|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02258711 |
|
Date of registration:
|
03/10/2014 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Self-Monitoring and Psychoeducation in Bipolar Patients With a Smart-phone Application
SIMPLE |
|
Scientific title:
|
SIgns and Symptoms Self-Monitoring and Psychoeducation in bipoLar Patients With a Smart-phonE Application (SIMPLE) |
|
Date of first enrolment:
|
October 2014 |
|
Target sample size:
|
148 |
|
Recruitment status: |
Suspended |
|
URL:
|
https://clinicaltrials.gov/show/NCT02258711 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Care Provider).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Spain
| | | | | | | |
|
Contacts
|
|
Name:
|
Eduard Vieta, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Hospital Clínic of Barcelona |
|
|
Name:
|
Francesc Colom, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Institut Hospital del Mar d'Investigacions Mèdiques (IMIM) |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients with the current diagnosis of Bipolar disorder type I or type II according to
current DSM-5 criteria and confirmed with a semi structured interview (SCID).
- Hamilton Depression Scale score under or equal to 8 during the last month.
- Young Mania Rating Scale score under or equal to 6 during the last month.
- No history of relapses during the last 3 previous months but at least 1 relapse during
the last year.
- Availability of a telephone account with an unlimited data plan during the 12
following months.
Exclusion Criteria:
- Lack of skills to use the offered smart-phone or unwillingness to learn them.
- FAST score above or equal to 20.
- Past or current participation in psychoeducation groups.
- Obsessive-compulsive disorder according to DSM-5 criteria.
- Concomitant severe medical condition.
- Pregnancy.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Bipolar Disorder
|
|
Intervention(s)
|
|
Device: SIMPLE 2.0
|
|
Primary Outcome(s)
|
|
Number of relapses during intervention
[Time Frame: During the entire 6 months study period]
|
|
Secondary Outcome(s)
|
|
Quality of life
[Time Frame: During the entire 6 months study period of the clinical trial and during 6-month post-intervention follow-up]
|
|
Number of Relapses during 6-month post-intervention
[Time Frame: 6-months post-intervention]
|
|
Number of Manic and depressive symptoms
[Time Frame: During the entire 6 months study period]
|
|
Biological rhythms
[Time Frame: During the entire 6 months study period of the clinical trial and during 6-month post-intervention follow-up]
|
|
Functional impairment
[Time Frame: During the entire 6 months study period of the clinical trial and during 6-month post-intervention follow-up.]
|
|
Treatment adherence
[Time Frame: During the entire 6 months study period of the clinical trial and during 6-month post-intervention follow-up]
|
|
Secondary ID(s)
|
|
HCPPFR02062014
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|