About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be at least 50 years old
Reside in Galicia
Present suicidal ideation
Disqualifiers
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 design
Parallel
Treatments tested in this trial
Problem-solving-based psychological intervention
BehavioralThe 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).
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
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.
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.
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.
Other outcomes
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).
Sponsors and contacts
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University of Santiago de Compostela
Lead sponsor
Ministry of Science and Innovation, Spain
Collaborator