Comparison of the effectiveness of the Coping Long-Term with Active Suicide Program alone and in combination with pharmacotherapy, compared with pharmacotherapy and control, in reducing suicide motivation and suicidality after a suicide attempt
Design
Controlled clinical trial with four parallel groups was conducted among 77 individuals with a history of suicide attempt.
Settings and conduct
Eligible suicide attempters presenting to Imam Hossein Educational and Medical Center were enrolled. Participants were matched by age, gender, and previous suicide attempt history, then allocated using a random number table to four groups. Assessments were conducted at baseline, post-intervention, and three- and six-month follow-ups. Blinding was not feasible due to the nature of the interventions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 18–60 years, at least one suicide attempt within the past six months, and providing informed consent to participate in the study;
Exclusion criteria: Diagnosis of an active psychotic disorder, severe cognitive impairment
Intervention groups
Intervention group 1:The Coping Long-Term with Active Suicide Program (CLASP);
Received three individual sessions, one family session, and 11 follow-up telephone contacts over six months. Intervention group 2: CLASP plus pharmacotherapy; Received CLASP with psychiatrist-supervised pharmacotherapy for six months.
Intervention group 3: Pharmacotherapy; Received psychiatrist-supervised pharmacotherapy for six months. Control group:
Received no active intervention during the study period.
Main outcome variables
Suicidal ideation, Suicidal motivation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221024056281N3
Registration date:2026-10-14, 1405/07/22
Registration timing:retrospective
Last update:2026-10-14, 1405/07/22
Update count:0
Registration date
2026-10-14, 1405/07/22
Registrant information
Name
Hedieh Babakhanzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 388 6351
Email address
hedieh.khanzadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-20, 1404/08/29
Expected recruitment end date
2026-01-15, 1404/10/25
Actual recruitment start date
2025-11-20, 1404/08/29
Actual recruitment end date
2026-01-15, 1404/10/25
Trial completion date
2026-06-17, 1405/03/27
Scientific title
Effectiveness of the Coping Long-Term with Active Suicide Program (CLASP) in Reducing Suicide Motivational Factors in Suicide Attempters
Public title
Effectiveness of the Coping Long-Term with Active Suicide Program in Suicide Attempters
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18–60 years
Having at least one suicide attempt within the past six months
Providing informed consent to participate in the study
no questionnaire score or cutoff was defined as an eligibility criterion. The Beck Scale for Suicide Ideation and the Inventory of Motivations for Suicide Attempts were used to measure the study variables.
Exclusion criteria:
Diagnosis of active psychotic disorder
Severe cognitive impairment
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
77
Actual sample size reached:
77
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Faculty of Psychology and Education, University of Tehran
Street address
Kardan St., Jalal Al-e Ahmad Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1445983861
Approval date
2025-11-17, 1404/08/26
Ethics committee reference number
IR.UT.PSYEDU.REC.1404.095
Health conditions studied
1
Description of health condition studied
Individuals with a history of suicide attempts
ICD-10 code
T14.91
ICD-10 code description
Suicide attempt
Primary outcomes
1
Description
Suicidal ideation score based on the Beck Scale for Suicide Ideation(BSSI)
Timepoint
Suicidality was measured at baseline (before the intervention), and at three- and six-month follow-ups after the intervention.
Method of measurement
Beck Scale for Suicide Ideation (BSSI)
2
Description
Suicidal motivation score based on the Inventory of Motivations for Suicide Attempts(IMSA)
Timepoint
Suicide motivation was measured at baseline (before the intervention), and at three- and six-month follow-ups after the intervention
Method of measurement
Inventory of Motivations for Suicide Attempts (IMSA)
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Coping Long-Term with Active Suicide Program: Participants in this group received the Coping Long-Term with Active Suicide Program (CLASP) over a six-month period. This intervention is a follow-up and adjunctive psychological program to usual treatments, designed to reduce the risk of recurrent suicidal behavior and to target psychological and behavioral factors associated with the continuation of risk. The program consisted of three individual face-to-face sessions, one family session, and 11 post-discharge follow-up telephone contacts.During the three individual face-to-face sessions, the intervention content included assessment of factors associated with the suicide attempt and level of risk, review of experiences and factors contributing to the crisis, development and review of a safety plan, identification of risk-enhancing and protective factors, training in coping skills, enhancement of problem-solving skills, reduction of hopelessness, strengthening motivation for continued living, identification of individual values and goals, and enhancement of adherence to treatment and follow-up with mental health services.The family session was conducted with the participant and one key family member or support person and focused on increasing social support, improving family communication, identifying warning signs, training on how to support the individual during crisis situations, and involving the family in the prevention of suicidal behavior.After the face-to-face sessions, 11 follow-up telephone contacts were conducted over six months. Each contact lasted approximately 15 to 30 minutes and included monitoring psychological status, reassessment of suicide risk, review of problems and stressors, review of coping skills and the safety plan, review of receipt of treatment services, strengthening supportive contact, and providing support during crisis situations.
Category
Prevention
2
Description
Second intervention group: Coping Long-Term with Active Suicide Program (CLASP) plus pharmacotherapy: Participants in this group, in addition to receiving the Coping Long-Term with Active Suicide Program (CLASP), also received usual pharmacological treatment under the supervision of the treating psychiatrist. The Coping Long-Term with Active Suicide Program was implemented over a six-month period and consisted of three individual face-to-face sessions, one family session, and 11 follow-up telephone contacts.The individual sessions focused on assessment of factors associated with suicidal behavior and level of risk, development and review of a safety plan, identification of triggers and warning signs, training and strengthening of coping skills, enhancement of problem-solving skills, reduction of hopelessness, strengthening motivation for continued living, and increasing adherence to treatment.The family session was conducted with the aim of increasing the participation of a significant person in the participant’s life or a family member in the treatment process, enhancing social support, providing training in the identification of warning signs, improving family communication, and establishing an effective support network for the prevention of suicidal behavior.The follow-up telephone contacts were conducted over six months after discharge, with each contact lasting approximately 15 to 30 minutes. These contacts were intended to monitor psychological status, reassess suicide risk, review the safety plan, assess barriers to treatment, strengthen coping strategies, and provide support during crisis situations.Pharmacotherapy was provided based on the psychiatrist’s clinical assessment, the diagnosis of comorbid disorders, the individual’s clinical condition, and the treatment protocol of the center. The type of medication, dosage, and changes in pharmacological treatment were determined according to the treating psychiatrist’s judgment and the condition of each patient, and participants in this group received standard pharmacological care alongside the psychological intervention.
Category
Prevention
3
Description
Third intervention group: Pharmacotherapy alone: Participants in this group received usual pharmacotherapy under the supervision of a psychiatrist, based on the clinical diagnosis, the patient's condition, and the treatment program of the center. Pharmacotherapy continued throughout the six-month study period, and the type and dose of medication were adjusted according to each patient's clinical condition by the treating psychiatrist.
Category
Prevention
4
Description
Control group: control: Participants in this group did not receive any active intervention during the study period. They were provided with access to treatment services after completion of the follow-up period.
Vice-Presidency for Research and Technology, Central Campus, University of Tehran, 16 Azar St., Enghelab St., Enghelab Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
۱۴۱۷۶۱۴۴۱۱
Phone
+98 21 6648 6500
Fax
+98 21 6648 6500
Email
Moradih@ut.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Tehran
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Hedieh Babakhanzadeh
Position
Clinical Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Kardan St., Jalal Al-e Ahmad Hwy., Faculty of Psychology and Education, University of Tehran, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445983861
Phone
+98 21 8823 4409
Email
Hedieh.khanzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University
Full name of responsible person
Hedieh Babakhanzadeh
Position
Cilinical Psycologhy
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Kardan St., Jalal Al-e Ahmad Hwy., Faculty of Psychology and Education, University of Tehran, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445983861
Phone
+98 21 8823 4409
Email
Hedieh.khanzadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of Tehran
Full name of responsible person
Hedieh Babakhanzadeh
Position
Clinical Psychologist
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Kardan St., Jalal Al-e Ahmad Hwy., Faculty of Psychology and Education, University of Tehran, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445983861
Phone
+98 21 8823 4409
Email
Hedieh.khanzadeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the sensitive nature of individual participant data, particularly information related to suicide attempts and psychological variables, identifiable individual-level data will not be publicly shared. Data sharing may compromise participants’ confidentiality and privacy. Upon a valid scientific request and ethical review, limited access to anonymized data may be considered.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available