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SuicideSOLPROSU50+NCT06338904

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

A study testing Problem-solving-based psychological intervention in people with Suicide, run by University of Santiago de Compostela at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Suicide
What is being tested?
Problem-solving-based psychological intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
212 participants
Where
1 siteSpain
Study dates
1 Sep 2023to 31 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fernando L. Vázquez González, PhD. contact

(00 34) 881811000 ext. 13705

fernandolino.vazquez@usc.es

Spain1 site, 1 recruiting

  • Research Group on Mental Health and Psychopatology

    Santiago de Compostela, A Coruña, 15782

    Fernando L. Vázquez González, Dr., 881811000 ext. 13705, fernandolino.vazquez@usc.es

    Ángela J. Torres Iglesias, MD, PhD.

    Recruiting

Other trials in Spain

About this study

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

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
Being tested
Problem-solving-based psychological intervention
Keywords
randomized controlled trial, prevention, problem solving, conference call, App, Adults over 50
Medical subject headings
Suicide, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Problem-solving-based psychological interventionBehavioural

    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).

Study groups in NCT06338904
Study groupRoleWhat they receive
Problem-solving-based psychological intervention delivered in a face-to-face format (PSPI-FF)ExperimentalParticipants 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.
Receives: Behavioral: Problem-solving-based psychological intervention
Problem-solving-based psychological intervention delivered via telephone conference call (PSPI-CC)ExperimentalParticipants in this group will receive the intervention described in a teleconference call format, with the same duration, contents, and structure.
Receives: Behavioral: Problem-solving-based psychological intervention
Problem-solving-based psychological intervention delivered via a smartphone app (PSPI-A)ExperimentalParticipants 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).
Receives: Behavioral: Problem-solving-based psychological intervention
Usual care (UCCG)No interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (9)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

    Measured: During the intervention sessions (6 weeks)]

  9. 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.

    Measured: Post-intervention (7 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2024
  2. Study start1 Sep 2023
  3. Primary completion31 May 2026 (estimated)
  4. Study completion31 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
212 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06338904
Sponsor's protocol ID
PID2022-141225OB-I00
Acronym
SOLPROSU50+
Status last verified
Apr 2026
First submitted
2 Mar 2024
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

  • 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.

  • 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.

    PubMed 25331992

  • 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.

    PubMed 23336549

  • 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.

    PubMed 31017076

  • 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.

    PubMed 31237377

  • 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.

    PubMed 469082

  • 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.

    PubMed 22193671

  • 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.

    PubMed 4436473

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

  • 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.

    PubMed 6841772

  • 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.

    PubMed 8778124

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

  • 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.

    PubMed 3393031

  • 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.

    PubMed 7797645

Questions about this trial

What is this clinical trial studying?

A study testing Problem-solving-based psychological intervention in people with Suicide, run by University of Santiago de Compostela at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Fernando L. Vázquez González, PhD. ((00 34) 881811000 ext. 13705, fernandolino.vazquez@usc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline suicidal ideation to post-treatment (7 weeks), and follow-ups at 6 and 12 months. (time frame: Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06338904, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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