Suicidal and Self-injurious BehaviourNCT01342809
Follow up by General Practitioner After Self-poisoning
A study testing Follow up in people with Suicidal and Self-injurious Behaviour, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The study hypothesis is that follow up from general practitioner after hospitalization for self poisoning will decrease suicidal behaviour. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Suicidal and Self-injurious Behaviour
- What is being tested?
- Follow up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 202 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2009to May 2014
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Self Poisoning (according to the WHO definition)
- Ability to fill out questionnaire
Who cannot join
- Hospitalization into psychiatric ward
- Unknown address or ID
- Not registered with General Practitioner
- If institutionalized or in jail.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Follow up After Self-poisoning by General Practitioner- a Randomised Clinical Trial
The study hypothesis is that follow up from general practitioner after hospitalization for self poisoning will decrease suicidal behaviour.
Read the detailed description
Patients hospitalized after an episode of self poisoning will be randomly assigned into intervention an control groups. The intervention is close follow up by general practitioner six months. Both groups will receive treatment as usual.
- Conditions
- Suicidal and Self-injurious Behaviour
- Being tested
- Follow up
- Keywords
- Depression, Hopelessness, Suicidal ideation
- Medical subject headings
- Self-Injurious Behavior, Depression, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow upBehavioural
Also called General Practitioner
Follow up, consultations with general practitioner, written guidelines, supervision.
| Study group | Role | What they receive |
|---|---|---|
| Follow up | Experimental | Close follow up from written guidelines, supervision provided. Receives: Behavioral: Follow up |
| Usual Treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidal behaviour
Beck Cepression Inventory, Beck Hopelessness scale, Beck Suicide Ideation Scale
Measured: 3 and 6 months
Suicidal behaviour
Beck Depression Inventory, Beck Hopelessness scale, Beck Suicide Ideation Scale
Measured: 3 and 6 months
Secondary outcomes (1)
Treatment
Contacts with GP, and health care services, satisfaction with treatment GP (EUROPEP)
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2011 (estimated)
- Study startNov 2009
- Primary completionNov 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Suicidal and Self-injurious BehaviourStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Akershus, Lovisenberg Diakonale Hospital, Diakonhjemmet Hospital
- Responsible party
- Principal investigator, Tine K. Grimholt, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01342809
- Sponsor's protocol ID
- S-08708b
- Status last verified
- May 2014
- First submitted
- 18 Apr 2011
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
PubMed 33884617Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
PubMed 32368793Grimholt TK, Jacobsen D, Haavet OR, Sandvik L, Jorgensen T, Norheim AB, Ekeberg O. Effect of Systematic Follow-Up by General Practitioners after Deliberate Self-Poisoning: A Randomised Controlled Trial. PLoS One. 2015 Dec 2;10(12):e0143934. doi: 10.1371/journal.pone.0143934. eCollection 2015.
PubMed 26629812Grimholt TK, Jacobsen D, Haavet OR, Sandvik L, Jorgensen T, Norheim AB, Ekeberg O. Structured follow-up by general practitioners after deliberate self-poisoning: a randomised controlled trial. BMC Psychiatry. 2015 Oct 14;15:245. doi: 10.1186/s12888-015-0635-2.
PubMed 26467530
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow up After Self-poisoning by General Practitioner- a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT01342809
- Acronym / sponsor ID
- S-08708b
- Conditions
- Suicidal and Self-injurious Behaviour
- Keywords
- Depression, Hopelessness, Suicidal ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Akershus, Lovisenberg Diakonale Hospital, Diakonhjemmet Hospital
- Study start
- Nov 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 27 Apr 2011 (estimated)
- 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 study hypothesis is that follow up from general practitioner after hospitalization for self poisoning will decrease suicidal behaviour.
Detailed description
Patients hospitalized after an episode of self poisoning will be randomly assigned into intervention an control groups. The intervention is close follow up by general practitioner six months. Both groups will receive treatment as usual.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Follow up | Experimental | Behavioral: Follow upClose follow up from written guidelines, supervision provided. |
| Usual Treatment | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Self Poisoning (according to the WHO definition)
- Ability to fill out questionnaire
Key exclusion criteria (4 listed)
- Hospitalization into psychiatric ward
- Unknown address or ID
- Not registered with General Practitioner
- If institutionalized or in jail.
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 |
|---|---|---|
| Follow upAlso: General PractitionerFollow up, consultations with general practitioner, written guidelines, supervision. | Behavioural | Follow up |
Primary outcome
Suicidal behaviour
Time frame: 3 and 6 months
Beck Cepression Inventory, Beck Hopelessness scale, Beck Suicide Ideation Scale
Suicidal behaviour
Time frame: 3 and 6 months
Beck Depression Inventory, Beck Hopelessness scale, Beck Suicide Ideation Scale
1 secondary outcome
Treatment
Time frame: 3 and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
- Derived from this study: PubMed 33884617Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
- Derived from this study: PubMed 32368793Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
- Derived from this study: PubMed 26629812Grimholt TK, Jacobsen D, Haavet OR, Sandvik L, Jorgensen T, Norheim AB, Ekeberg O. Effect of Systematic Follow-Up by General Practitioners after Deliberate Self-Poisoning: A Randomised Controlled Trial. PLoS One. 2015 Dec 2;10(12):e0143934. doi: 10.1371/journal.pone.0143934. eCollection 2015.
- Derived from this study: PubMed 26467530Grimholt TK, Jacobsen D, Haavet OR, Sandvik L, Jorgensen T, Norheim AB, Ekeberg O. Structured follow-up by general practitioners after deliberate self-poisoning: a randomised controlled trial. BMC Psychiatry. 2015 Oct 14;15:245. doi: 10.1186/s12888-015-0635-2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Follow up in people with Suicidal and Self-injurious Behaviour, run by Oslo University Hospital at 1 site in Norway.
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 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: finished, as of the sponsor's last update on 7 May 2014. 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 Norway. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Suicidal behaviour (time frame: 3 and 6 months). 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?
On the ClinicalTrials.gov record for NCT01342809, which also lists 4 linked publications.
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 7 May 2014.