Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2025-12-27 @ 3:05 AM
Study NCT ID:
NCT05215392
Status:
UNKNOWN
Last Update Posted:
2022-03-04
First Post:
2022-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Smartphone Application of "Family Connections" to Relatives of People With Borderline Personality Disorder.
Sponsor:
Universitat Jaume I
Organization:
Study Overview
Official Title:
A Smartphone Application of "Family Connections" to Increase the Use of Skills and the Improving of Psychological Symptoms in Relatives of People With Borderline Personality Disorder: a Protocol Study for a Randomized Controlled Trial.
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aims of our study are the following: (a) testing the effectiveness of a combined intervention: "Family Connections" program with a smartphone app versus the same intervention supported by a paper-based manual, (b) studying the feasibility and acceptance of both conditions and (c) evaluating the perceptions and opinions of families about both interventions.
Detailed Description:
Family members of patients with borderline personality disorder (BPD) often experience high levels of suffering, anxiety, stress, burden and helplessness. The treatment program with the most empirical support is "Family Connections". It is one of the first programs specifically designed to help relatives of patients with BPD. The program is an adaptation of multiple strategies of Dialectical Behavioral Therapy. The results of these studies and their subsequent replications showed an improvement in family attitudes and perceived burden. Two of the technologies with very promising developments are Ecological Momentary Assessment and Ecological Momentary Intervention, that can act on each other. A large number of smartphone apps for people with psychological problems focus on the provision of instructions, adaptive self-help strategies, alarms, electronic diaries or emotional state ratings. The Family Connections app proposed in this article consists of a smartphone app built using EMA and EMI technologies.The aims of our study are the following: (a) testing the effectiveness of a combined intervention: "Family Connections" program with a smartphone app versus the same intervention supported by a paper-based manual, (b) studying the feasibility and acceptance of both conditions and (c) evaluating the perceptions and opinions of families about both interventions.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: