<p style="box-sizing: inherit; line-height: 1.5; margin-top: 1.2rem; margin-bottom: 1.2rem; color: rgb(33, 33, 33); font-family: BlinkMacSystemFont, -apple-system, &quot;Segoe UI&quot;, Roboto, Oxygen, Ubuntu, Cantarell, &quot;Fira Sans&quot;, &quot;Droid Sans&quot;, &quot;Helvetica Neue&quot;, sans-serif; font-size: 16px;"><span style="font-family: Helvetica; font-size: 14px;">The literature is to reveal that borderline personality disorder (BPD) is an important public mental health problem that affects both patients and their families.&nbsp; Studies indicate a high prevalence of psychological symptoms and burden in relatives of people with BPD. That's why it is necessary to develop useful and accessible interventions specifically addressed to the caregivers. Smartphone interventions with the Ecological Momentary Assessment (EMA) and Ecological Momentary Interventions (EMI) offer several potential advantages in this regard. This study is used to aims to test the effectiveness of a combined intervention supported by a smartphone app versus the same intervention supported by a paper-based manual, studying the feasibility and acceptance of both conditions and evaluating the perceptions and opinions of families about both interventions. </span></p><p style="box-sizing: inherit; line-height: 1.5; margin-top: 1.2rem; margin-bottom: 1.2rem; color: rgb(33, 33, 33); font-family: BlinkMacSystemFont, -apple-system, &quot;Segoe UI&quot;, Roboto, Oxygen, Ubuntu, Cantarell, &quot;Fira Sans&quot;, &quot;Droid Sans&quot;, &quot;Helvetica Neue&quot;, sans-serif; font-size: 16px;"><span style="font-family: Helvetica; font-size: 14px;">This research contains the study protocol.</span><strong class="sub-title" style="box-sizing: inherit;"><span style="font-family: Helvetica; font-size: 14px;">&nbsp;</span></strong><span style="font-family: Helvetica; font-size: 14px;">The design of this study protocol is a randomized controlled trial. A minimum of 116 relatives will be randomly assigned to two conditions: Treatment as usual (TAU) (</span><i style="box-sizing: inherit;"><span style="font-family: Helvetica; font-size: 14px;">N</span></i><span style="font-family: Helvetica; font-size: 14px;">&nbsp;= 58) or Treatment as usual + EMI (TAU+EMI) (N = 58), with TAU being the Family Connection program. The primary outcome will be a Burden Assessment Scale. Secondary outcomes will include psychological symptoms, mastery and empowerment, and resilience. Outcomes will be assessed from pre-treatment to post-treatment (3 months). Statistical analyses will be performed using Student's&nbsp;</span><i style="box-sizing: inherit;"><span style="font-family: Helvetica; font-size: 14px;">t</span></i><span style="font-family: Helvetica; font-size: 14px;">-tests, mixed models (ANCOVA), and intention-to-treat analysis.&nbsp;</span></p><p id="p0030" style="margin-bottom: 16px; padding: 0px; color: rgb(46, 46, 46); font-family: NexusSerif, Georgia, &quot;Times New Roman&quot;, Times, STIXGeneral, &quot;Cambria Math&quot;, &quot;Lucida Sans Unicode&quot;, &quot;Microsoft Sans Serif&quot;, &quot;Segoe UI Symbol&quot;, &quot;Arial Unicode MS&quot;, serif; font-size: 18px;"><span style="font-family: Helvetica;"><span style="font-size: 14px;">&nbsp;The experimental condition will result in significant reductions in psychological symptoms and burden and significant improvements in family functioning and quality of life, and (b) the experimental condition will be significantly more accepted by the relatives due to its interactivity, its many more dynamic and updated contents, and the alert reminders that make it easier to re</span><span style="font-size: 14px;">member to use it</span>.</span><img src="/media/django-summernote/2022-11-04/cdb00846-d2ca-4a20-a0af-68d3431a3c89.png" style="width: 100%;"></p><h4 id="st0070" class="u-margin-m-top u-margin-xs-bottom" style="margin-right: 0px; margin-left: 0px; padding: 0px; font-size: 1rem; line-height: 1.4; color: rgb(46, 46, 46); font-family: NexusSerif, Georgia, &quot;Times New Roman&quot;, Times, STIXGeneral, &quot;Cambria Math&quot;, &quot;Lucida Sans Unicode&quot;, &quot;Microsoft Sans Serif&quot;, &quot;Segoe UI Symbol&quot;, &quot;Arial Unicode MS&quot;, serif; margin-top: 24px !important; margin-bottom: 8px !important;"><b><span style="font-family: Helvetica; font-size: 14px;">Smartphone application:</span></b></h4><ul><li style="margin-bottom: 16px; padding: 0px; color: rgb(46, 46, 46); font-family: NexusSerif, Georgia, &quot;Times New Roman&quot;, Times, STIXGeneral, &quot;Cambria Math&quot;, &quot;Lucida Sans Unicode&quot;, &quot;Microsoft Sans Serif&quot;, &quot;Segoe UI Symbol&quot;, &quot;Arial Unicode MS&quot;, serif; font-size: 18px;"><span style="margin: 0px; padding: 0px;"><span style="margin: 0px; padding: 0px;"><span style="font-family: Helvetica; font-size: 14px;">Family members in the experimental group of this study will receive an ecological momentary intervention (EMI) derived from an&nbsp;</span><a href="https://www.sciencedirect.com/topics/medicine-and-dentistry/ecological-momentary-assessment" title="Learn more about ecological momentary assessment from ScienceDirect's AI-generated Topic Pages" class="topic-link" style="margin: 0px; padding: 0px; text-decoration-line: underline; text-decoration-thickness: 1px; text-decoration-color: rgb(46, 46, 46); color: rgb(46, 46, 46); word-break: break-word; text-underline-offset: 1px;"><span style="font-family: Helvetica; font-size: 14px;">ecological momentary assessment</span></a><span style="font-family: Helvetica; font-size: 14px;">&nbsp;(EMA) via the Family Connections smartphone app. </span></span></span></li><li style="margin-bottom: 16px; padding: 0px; color: rgb(46, 46, 46); font-family: NexusSerif, Georgia, &quot;Times New Roman&quot;, Times, STIXGeneral, &quot;Cambria Math&quot;, &quot;Lucida Sans Unicode&quot;, &quot;Microsoft Sans Serif&quot;, &quot;Segoe UI Symbol&quot;, &quot;Arial Unicode MS&quot;, serif; font-size: 18px;"><span style="margin: 0px; padding: 0px;"><span style="margin: 0px; padding: 0px;"><span style="font-family: Helvetica; font-size: 14px;">This app is to be used in real-time in a naturalistic setting and with multiple repeated measures (illness burden, global family functioning, depression, anxiety, stress, validation, emotional regulation, and quality of life).</span></span></span></li><li style="margin-bottom: 16px; padding: 0px; color: rgb(46, 46, 46); font-family: NexusSerif, Georgia, &quot;Times New Roman&quot;, Times, STIXGeneral, &quot;Cambria Math&quot;, &quot;Lucida Sans Unicode&quot;, &quot;Microsoft Sans Serif&quot;, &quot;Segoe UI Symbol&quot;, &quot;Arial Unicode MS&quot;, serif; font-size: 18px;"><span style="margin: 0px; padding: 0px;"><span style="margin: 0px; padding: 0px;"><span style="font-family: Helvetica; font-size: 14px;"> The EMIs are linked to the EMAs because the application of the techniques depends on the cut-off point for each variable, which is decided by experts, and the software instructs the participant to perform one skill or another through alerts. </span></span></span></li><li style="margin-bottom: 16px; padding: 0px; color: rgb(46, 46, 46); font-family: NexusSerif, Georgia, &quot;Times New Roman&quot;, Times, STIXGeneral, &quot;Cambria Math&quot;, &quot;Lucida Sans Unicode&quot;, &quot;Microsoft Sans Serif&quot;, &quot;Segoe UI Symbol&quot;, &quot;Arial Unicode MS&quot;, serif; font-size: 18px;"><span style="margin: 0px; padding: 0px;"><span style="margin: 0px; padding: 0px;"><span style="font-family: Helvetica; font-size: 14px;">The users will receive notifications twice a day reminding them to use the app. The notifications are programmed to occur twice a day, seven days a week, for three months. Moreover, the users can log in at any time to answer the EMAs, thus allowing the family member to perform the skill at the exact moment when the problem occurs in their environment.</span></span></span></li><li style="margin-bottom: 16px; padding: 0px; color: rgb(46, 46, 46); font-family: NexusSerif, Georgia, &quot;Times New Roman&quot;, Times, STIXGeneral, &quot;Cambria Math&quot;, &quot;Lucida Sans Unicode&quot;, &quot;Microsoft Sans Serif&quot;, &quot;Segoe UI Symbol&quot;, &quot;Arial Unicode MS&quot;, serif; font-size: 18px;"><span style="margin: 0px; padding: 0px;"><span style="margin: 0px; padding: 0px;"><span style="font-family: Helvetica; font-size: 14px;"> All the assessment measures and data on whether or not they performed the skill will be recorded by an automatic alert at the end of the day, and adherence to the intervention will be monitored. In addition, in the mobile application, the family members have a virtual “Library” where they can visualize the material available for each skill without the need for an alert and, thus, apply the technique at the desired moment.</span></span></span></li><li style="margin-bottom: 16px; padding: 0px; color: rgb(46, 46, 46); font-family: NexusSerif, Georgia, &quot;Times New Roman&quot;, Times, STIXGeneral, &quot;Cambria Math&quot;, &quot;Lucida Sans Unicode&quot;, &quot;Microsoft Sans Serif&quot;, &quot;Segoe UI Symbol&quot;, &quot;Arial Unicode MS&quot;, serif; font-size: 18px;"><span style="margin: 0px; padding: 0px;"><span style="margin: 0px; padding: 0px;"><span style="font-family: Helvetica; font-size: 14px;"> The FC application will be available for free download from the Google Play store. For the time being, it will be available for&nbsp;</span></span><a href="https://www.sciencedirect.com/topics/computer-science/android" title="Learn more about Android from ScienceDirect's AI-generated Topic Pages" class="topic-link" style="margin: 0px; padding: 0px; text-decoration-line: underline; text-decoration-thickness: 1px; text-decoration-color: rgb(46, 46, 46); color: rgb(46, 46, 46); word-break: break-word; text-underline-offset: 1px;"><span style="font-family: Helvetica; font-size: 14px;">Android</span></a><span style="font-family: Helvetica; font-size: 14px;">&nbsp;devices (version 2.3 or higher), and, hopefully, we will be able to develop it for iOS in the future. However, Android is the most widely used operating system in Spain by more than 90% of the population</span></span><span style="font-family: Helvetica; font-size: 14px;">, and 85% in Europe</span><span style="font-family: Helvetica; font-size: 14px;">. </span></li><li style="margin-bottom: 16px; padding: 0px; color: rgb(46, 46, 46); font-family: NexusSerif, Georgia, &quot;Times New Roman&quot;, Times, STIXGeneral, &quot;Cambria Math&quot;, &quot;Lucida Sans Unicode&quot;, &quot;Microsoft Sans Serif&quot;, &quot;Segoe UI Symbol&quot;, &quot;Arial Unicode MS&quot;, serif; font-size: 18px;"><span style="font-family: Helvetica; font-size: 14px;">Before downloading the app, a brief description will be available that includes the name and contact details of the principal investigator, the purpose of the app, and a statement guaranteeing the confidentiality of the data. Therapists and study investigators will receive specific training in the use of technologies and mobile applications.</span><img src="/media/django-summernote/2022-11-04/6ed4e8d8-493a-4b8f-b4f8-a81323fa214e.png" style="width: 100%;"></li></ul><p style="box-sizing: inherit; margin-top: 1.2rem; margin-bottom: 1.2rem; line-height: 1.5; color: rgb(33, 33, 33); font-family: BlinkMacSystemFont, -apple-system, &quot;Segoe UI&quot;, Roboto, Oxygen, Ubuntu, Cantarell, &quot;Fira Sans&quot;, &quot;Droid Sans&quot;, &quot;Helvetica Neue&quot;, sans-serif; font-size: 16px;"><span class="sub-title" style="box-sizing: inherit; font-weight: 700;"><span style="font-family: Helvetica; font-size: 14px;">Conclusion:</span></span></p><p style="box-sizing: inherit; margin-top: 1.2rem; margin-bottom: 1.2rem; line-height: 1.5; color: rgb(33, 33, 33); font-family: BlinkMacSystemFont, -apple-system, &quot;Segoe UI&quot;, Roboto, Oxygen, Ubuntu, Cantarell, &quot;Fira Sans&quot;, &quot;Droid Sans&quot;, &quot;Helvetica Neue&quot;, sans-serif; font-size: 16px;"><span class="sub-title" style="box-sizing: inherit; font-weight: 700;"><span style="font-family: Helvetica; font-size: 14px;">&nbsp;</span></span><span style="font-family: Helvetica; font-size: 14px;">The results of this study will provide a basis for future EMA- and EMI-based application interventions for family members of people with BPD and family members of people with other mental disorders who could benefit from the skills taught.&nbsp;</span></p>