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

Suicide Clinical Trial

— SOLPROSU50+  

Official title:

Efficacy of a Brief Poblem-solving Based Psychological Intervention Implemented in Different Formats for the Indicated Prevention of Suicide in Adults Over 50

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06338904
• Other study ID #: PID2022-141225OB-I00
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: May 31, 2026

Study information

• Verified date: March 2024
• Source: University of Santiago de Compostela
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 212
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Be at least 50 years old

• Reside in Galicia

• Present suicidal ideation

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Suicide

Intervention

Behavioral:
• Problem-solving-based psychological intervention
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).

Locations

Country	Name	City	State
Spain	Research Group on Mental Health and Psychopatology	Santiago de Compostela	A Coruña

Sponsors (2)

Lead Sponsor	Collaborator
University of Santiago de Compostela	Ministry of science and innovation of Spain

Country where clinical trial is conducted

Spain, 

References & Publications (17)

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. — View Citation

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. — View Citation

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. — View Citation

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

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.

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

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sociodemographic, familial, personal history, and current suicide risk variables	These variables will be assessed using a hetero-administered questionnaire, developed ad hoc for this study, following the recommended criteria in the Clinical Practice Guideline for the Prevention and Treatment of Suicidal Behavior (Grupo de Trabajo de la Guía de Práctica Clínica de Prevención y Tratamiento de la Conducta Suicida, 2012/2020). This questionnaire will include information on: sex, age, marital status, living arrangements, rural/urban setting, education level, main activity, family monthly income, characteristics of suicidal ideation (e.g., potential plans, access to lethal means, intent to die, previous suicide attempts); present/past risk factors (e.g., risk factors related to psychological and psychiatric problems, family history of suicidal behavior and mental disorder, history of physical abuse or sexual abuse); and health and psychosocial stress factors (e.g., presence of chronic illness, financial problems).	Pre-intervention.
Primary	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
Primary	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	Change from baseline hopelessness to post-treatment (7 weeks), and follow-ups at 6 and 12 months	Hopelessness will be assessed with the Beck Hopelessness Scale (HS; Beck et al., 1974), a self-administered instrument of 20 items with a range from 0 to 20. Higher scores mean higher hopelessness. It has an internal consistency (Kuder-Richardson 20 [KR-20]) of .93.	Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months
Secondary	Change from baseline anxiety and depressive symptoms to post-treatment (7 weeks), and follow-ups at 6 and 12 months	Anxiety and depression symptoms will be assessed with the General Health Questionnaire (GHQ-12; Goldberg & Williams, 1988), a self-administered questionnaire of 12 items designed to screen for non-psychotic psychiatric morbidity, with a range from 0 to 12. Higher scores mean higher anxiety and depressive symptoms. Its internal consistency (Cronbach's alpha) is .86 for individuals under 65 years of age and .90 for individuals aged 65 years or older.	Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months
Secondary	Change from baseline reasons for living to post-treatment (7 weeks), and follow-ups at 6 and 12 months	Deterrent reasons for attempting suicide will be assessed through the Reasons for Living Inventory (RFL; Linehan et al., 1983), a self-administered instrument of 48 items across six subscales, with a range from 48 to 288. Higher scores mean that individuals exhibit higher reasons for living. Internal consistencies (Cronbach's alphas) range from .72 to .89.	Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months
Secondary	Change from baseline impulsivity to post-treatment (7 weeks), and follow-ups at 6 and 12 months	Impulsivity will be assessed using the Barratt Impulsiveness Scale (BIS-11; Patton et al., 1995), a self-administered instrument of 30 items, with a range from 30 to 120. Higher scores mean higher impulsivity. Its internal consistencies (Cronbach's alphas) range from .79 to .82.	Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months
Secondary	Change from baseline problem-solving skills to post-treatment (7 weeks), and follow-ups at 6 and 12 months	Problem-solving skills will be assessed with the Revised Social Problem-Solving Inventory (SPSI-R; D'Zurilla et al., 1997), an inventory of 52 items with a range from 0 to 208, and an internal consistency (Cronbach's alpha) ranging from .68 to .92.	Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months
Secondary	Change from baseline social support to post-treatment (7 weeks), and follow-ups at 6 and 12 months	Social support will be evaluated with the DUKE-UNC Functional Social Support Questionnaire (Duke-UNC-11; Broadhead et al., 1988), an 11-item questionnaire with a range from 11 to 55 and an internal consistency (Cronbach's alpha) of .90. Higher scores mean higher social support.	Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months
Secondary	Change from baseline syndrome of clinical anger to post-treatment (7 weeks), and follow-ups at 6 and 12 months	The anger syndrome will be assessed with the Clinical Anger Scale (CAS; Snell et al., 1995), a self-administered instrument of 21 items with a range from 0 to 63, and an internal consistency (Cronbach's alpha) of .94. Higher scores correspond to greater clinical anger.	Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months
Secondary	Treatment adherence	Treatment adherence will be assessed by recording the number of sessions attended or modules completed by each participant, and the number of intersession tasks completed.	During the intervention sessions (6 weeks)]
Secondary	Satisfaction with the service received	Satisfaction with the intervention will be evaluated using the Client Satisfaction Questionnaire (CSQ-8; Larsen et al., 1979), an 8-item scale whose total score varies from 8 to 32, where a higher score indicates greater satisfaction with the service received. It has an internal consistency (Cronbach's alpha) of .80.	Post-intervention (7 weeks)