The main objective of this randomized controlled study is to investigate whether CT-sp in combination with treatment as usual (TAU) is more effective in reducing the severity and intensity of suicide ideation and suicidal behavior than only…
ID
Source
Brief title
Condition
- Suicidal and self-injurious behaviours NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is defined as the reduction of suicide ideation and
suicidal behavior in terms of severity and intensity as measured by the
Columbia-Suicide Severity Rating Scale (C-SSRS). Assessments of severity and
intensity of suicidal ideation and behavior will be made at baseline, after 6
and 12 weeks, and 9 months after the baseline measurement.
Secondary outcome
To refine the grid of suicidal ideation and behavior, several other explicit
and implicit measures of suicidal behavior will be used as secundary study
parameters. Furthermore, levels of depression and anxiety will respectively be
mapped, as well as quality of life, and severity of the mental illness of the
patient.
Lastly to enhance our understanding of the underlying factors that bring about
suicidal behavior, three theories of how suicidal behavior might arrise will be
investigated by the use of questionnaires:
- Interpersonal Theory of Suicide using the Interpersonal Needs Questionnaire
(INQ) and the Acquired Capability for Suicide Scale - Fearlessness About Death
(ACSS-FAD)
- Suicidal Crisis Syndrome, using the Suicide Crisis Inventory (SCI)
- An amplified sense of self-agency nurtures a positive attributional style to
self and self-control, which may buffer against effects of hopelessness. This
possible underlying mechanism will be investigated using the Pearlin Mastery
Scale (PMS)
Psychometric properties of the Dutch translations of the INQ, ACSS-FAD, and SCI
will be assessed.
At assesment T2, participants will be asked to evaluate the suicide prevention
interventions received during the study via a short questionnaire. At all
assessments, participants will be asked to what extent they think they are able
to cope with their own suicidality, using the Suicide-Related Coping Scale.
Background summary
Recent reviews pointed out that psychosocial and behavioral interventions that
treat suicidality directly have a better prognostic value than interventions
targeting suicidality indirectly by, for example, treating a major depressive
disorder (MDD) when the patient is suicidal and simultaneously suffering from
MDD. In this study we will act upon these findings through the implementation
of a promising cognitive behavioral intervention meant to directly reduce and
prevent suicidal ideation and behavior (the CT-sp protocol) among patients in
specialized mental health care (sGGZ), the Dutch equivalent of outpatient
mental health care for patients with complex psychological problems.
Study objective
The main objective of this randomized controlled study is to investigate
whether CT-sp in combination with treatment as usual (TAU) is more effective in
reducing the severity and intensity of suicide ideation and suicidal behavior
than only receiving treatment as usual.
Study design
This study is designed as a randomized controlled trial. Patients in the
experimental condition will receive CT-sp protocol delivered by a trained
psychologist in 12 sessions, as an add-on to their treatment as usual without
interruption. In the control condition patients will also remain in treatment
as usual with attention paid to suicidal behavior, albeit not in a specific
intervention.
There are 4 measurement moments: T0 (baseline), T1 (6 weeks after T0), T2 (12
weeks after T0) and T3 (9 months after T0).
Intervention
Ten sessions of CT-sp delivered face-to-face by a trained psychologist.
Study burden and risks
Participants in the experimental condition will be offered 12 sessions of CT-sp
added to their treatment as usual (TAU) aiming to reduce the severity and
intensity of their suicidal ideation and behavior. Participants are informed
that they can cancel their participation at any time without disclosing reasons
for their cancellation and without negative consequences for their future care.
Participants in the control condition will not be subjected to an additional
intervention to TAU, but are not restricted in the use of mental health care.
Data will be collected at two assessments in the course of treatment and at 9
months after the baseline measurement. The baseline assessment lasts
approximately 2 hours and 30 minutes. Each assessment after that lasts about 1
hour.
Oldenaller 1
Amsterdam 1081 HJ
NL
Oldenaller 1
Amsterdam 1081 HJ
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18
- Patient is newly referred to or in care at a participating sGGZ mental health care center
- Severe suicidal ideation in the last month, and/or a history of suicide attempt
- Speaking the Dutch language
Exclusion criteria
• Active (manic-)psychotic episode or cognitive impairment due to chronic (psychotic) disorganization, dementia, or mental retardation
• Insufficient mastery of the Dutch language
• Has previously had cognitive behavioral therapy for suicide prevention
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL65579.029.18 |
| OMON | NL-OMON25696 |