Suicide AttemptASSIPNCT02505373
ASSIP, Attempted Suicide Short Intervention Program. Two Year Follow-Up Study
A study testing Attempted Suicide Short Intervention Program (ASSIP) in people with Suicide Attempt and Suicide, run by University of Bern at 1 site in Switzerland.
Trial summary
Objective Attempted suicide is the main risk factor for repeated suicidal behavior. However, evidence of the effectiveness of follow-up treatments for these patients is limited. The authors evaluated the effectiveness of the Attempted Suicide Short Intervention Program (ASSIP), a novel brief therapy based on a… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Suicide Attempt, Suicide, Suicidal Ideation
- What is being tested?
- Attempted Suicide Short Intervention Program (ASSIP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2009to Jun 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male/female
- Inpatient/outpatient, day care treatment
- German language
- All diagnosis (except: psychosis)
- Written informed consent
Who cannot join
- Psychosis
- Imprisonment
- Foreign languages
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Psychiatry and Psychotherapy, University of Bern
Bern, Canton of Bern, 3008
About this study
Official title: A Novel Brief Therapy for Attempted Suicide: Two Year Follow-Up Randomized Controlled Study of the Attempted Suicide Short Intervention Program (ASSIP)
Objective
Attempted suicide is the main risk factor for repeated suicidal behavior. However, evidence of the effectiveness of follow-up treatments for these patients is limited. The authors evaluated the effectiveness of the Attempted Suicide Short Intervention Program (ASSIP), a novel brief therapy based on a patient-oriented model of suicidal behavior. The ASSIP consists of three sessions followed by regular letters for 24 months.
Read more
Method
In this treatment study, 120 patients were randomly assigned to either the ASSIP intervention or a control group that received a one-session clinical assessment. Both groups received in- and outpatient treatment as usual. Study participants also completed a set of psychosocial and clinical questionnaires every 6 months during a 24-month follow-up period.
Read the detailed description
Background
In the prevention and treatment of suicidality the main emphasis according to the traditional medical model has been on diagnosis and treatment of mental disorders, first and foremost depression. However, it is debatable how far this approach toward the suicidal patient can actually affect suicide rates. It has been argued that the mechanisms of suicidal behavior should be studied independently of any associated psychiatric disorder.
Follow-up studies strongly suggest that when a person has attempted suicide, the risk of future suicidal behavior, including death by suicide, cannot be "cured". Once a person has tried to solve an emotional crisis with a suicide attempt, this behavioral pattern will quickly re-emerge in similar situations in the future, not only because a suicide attempt provides a - temporary - solution, but also because very often it associated with an immediate sense of relief. The prevailing view emerging from recent developments in suicide research is that, following attempted suicide, it is crucial to establish individual safety strategies with patients for coping differently in future emotional crises. For as many patients as possible to benefit, treatments targeting suicidality should be brief and focused, and, of course, effective.
ASSIP combines aspects of action theory, cognitive behavior therapy, and attachment theory. A fundamental assumption is that an action theoretical approach toward the suicidal patient will establish a therapeutic alliance in the sense of a "secure base", which will enhance the effect of the regular letters following the four treatment sessions. ASSIP is not a stand-alone therapy but should be offered to suicidal patients in addition to the usual clinical management and follow-up treatment.
Objective
- How effective is ASSIP, compared to a control group in preventing suicidal behaviour after a suicide attempt?
- Primary outcome measures: Suicidal behaviour, suicidal ideation
- Secondary outcome measures: Depression, coping skills, contact to health care system
- Which parameters have a moderating influence on outcome measures?
- Therapeutic alliance
- Diagnosis
- Previous suicide attempts
Methods
In this treatment study, 120 patients were randomly assigned to either the ASSIP intervention or a control group that received a one-session clinical assessment. Both groups received in- and outpatient treatment as usual. The quality of the therapeutic alliance as a moderating factor for outcome was measured at the therapy sessions 1 (both groups) and 3 (ASSIP group only) using the Helping Alliance Questionnaire (HAq). Regarding outcome measures the study participants completed a set of psychosocial and clinical questionnaires every 6 months during a 24-months follow-up period.
- Conditions
- Suicide Attempt, Suicide, Suicidal Ideation
- Being tested
- Attempted Suicide Short Intervention Program (ASSIP), Control Group (CG)
- Keywords
- Brief Therapy, Attempted Suicide, Therapeutic Alliance, Suicidal Ideation, Suicide, ASSIP
- Medical subject headings
- Suicide, Attempted, Suicide, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attempted Suicide Short Intervention Program (ASSIP)Behavioural
The brief therapy ASSIP consists of three to four sessions, which are ideally administered within a period of 2 to 4 weeks. Therapy sessions are scheduled for 60 to 90 minutes.
Session 1: A narrative interview is conducted, in which the patient is asked to tell his or her personal story which led to the suicidal crisis. The narrative is video-recorded.
Session 2: Using video-playback of the recorded narrative, patient and therapist explore further details of the suicidal process.
Session 3: A case conceptualization focusing on the patient's vulnerability and the trigger of the suicidal crisis is formulated in writing. A list of safety strategies for the prevention of future suicidal behaviour is developed jointly with the patient.
Regular letters are sent to patients over a period of 2 years.
Control Group (CG)Behavioural
Participants assigned to the control group underwent a single clinical interview that included a structured assessment of suicide using the SSF (Jobes, 2006).
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group ASSIP | Experimental | Intervention Group ASSIP (Brief Therapy) Receives: Behavioral: Attempted Suicide Short Intervention Program (ASSIP) |
| Control Group CG | Active comparator | Control Group CG (structured interview) Receives: Behavioral: Control Group (CG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidal behaviour
Measured by socio-demographic \& clinical questionnaire
Measured: 2-year follow-up
Suicidal behaviour
Measured by socio-demographic \& clinical questionnaire
Measured: 1-year follow-up
Secondary outcomes (5)
Contact to health care system
Measured by questionnaire
Measured: At baseline, after 6 months, after 12 months, after 18 months, after 24 months
Suicidal ideation
Measured by Beck Scale for Suicidal Ideation (BSS)
Measured: At baseline, after 6 months, after 12 months, after 18 months, after 24 months
Depression
Measured by Beck Depression Inventory (BDI)
Measured: At baseline, after 6 months, after 12 months, after 18 months, after 24 months
Coping
Measured by Brief COPE
Measured: At baseline, after 6 months, after 12 months, after 18 months, after 24 months
Global distress
Measured by SCL-9
Measured: At baseline, after 6 months, after 12 months, after 18 months, after 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJan 2009
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Suicide AttemptStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Konrad Michel, Prof., Principal investigator, Hospital of Psychiatry and Psychotherapy, University of BernAnja C Gysin-Maillart, Ph.D., Principal investigator, Hospital of Psychiatry and Psychotherapy, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505373
- Sponsor's protocol ID
- 144/08
- Acronym
- ASSIP
- Status last verified
- Jan 2016
- First submitted
- 16 Jul 2015
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Alexander, L. B. & Luborsky, L. (1986).The Penn Helping Alliance Scales. In L. S. Greenberg & W. M. Pinsoff (Eds.), The psychotherapeutic process: A research handbook (pp. 325-366). New York, NY: Guilford Press.
Arensman E, Townsend E, Hawton K, Bremner S, Feldman E, Goldney R, Gunnell D, Hazell P, Van Heeringen K, House A, Owens D, Sakinofsky I, Traskman-Bendz L. Psychosocial and pharmacological treatment of patients following deliberate self-harm: the methodological issues involved in evaluating effectiveness. Suicide Life Threat Behav. 2001 Summer;31(2):169-80. doi: 10.1521/suli.31.2.169.21516.
PubMed 11459249Beck, A. T. & Steer, R. A. (1987). BDI, Beck depression inventory: manual. New York, NY: Psychological Corporation.
Beck, A. T. & Steer, R. A. (1991). Manual for the Beck scale for suicide ideation. San Antonio, TX: Psychological Corporation.
Brown GK, Ten Have T, Henriques GR, Xie SX, Hollander JE, Beck AT. Cognitive therapy for the prevention of suicide attempts: a randomized controlled trial. JAMA. 2005 Aug 3;294(5):563-70. doi: 10.1001/jama.294.5.563.
PubMed 16077050Carter GL, Clover K, Whyte IM, Dawson AH, D'Este C. Postcards from the EDge: 5-year outcomes of a randomised controlled trial for hospital-treated self-poisoning. Br J Psychiatry. 2013 May;202(5):372-80. doi: 10.1192/bjp.bp.112.112664. Epub 2013 Mar 21.
PubMed 23520223Claassen CA, Pearson JL, Khodyakov D, Satow PM, Gebbia R, Berman AL, Reidenberg DJ, Feldman S, Molock S, Carras MC, Lento RM, Sherrill J, Pringle B, Dalal S, Insel TR. Reducing the burden of suicide in the U.S.: the aspirational research goals of the National Action Alliance for Suicide Prevention Research Prioritization Task Force. Am J Prev Med. 2014 Sep;47(3):309-14. doi: 10.1016/j.amepre.2014.01.004. Epub 2014 Apr 18.
PubMed 24750971Granboulan V, Roudot-Thoraval F, Lemerle S, Alvin P. Predictive factors of post-discharge follow-up care among adolescent suicide attempters. Acta Psychiatr Scand. 2001 Jul;104(1):31-6. doi: 10.1034/j.1600-0447.2001.00297.x.
PubMed 11437747Gysin-Maillart, A. & Michel, K. (2013). Kurztherapie nach Suizidversuch. ASSIP-Attempted Suicide Short Intervention Program. Therapiemanual. Bern: Huber. ISBN: 9783456852386
Hatcher S, Sharon C, Coggan C. Beyond randomized controlled trials in attempted suicide research. Suicide Life Threat Behav. 2009 Aug;39(4):396-407. doi: 10.1521/suli.2009.39.4.396.
PubMed 19792981Jobes DA. Collaborating to prevent suicide: a clinical-research perspective. Suicide Life Threat Behav. 2000 Spring;30(1):8-17.
PubMed 10782715Monti, K., Cedereke, M. & Ojehagen, A. (2003). Treatment attendance and suicidal behavior 1 month and 3 months after a suicide attempt: A comparison between two samples. Archives of Suicide Research, 7, 167-174. http://doi.org/10.1080/13811110301581
Michel, K. & Valach, L. (1997). Suicide as goal-directed action. Archives of Suicide Research, 3, 213-221. http://doi.org/10.1080/13811119708258273
Michel K, Dey P, Stadler K, Valach L. Therapist sensitivity towards emotional life-career issues and the working alliance with suicide attempters. Arch Suicide Res. 2004;8(3):203-13. doi: 10.1080/13811110490436792.
PubMed 16081387Michel K, Maltsberger JT, Jobes DA, Leenaars AA, Orbach I, Stadler K, Dey P, Young RA, Valach L. Discovering the truth in attempted suicide. Am J Psychother. 2002;56(3):424-37. doi: 10.1176/appi.psychotherapy.2002.56.3.424.
PubMed 12400207
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Brief Therapy for Attempted Suicide: Two Year Follow-Up Randomized Controlled Study of the Attempted Suicide Short Intervention Program (ASSIP)
- ClinicalTrials.gov ID
- NCT02505373
- Acronym / sponsor ID
- ASSIP / 144/08
- Conditions
- Suicide Attempt, Suicide, Suicidal Ideation
- Keywords
- Brief Therapy, Attempted Suicide, Therapeutic Alliance, Suicidal Ideation, Suicide, ASSIP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 22 Jul 2015 (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.
Objective
Attempted suicide is the main risk factor for repeated suicidal behavior. However, evidence of the effectiveness of follow-up treatments for these patients is limited. The authors evaluated the effectiveness of the Attempted Suicide Short Intervention Program (ASSIP), a novel brief therapy based on a patient-oriented model of suicidal behavior. The ASSIP consists of three sessions followed by regular letters for 24 months.
Method
In this treatment study, 120 patients were randomly assigned to either the ASSIP intervention or a control group that received a one-session clinical assessment. Both groups received in- and outpatient treatment as usual. Study participants also completed a set of psychosocial and clinical questionnaires every 6 months during a 24-month follow-up period.
Detailed description
Background
In the prevention and treatment of suicidality the main emphasis according to the traditional medical model has been on diagnosis and treatment of mental disorders, first and foremost depression. However, it is debatable how far this approach toward the suicidal patient can actually affect suicide rates. It has been argued that the mechanisms of suicidal behavior should be studied independently of any associated psychiatric disorder.
Follow-up studies strongly suggest that when a person has attempted suicide, the risk of future suicidal behavior, including death by suicide, cannot be "cured". Once a person has tried to solve an emotional crisis with a suicide attempt, this behavioral pattern will quickly re-emerge in similar situations in the future, not only because a suicide attempt provides a - temporary - solution, but also because very often it associated with an immediate sense of relief. The prevailing view emerging from recent developments in suicide research is that, following attempted suicide, it is crucial to establish individual safety strategies with patients for coping differently in future emotional crises. For as many patients as possible to benefit, treatments targeting suicidality should be brief and focused, and, of course, effective.
ASSIP combines aspects of action theory, cognitive behavior therapy, and attachment theory. A fundamental assumption is that an action theoretical approach toward the suicidal patient will establish a therapeutic alliance in the sense of a "secure base", which will enhance the effect of the regular letters following the four treatment sessions. ASSIP is not a stand-alone therapy but should be offered to suicidal patients in addition to the usual clinical management and follow-up treatment.
Objective
- How effective is ASSIP, compared to a control group in preventing suicidal behaviour after a suicide attempt?
- Primary outcome measures: Suicidal behaviour, suicidal ideation
- Secondary outcome measures: Depression, coping skills, contact to health care system
- Which parameters have a moderating influence on outcome measures?
- Therapeutic alliance
- Diagnosis
- Previous suicide attempts
Methods
In this treatment study, 120 patients were randomly assigned to either the ASSIP intervention or a control group that received a one-session clinical assessment. Both groups received in- and outpatient treatment as usual. The quality of the therapeutic alliance as a moderating factor for outcome was measured at the therapy sessions 1 (both groups) and 3 (ASSIP group only) using the Helping Alliance Questionnaire (HAq). Regarding outcome measures the study participants completed a set of psychosocial and clinical questionnaires every 6 months during a 24-months follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group ASSIP | Experimental | Behavioral: Attempted Suicide Short Intervention Program (ASSIP)Intervention Group ASSIP (Brief Therapy) |
| Control Group CG | Active comparator | Behavioral: Control Group (CG)Control Group CG (structured interview) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male/female
- Inpatient/outpatient, day care treatment
- German language
- All diagnosis (except: psychosis)
- Written informed consent
Key exclusion criteria (3 listed)
- Psychosis
- Imprisonment
- Foreign languages
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 |
|---|---|---|
| Attempted Suicide Short Intervention Program (ASSIP)The brief therapy ASSIP consists of three to four sessions, which are ideally administered within a period of 2 to 4 weeks. Therapy sessions are scheduled for 60 to 90 minutes. Session 1: A narrative interview is conducted, in which the patient is asked to tell his or her personal story which led to the suicidal crisis. The narrative is video-recorded. Session 2: Using video-playback of the recorded narrative, patient and therapist explore further details of the suicidal process. Session 3: A case conceptualization focusing on the patient's vulnerability and the trigger of the suicidal crisis is formulated in writing. A list of safety strategies for the prevention of future suicidal behaviour is developed jointly with the patient. Regular letters are sent to patients over a period of 2 years. | Behavioural | Intervention Group ASSIP |
| Control Group (CG)Participants assigned to the control group underwent a single clinical interview that included a structured assessment of suicide using the SSF (Jobes, 2006). | Behavioural | Control Group CG |
Primary outcome
Suicidal behaviour
Time frame: 2-year follow-up
Measured by socio-demographic \& clinical questionnaire
Suicidal behaviour
Time frame: 1-year follow-up
Measured by socio-demographic \& clinical questionnaire
5 secondary outcomes
Contact to health care system
Time frame: At baseline, after 6 months, after 12 months, after 18 months, after 24 months
Suicidal ideation
Time frame: At baseline, after 6 months, after 12 months, after 18 months, after 24 months
Depression
Time frame: At baseline, after 6 months, after 12 months, after 18 months, after 24 months
Coping
Time frame: At baseline, after 6 months, after 12 months, after 18 months, after 24 months
Global distress
Time frame: At baseline, after 6 months, after 12 months, after 18 months, after 24 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 14 Jan 2016.
- BackgroundAlexander, L. B. & Luborsky, L. (1986).The Penn Helping Alliance Scales. In L. S. Greenberg & W. M. Pinsoff (Eds.), The psychotherapeutic process: A research handbook (pp. 325-366). New York, NY: Guilford Press.
- Background: PubMed 11459249Arensman E, Townsend E, Hawton K, Bremner S, Feldman E, Goldney R, Gunnell D, Hazell P, Van Heeringen K, House A, Owens D, Sakinofsky I, Traskman-Bendz L. Psychosocial and pharmacological treatment of patients following deliberate self-harm: the methodological issues involved in evaluating effectiveness. Suicide Life Threat Behav. 2001 Summer;31(2):169-80. doi: 10.1521/suli.31.2.169.21516.
- BackgroundBeck, A. T. & Steer, R. A. (1987). BDI, Beck depression inventory: manual. New York, NY: Psychological Corporation.
- BackgroundBeck, A. T. & Steer, R. A. (1991). Manual for the Beck scale for suicide ideation. San Antonio, TX: Psychological Corporation.
- Background: PubMed 16077050Brown GK, Ten Have T, Henriques GR, Xie SX, Hollander JE, Beck AT. Cognitive therapy for the prevention of suicide attempts: a randomized controlled trial. JAMA. 2005 Aug 3;294(5):563-70. doi: 10.1001/jama.294.5.563.
- Background: PubMed 23520223Carter GL, Clover K, Whyte IM, Dawson AH, D'Este C. Postcards from the EDge: 5-year outcomes of a randomised controlled trial for hospital-treated self-poisoning. Br J Psychiatry. 2013 May;202(5):372-80. doi: 10.1192/bjp.bp.112.112664. Epub 2013 Mar 21.
- Background: PubMed 24750971Claassen CA, Pearson JL, Khodyakov D, Satow PM, Gebbia R, Berman AL, Reidenberg DJ, Feldman S, Molock S, Carras MC, Lento RM, Sherrill J, Pringle B, Dalal S, Insel TR. Reducing the burden of suicide in the U.S.: the aspirational research goals of the National Action Alliance for Suicide Prevention Research Prioritization Task Force. Am J Prev Med. 2014 Sep;47(3):309-14. doi: 10.1016/j.amepre.2014.01.004. Epub 2014 Apr 18.
- Background: PubMed 11437747Granboulan V, Roudot-Thoraval F, Lemerle S, Alvin P. Predictive factors of post-discharge follow-up care among adolescent suicide attempters. Acta Psychiatr Scand. 2001 Jul;104(1):31-6. doi: 10.1034/j.1600-0447.2001.00297.x.
- BackgroundGysin-Maillart, A. & Michel, K. (2013). Kurztherapie nach Suizidversuch. ASSIP-Attempted Suicide Short Intervention Program. Therapiemanual. Bern: Huber. ISBN: 9783456852386
- Background: PubMed 19792981Hatcher S, Sharon C, Coggan C. Beyond randomized controlled trials in attempted suicide research. Suicide Life Threat Behav. 2009 Aug;39(4):396-407. doi: 10.1521/suli.2009.39.4.396.
- Background: PubMed 10782715Jobes DA. Collaborating to prevent suicide: a clinical-research perspective. Suicide Life Threat Behav. 2000 Spring;30(1):8-17.
- BackgroundMonti, K., Cedereke, M. & Ojehagen, A. (2003). Treatment attendance and suicidal behavior 1 month and 3 months after a suicide attempt: A comparison between two samples. Archives of Suicide Research, 7, 167-174. http://doi.org/10.1080/13811110301581
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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.
Konrad Michel, Prof. principal investigator
Hospital of Psychiatry and Psychotherapy, University of Bern
Anja C Gysin-Maillart, Ph.D. principal investigator
Hospital of Psychiatry and Psychotherapy, University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attempted Suicide Short Intervention Program (ASSIP) in people with Suicide Attempt and Suicide, run by University of Bern at 1 site in Switzerland.
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 5 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 14 Jan 2016. 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 Switzerland. 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: 2-year 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?
On the ClinicalTrials.gov record for NCT02505373, which also lists 26 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 14 Jan 2016.