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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Relatives

Intervention / Treatment
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* Behavioral: Family Connections program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, Efficacy Study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smartphone Application<br>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<br>* 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.<br>|
| Active Comparator: Treatment As Usual<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Changes will be assessed from pre-treatment to immediately after the intervention (3 months) | 
| 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) | 
| 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). | Changes will be assessed from pre-treatment to immediately after the intervention (3 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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family connections, relatives, borderline personality disorder, dbt, smartphone app, technology