Suicide RiskNCT05095233
MIN PLAN VS CBT for Suicide Prevention
A study testing Young Adults Culturally Adapted Manual Assisted Psychological Therapy (YA-CMAP) and Min Plan Tool in people with Suicide Risk, run by Syeda AYAT E ZAINAB Ali at 1 site in Pakistan.
Trial summary
1. To investigate the effectiveness of Young Adults Culturally Adapted Manual Assisted Psychological Therapy (YA-CMAP) in University students with Suicide Risk 2. To compare the effectiveness of Young Adults Culturally Adapted Manual Assisted Psychological Therapy (YA-CMAP) against MinPlan tool in University students… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Suicide Risk
- What is being tested?
- Young Adults Culturally Adapted Manual Assisted Psychological Therapy (YA-CMAP) and Min Plan Tool
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Nov 2021to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Participants who are not taking any psychological help or psychotherapy in the past and present.
- Participants who are at risk of suicide without a history of suicidal attempts but with a history of suicidal ideation in the past two months will be included.
Who cannot join
- Participants with a history of substance misuse/drug dependence/alcohol dependence and psychosis.
- Participants diagnosed with dementia, schizophrenia, delirium, bipolar disorder, and learning disability.
- Participants with a diagnosis of DSM-V mental disorders due to general medical condition.
- Participants who are taking any psychiatric medication.
- Participants residing on a temporary basis in the study area.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
International Islamic University
Islamabad, Capital, 44000
About this study
Official title: A Randomized Controlled Trial Targeting Intervention and Prevention of Suicide Risk (TIPS'r) Among University Students: CBT Vs Min Plan
- To investigate the effectiveness of Young Adults Culturally Adapted Manual Assisted Psychological Therapy (YA-CMAP) in University students with Suicide Risk
- To compare the effectiveness of Young Adults Culturally Adapted Manual Assisted Psychological Therapy (YA-CMAP) against MinPlan tool in University students with Suicide Risk
- Conditions
- Suicide Risk
- Being tested
- Young Adults Culturally Adapted Manual Assisted Psychological Therapy (YA-CMAP), Min Plan Tool
- Keywords
- Suicidal ideation, Suicide Probability, Depression, CBT, Self Help Tool, MINPLAN
- Medical subject headings
- Suicidal Ideation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Young Adults Culturally Adapted Manual Assisted Psychological Therapy (YA-CMAP)Behavioural
Also called Psychosocial Intervention, Cognitive Behavior Therapy
YA-CMAP is a manual assisted brief psychological intervention based on the principles of Cognitive Behavior Therapy (CBT), including 8-10 sessions delivered over three months.
This intervention includes evaluation of the suicide risk mainly suicidal ideation, psycho education, crisis skills, problem solving and simple cognitive techniques to manage emotions, negative thinking, relapse prevention strategies, training on interoceptive awareness, mood management and behavior.
Min Plan ToolDevice
Self-help Tool are common evidence-based methods to help deal with mental health problems.The 'MIN PLAN APP' aims to support people at risk of suicide by letting them create a safety plan based on cognitive therapeutic intervention and behavioral techniques.
| Study group | Role | What they receive |
|---|---|---|
| Young Adults Culturally Adapted Therapy for Suicidal Prevention | Experimental | Young Adults Adapted Manual Assisted Psychological Therapy for Suicide Prevention Receives: Behavioral: Young Adults Culturally Adapted Manual Assisted Psychological Therapy (YA-CMAP) |
| MINPLAN TOOL | Active comparator | Research has shown that user engagement, rather than the modality of therapy is the key to achieving successful outcomes and given that just 50% and 13% of patients currently have a choice of when and where they receive therapy, self-help tool apps Like MIN PLAN may not only be equally effective as some forms of traditional psychotherapy but also provide a flexible and pragmatic means of increasing patient access, through removing barriers to treatment that do not respond to financial impetus. Receives: Device: Min Plan Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide Probability Scale
The Suicide Probability Scale (SPS) is a Likert-type scale which will be used to evaluate suicide probability in participants and consists of 36 items.
Measured: Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session). Outcome assessment will be used to asses the change from baseline to follow-up.
Suicidal Ideation
The Suicide Probability Scale (SPS) is a Likert-type scale with four subscales (hopelessness=12 items, suicide ideation=8 items, negative self evaluation=9 items and hostility=7 items), which has been developed by Cull and Wayne (1982). Suicidal Ideation will be measure through Suicide Probability Scale.
Measured: Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session). Outcome assessment will be used to asses the change from baseline to follow-up.
Secondary outcomes (9)
Beck Depression Inventory-21
Beck depression inventory-21 will be used to measure the symptoms of depression.
Measured: Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session). Outcome assessment will be used to asses the change from baseline to follow-up.
Psychache scale
Psychache scale is a 13-item scale that will be used to measures psychological/emotional or mental pain as conceptualized by Shneidman (1993).
Measured: Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session).Outcome assessment will be used to asses the change from baseline to follow-up.
Hopelessness
The Suicide Probability Scale (SPS) is a Likert-type scale with four subscales (hopelessness=12 items, suicide ideation=8 items, negative self evaluation=9 items and hostility=7 items), which has been developed by Cull and Wayne (1982). Hopelessness will be measure through Suicide Probability Scale.
Measured: Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session).Outcome assessment will be used to asses the change from baseline to follow-up.
Negative Self Evaluation
The Suicide Probability Scale (SPS) is a Likert-type scale with four subscales (hopelessness=12 items, suicide ideation=8 items, negative self evaluation=9 items and hostility=7 items), which has been developed by Cull and Wayne (1982). Negative Self Evaluation will be measure through SPS.
Measured: Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session).Outcome assessment will be used to asses the change from baseline to follow-up.
Hostility
The Suicide Probability Scale (SPS) is a Likert-type scale with four subscales (hopelessness=12 items, suicide ideation=8 items, negative self evaluation=9 items and hostility=7 items), which has been developed by Cull and Wayne (1982). Hostility will be measure through SPS.
Measured: Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session).Outcome assessment will be used to asses the change from baseline to follow-up.
Interpersonal Needs questionnaire
Interpersonal Needs questionnaire will be used to measure participants' beliefs about the extent to which they feel connected to others (i.e., belongingness) and the degree to which they feel they are a burden to others (i.e., burdensomeness).
Measured: Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session).Outcome assessment will be used to asses the change from baseline to follow-up.
Problem-Solving Inventory
The Problem-Solving Inventory is a 35-item instrument that measures perceptions of problem-solving behaviors and problem solving attitudes.
Measured: Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session).Outcome assessment will be used to asses the change from baseline to follow-up.
Multidimensional Assessment of Interoceptive Awareness (MAIA-2)
The Multidimensional Assessment of Interoceptive Awareness (MAIA-2) is an 8-scale state-trait questionnaire with 37 items to measure multiple dimensions of interoception by self-report.
Measured: Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session).Outcome assessment will be used to asses the change from baseline to follow-up.
Client Satisfaction Questionnaire (CSQ)
Client Satisfaction Questionnaire is a brief scale to measure the patient's satisfaction with mental health services.
Measured: Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session). This Questionnaire will be used to evaluate client satisfaction with mental health services.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start15 Nov 2021
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is based on single blind randomized controlled trial with the randomization of study participants across two groups (1). Young Adults Culturally Adapted Manual Assisted Psychological Therapy (2). MINPLAN Tool
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syeda AYAT E ZAINAB Ali
- Sponsor type
- University, hospital or other
- Collaborators
- Pakistan Institute of Living and Learning, MinPlan Organization
- Responsible party
- Sponsor-investigator, Syeda AYAT E ZAINAB Ali, International Islamic University, Islamabad
- Investigators
- Dr Tamkeen Saleem, PhD, Study chair, International Islamic University, Islamabad, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095233
- Sponsor's protocol ID
- LWL
- Status last verified
- Mar 2023
- First submitted
- 11 Sep 2021
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Targeting Intervention and Prevention of Suicide Risk (TIPS'r) Among University Students: CBT Vs Min Plan
- ClinicalTrials.gov ID
- NCT05095233
- Acronym / sponsor ID
- LWL
- Conditions
- Suicide Risk
- Keywords
- Suicidal ideation, Suicide Probability, Depression, CBT, Self Help Tool, MINPLAN
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Syeda AYAT E ZAINAB AliUniversity, hospital or other
- Collaborators
- Pakistan Institute of Living and Learning, MinPlan Organization
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To investigate the effectiveness of Young Adults Culturally Adapted Manual Assisted Psychological Therapy (YA-CMAP) in University students with Suicide Risk
- To compare the effectiveness of Young Adults Culturally Adapted Manual Assisted Psychological Therapy (YA-CMAP) against MinPlan tool in University students with Suicide Risk
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study is based on single blind randomized controlled trial with the randomization of study participants across two groups (1). Young Adults Culturally Adapted Manual Assisted Psychological Therapy (2). MINPLAN Tool
| Arm | Type | Receives |
|---|---|---|
| Young Adults Culturally Adapted Therapy for Suicidal Prevention | Experimental | Behavioral: Young Adults Culturally Adapted Manual Assisted Psychological Therapy (YA-CMAP)Young Adults Adapted Manual Assisted Psychological Therapy for Suicide Prevention |
| MINPLAN TOOL | Active comparator | Device: Min Plan ToolResearch has shown that user engagement, rather than the modality of therapy is the key to achieving successful outcomes and given that just 50% and 13% of patients currently have a choice of when and where they receive therapy, self-help tool apps Like MIN PLAN may not only be equally effective as some forms of traditional psychotherapy but also provide a flexible and pragmatic means of increasing patient access, through removing barriers to treatment that do not respond to financial impetus. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Participants who are not taking any psychological help or psychotherapy in the past and present.
- Participants who are at risk of suicide without a history of suicidal attempts but with a history of suicidal ideation in the past two months will be included.
Key exclusion criteria (5 listed)
- Participants with a history of substance misuse/drug dependence/alcohol dependence and psychosis.
- Participants diagnosed with dementia, schizophrenia, delirium, bipolar disorder, and learning disability.
- Participants with a diagnosis of DSM-V mental disorders due to general medical condition.
- Participants who are taking any psychiatric medication.
- Participants residing on a temporary basis in the study area.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Young Adults Culturally Adapted Manual Assisted Psychological Therapy (YA-CMAP)Also: Psychosocial Intervention, Cognitive Behavior TherapyYA-CMAP is a manual assisted brief psychological intervention based on the principles of Cognitive Behavior Therapy (CBT), including 8-10 sessions delivered over three months. This intervention includes evaluation of the suicide risk mainly suicidal ideation, psycho education, crisis skills, problem solving and simple cognitive techniques to manage emotions, negative thinking, relapse prevention strategies, training on interoceptive awareness, mood management and behavior. | Behavioural | Young Adults Culturally Adapted Therapy for Suicidal Prevention |
| Min Plan ToolSelf-help Tool are common evidence-based methods to help deal with mental health problems.The 'MIN PLAN APP' aims to support people at risk of suicide by letting them create a safety plan based on cognitive therapeutic intervention and behavioral techniques. | Device | MINPLAN TOOL |
Primary outcome
Suicide Probability Scale
Time frame: Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session). Outcome assessment will be used to asses the change from baseline to follow-up.
The Suicide Probability Scale (SPS) is a Likert-type scale which will be used to evaluate suicide probability in participants and consists of 36 items.
Suicidal Ideation
Time frame: Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session). Outcome assessment will be used to asses the change from baseline to follow-up.
The Suicide Probability Scale (SPS) is a Likert-type scale with four subscales (hopelessness=12 items, suicide ideation=8 items, negative self evaluation=9 items and hostility=7 items), which has been developed by Cull and Wayne (1982). Suicidal Ideation will be measure through Suicide Probability Scale.
9 secondary outcomes
Beck Depression Inventory-21
Time frame: Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session). Outcome assessment will be used to asses the change from baseline to follow-up.
Psychache scale
Time frame: Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session).Outcome assessment will be used to asses the change from baseline to follow-up.
Hopelessness
Time frame: Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session).Outcome assessment will be used to asses the change from baseline to follow-up.
Negative Self Evaluation
Time frame: Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session).Outcome assessment will be used to asses the change from baseline to follow-up.
Hostility
Time frame: Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session).Outcome assessment will be used to asses the change from baseline to follow-up.
Interpersonal Needs questionnaire
Time frame: Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session).Outcome assessment will be used to asses the change from baseline to follow-up.
Problem-Solving Inventory
Time frame: Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session).Outcome assessment will be used to asses the change from baseline to follow-up.
Multidimensional Assessment of Interoceptive Awareness (MAIA-2)
Time frame: Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session).Outcome assessment will be used to asses the change from baseline to follow-up.
Client Satisfaction Questionnaire (CSQ)
Time frame: Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session). This Questionnaire will be used to evaluate client satisfaction with mental health services.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Cognitive behavioral therapy approach for suicidal Thinking and behaviors in depression.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Tamkeen Saleem, PhD study chair
International Islamic University, Islamabad, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Young Adults Culturally Adapted Manual Assisted Psychological Therapy (YA-CMAP) and Min Plan Tool in people with Suicide Risk, run by Syeda AYAT E ZAINAB Ali at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Syeda Ayat e Zainab Ali, PhD Scholar (+923121319004, zai_nab1@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicide Probability Scale (time frame: Assessments will be conducted at 3rd week after the baseline (1st follow up session), 6th week (2nd follow up session) and at 3rd month (3rd follow up session). Outcome assessment will be used to asses the change from baseline to follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.