Suicidal IdeationNCT04781166
An Online Intervention to Reduce Self-Harm Among Persons With High Emotion-Related Impulsivity
A study testing Calm program in people with Suicidal Ideation and Deliberate Self-harm, run by University of California, Berkeley at 1 site in United States.
Trial summary
The goal of this program is to test a brief, online, cognitive behavioral intervention for people who struggle with self-harm or suicidal urges or behavior in the context of emotion-related impulsivity. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Suicidal Ideation, Deliberate Self-harm, Impulsivity
- What is being tested?
- Calm program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2021to 1 Oct 2021
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- at least 13 years of age
- engaged in mental health care
- evidence of either self-harm or suicidal urges or behavior in the past 3 months
- high levels of emotion-related impulsivity.
Who cannot join
- inability to adequately take part in the online measures due to problems with intellectual function, language, or other conditions,
- psychosis,
- not currently living in California,
- lack of access to a device to privately complete online modules.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California
Berkeley, California, 94720
About this study
Official title: An Online Intervention to Reduce Self-Harm Among Persons With High Emotion-Related
The goal of this program is to test a brief, online, cognitive behavioral intervention for people who struggle with self-harm or suicidal urges or behavior in the context of emotion-related impulsivity.
Read the detailed description
Participants will be asked to complete 7 brief online modules to cover how to understand emotion-triggered impulsivity, to better detect states of high emotion and arousal, to learn new strategies for self-calming high arousal, and to pre-plan how to cope with high arousal states. As part of the program, participants receive daily texts and prompts to remind them of the intervention content and skills. At baseline and follow-up, participants will complete measures of emotion-related impulsivity, self-harm, and suicidality.
- Conditions
- Suicidal Ideation, Deliberate Self-harm, Impulsivity
- Being tested
- Calm program
- Medical subject headings
- Suicidal Ideation, Self-Injurious Behavior, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calm programBehavioural
7 online modules designed to teach cognitive behavioral skills
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will be immediately assigned to the intervention. Receives: Behavioral: Calm program |
| Waitlist control | Other | Participants will complete measures before and after a waitlist equivalent to the duration of the intervention, to assess whether change is observed with time and repeated assessment. After the waitlist control, participants will be provided the opportunity to take part in the intervention. In this RDICT design, the pre- post- treatment data will be included in analyses. Receives: Behavioral: Calm program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in suicidal ideation among adults
Columbia Suicide Severity Rating scale suicidal ideation severity score; scores range from 0 to 5, where 5 is more severe.
Measured: immediately before the intervention and one week after intervention
Change in interview-rated suicidal ideation among adolescent patients
Self-Injurious Thoughts and Behaviors Interview suicidal ideation in the past month scored as the sum of the items on the worst intensity, average intensity, and likelihood of suicidal ideation items; scores range from 0 to 12, with higher scores reflecting greater severity.
Measured: immediately before the intervention and one week after intervention
Change in self-rated suicidal ideation among adolescent patients
Suicide Ideation Questionnaire Jr; scores range from 0 to 6, where 6 is more severe
Measured: immediately before the intervention and one week after intervention
Change in self-rated deliberate self-harm
Deliberate Self-Harm Inventory Frequency in past month score, from 0 to number of incidents reported (higher scores are worse outcomes)
Measured: immediately before the intervention and one week after intervention
Change in interview-based self-harm among adolescent patients
Self-Injurious Thoughts and Behaviors Interview NSSI severity in the past month, scored as the sum of the items on the worst intensity, average intensity, and likelihood of NSSI items; scores range from 0 to 12 with higher scores reflecting greater severity.
Measured: immediately before the intervention and one week after intervention
Change in impulsivity
self-rated Three factor impulsivity Feelings Trigger Action subscale; scores range from 1 to 5, where 5 reflects more severe impulsivity
Measured: immediately before the intervention and one week after intervention
Change in interview-based impulsivity among adolescent patients
Urgency interview scores, scored as the sum of 8 items, range = 0 to 16, where higher scores reflect more impulsivity.
Measured: immediately before the intervention and one week after intervention
Secondary outcomes (1)
Change in aggression
Bryant Aggression scale: mean of physical aggression, verbal aggression, and anger subscales; range of scores from 1 to 5, where 5 = more severe aggression
Measured: immediately before the intervention and one week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start15 Apr 2021
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IdeationStudies 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
- Adult participants will be enrolled in the intervention, and we will use pre-, post-data to evaluate whether the program appears to be helpful. Adolescent participants will be randomly assigned to a waitlist control or intervention; those in the waitlist will be offered the intervention after they complete the waitlist period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheri L. Johnson, University of California, Berkeley
- Investigators
- Sheri L Johnson, Ph.D., Principal investigator, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781166
- Sponsor's protocol ID
- UC CPHS 2016-01-8287
- Status last verified
- Nov 2023
- First submitted
- 19 Feb 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will provide fully de-identified data on OSF.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online Intervention to Reduce Self-Harm Among Persons With High Emotion-Related
- ClinicalTrials.gov ID
- NCT04781166
- Acronym / sponsor ID
- UC CPHS 2016-01-8287
- Conditions
- Suicidal Ideation, Deliberate Self-harm, Impulsivity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 4 Mar 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.
The goal of this program is to test a brief, online, cognitive behavioral intervention for people who struggle with self-harm or suicidal urges or behavior in the context of emotion-related impulsivity.
Detailed description
Participants will be asked to complete 7 brief online modules to cover how to understand emotion-triggered impulsivity, to better detect states of high emotion and arousal, to learn new strategies for self-calming high arousal, and to pre-plan how to cope with high arousal states. As part of the program, participants receive daily texts and prompts to remind them of the intervention content and skills. At baseline and follow-up, participants will complete measures of emotion-related impulsivity, self-harm, and suicidality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Adult participants will be enrolled in the intervention, and we will use pre-, post-data to evaluate whether the program appears to be helpful. Adolescent participants will be randomly assigned to a waitlist control or intervention; those in the waitlist will be offered the intervention after they complete the waitlist period.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Calm programParticipants will be immediately assigned to the intervention. |
| Waitlist control | Other | Behavioral: Calm programParticipants will complete measures before and after a waitlist equivalent to the duration of the intervention, to assess whether change is observed with time and repeated assessment. After the waitlist control, participants will be provided the opportunity to take part in the intervention. In this RDICT design, the pre- post- treatment data will be included in analyses. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- at least 13 years of age
- engaged in mental health care
- evidence of either self-harm or suicidal urges or behavior in the past 3 months
- high levels of emotion-related impulsivity.
Key exclusion criteria (4 listed)
- inability to adequately take part in the online measures due to problems with intellectual function, language, or other conditions,
- psychosis,
- not currently living in California,
- lack of access to a device to privately complete online modules.
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 |
|---|---|---|
| Calm program7 online modules designed to teach cognitive behavioral skills | Behavioural | Intervention, Waitlist control |
Primary outcome
Change in suicidal ideation among adults
Time frame: immediately before the intervention and one week after intervention
Columbia Suicide Severity Rating scale suicidal ideation severity score; scores range from 0 to 5, where 5 is more severe.
Change in interview-rated suicidal ideation among adolescent patients
Time frame: immediately before the intervention and one week after intervention
Self-Injurious Thoughts and Behaviors Interview suicidal ideation in the past month scored as the sum of the items on the worst intensity, average intensity, and likelihood of suicidal ideation items; scores range from 0 to 12, with higher scores reflecting greater severity.
Change in self-rated suicidal ideation among adolescent patients
Time frame: immediately before the intervention and one week after intervention
Suicide Ideation Questionnaire Jr; scores range from 0 to 6, where 6 is more severe
Change in self-rated deliberate self-harm
Time frame: immediately before the intervention and one week after intervention
Deliberate Self-Harm Inventory Frequency in past month score, from 0 to number of incidents reported (higher scores are worse outcomes)
Change in interview-based self-harm among adolescent patients
Time frame: immediately before the intervention and one week after intervention
Self-Injurious Thoughts and Behaviors Interview NSSI severity in the past month, scored as the sum of the items on the worst intensity, average intensity, and likelihood of NSSI items; scores range from 0 to 12 with higher scores reflecting greater severity.
Change in impulsivity
Time frame: immediately before the intervention and one week after intervention
self-rated Three factor impulsivity Feelings Trigger Action subscale; scores range from 1 to 5, where 5 reflects more severe impulsivity
Change in interview-based impulsivity among adolescent patients
Time frame: immediately before the intervention and one week after intervention
Urgency interview scores, scored as the sum of 8 items, range = 0 to 16, where higher scores reflect more impulsivity.
1 secondary outcome
Change in aggression
Time frame: immediately before the intervention and one week after intervention
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Yes. We will provide fully de-identified data on OSF.
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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.
Sheri L Johnson, Ph.D. principal investigator
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calm program in people with Suicidal Ideation and Deliberate Self-harm, run by University of California, Berkeley at 1 site in United States.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 18 Nov 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 United States. 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?
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in suicidal ideation among adults (time frame: immediately before the intervention and one week after intervention). The study lists 7 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 18 Nov 2023.