Development of a Personalized Real-time Intervention for Bipolar Disorder (PRISM)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Colin Depp, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01670123
First received: August 17, 2012
Last updated: August 20, 2012
Last verified: August 2012
  Purpose

This three-year intervention development proposal is submitted to the NIMH DATR Mood Disorders/Sleep Disorders Program A2-AID and is led by a New Investigator. The goal of this study is to further develop and then evaluate the clinical utility of a new personalized smart-phone intervention to enhance illness self-management in people with bipolar disorder. Bipolar disorder is a heterogeneous fluctuating condition and a leading source of disability. Consistent with NIMH Strategic Aim 3.2, self-monitoring tools are vital to clinical management and evidence-based psychosocial interventions for bipolar disorder. Practice guidelines state that all patients should receive education in self-monitoring and identifying adaptive responses to early warning signs and symptoms. Advances in technology have enabled electronic monitoring of patient-reported outcomes using mobile devices - an assessment strategy called Ecological Momentary Assessment (EMA). Using freely available software, we have developed a preliminary version of a novel smart-phone intervention that integrates EMA with brief psychosocial intervention designed for people with bipolar disorder. Mobile real-time interventions have been successfully applied in other chronic illnesses and have theoretical advantages over clinic-based interventions in motivating and cuing health-protective behavior. Our new intervention is called Personalized Real-Time Intervention for Stabilizing Mood (PRISM), and it delivers tailored intervention content naturalistically at the moment that symptoms occur. We recently conducted a small proof-of-concept study of PRISM in outpatient adults with bipolar disorder that suggests the intervention is feasible, presents no technological or operational barriers, yields data that corresponds with clinical ratings, and is perceived as useful by participants. Building from our preliminary work, we propose to further develop the intervention based on participant feedback and theoretically-driven enhancements. We will then conduct a randomized trial to assess the clinical utility of this new intervention over 12 weeks. Specifically, we will randomize a sample of 90 adults aged 18 and older with Bipolar Disorder I or II to one of two experimental conditions. Participants in both conditions will participate in two in-person sessions adapted from an evidence-based psychosocial intervention for bipolar disorder, aimed at identifying early warning signs and adaptive responses to symptom fluctuations. The Control condition will participate in the in-person sessions, and the PRISM condition will also utilize the smart phone device for 12 weeks. In this pilot trial, we will compare outcomes between the two conditions on standard clinical ratings of depressive and manic symptoms, along with psychosocial functioning. We will assess predictors of compliance and changes in outcomes in the PRISM condition to inform a larger effectiveness trial. We will use exploratory analyses to further refine the intervention, including capitalizing on the rich repeated measures obtained by the device. This study will provide a strong basis for a larger effectiveness trial, along with a potentially useful tool to enhance self-management in bipolar disorder. PUBLIC HEALTH RELEVANCE: Bipolar disorder is a leading cause of disability, and many people do not have access to evidence-based psychosocial interventions. Mobile devices may prove more effective than clinic-based interventions, because they deliver self-management strategies at the moment that symptoms occur. To lead to a larger effectiveness study, we propose to further develop our novel intervention uses mobile technology to monitor and intervene with symptoms in real-time, and then conduct a 12-week randomized trial in 90 patients to evaluate the acceptability and short-term efficacy of our smart-phone based intervention for bipolar disorder.


Condition Intervention
Bipolar Disorder
Behavioral: Personalized Real-Time Intervention for Stabilizing Mood

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Development of a Personalized Real-time Intervention for Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    Depression severity measure


Secondary Outcome Measures:
  • Young Mania Rating Scale [ Time Frame: 3 Month ] [ Designated as safety issue: No ]
    Mania symptom severity


Estimated Enrollment: 90
Study Start Date: July 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mobile Phone Condition
This arm will involve daily self-monitoring with an electronic mobile device with responses to survey questions about mood status. Mood status reports are linked with personalized coping strategies.
Behavioral: Personalized Real-Time Intervention for Stabilizing Mood
Interactive mobile web-based behavioral intervention targeting symptoms of bipolar disorder
Placebo Comparator: Paper-and-pencil condition
This arm will complete a paper-and-pencil mood chart on a daily basis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • DSM-IV diagnosis of bipolar disorder
  • Currently an outpatient

Exclusion Criteria:

  • Psychiatric hospitalization in the past month
  • Substance abuse diagnosis in the past 6 months
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670123

Contacts
Contact: Colin A Depp, Ph.D. 858 822 4251 cdepp@ucsd.edu
Contact: Vicki Wang, BA 858 822 6207 vcwang@ucsd.edu

Locations
United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92037
Contact: Colin A Depp, Ph.D.       cdepp@ucsd.edu   
Principal Investigator: Colin A Depp, Ph.D.         
Sponsors and Collaborators
University of California, San Diego
  More Information

No publications provided

Responsible Party: Colin Depp, Associate Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT01670123     History of Changes
Other Study ID Numbers: MH091260
Study First Received: August 17, 2012
Last Updated: August 20, 2012
Health Authority: United States: National Institute of Mental Health

Keywords provided by University of California, San Diego:
Mobile phone
electronic intervention
behavioral intervention
telehealth
bipolar disorder

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014