Clinical trial NCT06338904: Brief Problem-solving Intervention in Different Formats for the Prevention of Suicide in Adults Over 50
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Suicide
Keywords: randomized controlled trial
prevention
problem solving
conference call
App
Adults over 50
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Innovation, Spain
First posted: 2024-04-01
Enrollment: 212
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline suicidal ideation to post-treatment (7 weeks), and follow-ups at 6 and 12 months.
timeFrame: Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months
measure: Change from baseline suicidal ideation to post-treatment (7 weeks), and follow-ups at 6 and 12 months.
timeFrame: Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months
Secondary outcomes:
measure: Change from baseline hopelessness to post-treatment (7 weeks), and follow-ups at 6 and 12 months
timeFrame: Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months
measure: Change from baseline anxiety and depressive symptoms to post-treatment (7 weeks), and follow-ups at 6 and 12 months
timeFrame: Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months
measure: Change from baseline reasons for living to post-treatment (7 weeks), and follow-ups at 6 and 12 months
timeFrame: Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months
measure: Change from baseline impulsivity to post-treatment (7 weeks), and follow-ups at 6 and 12 months
timeFrame: Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months
measure: Change from baseline problem-solving skills to post-treatment (7 weeks), and follow-ups at 6 and 12 months
timeFrame: Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months
measure: Change from baseline social support to post-treatment (7 weeks), and follow-ups at 6 and 12 months
timeFrame: Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months
measure: Change from baseline syndrome of clinical anger to post-treatment (7 weeks), and follow-ups at 6 and 12 months
timeFrame: Pre- and post-intervention (7 weeks) with follow-ups at 3, 6 and 12 months
measure: Treatment adherence
timeFrame: During the intervention sessions (6 weeks)]
measure: Satisfaction with the service received
timeFrame: Post-intervention (7 weeks)
Other outcomes:
measure: Sociodemographic, familial, personal history, and current suicide risk variables
timeFrame: Pre-intervention.
Locations:
city: Santiago de Compostela
country: Spain
facility: Research Group on Mental Health and Psychopatology
state: A Coruña
Study officials:
affiliation: University of Santiago de Compostela
name: Fernando L. Vazquez González, PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Santiago de Compostela
name: Ángela J. Torres Iglesias, PhD.
role: PRINCIPAL_INVESTIGATOR
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