Effectiveness of a CBT Online-based Program to Reduce Suicide Ideation Among School Adolescents

NCT05229302 | Completed DMC

• 1 other identifier: Fondecyt_1210093
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-blind two armed cluster randomized controlled trial (cRCT) aimed to determine the effectiveness of an integrated blended intervention (online a face-to face sessions) to reduce suicidal ideation (primary outcome). Additionally, the effect of the program on the following secondary outcomes will be assessed: suicidal attempts, depressive symptoms, hopelessness and problem-solving skills. On the other side, given its probable role as underlying mechanism in SI reduction, the effect of the intervention on emotional regulation will be assessed. Moreover, the study will evaluate whether the effects of the cRCT on primary and secondary outcomes remain at post-intervention and at 3-month, 6-month and 12-month follow-up.

Conditions

Suicidal Ideation

Keywords

Suicidal ideation; Web-based intervention; Effectiveness; Adolescents

Outcome Measures

Primary Outcomes (1)

• Suicide ideation

  The Suicidal Ideation Questionnaire (SIQ; Reynolds, 1988), a 15-item self-report measure designed to assess suicidal ideation in adolescents. Answers to each item are on a scale from 1 to 7. The scores to each item are summed to generate a total score with a range between 7 and 105. A higher score means higher intensity of suicidal ideation

  One month

Secondary Outcomes (8)

• Suicide attempt

  One month

• Depressive symptoms

  One month

• Anxiety as trait

  One Month

• Anxiety as state

  One month

• Hopelessness

  One month

Study Arms (2)

Intervention

EXPERIMENTAL

Secondary students with suicidal ideation participating in the intervention (Reframe-IT). The students will be referred to Primary care where they will be assessed by a physician who will determine if the adolescent could enter into the National Depression Treatment Program for people aged 15 and above, which is organized as a step care treatment

Behavioral: Reframet IT; Behavioral: Usual care

Control

ACTIVE COMPARATOR

Secondary students referred to Primary care where they will be assessed by a physician who will determine if the adolescent could enter into the National Depression Treatment Program for people aged 15 and above, which is organized as a step care treatment.

Behavioral: Usual care

Interventions

Reframet IT BEHAVIORAL

The online intervention comprises 8 modules of cognitive behavioral therapy (CBT) delivered at schools by psychologists over 10 weeks. Contents: engagement and problem identification, emotional recognition and distress tolerance, identification of negative automatic thinking, help seeking and activity scheduling, problem solving, and cognitive restructuring, and a wrap up session. Two activities per module. Using a message board, the participant could communicate with research therapists who also check completed activities and respond with personalized messages. The face-to-face intervention comprises 4 CBT-based sessions to help the students in three aspects: i) close support and monitoring in case of an increase of symptomatology; ii) motivation to persist with the CBT; and iii) support the interaction between the students and CBT. Additionally, participants will be referred to a primary care clinic to receive treatment as usual.

Intervention

Usual care BEHAVIORAL

Treatment as usual consists of identification and assisted referral to a primary care clinic where trained psychologists will assess the symptomatology and propose a course of actions, from initiation of psychotherapy to referral to a General practitioner to initiate medication if needed. Psychoterapy in primary care clinics consists of a range of 4-8 sessions twice a month. Most of the content of the psychotherapy are based on Cognitive-Behavioral Model. When needed, general practioners may suggest using medication, which normally are SSRI anditepressant (e.g., Fluoxetine, Sertraline). Medical check-up is conducted every month or every two months.

Control; Intervention

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Secondary students aged 13-18 years
• High scores in suicidal ideation, last month (score \> 3 in the Columbia Suicide Severity Rating Scale (C-SSRS; Posner et al., 2011)
• Fluent in Spanish language

You may not qualify if:

• Suicide attempt(s), last month
• Severe depressive symptoms, assessed by the PHQ-9 (\> 3 points)
• High severity of psychotic symptoms assessd by the Community Assessment of Psychic Positive-scale (CAPE, P15, Capra et al., 2013) (cut-off= 1.47, as suggested by Bukenaite et al., 2017)

Sponsors & Collaborators

• University of Talca: lead
• Universidad de los Andes, Chile: collaborator
• Centre for Youth Mental Health, University of Melbourne, Australia: collaborator

Study Sites (1)

Daniel Núñez

Talca, Maule Region, Chile

Location

Related Publications (12)

• Reynolds, W.M. (1988). Suicidal Ideation Questionnaire: Professional manual. Odessa, FL: Psychological Assessment Resources.

  BACKGROUND

• Beck, A.T., Steer. R.A., Brown. G.K. (1996) Manual for Beck Depression Inventory-II (BDI-II). San Antonio: The Psychological Corporation.

  BACKGROUND

• Spielberger, C, Gorsuch, R. & Lushene, R. (1970). Manual for the State-Trait Anxiety Inventory. Palo Alto, California, Consulting Psychologist Press. (Adapt. Española, TEA, 1982).

  BACKGROUND

• D'Zurilla, T. J., Nezu, A. M., & Maydeu-Olivares, A. (1998). Manual for the social problem-solving inventory-revised. North Tonawanda, New York: Multi-Health Systems

  BACKGROUND

• Jacob KL, Christopher MS, Neuhaus EC. Development and validation of the cognitive-behavioral therapy skills questionnaire. Behav Modif. 2011 Nov;35(6):595-618. doi: 10.1177/0145445511419254. Epub 2011 Sep 5.

  PMID: 21893554 BACKGROUND

• Gullone E, Taffe J. The Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA): a psychometric evaluation. Psychol Assess. 2012 Jun;24(2):409-17. doi: 10.1037/a0025777. Epub 2011 Oct 24.

  PMID: 22023559 BACKGROUND

• Capra C, Kavanagh DJ, Hides L, Scott J. Brief screening for psychosis-like experiences. Schizophr Res. 2013 Sep;149(1-3):104-7. doi: 10.1016/j.schres.2013.05.020. Epub 2013 Jul 3.

  PMID: 23830544 BACKGROUND

• Bukenaite A, Stochl J, Mossaheb N, Schafer MR, Klier CM, Becker J, Schloegelhofer M, Papageorgiou K, Montejo AL, Russo DA, Jones PB, Perez J, Amminger GP. Usefulness of the CAPE-P15 for detecting people at ultra-high risk for psychosis: Psychometric properties and cut-off values. Schizophr Res. 2017 Nov;189:69-74. doi: 10.1016/j.schres.2017.02.017. Epub 2017 Feb 27.

  PMID: 28254243 BACKGROUND

• 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.

  PMID: 22193671 BACKGROUND

• Robinson J, Hetrick S, Cox G, Bendall S, Yung A, Pirkis J. The safety and acceptability of delivering an online intervention to secondary students at risk of suicide: findings from a pilot study. Early Interv Psychiatry. 2015 Dec;9(6):498-506. doi: 10.1111/eip.12136. Epub 2014 Mar 31.

  PMID: 24684927 BACKGROUND

• Hetrick SE, Yuen HP, Bailey E, Cox GR, Templer K, Rice SM, Bendall S, Robinson J. Internet-based cognitive behavioural therapy for young people with suicide-related behaviour (Reframe-IT): a randomised controlled trial. Evid Based Ment Health. 2017 Aug;20(3):76-82. doi: 10.1136/eb-2017-102719. Epub 2017 Jul 12.

  PMID: 28701336 BACKGROUND

• Nunez D, Meza D, Andaur J, Robinson J, Gaete J. Reframe-IT+, an indicated preventive school-based intervention, reduces suicidal ideation among adolescents in vulnerable contexts in Chile. BMC Psychol. 2024 Dec 24;12(1):780. doi: 10.1186/s40359-024-02300-9.

  PMID: 39719648 DERIVED

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Daniel Nuñez, PhD

  University of Talca

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Outcome Assessor will be unaware of which treatment arms participants have been assigned to El evaluador será ciego a la pertenencia de los participantes al grupo control o de intervención
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Cluster randomized controlled trial

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: February 8, 2022
• Study Start: April 1, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)