Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04280614 |
| Other study ID # |
H2019:485 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2020 |
| Est. completion date |
March 17, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
University of Manitoba |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Objective: The goal of this proposed research project is a quantitative analysis of a day
hospital program designed to treat persons with emotional dysregulation.
Background: The Short-term Assessment and Treatment (STAT) program has been operating at
Health Sciences Center, Winnipeg, Manitoba for many decades. The STAT program is based on the
principles of dialectical and cognitive behavior therapy. The STAT program is a five week day
hospital program employing multi-modal treatment methods to treat patients with emotional
dysregulation. The literature provides evidence of numerous treatment models with varying
effectiveness for this population of patients. The STAT program hasn't had a quantitative
analysis of its treatment model.
Problem Statement: Is the 5 week day hospital treatment model developed and employed by the
STAT program effective in improving the mental health of participants admitted to the
program?
Description:
Research on brief therapeutic interventions for those diagnosed with BPD have often involved
a year or more of treatment in an outpatient, inpatient or partial hospitalization setting.
The goal of this research proposal is to examine if a 5-week day hospital treatment program
at a tertiary hospital within Shared Health can demonstrate effective amelioration of subject
symptoms on a number of measures.
As noted in the introduction there is significant public health considerations associated
with persons living with borderline personality disorder pathology. Evidence-based public
health should be informed by practice-based evidence stemming from the rigorous evaluation of
relevant natural experiments. Due to logistic and ethical considerations a randomized control
trial isn't feasible. Given these considerations, the proposed research design is a
naturalistic pre- post-intervention with no control group. Although causality cannot be
determined in a naturalistic design, methodological rigour employed will mitigate the impact
of outside variable from invalidating the results obtained from the proposed research.
Participants data will be collected at two times and the data from the same individual will
be compared focusing on differences between pre- and post-intervention. The benefit in the
longitudinal design is the potential to control for temporal or secular changes observed in
the outcome. A challenge in interpreting randomized control trials is potential biases that
impact external validity and reduce the ability of the researchers to generalize the outcomes
associated with an intervention. Naturalistic studies can reduce the impact of confounding
variable by identifying and controlling potential variables, such as socio-economic factors.
Sample Characteristics and Selection Participants are referred to the STAT program through
emergency room consultations, family physician referrals and from psychiatrists working in
the community, outpatient department or during an inpatient admission. Participants are
individuals 18 years and older.
Although participants in the STAT program are primarily females there is no exclusion
criteria based on gender. These participants are assigned a therapist who will complete a
psychiatric interview and review a self-report each participant is required to complete prior
to the initial interview. Potential participants will meet with a psychiatrist to review the
information gathered in the therapist interview and determine if the client will be admitted
to the STAT day hospital program. Participants are accepted if they meet admission criteria
as determined by the psychiatrist. Participants are excluded if they have a diagnosis of
antisocial personality disorder, criminal charges, or significant substance abuse.
Participants are required to formulate behaviour-oriented goals to work on while
participating in the STAT program. Participants are not admitted to the program if they do
not formulate treatment goals. Potential participants referred from one of the above noted
sources are assigned to a therapist each Tuesday at a weekly meeting of the STAT program
staff. The therapist will contact the individual and arrange a date for an initial interview.
If a therapist is unable to reach an individual by phone, a letter with the date for an
appointment is mailed along with the self-report questionnaire each client is expected to
complete for the first interview with the therapist. The self-report materials include a
series of questions to elicit a social history of the individual along with current stressors
and self-identified problems. The assessment process involves roughly two appointments with
the therapist and an additional appointment with the psychiatrist requiring roughly three
weeks to complete. Participants will be given a letter of invitation outlining the research
project as well as the SCL-90-R and DERS psychometric questionnaires. Individuals will be
asked to complete the SCL-90-R and DERS at the beginning of their first appointment if they
agree to participate in the research project.
Once an individual is accepted to the STAT Program, they are placed on the waiting list for a
period of roughly four to six weeks. During that period, the therapist will meet with clients
roughly two times to assist in formulating treatment goals and develop a therapeutic rapport.
While a client is admitted to the program and participating in the groups, they are also seen
by their assigned therapists on a weekly basis for an individual therapy session. Individual
sessions with the therapist assist participants in understanding the psychoeducation group
learning materials, assist with homework, and to process current stressors.
The participants will complete the Symptom Checklist-90-Revised (SCL-90-R) and Difficulties
in Emotion Regulation Scale (DERS) prior to the first interview. Participants will be
re-administered the SCL-90-R and DERS following completion of the 5-week treatment.
Program Description The Short-term Assessment and Treatment (STAT) program is a day hospital
program operated at Health Sciences Center in Winnipeg, Manitoba. The STAT program operates a
5 week continuously running treatment program. Clients are admitted to and complete the
program weekly. Similarly, other researchers have had participant entering the program at
different points in the skill training and found no interaction effect and didn't
significantly influence the participants' frequency or type of skills practised. The number
of clients in the group is roughly 15 - 18. The STAT program employs a multidisciplinary team
comprised of social workers, an occupational therapist, several nurses and psychiatrists.
The STAT program is comprised of psychoeducation and psychotherapy groups, and individual
therapy with an assigned therapist. Clients attend morning and afternoon groups daily for the
5-week duration of the program. Groups are scheduled for 1 hr 30 min with an hour break for
lunch. Two therapists lead each group and rotate through groups on a predetermined schedule.
Psychoeducation groups are informed by the principles of DBT and CBT. Many of the skills
taught are directly taken from Dr. M. Linehan's DBT skills training manual. Psychoeducation
is taught in the morning with the assigned module handed out at the beginning of the week.
There are six psychoeducation topics that clients will be taught during the course of
treatment. One of five topics is introduced on Monday and mindfulness is taught each Friday.
These topics are: Distorted Thinking, Anger Being Effective, Communication and Assertiveness,
Goal-Setting and Self-Esteem. A new skill related to the mindfulness psychoeducation module
is introduced each Friday. Participants are given daily reading material and homework to
complete related to the weekly topic. Participants are asked to share daily from their
homework in the group.
Many people with emotional struggles cope by engaging in self-injurious behaviours. Monday
afternoon group focuses on the principles of Harm Reduction. Harm reduction groups teach the
principles of stages of change, effective coping, and distress tolerance skills taught in
DBT. Psychotherapy groups occur in the afternoon between Tuesday and Thursday. Participants
are required to "check-in" at the beginning of group with a topic they would like to discuss.
Procedure As outlined above, participants will be given a letter of invitation outlining the
research project a demographics questionnaire, the SCL-90-R and the DERS psychometric
questionnaires. Individuals will be asked to complete the SCL-90-R and DERS at their first
appointment if they agree to participate in the research project. The two questionnaires will
be handed into the therapist along with the original copy of their signed Informed Consent.
Participants will retain a copy of the informed consent letter along with the letter of
invitation. The therapists will have adhesive identifiers to correspond the pre- and
post-intervention self-report questionnaire to the participant. The therapist will affix an
identifier to the envelope indicating the anonymous participant envelop contains
preintervention self-report data. The therapist will code if the patient participated in
psychoeducation and psychotherapy groups or just the psychoeducation groups. The rationale
for the distinction is to control the confounding variable of differences in the treatment a
participant will receive. For the purposes of this research project only participants that
attend both psychoeducation and psychotherapy groups will be examined. Attrition will be
accounted for and those participants will be compared with treatment completers to examine
potential significant differences between these groups. Attrition will be identified by only
having a pre-intervention self-report surveys completed. The participant will be given a card
with the identifier number and the therapist will affix the third adhesive identifier to an
envelope for the post-intervention assessment. Participants will be re-administered the
SCL-90-R and DERS following completion of the 5-week treatment. The participants will be
given the two instruments on the last day in the program to complete. The therapist will ask
the participants if they have the card given to them with identifier affixed when they
completed the pre-intervention questionnaire. The participants will be given the
corresponding post-intervention envelope containing the SCL-90-R and DERS surveys. The
participants will hand in the completed questionnaires to their therapist. The goal will be
to solicit 60 clients to the research project.
Anticipated Outcomes The author expects that there will be an improvement in global severity
index, improvement of emotion regulation, and a reduction hostility and improved
interpersonal relationships as self-reported. Literature has reported attrition rates upwards
of 30% for treatment programs with those who have borderline personality disorder attributed
to a lack of motivation, interpersonal conflict, difficulties with emotional distress,
substance use, suicide attempts and antisocial personality disorder. The STAT program model
may reduce the attrition rate because potential participants with significant substance abuse
and an antisocial personality disorder are excluded from participating in the program.
Researchers have noted attrition was related to treatment characteristics and life
circumstances. The STAT program will not admit participants that don't have housing, stable
finances such as employment insurance, and a family physician. Many treatments including
standard DBT and mentalization-based therapy are also lengthier potentially making commitment
for participants more difficult. Related to the admission criteria and the brief structure of
STAT program the author expects the rate of attrition to be below the 30% rate noted above.
Proposed Data Analysis
A repeated measures t-test or an ANOVA data analysis will be used to determine if there is a
predicted significant improvement in participants self-reports between pre- and
post-intervention. An exploratory correlation data analysis will be used to examine if there
are differences between participants that complete the STAT program versus those that don't
complete the program.
