Brief Problem-solving Intervention in Different Formats for the Prevention of Suicide in Adults Over 50

NCT06338904 | Recruiting

• 1 other identifier: PID2022-141225OB-I00
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

Suicide represents a personal tragedy and an enormous global public health problem. One of the most vulnerable groups is adults 50 years and older. Despite this stage of life is particularly amenable to the implementation of targeted suicide prevention strategies, we have few studies of the efficacy of psychological interventions, those that do exist have methodological limitations, and none were implemented in formats other than face-to-face, which limits their accessibility. There is a need for brief psychological interventions that can be administered in both face-to-face and remote formats, do not require long training periods, and are effective in different contexts: for example, problem-solving therapy. The main objective of this project is to evaluate the efficacy of a brief problem-solving psychological intervention for targeted suicide prevention in people aged 50 years and older, administered in face-to-face, conference call, and smartphone app formats. A randomized controlled trial will be performed. Participants will be recruited through healthcare centers in the Autonomous Community of Galicia (Spain). To be included, participants must: (a) be at least 50 years old, (b) reside in Galicia, and (c) present suicidal ideation. Subjects will be excluded if they: (a) present serious mental health or medical disorders; (b) have begun receiving psychological or psychopharmacological treatment in the previous two months or are participating in other suicide prevention research; (c) do not have an appropriate mobile device or sufficient fluency to communicate in Spanish, or have problems that make it impossible to participate; or (d) plan to move in the next 18 months. At pre-intervention information will be collected on sociodemographic, family, personal history, current suicide risk and other clinical variables. 212 participants will be randomly assigned to (1) a problem-solving-based psychological intervention delivered face-to-face (PSPI-FF; experimental group 1); (2) a problem-solving-based psychological intervention delivered via telephone conference call (PSPI-CC; experimental group 2); (3) a problem-solving-based psychological intervention delivered via a smartphone app (PSPI-A; experimental group 3); or (4) a usual care control group (UCCG). Participants in the experimental groups will complete the six sessions/modules of the interventions. Finally, subjects in all groups will be evaluated at post-intervention and 3, 6 and 12-month follow-ups.

Conditions

Suicide

Keywords

randomized controlled trial; prevention; problem solving; conference call; App; Adults over 50

Outcome Measures

Primary Outcomes (2)

• Change from baseline suicidal ideation to post-treatment (7 weeks), and follow-ups at 6 and 12 months.

  Suicidal ideation will be assessed using the Suicidal Ideation Scale (SSI; Beck et al., 1979), a semi-structured scale of 19 items with an internal consistency (Kuder-Richardson coefficient \[KR-20\]) of .89 and an inter-rater reliability (k) of .83.

  Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months

• Change from baseline suicidal ideation to post-treatment (7 weeks), and follow-ups at 6 and 12 months.

  Aditionally, the severity of ideation and suicidal behavior over the last month will be assessed using the Columbia Scale for assessing suicide risk (C-SSRS; Posner et al., 2011). It consists of a semi-structured interview with good convergent and discriminant validity and high sensitivity (100.0%) and specificity (99.4%) for the classification of suicidal behavior; the ideation intensity subscale showed a Cronbach's alpha of .73-.95.

  Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months

Secondary Outcomes (9)

• Change from baseline hopelessness to post-treatment (7 weeks), and follow-ups at 6 and 12 months

  Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months

• Change from baseline anxiety and depressive symptoms to post-treatment (7 weeks), and follow-ups at 6 and 12 months

  Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months

• Change from baseline reasons for living to post-treatment (7 weeks), and follow-ups at 6 and 12 months

  Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months

• Change from baseline impulsivity to post-treatment (7 weeks), and follow-ups at 6 and 12 months

  Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months

• Change from baseline problem-solving skills to post-treatment (7 weeks), and follow-ups at 6 and 12 months

  Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months

Other Outcomes (1)

• Sociodemographic, familial, personal history, and current suicide risk variables

  Pre-intervention.

Study Arms (4)

Problem-solving-based psychological intervention delivered in a face-to-face format (PSPI-FF)

EXPERIMENTAL

Participants in this group will receive a problem-solving intervention for suicide prevention in a face-to-face format. The intervention will consist of 6 sessions, approximately 90 minutes in duration each, once a week, in a group format, in person.

Behavioral: Problem-solving-based psychological intervention

Problem-solving-based psychological intervention delivered via telephone conference call (PSPI-CC)

EXPERIMENTAL

Participants in this group will receive the intervention described in a teleconference call format, with the same duration, contents, and structure.

Behavioral: Problem-solving-based psychological intervention

Problem-solving-based psychological intervention delivered via a smartphone app (PSPI-A)

EXPERIMENTAL

Participants in this group will receive the intervention described adapted to be administered through a smartphone app, with equivalent duration, content, and structure (approximately 90 minutes to complete each of the 6 modules).

Behavioral: Problem-solving-based psychological intervention

Usual care (UCCG)

NO INTERVENTION

Participants in this group will receive usual care. Usual treatment will include individual and group psychotherapy and/or psychiatric medication as determined by the health professionals they are currently consulting, whether in public or private facilities.

Interventions

Problem-solving-based psychological intervention BEHAVIORAL

The intervention will include training in the components of the problem-solving model and other behavioral and cognitive skills such as detecting warning signals, monitoring mood, relaxation techniques, self-reinforcement, strategies for acting in crisis situations, engaging in enjoyable activities, mindfulness meditation techniques, or strategies for reframing irrational thoughts. It will be developed from the problem-solving model (D'Zurilla and Nezu, 1982) and will reference the indicated prevention program for depression (Vázquez et al., 2015), which has shown efficacy in reducing depressive symptoms and preventing the onset of depression episodes (Otero et al., 2015; Vázquez et al., 2013), with results on symptomatology maintained at 8 years (López et al., 2020); and the indicated prevention intervention that demonstrated efficacy in reducing suicide risk (Xavier et al., 2019).

Problem-solving-based psychological intervention delivered in a face-to-face format (PSPI-FF); Problem-solving-based psychological intervention delivered via a smartphone app (PSPI-A); Problem-solving-based psychological intervention delivered via telephone conference call (PSPI-CC)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 50 years old
• Reside in Galicia
• Present suicidal ideation

You may not qualify if:

• Present serious mental health or medical disorders
• Have begun receiving psychological or psychopharmacological treatment in the previous two months or are participating in other suicide prevention research
• Do not have an appropriate mobile device or sufficient fluency to communicate in Spanish, or have problems that make it impossible to participate
• Plan to move in the next 18 months.

Sponsors & Collaborators

• University of Santiago de Compostela: lead
• Ministry of Science and Innovation, Spain: collaborator

Study Sites (1)

Research Group on Mental Health and Psychopatology

Santiago de Compostela, A Coruña, 15782, Spain

RECRUITING

Related Publications (18)

• D'Zurilla TJ, Nezu, A. Social problem solving in adults. In: Kendall PC (editor). Advances in cognitive-behavioral research on therapy. New York: Academic Press; 1982. vol. 1, p. 202-74.

  BACKGROUND

• Vázquez FL, Otero P, Blanco V, Torres AJ. Terapia de solución de problemas para la depresión: una breve guía práctica en grupo. Madrid: Alianza Editorial. 2015.

  BACKGROUND

• Otero P, Smit F, Cuijpers P, Torres A, Blanco V, Vazquez FL. Long-term efficacy of indicated prevention of depression in non-professional caregivers: randomized controlled trial. Psychol Med. 2015 May;45(7):1401-12. doi: 10.1017/S0033291714002505. Epub 2014 Oct 21.

  PMID: 25331992 BACKGROUND

• Vazquez Gonzalez FL, Otero Otero P, Torres Iglesias A, Hermida Garcia E, Blanco Seoane V, Diaz Fernandez O. A brief problem-solving indicated-prevention intervention for prevention of depression in nonprofessional caregivers. Psicothema. 2013 Feb;25(1):87-92. doi: 10.7334/psicothema2012.89.

  PMID: 23336549 BACKGROUND

• Lopez L, Smit F, Cuijpers P, Otero P, Blanco V, Torres A, Vazquez FL. Problem-solving intervention to prevent depression in non-professional caregivers: a randomized controlled trial with 8 years of follow-up. Psychol Med. 2020 Apr;50(6):1002-1009. doi: 10.1017/S0033291719000916. Epub 2019 Apr 24.

  PMID: 31017076 BACKGROUND

• Xavier A, Otero P, Blanco V, Vazquez FL. Efficacy of a problem-solving intervention for the indicated prevention of suicidal risk in young Brazilians: Randomized controlled trial. Suicide Life Threat Behav. 2019 Dec;49(6):1746-1761. doi: 10.1111/sltb.12568. Epub 2019 Jun 25.

  PMID: 31237377 BACKGROUND

• Beck AT, Kovacs M, Weissman A. Assessment of suicidal intention: the Scale for Suicide Ideation. J Consult Clin Psychol. 1979 Apr;47(2):343-52. doi: 10.1037//0022-006x.47.2.343. No abstract available.

  PMID: 469082 BACKGROUND

• Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.

  PMID: 22193671 BACKGROUND

• Beck AT, Weissman A, Lester D, Trexler L. The measurement of pessimism: the hopelessness scale. J Consult Clin Psychol. 1974 Dec;42(6):861-5. doi: 10.1037/h0037562. No abstract available.

  PMID: 4436473 BACKGROUND

• Goldberg D, Williams P.. A user's guide to the General Health Questionnaire. Windsor: NFER-Nelson. 1988.

  BACKGROUND

• Linehan MM, Goodstein JL, Nielsen SL, Chiles JA. Reasons for staying alive when you are thinking of killing yourself: the reasons for living inventory. J Consult Clin Psychol. 1983 Apr;51(2):276-86. doi: 10.1037//0022-006x.51.2.276. No abstract available.

  PMID: 6841772 BACKGROUND

• Patton JH, Stanford MS, Barratt ES. Factor structure of the Barratt impulsiveness scale. J Clin Psychol. 1995 Nov;51(6):768-74. doi: 10.1002/1097-4679(199511)51:63.0.co;2-1.

  PMID: 8778124 BACKGROUND

• D'Zurilla TJ, Nezu AM, Maydeu-Olivares A.Manual for the social problem solving inventory-revised. North Tonawanda, NY: Multi-Health Systems. 1997.

  BACKGROUND

• Broadhead WE, Gehlbach SH, de Gruy FV, Kaplan BH. The Duke-UNC Functional Social Support Questionnaire. Measurement of social support in family medicine patients. Med Care. 1988 Jul;26(7):709-23. doi: 10.1097/00005650-198807000-00006.

  PMID: 3393031 BACKGROUND

• Snell WE Jr, Gum S, Shuck RL, Mosley JA, Hite TL. The Clinical Anger Scale: preliminary reliability and validity. J Clin Psychol. 1995 Mar;51(2):215-26. doi: 10.1002/1097-4679(199503)51:23.0.co;2-z.

  PMID: 7797645 BACKGROUND

• Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.

  PMID: 10245370 BACKGROUND

• Grupo de Trabajo de la Guía de Práctica Clínica de Prevención y Tratamiento de la Conducta Suicida Guía de práctica clínica de prevención y tratamiento de la conducta suicida [Clinical Practice Guideline for the Prevention and Treatment of Suicidal Behavior] (Ed. Rev. 2020).Santiago de Compostela: Plan de calidad para el Sistema Nacional de Salud del Ministerio de Sanidad, Política Social e Igualdad, Agencia de Evaluación de Tecnologías Sanitarias de Galicia (avaliat-t). 2012.

  BACKGROUND

• Vazquez FL, Torres AJ, Blanco V, Bouza Q, Otero P, Andrade E, Simon MA, Bueno AM, Arrojo M, Paramo M, Fernandez A. Brief psychological intervention for suicide prevention based on problem-solving applied in different formats to people over 50 years old: protocol for a randomized controlled trial. BMC Psychiatry. 2024 Sep 27;24(1):628. doi: 10.1186/s12888-024-06076-5.

  PMID: 39334120 DERIVED

MeSH Terms

Conditions

Suicide; Alzheimer Disease

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Fernando L. Vazquez González, PhD.

  University of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

• Ángela J. Torres Iglesias, PhD.

  University of Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando L. Vázquez González, PhD.

CONTACT

(00 34) 881811000; fernandolino.vazquez@usc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: March 2, 2024
• First Posted: April 1, 2024
• Study Start: September 1, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)