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RelativesNCT05215392

A Smartphone Application of "Family Connections" to Relatives of People With Borderline Personality Disorder.

A study testing Family Connections program in people with Relatives, run by Universitat Jaume I at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Relatives
What is being tested?
Family Connections program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteSpain
Study dates
1 Sep 2022to 15 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Verónica Guillén Botella, Dr contact

963864386 ext. 4386

vguillenbotella@gmail.com

Azucena García Palacios, Dr contact

964387640 ext. 7640

azucena@uji.es

Spain1 site

  • Universitat Jaume I

    Castellon, Castellón, 12071

    Verónica Guillén Botella, Dr, 964864386 ext. 4386, fernandi@uji.es

    Azucena García Palacios, Dr, 964387640 ext. 7640, azucena@uji.es

Other trials in Spain

About this study

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.

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.

Read the 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.

Conditions
Relatives
Being tested
Family Connections program
Keywords
borderline personality disorder, family connections, relatives, dbt, smartphone app, technology
Medical subject headings
Borderline Personality Disorder, Maple syrup urine disease, type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Family Connections programBehavioural

    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.

Study groups in NCT05215392
Study groupRoleWhat they receive
Smartphone ApplicationExperimentalFamily 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.
Receives: Behavioral: Family Connections program
Treatment As UsualActive comparatorFamily 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.
Receives: Behavioral: Family Connections program

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (3)

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

    Depression, Anxiety and Stress Scale (DASS) have 42 items about negative emotional symptoms (Lovibond \& Lovibond, 1995). Lovibond \& Lovinbod (1995) proposed that a part of these subscales for can become part of a short version creating a new questionnaire of 21 items. Items are rated on a 4-point Likert scale ranging from 0 (It did not happen to me) to 3 (It happened to me a lot or most of the time), and higher scores indicate worse symptoms of depression, anxiety or stress. DASS-21 showed fantastic factor structures. Regarding to the internal consistency, Cronbach's alphas were excellent for the DASS-21 subscales: Depression (α = .94), Anxiety (α = .87) and Stress (α = .91) (Antony, Bieling, Cox, Enns \& Swinson, 1998).

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

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

    Family Empowerment Scale (FES) consists of 34 items divided in three subscales: family, service system, and involvement in community that is refered to three ways of empowerment, attitudes, knowledge, and behaviors (Koren, DeChillo \& Friesen, 1992). Items are rated on a scale of 1 (completely false) to 5 (totally true), and higher scores indicate a greater sense of empowerment. The psychometric properties are the following: regarding to the internal consistency of FES subscores, the coefficients ranged from .87 to .88 and validity and reliability are adequated (Koren, DeChillo \& Friesen, 1992).

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

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

    Connor-Davidson Resilience scale is a 25-item measure of resilience. Items are rated on a 5-point Likert scale ranging from 0 (absolutely not) to 4 (almost always) and the punctuation is based on how the participant has felt over the last month. Higher scores means greater resilience (Connor \& Davidson, 2003). The CD-RISC authors reported acceptable test-retest reliability (r = 0.87) and strong internal consistency (α = .89) (Connor \& Davidson, 2003).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2022
  2. Study start1 Sep 2022 (estimated)
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion15 Jan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, Efficacy Study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
116 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05215392
Sponsor's protocol ID
UJaumeI22-1
Status last verified
Feb 2022
First submitted
17 Jan 2022
Last updated
4 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data will be available after deidentification.

Publications

  • 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.

    PubMed 17257517

  • 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.

    PubMed 16013747

  • 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.

    PubMed 14979218

  • 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.

    PubMed 10668619

  • 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.

    PubMed 28861273

  • 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.

    PubMed 19590999

Questions about this trial

What is this clinical trial studying?

A study testing Family Connections program in people with Relatives, run by Universitat Jaume I at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Verónica Guillén Botella, Dr (963864386 ext. 4386, vguillenbotella@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Burden Assessment Scale (BAS; Horwitz & Reinhard, 1992) (time frame: Changes will be assessed from pre-treatment to immediately after the intervention (3 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05215392, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2022.

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