Clinical trial NCT01670123: Development of a Personalized Real-time Intervention for Bipolar Disorder
Official title: Development of a Personalized Real-time Intervention for Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: Mobile phone
electronic intervention
behavioral intervention
telehealth
bipolar disorder
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2012-08-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale
timeFrame: 3 month
Secondary outcomes:
measure: Young Mania Rating Scale
timeFrame: 3 Month
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
References:
citation: Depp CA, Kim DH, de Dios LV, Wang V, Ceglowski J. A Pilot Study of Mood Ratings Captured by Mobile Phone Versus Paper-and-Pencil Mood Charts in Bipolar Disorder. J Dual Diagn. 2012 Jan 1;8(4):326-332. doi: 10.1080/15504263.2012.723318.