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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001445460
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
28/10/2025
Date registered
Help: Date registered
19/12/2025
Date last updated
Help: Date last updated
19/12/2025
Date data sharing statement initially provided
Help: Data sharing statement date
19/12/2025
Date results provided
Help: Date results provided
19/12/2025
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of online cognitive behavioral therapy program on suicidal thoughts, hopelessness, and cognitive flexibility in people with depression and a history of suicide attempt
Scientific title
The Efficacy of Online Cognitive Behavioral Therapy on Suicidal Ideation, Cognitive Flexibility, and Hopelessness in Persons Diagnosed with Depression Who Attempted Suicide: Randomized Controlled Trial
Additional trial identifiers [1] 315718 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Depression 339424 0
History of suicide attempt 339425 0
Suicidal ideation 339426 0
Hopelessness 339427 0
Condition category
Condition code
Mental Health 335679 335679 0 0
Depression
Mental Health 335680 335680 0 0
Suicide
Mental Health 335682 335682 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
INTERVENTION NAME: Online Individual Cognitive Behavioral Therapy (Online CBT)

CONTENT AND PROCEDURES: Participants received a total of 20 individual online CBT sessions. Each session followed the standard CBT structure recommended by Beck: mood check, previous session feedback and homework review, agenda setting and addressing agenda items, assignment of new homework, session summary and feedback.

SESSION CONTENT:
Session 1: Introduction, CBT rationale, problem identification, therapy goal setting
Sessions 2-3: Psychoeducation on cognitive model of depression and suicide, suicide action formulation, activity scheduling
Sessions 4-7: Behavioral interventions including emotion-behavior-environment relationship, happiness/unhappiness cycles, increasing pleasurable activities, reducing avoidance behaviors, enhancing social support, addressing hopelessness, developing problem-solving skills, reducing impulsivity, creating coping cards
Sessions 8-12: Cognitive interventions including identifying and modifying automatic thoughts, creating cognitive formulation schema, recognizing cognitive distortions, evidence examination, double standard technique, separating thoughts from facts
Sessions 13-15: Working with intermediate beliefs including identifying and modifying intermediate beliefs, developing alternative thoughts, behavioral experiments
Sessions 16-18: Working with core beliefs including identifying core beliefs, framing beliefs, cost-benefit analysis, core belief change interventions
Session 19: Relapse prevention planning
Session 20: Therapy process evaluation and termination

SUICIDE RISK MANAGEMENT: Before therapy initiation, each participant underwent face-to-face assessment including evaluation of suicidal thoughts and attempts, identification of suicide risk and protective factors, and development of a personalized suicide safety plan. The safety plan included warning sign recognition, self-management coping strategies, list of family members and friends to contact, professional contacts and institutions with phone numbers, and means restriction. The plan was signed by both participant and researcher and updated throughout therapy.

MATERIALS: Activity schedules, automatic thought records, homework assignments for each session, coping cards, cognitive formulation schemas

INTERVENTION PROVIDER:
Therapist Qualifications: Sessions were delivered by a doctoral researcher in psychiatric nursing with clinical experience.
Clinical Experience: 6 years clinical experience in psychiatry clinics at Gaziantep Dr. Ersin Arslan Training and Research Hospital and Aydin State Hospital, with direct experience working with patients with suicide attempt history.
CBT Training: Cognitive and Behavioral Therapy Theoretical Training 50 hours from Cognitive Behavioral Psychotherapy Association October 2019 to May 2020; CBT Skills Training 30 hours from Cognitive Behavioral Psychotherapy Association February to March 2021; Cognitive Behavioral Therapy Practitioner Certification from Izmir Psychology Institute February to March 2021.
Academic Training: Completed Behavioral Therapies course during doctoral program.
Supervision: Regular monthly supervision provided by Prof. Dr. Hulya Arslantas, thesis advisor, throughout therapy process.

DELIVERY MODE: Individual, live synchronous video conference sessions via Aydin Adnan Menderes University Distance Education Center platform. Participants connected from their homes. All sessions were recorded with written and verbal consent obtained.

DURATION AND FREQUENCY: 50-minute sessions, twice weekly, 10 weeks total with 20 sessions. Therapy days were scheduled individually for each participant on Monday-Thursday or Wednesday-Saturday.

SCHEDULING AND REMINDERS: Appointments were scheduled every Sunday for the following week. Session time and connection link were sent via SMS at 08:00 on the session day.

PERSONALIZATION: Therapy content was adapted to each participant's individual characteristics, suicide risk profile, and needs. Homework assignments were tailored to individual goals.

ADHERENCE AND FIDELITY ASSESSMENT: All sessions were video recorded, homework was reviewed at each session, all 25 participants completed all 20 sessions with no attrition, and sessions adhered to Beck's standard CBT structure.

IMPLEMENTATION DATES: First cohort of 13 participants from August 9 to October 16, 2021. Second cohort of 12 participants from December 6, 2021 to February 12, 2022.
Intervention code [1] 332337 0
Treatment: Other
Intervention code [2] 332338 0
Prevention
Intervention code [3] 332339 0
Behaviour
Description of the comparator or control
CONTROL GROUP NAME: Wait-list Control Group

DESCRIPTION: Control group participants (n=25) did not receive the online CBT program during the intervention period. During this time, they continued their standard psychiatric care, maintained routine medication treatment, continued regular psychiatrist follow-ups, and had access to emergency psychiatric services in crisis situations.

ASSESSMENT TIME POINTS: Control group participants were assessed at the same time points as the intervention group: baseline (pretest), 1 month, 3 months, and 6 months.

POST-STUDY INTERVENTION: After the 6-month follow-up period, control group participants were offered 4 psychoeducation group CBT sessions on an optional basis. 16 of 25 participants accepted this offer. Group CBT sessions consisted of 4 sessions of 50 minutes each, delivered in two groups with 8 participants per group, on September 5, 6, 8, 9, 12, 13, 15, and 16, 2022.

DURATION: The control group was followed for 6 months with assessments only, approximately 24 weeks.
Control group
Active

Outcomes
Primary outcome [1] 343232 0
Suicide probability level
Timepoint [1] 343232 0
Baseline (before therapy initiation - Week 0), at 10 weeks (after completion of 20 therapy sessions, 2 sessions per week) - PRIMARY TIMEPOINT, at 1 month (4 weeks) after therapy completion (Week 14), at 3 months after therapy completion (Week 22), and at 6 months after therapy completion (Week 34)
Primary outcome [2] 343233 0
Cognitive flexibility level
Timepoint [2] 343233 0
Baseline (before therapy initiation - Week 0), at 10 weeks (after completion of 20 therapy sessions, 2 sessions per week) - PRIMARY TIMEPOINT, at 1 month (4 weeks) after therapy completion (Week 14), at 3 months after therapy completion (Week 22), and at 6 months after therapy completion (Week 34)
Primary outcome [3] 343234 0
Hopelessness level
Timepoint [3] 343234 0
Baseline (before therapy initiation - Week 0), at 10 weeks (after completion of 20 therapy sessions, 2 sessions per week) - PRIMARY TIMEPOINT, at 1 month (4 weeks) after therapy completion (Week 14), at 3 months after therapy completion (Week 22), and at 6 months after therapy completion (Week 34)
Secondary outcome [1] 453735 0
Severity of depressive symptoms
Timepoint [1] 453735 0
Baseline (Week 0) and at 3 months after therapy completion (Week 22) for clinical monitoring purposes
Secondary outcome [2] 453736 0
Severity of anxiety symptoms
Timepoint [2] 453736 0
Baseline (Week 0) and at 3 months after therapy completion (Week 22) for clinical monitoring purposes

Eligibility
Key inclusion criteria
1. Aged 18 years or older
2. Diagnosed with Depression according to ICD-10 criteria
3. At least one suicide attempt within the last 6 months
4. Ability to use computer and manage Google Meet platform
5. Able to read and write (as assessment tools are self-report measures)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Presence of any chronic medical condition requiring continuous care and support, other than depression
2. Diagnosis of any other psychiatric disorder in addition to depression
3. Hearing or vision impairment
4. Inability to read and write (as assessment tools are self-report questionnaires)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was concealed through the use of Q-minim, an online minimization tool. The randomization sequence was generated and implemented by Q-minim software, ensuring that investigators and participants were unaware of upcoming allocations at the time of enrollment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was performed using Q-minim, an online minimization tool (http://www-users.york.ac.uk/~mb55/guide/qminim.htm). Minimization is a dynamic allocation method that balances treatment groups on key prognostic factors including age, sex, and number of prior suicide attempts. This method was chosen to ensure optimal group comparability given the relatively small sample size (n=50). The randomization process followed the CONSORT 2010 guidelines for reporting parallel group randomized trials.

Participants were allocated in a 1:1 ratio to either:
- Intervention group (n=25): Receiving [specify therapy name]
- Control group (n=25): Receiving [standard care / waitlist / alternative treatment - specify]

Stratification factors:
1. Age
2. Sex
3. Number of prior suicide attempts
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size and Randomization:
A total of 50 participants were recruited and randomly allocated using Q-minim, an online minimization tool, to achieve balance between intervention (n=25) and control (n=25) groups on key prognostic factors: age, sex, and number of prior suicide attempts. Sample size was calculated to detect a medium effect size (Cohen's d = 0.5) with 80% power and alpha level of 0.05.

Statistical Analysis:
All analyses were conducted using IBM SPSS Statistics version 22.0 (IBM Corp., Armonk, NY, USA).

Descriptive Statistics:
Continuous variables are presented as means ± standard deviations with ranges. Chi-square tests were used to compare categorical baseline variables between groups.

Assumption Testing:
Shapiro-Wilk tests verified normality assumptions, and Levene's tests verified homogeneity of variance.

Primary Outcomes Analysis (SPS, CFI, BHS):
- Between-group comparisons at each timepoint: Independent samples t-tests
- Within-group and between-group changes across four assessment points: Repeated measures ANOVA
- Effect sizes reported as partial eta-squared (?p²)

Secondary Outcomes Analysis (BDI, BAI):
- Non-parametric analyses using Mann-Whitney U tests for between-group comparisons

Missing Data:
Two control group participants provided incomplete follow-up data (one missing both 3- and 6-month assessments; one missing only 6-month assessment). Following intention-to-treat principles, both participants were retained in analyses with missing values imputed using appropriate methods.

Statistical Significance:
All tests were two-tailed with significance level set at p < 0.05. 95% confidence intervals were calculated for all estimates.

The study adheres to CONSORT 2010 guidelines for reporting parallel group randomized trials.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2021
Date of last participant enrolment
Anticipated
Actual
1/08/2021
Date of last data collection
Anticipated
Actual
12/08/2022
Sample size
Target
50
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 27509 0
Turkey
State/province [1] 27509 0
AYDIN

Funding & Sponsors
Funding source category [1] 320323 0
Self funded/Unfunded
Name [1] 320323 0
Rahime Aslan
Country [1] 320323 0
Turkey
Primary sponsor type
Individual
Name
Rahime Aslan - Kutahya Health Sciences University
Address
Country
Turkey
Secondary sponsor category [1] 322903 0
University
Name [1] 322903 0
Aydin Adnan Menderes University
Address [1] 322903 0
Country [1] 322903 0
Turkey
Secondary sponsor category [2] 322905 0
University
Name [2] 322905 0
Aydin State Hospital
Address [2] 322905 0
Country [2] 322905 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318871 0
Aydin Adnan Menderes University Faculty of Nursing Non-Interventional Clinical Research Ethics Committee
Ethics committee address [1] 318871 0
Ethics committee country [1] 318871 0
Turkey
Date submitted for ethics approval [1] 318871 0
01/03/2021
Approval date [1] 318871 0
22/03/2021
Ethics approval number [1] 318871 0
2021/240

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 145506 0
Miss Rahime Aslan
Address 145506 0
Faculty of Health Sciences, Department of Nursing, Psychiatric Nursing Division, Kutahya Health Sciences University, 43100 Kutahya, Turkey
Country 145506 0
Turkey
Phone 145506 0
+905076672004
Fax 145506 0
Email 145506 0
[email protected]
Contact person for public queries
Name 145507 0
Rahime Aslan
Address 145507 0
Faculty of Health Sciences, Department of Nursing, Psychiatric Nursing Division, Kutahya Health Sciences University, 43100 Kutahya, Turkey
Country 145507 0
Turkey
Phone 145507 0
+905076672004
Fax 145507 0
Email 145507 0
[email protected]
Contact person for scientific queries
Name 145508 0
Rahime Aslan
Address 145508 0
Faculty of Health Sciences, Department of Nursing, Psychiatric Nursing Division, Kutahya Health Sciences University, 43100 Kutahya, Turkey
Country 145508 0
Turkey
Phone 145508 0
+905076672004
Fax 145508 0
Email 145508 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Individual participant data (IPD) will not be shared due to confidentiality and institutional data security policies. IPD sharing is not planned in order to protect participant privacy and ensure compliance with applicable data protection regulations.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    Ethics committee decision letter for protocol amen... [More Details] 20.05.2022-Tarihli Etik Kurul karari-2021-240 nolu çalismaniz.pdf
Informed consent form    Informed consent form for control group participan... [More Details] Control Group Informed Consent Form.pdf
Informed consent form    Informed consent form for intervention group parti... [More Details] Intervention Group Informed Consent Form.pdf
Study protocol    Full study protocol describing online CBT interven... [More Details] Study Protocol.pdf
Ethical approval    Original ethics approval letter (Protocol 2021/240... [More Details] Tez Etik Kurul 25.03.2021.pdf
Ethical approval    Ethics committee approval letter (dated 6 May 2021... [More Details] Tez Etik Kurul 06.05.2021.pdf
Ethical approval    Ethics committee amendment approval letter (dated ... [More Details] Tez Etik Kurul 17.04.2023.pdf
Informed consent form    Informed consent form for video recording of onlin... [More Details] Video Recording Consent Form.pdf
Other    Suicide safety plan template used for risk managem... [More Details] Suicide Safety Plan.pdf


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Conference abstractYeshttps://doi.org/Not applicable Aslan R, Arslantas H. The Effect of Online Cogniti... [More Details]

Documents added automatically
No additional documents have been identified.