Relatives Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 116 |
Est. completion date | January 15, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Universitat Jaume I | Castellón De La Plana | Castellón |
Lead Sponsor | Collaborator |
---|---|
Universitat Jaume I | University of Valencia |
Spain,
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 — View Citation
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. — View Citation
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. — View Citation
Hoffman PD, Fruzzetti AE, Swenson CR. Dialectical behavior therapy--family skills training. Fam Process. 1999 Winter;38(4):399-414. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | System Usability Scale (SUS; Brooke, 2013). | It consists of 10 items measured with a Likert scale with five response options from Strongly agree to Strongly disagree. It is reliable (coefficient alpha of .91) and useful (Bangor, Kortum, & Miller, 2008). | Changes will be assessed immediately after the intervention (3 months) | |
Primary | 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 | 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 (a = .94), Anxiety (a = .87) and Stress (a = .91) (Antony, Bieling, Cox, Enns & Swinson, 1998). | Changes will be assessed from pre-treatment to immediately after the intervention (3 months) | |
Secondary | 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). | Changes will be assessed from pre-treatment to immediately after the intervention (3 months) | |
Secondary | 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 (a = .89) (Connor & Davidson, 2003). | Changes will be assessed from pre-treatment to immediately after the intervention (3 months) |
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