Self-Injurious BehaviorNCT03035110
A Feasibility Study to Evaluate Self-Harm Group in Inpatient Settings
A study testing Dialectical Behavioural Therapy (DBT) based skills groups in people with Self-Injurious Behavior, run by University of Essex at 1 site in United Kingdom.
Trial summary
The current research is being undertaken as part of a professional doctorate in clinical psychology, which aims to evaluate the feasibility of a group programme to address self-harm within 23 days, to provide evidence for a controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Self-Injurious Behavior
- What is being tested?
- Dialectical Behavioural Therapy (DBT) based skills groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Apr 2017to 15 May 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be screened by their allocated clinician and included if they are aged between 18-65
- admitted to hospital
- have a history of or engaged in at least one episode of self-harm, iv) have capacity to understand the information sheet.
Who cannot join
- Participants will be screened by clinicians and they will exclude people if i) they are Non-English speakers (due to translation costs)
- they lack the capacity to give informed consent (assessed by their key clinician)
- their symptoms prevent them from concentrating for an hour at a time (i.e. severe thought disorder), and therefore not benefiting from the group (assessed by their key clinician)
Trial locations and contacts
1 site in 1 country.
About this study
The current research is being undertaken as part of a professional doctorate in clinical psychology, which aims to evaluate the feasibility of a group programme to address self-harm within 23 days, to provide evidence for a controlled trial. The intervention will include four group sessions conducted over 2 weeks, based on Dialectical Behavioural Therapy. Specifically the aims are to determine 1) means and a standard deviation for two pre and post treatment outcome measures in order to estimate sample size for the main study, 2) the need for an inpatient intervention for self-harm measured by number of participants eligible and accepting of the treatment, 3) retention of participants for 4 groups given the predicted short stays of patients on wards, and 4) the acceptability of the research process for this client group through feedback.
- Conditions
- Self-Injurious Behavior
- Being tested
- Dialectical Behavioural Therapy (DBT) based skills groups
- Medical subject headings
- Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical Behavioural Therapy (DBT) based skills groupsBehavioural
Dialectical Behavioural Therapy (DBT) involves skills that help people manage their emotions and tolerate distress. This therapy is found effective in reducing self-harm behaviour for outpatients with Borderline Personality Disorder.
| Study group | Role | What they receive |
|---|---|---|
| Dialectical Behavioural Therapy (DBT) skills group | Experimental | Four group sessions, based on DBT, over two weeks, with a group of four to eight participants in attendance located on the hospital ward where the participant is a patient. Receives: Behavioral: Dialectical Behavioural Therapy (DBT) based skills groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Inventory of Statements About Self-Injury (ISAS)
ISAS is a self-report measure designed to assess the function and frequency of deliberate self-harm. It will be administered pre- and post-intervention.
Measured: 23 days
The Distress Tolerance Scale (DTS)
The DTS consists of 15 items, which measure a person's appraisal of their emotional distress, their ability to tolerate this distress and any regulation efforts to alleviate it. It will be administered pre- and post-intervention.
Measured: 23 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start18 Apr 2017
- Primary completion15 May 2018
- Study completion15 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-Injurious BehaviorStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Essex
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035110
- Sponsor's protocol ID
- 205350
- Status last verified
- Jun 2018
- First submitted
- 25 Jan 2017
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study to Evaluate Self-Harm Group in Inpatient Settings
- ClinicalTrials.gov ID
- NCT03035110
- Acronym / sponsor ID
- 205350
- Conditions
- Self-Injurious Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of EssexUniversity, hospital or other
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 15 May 2018 (actual)
- Study completion
- 15 May 2018 (actual)
- First posted
- 27 Jan 2017 (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 current research is being undertaken as part of a professional doctorate in clinical psychology, which aims to evaluate the feasibility of a group programme to address self-harm within 23 days, to provide evidence for a controlled trial. The intervention will include four group sessions conducted over 2 weeks, based on Dialectical Behavioural Therapy. Specifically the aims are to determine 1) means and a standard deviation for two pre and post treatment outcome measures in order to estimate sample size for the main study, 2) the need for an inpatient intervention for self-harm measured by number of participants eligible and accepting of the treatment, 3) retention of participants for 4 groups given the predicted short stays of patients on wards, and 4) the acceptability of the research process for this client group through feedback.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dialectical Behavioural Therapy (DBT) skills group | Experimental | Behavioral: Dialectical Behavioural Therapy (DBT) based skills groupsFour group sessions, based on DBT, over two weeks, with a group of four to eight participants in attendance located on the hospital ward where the participant is a patient. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants will be screened by their allocated clinician and included if they are aged between 18-65
- admitted to hospital
- have a history of or engaged in at least one episode of self-harm, iv) have capacity to understand the information sheet.
Key exclusion criteria (3 listed)
- Participants will be screened by clinicians and they will exclude people if i) they are Non-English speakers (due to translation costs)
- they lack the capacity to give informed consent (assessed by their key clinician)
- their symptoms prevent them from concentrating for an hour at a time (i.e. severe thought disorder), and therefore not benefiting from the group (assessed by their key clinician)
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 |
|---|---|---|
| Dialectical Behavioural Therapy (DBT) based skills groupsDialectical Behavioural Therapy (DBT) involves skills that help people manage their emotions and tolerate distress. This therapy is found effective in reducing self-harm behaviour for outpatients with Borderline Personality Disorder. | Behavioural | Dialectical Behavioural Therapy (DBT) skills group |
Primary outcome
The Inventory of Statements About Self-Injury (ISAS)
Time frame: 23 days
ISAS is a self-report measure designed to assess the function and frequency of deliberate self-harm. It will be administered pre- and post-intervention.
The Distress Tolerance Scale (DTS)
Time frame: 23 days
The DTS consists of 15 items, which measure a person's appraisal of their emotional distress, their ability to tolerate this distress and any regulation efforts to alleviate it. It will be administered pre- and post-intervention.
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 4 Jun 2018.
- 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.
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 Dialectical Behavioural Therapy (DBT) based skills groups in people with Self-Injurious Behavior, run by University of Essex at 1 site in United Kingdom.
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 3 inclusion and 3 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 4 Jun 2018. 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 Kingdom. 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?
The Inventory of Statements About Self-Injury (ISAS) (time frame: 23 days). 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 4 Jun 2018.