Relatives
Conditions
Keywords
Family Connections, Suicidal Behavior Disorder, Suicide Attempts, Caregivers, Dialectical Behavior Therapy
Brief summary
The aim of our study is to verify the efficacy of the Family Connections intervention for relatives of people diagnosed with suicidal behavior disorder in a randomized control trial with a Spanish participants.
Detailed description
Family members of people who have attempted suicide feel guilty, afraid, hopeless, depression and anxiety. The needs of family members of people with suicide attempts are not adequately addressed in the current treatments for people with suicide attempts. Therefore, it is necessary to help the relatives of people with suicidal behaviors to reduce the discomfort and burden they experience by giving them information and skills to improve their relationship with patients. Family Connections (FC) is a program that has been shown to be effective in reducing burden, depression, and anxiety, and in increasing dominance and validating behaviors in relatives of people with borderline personality disorder. However, there are no Randomized Control Trials that demonstrate the efficacy of FC program in patients with suicide attempts. In a previous study, FC was adapted in an open trial with relatives of people who had attempted suicide. The results of this pilot study suggest that the FC program tailored to relatives of patients with suicide attempts may be effective in improving well-being and reducing the burden of illness in relatives. Our research team adapted FC for relatives of people diagnosed with suicidal behavior disorder (SBD) for delivery in the Spanish population. The FC-SCD program contains 12 two-hour sessions held once a week. The first aim is to verify the efficacy of the FC intervention for relatives of people diagnosed with SBD in a randomized control trial with a Spanish sample of participants from mental health services. 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. The study design consists of a two-arm randomized controlled trial, there will be two conditions: Family Connections (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 INQ, PHQ-9, OASIS, VIRS, LUMP. Participants will be assessed at pretreatment, post-treatment, and 6-month follow-up. The intention-to-treat principle will be used when analyzing data, using mixed-effects models with full information and maximum likelihood estimation.
Interventions
BEHAVIORALFamily Connections Protocol for Relatives of Patients with SBD.
Family Connections is a Dialectical Behavioral Therapy. All the modules include practice exercises, video viewing, and homework assignments. In addition, throughout the program, with the aim of increasing social support, the FC-SBD program provides a forum where participants can stay in touch and share common problems and solutions.
BEHAVIORALTreatment as Usual Optimized Protocol (TAU-O)
Participants will receive the usual treatment in their mental health service and will also receive a psychoeducation session of approximately 3 hours where the predictive and protective factors of suicidal behavior will be explained.
Sponsors
University of Valencia
Universitat Jaume I
Funding for the study was provided by (R + D + I) Projects of the State Programs Oriented to the Challenges of Society, within the framework of the State Resear
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized Control Trial, efficacy Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* Being a caregiver of one patient with a diagnosis of Suicide Behavior Disorder * Understand spoken and written Spanish; * Signing the informed consent.
Exclusion criteria
* The presence of a diagnosis of severe mental disorder in the caregivers as: Psychosis, schizophrenia, substance dependence, or high suicide ideation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Burden assessment scale (BAS) | Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up. | This 19-item scale assesses two dimensions of caregiver burden of a loved one's illness (objective and subjective) in the past six months. The items are rated on a 4-point Likert scale (1-4), where higher scores indicate higher levels of illness burden. The psychometric properties of this scale are adequate, with an internal reliability between .89 and .91 and adequate validity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Family empowerment scale (FES) | Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up. | This scale has a total of 34 items. It is composed of three subscales referring to attitudes, knowledge, and behaviors related to (1) Family, (2) the Service System, and (3) Community Participation. The items are rated on a Likert scale (1-5), where higher scores show greater feelings of empowerment. Both the validity and reliability of this scale are adequate, and the internal consistency of the subscales shows coefficients between α = .87 and α =.88. |
| Depression, anxiety, and stress scale (DASS-21) | Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up. | We have used the short, validated Spanish version with 21 items on the frequency of negative emotional symptoms in the past week. The items are rated on a Likert scale (0-3) where the higher the score, the higher the frequency of symptoms of depression, anxiety, and/or stress. The internal consistency of the scale was excellent, with Cronbach's alphas for the DASS-21 subscales: Depression (α = .94), Anxiety (α = .87) and Stress (α = .91) |
| Difficulties in emotion regulation scale - Spanish version | Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up. | We used the Spanish validation containing 28 items. This questionnaire is divided into five subscales: (1) Lack of emotional control, (2) Life interference, (3) Emotional inattention, (4) Emotional confusion, and (5) Emotional rejection. The items are rated on a Likert scale (1-5) where higher scores indicate greater difficulty in regulating emotions. Psychometric properties are excellent, with an internal consistency of α = .93 and test-retest reliability of pl = .74, p \< .001 |
| Quality of life index-Spanish version (QLI-Sp) | Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up. | It consists of a 10-item index of perceived quality of life. It refers to physical and emotional well-being, functioning at work, satisfaction with personal relationships and self-independence, support in the community and from an emotional point of view, spiritual well-being, and perceived overall quality of life. The items are rated on a Likert scale (0-10) where higher scores indicate higher perceived quality of life. The psychometric properties are good for both internal consistency (α = .89) and test-retest reliability (r = 0.87). |
| Opinion and Expectations of Treatment Scale (OTSM) | Changes will be assessed from pre-treatment to immediately after the intervention | This scale was designed and developed by members of the research team and constructed from an adaptation of another opinion and expectations questionnaire \[49\]. The constructs this scale assesses are: opinion, acceptance and satisfaction with the skills training program, and the changes in the participants after the completion of each module. The questions refer to the rationale for the intervention, recommendation of the program, satisfaction with the program, usefulness and expectations of the skills training. The items are rated on a Likert-type scale ranging from 0 "Not at all" to 10 "Very much". |
| Register of critical incidents with the family member with SBD | Changes will be assessed from pre-treatment to immediately after the intervention, and also at 6-month follow-up. | his register was developed ad hoc for this study. The questions recorded are the following: frequency of suicide attempts in the past six months, number of days of self-harm in the past six months, number of episodes of verbal/physical violence with caregivers in the past six months; frequency of visits to the psychiatric emergency room in the past six months, frequency of therapy sessions conducted out of schedule in the past six months (face-to-face, phone calls, etc.). |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORIsabel Fernández Felipe, PhDStudent
Universitat Jaume I
PRINCIPAL_INVESTIGATORSara Fonseca, PhDStudent
University of Valencia
PRINCIPAL_INVESTIGATORAzucena Garcia-Palacios, PhD
Universitat Jaume I
PRINCIPAL_INVESTIGATORSandra Perez, PhD
Universitat de Valencia
PRINCIPAL_INVESTIGATORRosa Baños, PhD
Universitat de Valencia
PRINCIPAL_INVESTIGATORCristina Botella Arbona, PhD
Universitat Jaume I
PRINCIPAL_INVESTIGATORJoaquin Garcia-Alandete, PhD
Universitat de Valencia
Outcome results
None listed