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NCT Number: NCT06338904

Brief Problem-solving Intervention in Different Formats for the 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.

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Group on Mental Health and Psychopatology

Santiago de Compostela, A Coruña, 15782, Spain

Location status: Recruiting

Location contact

Ana M. Bueno Palomino, PhD.

SUB_INVESTIGATOR

Elena Andrade Fernández, PhD.

SUB_INVESTIGATOR

Fernando L. Vázquez González, Dr.

CONTACT

[email protected]

881811000 ext. 13705

Manuel Arrojo Romero, MD, PhD.

SUB_INVESTIGATOR

Mario Páramo Fernández, MD, PhD.

SUB_INVESTIGATOR

Miguel A. Simón López, PhD.

SUB_INVESTIGATOR

Patricia Otero Otero, PhD.

SUB_INVESTIGATOR

Vanessa Blanco Seoane, PhD.

SUB_INVESTIGATOR

Ángela J. Torres Iglesias, MD, PhD.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. 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

    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.

  2. 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

    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.

Secondary outcomes

  1. Change from baseline hopelessness 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

    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.

  2. Change from baseline anxiety and depressive symptoms 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

    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.

  3. Change from baseline reasons for living 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

    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.

  4. Change from baseline impulsivity 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

    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.

  5. Change from baseline problem-solving skills 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

    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.

  6. Change from baseline social support 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

    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.

  7. Change from baseline syndrome of clinical anger 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 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.

  8. Treatment adherence

    Time frame: During the intervention sessions (6 weeks)]

    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.

  9. Satisfaction with the service received

    Time frame: Post-intervention (7 weeks)

    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.

Other outcomes

  1. Sociodemographic, familial, personal history, and current suicide risk variables

    Time frame: Pre-intervention.

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Fernando L. Vázquez González, PhD.

CONTACT

[email protected]

(00 34) 881811000 ext. 13705

Sponsors and collaborators

Lead sponsor

University of Santiago de Compostela

Other

Collaborators

  • Ministry of Science and Innovation, Spain

Registry information

Official study title

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

Acronym: SOLPROSU50+

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 1, 2024
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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