Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02421965
Recruitment Status : Completed
First Posted : April 21, 2015
Last Update Posted : November 20, 2018
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

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) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : June 2015
Actual Primary Completion Date : July 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

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.




Primary Outcome Measures :
  1. Patient willingness to enroll / initiate the intervention (WRAP / FOCUS) [ Time Frame: 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.

  2. Patient Engagement [ Time Frame: 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.

  3. Patient Satisfaction [ Time Frame: 3 months ]
    Patient satisfaction will be assessed by a 5-item questionnaire on a 7-point scale.

  4. Change in the Severity of Symptoms [ Time Frame: 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.

  5. Recovery [ Time Frame: 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.

  6. Change in the Quality of Life [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02421965


Locations
Layout table for location information
United States, Illinois
Thresholds Psychiatric Rehabilitation Centers
Chicago, Illinois, United States, 60613
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Patient-Centered Outcomes Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Dror Ben-Zeev, PhD Dartmouth Psychiatric Research Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02421965    
Other Study ID Numbers: STUDY00028548
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Keywords provided by Dartmouth-Hitchcock Medical Center:
Schizophrenia
Schizoaffective Disorder
Bipolar Disorder
Major Depressive Disorder
Mobile Application
Smartphone
SMI
Illness Self-Management
EHealth
E-Health
Health Technology
mHealth
m-Health
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Schizophrenia
Depressive Disorder
Depression
Depressive Disorder, Major
Bipolar Disorder
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Mood Disorders
Behavioral Symptoms
Bipolar and Related Disorders