Family connections in the treatment of relatives of people with eating disorders and personality disorders: study protocol of a randomized control trial.

BACKGROUND: Eating disorders (EDs) are serious disorders that significantly affect not only the lives of patients, but also those of their family members who often experience high levels of burden, suffering and helplessness. If, in addition to ED, the patient has a personality disorder (PD), the psychological distress experienced by family members can be devastating. However, few treatments have been developed for family members of people with ED and PD. Family Connections (FC) is a programme that has been shown to be effective for family members of people with borderline personality disorder. The overall aims of this work are: (a) to adapt FC for application to family members of patients with BPD-PD (FC: ED-PD); (b) to analyse, in a randomised controlled clinical trial, the efficacy of this programme in a Spanish population, compared to a control condition consisting of treatment as usual optimised treatment (TAU-O); (c) to analyse the feasibility of the intervention protocol; (d) to analyse whether the changes that may occur in relatives are related to improvements in the family climate and/or improvements observed in patients; and (e) to analyse the perceptions and opinions of relatives and patients about the two intervention protocols. METHODS: The study uses a two-arm randomised controlled clinical trial with two experimental conditions: adaptation of FC programme (FC: ED-PD) or Treatment as usual optimised (TAU-O). Participants will be family members of patients who meet DSM-5 criteria for ED and PD or dysfunctional personality traits. Participants will be assessed before and after treatment and at one-year follow-up. The intention-to-treat principle will be used when analysing the data. DISCUSSION: The results obtained are expected to confirm the effectiveness of the programme and its good acceptance by family members. Trial registration ClinicalTrials.gov Identifier: NCT05404035. Accepted: May 2022.

Spanish adaptation of the Burden Assessment Scale in family caregivers of people diagnosed with borderline personality disorder.

BACKGROUND: Caregiving is a strong source of stress and leads the family caregiver to experience the burden of being responsible for the care of a severely mentally ill family member. The Burden Assessment Scale (BAS) assesses burden in family caregivers. This study aimed to analyze the psychometric properties of the BAS in a sample of family caregivers of people diagnosed with Borderline Personality Disorder (BPD). METHODS: Participants were 233 Spanish family caregivers (157 women and 76 men aged between 16-76 years old, M = 54.44, SD = 10.09) of people diagnosed with BPD. The BAS, the Multicultural Quality of Life Index, and the Depression Anxiety Stress Scale-21 were used. RESULTS: An exploratory analysis resulted in a three-factor 16-item model (Disrupted Activities; Personal and Social Dysfunction; Worry, Guilt, and Being Overwhelmed) with an excellent fit (χ2(101) = 56.873, p = 1.000, CFI = 1.000, TLI = 1.000, RMSEA = .000, SRMR = .060), good internal consistency (ω = .93), a negative correlation with quality of life, and a positive correlation with anxiety, depression, and stress. CONCLUSION: The model obtained for the BAS is a valid, reliable, and useful tool for assessing burden in family caregivers of relatives diagnosed with BPD.

Multicultural Quality of Life Index in Relatives of People With Borderline Personality Disorder.

Purpose: The aim of the present study was to confirm the original factor structure of the Multicultural Quality of Life Index (MQLI) and analyze its psychometric properties in a sample of caregivers of people with borderline personality disorder (BPD). Methods: The MQLI was administered to 233 relatives of people with BPD. Participants completed the MQLI, the Depression, Anxiety and Stress Scale (DASS-21), and the Connor-Davidson Resilience Scale (CD-RISC). Results: Factor analysis of the relatives indicated that the MQLI generated a one-factor solution. The MQLI showed good internal consistency, ϖ = 0.91 [95% CI (0.90, 0.93)] and correlated significantly and positively with the CD-RISC (r s = 0.576) and negatively with the DASS-21 (r s = -0.583). Conclusion: Consistent with other studies, the MQLI demonstrated feasibility, strong internal consistency, and good convergent and discriminant validity, which means it is a psychometrically robust measure for the assessment of quality of life in relatives of people with BPD. Along with other validation studies, this measure will be a useful tool for assessing quality of life in relatives of people with mental disorders.

Family connections vs treatment at usual optimized in the treatment of relatives of people with suicidal behavior disorder: study protocol of a randomized control trial.

BACKGROUND: Relatives of people diagnosed with suicidal behavior disorder (SBD) feel guilty, afraid, hopeless, depression and anxiety. It is necessary to help the relatives of people with SBD to reduce their discomfort and burden. Family Connections (FC) is a program that has been shown to be effective in reducing burden, depression, and anxiety, and increasing dominance and validating behaviors in relatives of people with borderline personality disorder. However, there are no RCTs that demonstrate the efficacy of the FC program in patients with SBD. Our research team adapted FC for relatives of people with SBD for delivery in the Spanish population (FC-SBD). The FC-SBD program contains 12 two-hour sessions held once a week. The first aim is to verify the efficacy of the FC-SBD intervention for relatives of people diagnosed with SBD in a randomized control trial with a Spanish sample. The second objective is to analyze the feasibility and acceptance of FC-SBD in relatives. The third aim is to analyze whether the changes produced in the psychological variables in the relatives after the intervention are related to changes in the psychological variables of the patients. This paper presents the study protocol. METHODS: The study design consists of a two-arm randomized controlled trial with two conditions: FC-SBD or Treatment as usual optimized (TAU-O). Participants will be relatives of patients who meet DSM-5 criteria for SBD. The caregivers` primary outcome measures will be the BAS. Secondary outcomes will be DASS-21, FES, DERS, QoL. The patient's primary outcome measures will be the frequency of critical incidents with the family member with SBD. Secondary measures will be the INQ, PHQ-9, OASIS. Participants will be assessed at pretreatment, post-treatment, and 6-month follow-up. The intention-to-treat principle will be used when analyzing the data. DISCUSSION: This study will provide results that confirm the efficacy of the FC-SBD in relatives of people with SBD. These results will also confirm its good acceptance by family members and help us to find out whether it is a good program to improve the prevention of suicidal behaviors in the family environment. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT05157607 . Registered 15 December 2021.

Preventing Emotional Dysregulation: Acceptability and Preliminary Effectiveness of a DBT Skills Training Program for Adolescents in the Spanish School System.

Emotional dysregulation is a key factor in the development and maintenance of multiple disabling mental disorders through a person's lifespan. Therefore, there is an urgent need to prevent emotional dysregulation as early as possible. The main aim of this study was to evaluate the acceptability and preliminary effectiveness of an adapted Dialectical Behavior Therapy Skills Training program for Emotional Problem Solving in Adolescents (DBT STEPS-A) during secondary school. The sample included 93 adolescents (mean age = 12.78; SD = 0.54; and 53% female) studying in their 2nd year of secondary school in a public center in Catalonia (Spain). Measures of acceptability, difficulties of emotional regulation, mental health problems, and life satisfaction were completed before and after participation in the DBT STEPS-A program during one academic year. The majority of students rated the program as useful (64%) and enjoyed the classes (62%) and 48% of them reported practicing the newly learned skills. Statistically significant improvements were revealed in some emotional regulation-related variables, namely the number of peer problems (p = 0.003; d = 0.52) and prosocial behaviors (p < 0.001; d = -0.82). Although non-significant, the scores in the remaining outcomes indicated a general positive trend in emotional dysregulation, mental health, and life satisfaction. The adapted DBT STEPS-A was very well-accepted and helped overcome some emotional regulation difficulties in Spanish adolescents.

"Skills for pills": The dialectical-behavioural therapy skills training reduces polypharmacy in borderline personality disorder.

OBJECTIVE: Polypharmacy and overprescription of off-label medications are common in patients with borderline personality disorder (BPD). The aim of the present naturalistic study was to explore whether the skills training module of dialectical-behavioural therapy (DBT) can reduce polypharmacy in these patients in routine clinical practice. METHODS: Retrospective, observational study of 377 patients with a primary diagnosis of BPD consecutively admitted to the BPD outpatient unit from 2010 through 2020. All patients were invited to participate in the DBT skills training module (DBT-ST). DBT-ST participants (n = 182) were compared with a control group who did not participate in DBT-ST (n = 195). Pre-post intervention changes in medication load and use of antidepressants, benzodiazepines, mood stabilizers, and antipsychotics were evaluated. RESULTS: At baseline, most patients (84.4%) were taking at least one medication and 46.9% were on polypharmacy. Compared to controls, patients in the DBT-ST group presented a significant reduction in the number of medications (2.67-1.95 vs. 2.16-2.19; p < 0.001), medication load (4.25-3.05 vs. 3.45-3.48; p < 0.001), use of benzodiazepines (54.4%-27.5% vs. 40%-40.5%; p < 0.001), mood stabilizers (43.4%-33% vs. 36.4%-39.5%; p < 0.001), and antipsychotics (36.3%-29.1% vs. 34.4%-36.9%; p < 0.001). CONCLUSIONS: These findings suggest that patients with BPD can benefit from the DBT-ST module, which may reduce the medication load, particularly of sedatives. The results suggest that DBT-ST may be useful to treat overmedication in patients with BPD and could help to promote "deprescription" in clinical practice.

Confirmatory factor analysis and psychometric properties of the Emotion Regulation Questionnaire in participants with personality disorders.

Emotional dysregulation is a key symptom in participants with personality disorders. The Emotional Regulation Questionnaire (ERQ) has been studied with nonclinical samples; however, it is necessary to confirm the factorial structure of the ERQ in participants with personality disorders. The aims of the present study were to confirm the factorial structure of the Spanish version of the ERQ and analyse its psychometric properties as well as the association between the ERQ and the Borderline Symptoms List (BSL-23) and the Difficulties in Emotion Regulation Scale (DERS). The overall sample was composed of 250 patients with personality disorders, of whom 195 met the criteria for borderline personality disorder. Confirmatory factor analysis was conducted. The two-factor model showed an acceptable fit, similar to the original structure, in the participants with personality disorders and with borderline personality disorder. Cognitive reappraisal was negatively correlated with the DERS and BSL-23, and expressive suppression was positively correlated with the BSL-23. The ERQ is a reliable and valid instrument to evaluate emotional dysregulation in participants with personality disorders and participants with borderline personality disorder.

Blended transdiagnostic group CBT for emotional disorders: A feasibility trial protocol.

INTRODUCTION: Emotional disorders (anxiety and depressive disorders) are a relevant public health concern associated with high prevalence, high costs, and important disability. Therefore, research priorities include designing and testing cost-effective interventions to reach everyone in need. Internet-delivered interventions for emotional disorders are effective and can help to disseminate and implement evidence-based treatments. However, although these treatments are generally effective, not all patients benefit from this treatment format equally. Blended treatments are a new form of intervention that combines the strengths of face-to-face and Internet approaches. Nevertheless, research on blended interventions has focused primarily on individual therapy, and less attention has been paid to the potential of using this format in group psychotherapy. This study aims to analyze the feasibility of blended transdiagnostic group CBT for emotional disorders. The current article describes the study protocol for this trial. METHOD AND ANALYSIS: A one-armed pilot trial will be conducted. Participants will be 30 adults suffering from DSM-5 anxiety and/or depressive disorders. The treatment consists of a blended transdiagnostic group intervention delivered during a period of 24 weeks. Groups of 6 to 10 patients will attend a total of eight 2-hour, face-to-face sessions, alternated with the use of an online platform where they will find the contents of the treatment protocol. The intervention has four core components: present-focused awareness, cognitive flexibility, identification and modification of behavioral and cognitive patterns of emotional avoidance, and interoceptive and situational exposure. These components are delivered in 16 modules. Assessments will be performed at baseline, during the treatment, at post-treatment, and at 3-month follow-up. Clinical and treatment acceptability outcomes will be included. Quantitative and qualitative data (participants' views about blended group psychotherapy) will be analyzed. ETHICS AND DISSEMINATION: The trial has received ethical approval from the Ethics Committee of Universitat Jaume I (September 2019) and will be conducted in accordance with the study protocol, the Declaration of Helsinki, and good clinical practice. The results of this study will be disseminated by presentation at conferences and will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04008576. Registered 05 July 2019, https://clinicaltrials.gov/ct2/show/NCT04008576.

"Family Connections", a DBT-Based Program for Relatives of People with Borderline Personality Disorder during the COVID-19 Pandemic: A Focus Group Study.

The COVID-19 pandemic has had a significant impact on the family environment due to the difficulties that have been generated by job losses, deaths, increase rates of family and domestic violence, poor mental health outcomes, and estrangement in personal relationships. "Family Connections" (FC) is an internationally renowned DBT-based program that supports the families and caregivers of people with borderline personality disorder. The study took place at a Specialized Health Centre in Spain. A focus group with seven participants was organized for people who had previously attended an FC group. The participants were asked about their experiences during the confinement periods that was caused by COVID-19 as well as their experiences and opinions on relatives, skills practiced, their need to and the advantages of attending the group, and satisfaction with the FC group. The qualitative research web program Dedoose was used for the thematic analysis of the data. The results showed that the participants experienced various experiences during confinement; validation and radical acceptance were determined to be the most useful skills; the importance of professionals and the content as well as the sincerity of attendees and having a safe space were determined to be the greatest benefits of the programs; and the participants all indicated great satisfaction of the program. This study allowed us to explore the experiences of family members of people with BPD with their loved ones during the confinement period caused by the COVID-19 pandemic. We evaluated the use of the FC program skills in the family environment during confinement, and we analyzed the acceptability and satisfaction with the FC program.

Efficacy of "Family Connections", a program for relatives of people with borderline personality disorder, in the Spanish population: study protocol for a randomized controlled trial.

BACKGROUND: Patients with borderline personality disorder (BPD) experience significant affect regulation difficulties that cause serious consequences in their work, emotional, and social environments. This dysfunctional pattern also produces great suffering and a heavy burden on their relatives. Fortunately, some studies show that treatment of relatives of people with BPD begins to be important in the patients' recovery and in improving family dynamics. One of the treatments that has obtained the most empirical support is Family connections (FC). This 12-session program is an adaptation of different Dialectical Behavior Therapy strategies. To test the efficacy of FC, five uncontrolled clinical trials were conducted, with pre-post treatment and follow-up assessments. The results of these studies and subsequent replications showed an improvement in family attitudes and caregiver burnout. Our research team adapted FC for delivery in the Spanish population. We intend to test the efficacy of this program versus a treatment as usual condition. Moreover, we aim to test the efficacy of this program and study its effectiveness (in terms of participants' acceptance). This paper presents the study protocol. METHODS: The study is a randomized controlled trial. The participants will be recruited in a Personality Disorders Unit and randomly assigned to one of two treatment conditions: Family Connections group (FC) or Treatment As Usual (TAU). Primary outcome measures will be the BAS and FAD-GFS. Secondary outcomes will include DASS-21, FES, GS, and QLI. Participants' treatment acceptance and degree of satisfaction will also be measured. Participants will be assessed at pre-, post-treatment, and 6-month follow-up. Intention to treat and per protocol analyses will be performed. DISCUSSION: This is the first study on FC for relatives of people with borderline personality disorder (BPD) compared to an active condition (TAU), and this is the first time relatives' and patients' data will be analyzed. In addition, it is the first study to test the efficacy of the program in Spain. This intervention could contribute to improving the efficiency and effectiveness of current treatment programs for relatives of people with BPD, help to decrease burden, and improve the family connection. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04160871. Registered November 15th 2019.