Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00700089 |
| Other study ID # |
AID-trial Copenhagen |
| Secondary ID |
Psychiatric Cent |
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
June 16, 2008 |
| Last updated |
October 24, 2016 |
| Start date |
November 2007 |
| Est. completion date |
December 2011 |
Study information
| Verified date |
October 2016 |
| Source |
University of Copenhagen |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Denmark: Ethics Committee |
| Study type |
Interventional
|
Clinical Trial Summary
Background
Previous suicide attempts is a high-risk factor with a repetition rate between 12-30
percent. Compliance with after treatment is often poor. A systematic review by Hawton, 1999
states a lack of evidence on psychosocial interventions due to selections bias or
statistical power.
Objective
The aim is to investigate if assertive outreach, incorporating hands-on guidance and
motivational support of compliance with follow-up treatment after suicide attempts is able
to reduce the frequency of non-fatal and fatal suicide acts in a one-year follow-up period.
Method and Design
A randomized, controlled intervention trial in a prospective design. The patients included
will be randomized to either standard treatment (n = 120) or intervention treatment (N =
120), representing 6 - 8 assertive outreach contacts with a research nurse after suicide
attempts or deliberate self-harm. The outreach contacts are thought of as supporting and
guiding home visits towards compliance with after care or follow-up treatment Inclusion
criteria Males and females, aged 12 years or older with a recent suicide attempt or act of
deliberate self-harm, living independently and not diagnosed with severe mental illness
(psychosis, severe dementia)
Outcome
The primary outcome measure is repeated fatal suicidal act (fatal or non fatal)assessed by
the Danish Cause of Death Register and the rate of repeated suicide attempts/deliberate
self-harm registered in the medical records by the collaborating wards and units in their
routine procedure of treating people applying for help in relation to suicidal behavior.
Description:
SPECIFIC AIMS/HYPOTHESES
The aim of this study is to investigate if assertive outreach incorporating hands-on
guidance and motivational support of compliance with follow-up treatment after suicide
attempts is able to reduce the frequency of non-fatal and fatal suicide acts.
BACKGROUND AND SIGNIFICANCE
Suicidal behavior is associated with considerable risk of subsequent self-harm, including
completed suicide. Owens et al. (Owens, Horrocks, & House 2002a) conducted a systematic
review of fatal and non-fatal repetition of self-harm. Owens found that the median one-year
repetition rate was 16 percent non-fatal and two percent fatal. Results from the
epidemiological European Multicentre Study (WHO/EURO) also shows a repetition rate between
12 and 30 percent within the first year, making suicide attempts a very important high-risk
factor (Cedereke, Monti, & Ojehagen 2002;Schmidtke et al. 1996).
Unfortunately there are still very few randomized controlled trials with evidence based
recommendations for suicide prevention. The studies conducted are often flawed due to
selection bias or lack statistical power (Crawford et al. 2007;Hawton et al. 1998b;van der
et al. 1997). A systematic review of randomised clinical trials of psychosocial and
pharmacological interventions for persons who have attempted suicide revealed that until
now, no intervention has proven effective in reducing suicide rate or repetition rate
(Hawton et al. 1999). The authors identified non-significant trends toward reduced
repetition of deliberate self-harm for problem-solving therapy compared with standard
aftercare, for provision of an emergency contact card in addition to standard care compared
with standard aftercare alone, and for intensive aftercare plus outreach compared with
standard aftercare. In one relatively large study in this group, which evaluated community
follow-up of patients who did not attend outpatient appointments, there was a near
significant difference in repetition of deliberate self-harm of 10.7 percent compared with
17.4 percent (0.57; 0.32 to 1.02), (Van Heeringen et al. 1995).
Hawton et al. concluded that the results of the systematic review indicate that there is
currently insufficient evidence on which to base firm recommendations about the most
effective forms of treatment for patients who have recently deliberately harmed themselves.
Given the size of the problem, they consider this situation serious (Hawton, Townsend,
Arensman, Gunnell, Hazell, House, & Van Heeringen 1999). The main problem with nearly all
trials in the meta-analysis was that they included far too few subjects to have the
statistical power to detect clinically meaningful differences in rates of repetition of
deliberate self-harm between experimental and control treatments, if such differences
existed. Even when the results from similar trials were synthesized with meta-analytical
techniques, there were insufficient numbers of patients to detect such differences.
After the Cochrane review, six randomised clinical trials have been published, among them
the POPMATC study, which has a large sample size of 480 patients. The study examines the
effect of up to five plus two booster sessions of manual-assisted
cognitive-behavioral-therapy sessions versus various control conditions, some of which bear
some resemblance to cognitive therapy (problem solving). In the study, there was no
significant difference in repetition of self-harm between experimental group and control
group (Tyrer et al. 2003). In a randomised clinical trial, Brown et al. found that cognitive
therapy (mean 9 sessions) for adults who attempted suicide (N=120) reduced repetition rate
and increased the repetition-free period (Brown et al. 2005). Recently, Vaiva et al.
published the results of a large French multi-centre trial in which telephone contact after
one and three months were compared to standard treatment (Vaiva et al. 2006). Comparison of
both experimental groups combined versus standard treatment did not show that telephone
contact was superior to standard treatment, but the authors point out that there was a
significant difference between the proportion that repeated suicide attempt in the one-month
telephone call group compared to control treatment in the first 6 months of the trial. The
odds ratios in all trials point in the same direction, namely toward a protective effect of
the experimental conditions.
As pointed out by Hawton, it might be necessary for such conditions to be combined with
assertive outreach.
RESEARCH METHODS
METHOD, DESIGN AND PROCEDURE
The AID-study is a randomized, clinical trial. The patients included will be centrally
randomized to either standard treatment (n = 120) or intervention treatment (N = 120),
representing 6 - 8 assertive outreach contacts after suicide attempts or deliberate
self-harm. The randomization is computerized and will, in prevention of allocation bias, be
conducted by an independent research assistant in the research unit. The intervention team
therefore will not know the block size of the study groups. The randomization is stratified
for three items:
1. First-evers or previous suicide attempts,
2. Previous psychiatric contact or no contact of the kind,
3. Alcohol or no alcohol involved.
Stratification variables will reported when calling the research assistant in charge of the
randomization. The research assistant in turn will provide the intervention team with the
assigned treatment and participant number. The intervention team is not blinded. The
patients will be recruited from the emergency room, intensive care, psychiatric emergency
room as well as those admitted to psychiatric wards. After discharge they will be contacted
by mail or phone at home. The experimental intervention treatment will go on for the first
six months followed by six months of no contact. One year from the inclusion date both
patients in standard treatment and intervention treatment will receive a final call focusing
on on-going compliance with follow-up treatment. Sociodemographic data, medical status,
information concerning abuse, previous psychiatric treatment and previous suicide attempts
will be obtained at baseline.
INTERVENTION - ASSERTIVE OUTREACH
Colleagues in Norway have developed a preventive intervention focusing on the 'gap' between
admission/emergency room and outpatient treatment (Dieserud, Loeb, & Ekeberg 2000). The
Bærum-model is named after the suburb north of Oslo where the intervention first took place.
The concept is to support and guide the person shortly after the in-hospital treatment for
self-injury through a recommended follow-up or after treatment based on assertive
principles. Poor compliance with treatment is addressed using active, caring individual
support to assist clients with feelings of being abandoned, depressed, shame, and ambivalent
(Dieserud, Loeb, & Ekeberg 2000). The Bærum-model has never previously been as researched in
a randomized controlled study (Dieserud, Loeb, & Ekeberg 2001). Knowing that the
precipitating factors for suicide are diverse, the prevention strategies have to be
likewise. The Bærum-model is a psychosocial approach to suicide prevention that underlines
the need for intervention tailored according to individual client needs. The intervention is
an indicated prevention strategy targeting people with suicide attempts and deliberate
self-harm as a high-risk group. They will be offered 6-8 assertive outreach contacts. The
outreach contacts will be home visits focusing on providing support and motivating patients
to comply with follow-up treatment. However, depending on individual needs, the contacts may
include or be substituted with admittance to alcohol units, somatic/oncological treatment,
counselling with a family doctor, family meetings and so on. The main target of the
intervention is to encourage and ensure that the patient will be referred and accompanied to
the necessary treatment and actually receive the recommended treatment.
STANDARD TREATMENT
Standard treatment consists of referral to a range of different treatment modalities
depending on the diagnosis and clinical and social condition of the patient. In standard
treatment there is no procedure for ensuring that the patient will actually receive the
recommended treatment. Patients are often referred to available treatment modalities such as
general practitioner, psychological treatment, treatment for alcohol abuse, and most often,
the patients are themselves responsible for getting into contact with the treatment to which
they are referred.
OUTCOME
The primary outcome measure is the number of suicides assessed by the Danish death-register
and the rate of repeated suicide attempts/deliberate self-harm registered by the
collaborating wards and units in their routine procedure of treating people applying for
help in relation to suicide behaviour. (Standardized hospital registration procedure). Where
it is not clear if the act was a suicide attempt medical an external evaluation committee
will review records.
STATISTICAL POWER
Alfa is assessed to 0.05 and beta to 0.2, which gives a power of 80 percent (power = 100-
beta). According to international literature(Hawton et al. 1998a;Owens, Horrocks, & House
2002b) the expected repetition rate (primary outcome) will be 30 percent in the standard
group and 15 percent in the intervention group at one year. Calculated that requires 120
people in each randomization treatment group(Dupont & Plummer, Jr. 1990), which makes 240
people included all together. Primary outcome based on register data and medical records
dropout does not have to be accounted for. The data collection period will be limited to 2
years. Patients will be drawn from two University Hospitals in Copenhagen and based on
routine registration; it is likely that we will be able to recruit 240 patients in a
two-year period.
STATISTICS AND DATA ANALYSIS
Statistical survival analysis will be used for investigating the differences in repeated
fatal and non-fatal acts of self harm between the standard group and the intervention group.
Cox-regression analysis will be used to investigate differences between the two groups in
the frequency of suicidal behaviour (suicide, suicide attempts and deliberate self-harm).
Analysis will be adjusted for confounding factors such as gender, age, and treatment with
antidepressants. The survival rates for the two randomization groups will be illustrated by
a Kaplan-Meyer Plot. Chi-square-test, Mann-Whitney and T-test will be used in the analysis
of compliance intensity in both standard and intervention groups.
