Family Connections for Caregivers of People With Suicidal Behavior

NCT ID: NCT05157607

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2023-04-01

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.

Conditions

Relatives

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Family Connections Protocol for Relatives of Patients with SBD.

The intervention lasts three months and includes 12 sessions with a weekly two-hour group format. The FC program is divided into six modules:

Module 1: Up-to-date information and research on suicide (Epidemiology, frequency, Risk factors, protective factors).

Module 2: Psychoeducation on the development of suicide, explanatory theories, available treatments, comorbidity.

Module 3: Emotional regulation skills, skills of acceptance, validation, approach, awareness, and to decrease emotional reactivity.

Module 4: Skills to improve the quality of relationships in family interactions (letting go of guilt and anger, acceptance skills in relationships).

Module 5: Communication skills and effective self-expression. Module 6: Problem management and making safe plans for crisis management.

Group Type: EXPERIMENTAL

Family Connections Protocol for Relatives of Patients with SBD.

Intervention Type: BEHAVIORAL

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.

Treatment as Usual Optimized Protocol (TAU-O).

Family members in this condition will continue to receive their treatment as usual in their care center of reference. In addition, we will optimize the treatment based on the recommendations of the international guidelines for the treatment of suicide. There will be one three-hour session in group format with the following component:

Module 1: Updated information and research on suicide (Epidemiology, frequency, Risk factors, protective factors). Psychoeducation on the development of Suicide, Explanatory theories. Available treatments, and comorbidity.

Group Type: ACTIVE_COMPARATOR

Treatment as Usual Optimized Protocol (TAU-O)

Intervention Type: BEHAVIORAL

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.

Interventions

Family 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.

Intervention Type: BEHAVIORAL

Treatment 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitat Jaume I

OTHER

Sponsor Role: collaborator

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabel Fernández Felipe, PhDStudent

Role: PRINCIPAL_INVESTIGATOR

Universitat Jaume I

Sara Fonseca, PhDStudent

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Azucena Garcia-Palacios, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitat Jaume I

Sandra Perez, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitat de Valencia

Rosa Baños, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitat de Valencia

Cristina Botella Arbona, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitat Jaume I

Joaquin Garcia-Alandete, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitat de Valencia

Locations

University of Valencia

Valencia, , Spain

Countries

Spain

References

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. doi: 10.1007/s11920-007-0012-z.

Reference Type: BACKGROUND

PMID: 17257517 (View on PubMed)

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. doi: 10.1111/j.1545-5300.2005.00055.x.

Reference Type: BACKGROUND

PMID: 16013747 (View on PubMed)

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. doi: 10.1111/j.1545-5300.2003.00469.x.

Reference Type: BACKGROUND

PMID: 14979218 (View on PubMed)

Hoffman PD, Fruzzetti AE, Swenson CR. Dialectical behavior therapy--family skills training. Fam Process. 1999 Winter;38(4):399-414. doi: 10.1111/j.1545-5300.1999.00399.x.

Reference Type: BACKGROUND

PMID: 10668619 (View on PubMed)

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 study. Borderline Personal Disord Emot Dysregul. 2017 Aug 30;4:18. doi: 10.1186/s40479-017-0069-1. eCollection 2017.

Reference Type: BACKGROUND

PMID: 28861273 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19590999 (View on PubMed)

Liljedahl SI, Kleindienst N, Wangby-Lundh M, Lundh LG, Daukantaite D, Fruzzetti AE, Westling S. Family Connections in different settings and intensities for underserved and geographically isolated families: a non-randomised comparison study. Borderline Personal Disord Emot Dysregul. 2019 Aug 26;6:14. doi: 10.1186/s40479-019-0111-6. eCollection 2019.

Reference Type: BACKGROUND

PMID: 31463066 (View on PubMed)

Marco JH, Fonseca S, Fernandez-Felipe I, Garcia-Palacios A, Banos R, Perez S, Garcia-Alandete J, Guillen V. 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. BMC Psychiatry. 2022 May 15;22(1):335. doi: 10.1186/s12888-022-03965-5.

Reference Type: DERIVED

PMID: 35570289 (View on PubMed)

Other Identifiers

UV-1623849

Identifier Type: -

Identifier Source: org_study_id