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

NCT02421965 | Completed DMC

• 1 other identifier: STUDY00028548
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• Patient Satisfaction

  Patient satisfaction will be assessed by a 5-item questionnaire on a 7-point scale.

  3 months

• 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)

• 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)

• 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)

Study Arms (2)

FOCUS (Smartphone Application)

EXPERIMENTAL

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)

WRAP (Wellness Recovery Action Planning)

ACTIVE COMPARATOR

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)

Interventions

FOCUS (Smartphone Application) BEHAVIORAL

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.

FOCUS (Smartphone Application)

WRAP (Wellness Recovery Action Planning) BEHAVIORAL

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.

WRAP (Wellness Recovery Action Planning)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chart diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Thresholds Psychiatric Rehabilitation Centers

Chicago, Illinois, 60613, United States

Location

Related Publications (2)

• 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.

  PMID: 30977736 DERIVED

• 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.

  PMID: 29793397 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Bipolar Disorder; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Depressive Disorder

Study Officials

• Dror Ben-Zeev, PhD

  Dartmouth Psychiatric Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: April 21, 2015
• Study Start: June 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 20, 2018

Record last verified: 2018-11

Locations

US (1)