NCT05215392

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 31, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
Last Updated

March 4, 2022

Status Verified

February 1, 2022

Enrollment Period

4 months

First QC Date

January 17, 2022

Last Update Submit

February 17, 2022

Conditions

Relatives

Keywords

borderline personality disorderfamily connectionsrelativesdbtsmartphone apptechnology

Outcome Measures

Primary Outcomes (1)

  • Burden Assessment Scale (BAS; Horwitz & Reinhard, 1992)

    Burden Assessment Scale (BAS) consists of 19 items and it assess the caregivers' objective and subjective burden within the past six months. Items are rated on a 4-point Likert scale ranging from 1(nothing) to 4 (a lot), and higher values indicate stronger burden. Internal reliability of the scale ranged from .89 to .91 and it shows adequated validity (Reinhard, Gubman, Horwitz \& Minsky, 1994).

    Changes will be assessed from pre-treatment to immediately after the intervention (3 months)

Secondary Outcomes (3)

  • Depression, Anxiety and Stress (DASS-21; Lovibond & Lovibond, 1995)

    Changes will be assessed from pre-treatment to immediately after the intervention (3 months)

  • Family Empowerment (FES; Koren, DeChillo & Friesen, 1992)

    Changes will be assessed from pre-treatment to immediately after the intervention (3 months)

  • Resilience (CD-RISC; Connor & Davidson, 2003)

    Changes will be assessed from pre-treatment to immediately after the intervention (3 months)

Other Outcomes (1)

  • System Usability Scale (SUS; Brooke, 2013).

    Changes will be assessed immediately after the intervention (3 months)

Study Arms (2)

Smartphone Application

EXPERIMENTAL

Family members in the experimental group of this study will receive an ecological momentary intervention (EMI) derived from an ecological momentary assessment (EMA) via the Family Connections smartphone app.

Behavioral: Family Connections program

Treatment As Usual

ACTIVE COMPARATOR

Family members in this condition will receive the manual of Family Connections which contains all the information on the program sessions conducted and the skills training strategies in writing.

Behavioral: Family Connections program

Interventions

Family Connections programBEHAVIORAL

Family members in the experimental group of this study will receive an ecological momentary intervention (EMI) derived from an ecological momentary assessment (EMA) via the Family Connections smartphone app. Family members in this condition will receive the manual of Family Connections which contains all the information on the program sessions conducted and the skills training strategies in writing.

Smartphone ApplicationTreatment As Usual

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having a family member diagnosed with borderline personality disorder.
  • Being 18 years of age or older.
  • Knowing and understanding the Spanish language.
  • Having a smartphone with Internet connection.
  • Completing the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Jaume I

Castellon, Castellón, 12071, Spain

Location

Related Publications (6)

  • Hoffman PD, Fruzzetti AE. Advances in interventions for families with a relative with a personality disorder diagnosis. Curr Psychiatry Rep. 2007 Feb;9(1):68-73. doi: 10.1007/s11920-007-0012-z.

    PMID: 17257517RESULT

  • Hoffman PD, Fruzzetti AE, Buteau E, Neiditch ER, Penney D, Bruce ML, Hellman F, Struening E. Family connections: a program for relatives of persons with borderline personality disorder. Fam Process. 2005 Jun;44(2):217-25. doi: 10.1111/j.1545-5300.2005.00055.x.

    PMID: 16013747RESULT

  • Hoffman PD, Buteau E, Hooley JM, Fruzzetti AE, Bruce ML. Family members' knowledge about borderline personality disorder: correspondence with their levels of depression, burden, distress, and expressed emotion. Fam Process. 2003 Winter;42(4):469-78. doi: 10.1111/j.1545-5300.2003.00469.x.

    PMID: 14979218RESULT

  • Hoffman PD, Fruzzetti AE, Swenson CR. Dialectical behavior therapy--family skills training. Fam Process. 1999 Winter;38(4):399-414. doi: 10.1111/j.1545-5300.1999.00399.x.

    PMID: 10668619RESULT

  • Flynn D, Kells M, Joyce M, Corcoran P, Herley S, Suarez C, Cotter P, Hurley J, Weihrauch M, Groeger J. Family Connections versus optimised treatment-as-usual for family members of individuals with borderline personality disorder: non-randomised controlled study. Borderline Personal Disord Emot Dysregul. 2017 Aug 30;4:18. doi: 10.1186/s40479-017-0069-1. eCollection 2017.

    PMID: 28861273RESULT

  • Rajalin M, Wickholm-Pethrus L, Hursti T, Jokinen J. Dialectical behavior therapy-based skills training for family members of suicide attempters. Arch Suicide Res. 2009;13(3):257-63. doi: 10.1080/13811110903044401.

    PMID: 19590999RESULT

MeSH Terms

Conditions

Borderline Personality DisorderMaple syrup urine disease, type 2

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Study Officials

  • Isabel Fernández Felipe, PhD Student

    Universitat Jaume I

    PRINCIPAL INVESTIGATOR

  • Diana Castilla López, Dr

    University of Valencia

    PRINCIPAL INVESTIGATOR

  • Mariví Navarro Haro, Dr

    Universidad de Zaragoza

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Verónica Guillén Botella, Dr

CONTACT

963864386vguillenbotella@gmail.com

Azucena García Palacios, Dr

CONTACT

964387640azucena@uji.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double (Participant, Investigator)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, Efficacy Study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2022

First Posted

January 31, 2022

Study Start

September 1, 2022

Primary Completion

December 31, 2022

Study Completion

January 15, 2023

Last Updated

March 4, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

Individual participant data will be available after deidentification.

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
The data will be available immediately following publication
Access Criteria
The data will be available to anyone who wishes to access them

Locations

ES(1)