrenia; Bipolar Disorder; Schizoaffective Disorder

Treatments: Behavioral: FOCUS (Smartphone Application); Behavioral: WRAP (Wellness Recovery Action Planning)

Study type: Interventional

Funder types: Other

Identifiers

NCT02421965

STUDY00028548

Details and patient eligibility

About

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.

Full 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.

Enrollment: 174 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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174 participants in 2 patient groups

FOCUS (Smartphone Application)

Experimental group

Description:

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.

Treatment:

Behavioral: FOCUS (Smartphone Application)

WRAP (Wellness Recovery Action Planning)

Active Comparator group

Description:

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.

Treatment:

Behavioral: WRAP (Wellness Recovery Action Planning)