Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04254809 |
| Other study ID # |
2019.28553 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 27, 2018 |
| Est. completion date |
August 1, 2020 |
Study information
| Verified date |
December 2021 |
| Source |
Florida State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
As rates of suicide have increased over the last several decades, research has identified
that roughly two-thirds of individuals who attempt suicide do so within one year from the
time that they begin to think about suicide. This suggests a greater need for interventions
designed to specifically help individuals learn to cope with thoughts of suicide to interrupt
the process by which thoughts may lead to suicidal behaviors (i.e, attempts).
This study aims to develop and test a novel intervention designed to help individuals feel
more confident in their ability to manage thoughts of suicide. It is common that individuals
with suicidal ideation may not understand where thoughts of suicide come from and are
therefore distressed at the prospect they might never escape these thoughts. As a result,
these individuals may attempt to distract from or avoid these thoughts in ways that
contribute to suicidal ideation becoming more frequent and intense over the long-term. This
'experiential avoidance' of suicidal ideation is therefore an excellent target for treatment
and has in fact been shown to help reduce the distress associated with suicidal thoughts in
several treatment studies.
The intervention to be tested in this study seeks to reduce the distress related to suicidal
thoughts by explaining that these thoughts are a normative response to extreme stress, and
provides strategies that help individuals observe that suicidal thoughts are temporary (i.e.,
will not last "forever") and something they can tolerate without needing to rigidly control
them. To maximize the potential of this intervention to help the largest number of
individuals, it is entirely computerized and takes only 30 minutes to complete. This will
help reduce many of the traditional barriers to treatment that individuals with suicidal
ideation face (e.g., costs, time restrictions, and stigma of help-seeking).
Individuals (N=106) with current suicidal ideation will be randomly assigned to participate
in either the experiential avoidance intervention for suicidal thoughts or a control
intervention. Experiential avoidance (i.e., distress or avoidance) and severity of suicide
risk will be measured one week, and one month after participants complete their assigned
intervention. It is expected that, compared to controls, individuals who receive the
experiential avoidance intervention will report: 1) less experiential avoidance at one week
follow-up, and 2) less severe suicide risk at one-month follow-up.
Description:
Each year in the United States nearly 47,000 people die by suicide. Despite over 50 years of
suicide prevention research, the field is no closer to identifying specific factors which
influence the transition of suicidal ideation to suicide attempts. Research suggests upwards
of 60% of individuals with suicidal ideation progress to making suicide plans or attempts
within 1 year, suggesting a specific, pernicious process is involved in this escalation.
Identifying which mechanisms contribute to the escalation of new-onset suicidal ideation is
crucial to developing interventions that target these underlying processes.
Conceptual models of suicide have long viewed suicidal ideation and behaviors as a form of
escape or avoidance from psychological distress with which individuals do not know how to
cope. Indeed, psychiatric disorders are roughly 4 times as prevalent among suicidal ideators
compared to non-ideators, and it is estimated 90% of suicide decedents evinced at least one
psychiatric disorder. Several empirical models of psychiatric disorders implicate behavioral
or experiential (i.e., emotional) avoidance as a driving mechanism of symptom severity (i.e.,
psychological distress. Similar to other psychiatric symptoms, suicidal ideation is
distressing insofar as some individuals view such thoughts as incompatible with their natural
instinct for self-preservation. To the extent that individuals respond to suicidal ideation
with avoidance, such responses may in part be responsible for the escalation of suicidal
ideation to plans or attempts.
Incidentally, models of psychological flexibility indicate a primary role for experiential
avoidance and have been applied to suicidal ideation and behaviors. Higher levels of
experiential avoidance are prospectively and concurrently associated with suicidal thoughts
and behaviors. Moreover, as a cognitive-behavioral indicator of experiential avoidance,
efforts to avoid or suppress suicidal thoughts are associated with greater concurrent levels
of suicidal ideation and risk, and relate to a paradoxical increase in the severity of
suicidal ideation over time.
Taken together, these studies suggest that individuals high in experiential avoidance with
concomitant suicidal ideation may benefit from interventions that mitigate experience
avoidance. Such interventions would ideally limit the psychological distress associated with
the occurrence of suicidal thoughts, and improve one's ability to adaptively cope with
suicidal thoughts rather than seeking to avoid, control, or suppress such thoughts. Indeed,
preliminary evidence suggests treatment modalities that incorporate this approach (i.e.,
Acceptance and Commitment Therapy [ACT]) reduce suicidal ideation. Unfortunately, as with
most traditional psychotherapies, this evidence stems from studies that required participants
to attend numerous in-person sessions with a trained psychotherapist. Outside of treatment
studies, the time and costs associated with this treatment would likely serve as a barrier to
individuals with suicidal ideation, who represent a segment of the population that critically
underutilize these types of mental health services. In order to increase suicide prevention
efforts, it would be beneficial to develop ACT-based interventions that are more scalable and
thus have the potential to address the needs of a greater number of individuals with suicidal
ideation.
The current study therefore aims to develop and test a brief, web-based intervention
primarily focused on reducing experiential avoidance of suicidal ideation among individuals
with current SI (N = 106). The study will consist of one baseline appointment (in person),
and two follow-up appointments one week (phone/online) and one month (phone/online) following
their baseline appointment. At the baseline appointment, participants will complete measures
of suicidal ideation severity and experiential avoidance. They will then be randomized to
complete either the computerized experiential avoidance intervention or a healthy living
control video safety planning with a clinician. Per best practices for maintaining
participant safety, following intervention condition, all participants will receive the
Safety Planning Intervention. One week after the baseline appointment, participants will
complete a suicide risk assessment over the telephone, during which time they will also
complete self-report measures of experiential avoidance and suicidal ideation severity. These
same procedures will be conducted again one month after baseline.
It is hypothesized that, compared to healthy living controls, individuals who receive the
experiential avoidance intervention will report: 1) less experiential avoidance at one week
follow-up, and 2) less severe suicidal ideation at one-month follow-up.
