Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04704973 |
| Other study ID # |
2020-03251 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 2, 2020 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
April 2023 |
| Source |
Uppsala University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The project aims to investigate the effects of a short-term cbt-based psychotherapy
intervention for a diagnostically mixed group of psychiatric inpatients. In a multiple
baseline single subject design, 5-10 patients with mixed diagnoses that are treated at any of
the inpatient units at the Hospital of Västmanland, Västerås, Sweden, will be offered a short
psychotherapeutic intervention. The intervention is cbt based, and consists of focused
functional analysis with identification of the main problem to be treated; an experiential
exercise called the life line, in which obstacles to living a valued life are investigated,
and in which alternative steps to be taken in spite of psychiatric symptoms are formulated; a
summary excercise called the pause, in which central principles of the treatment are
repeated, and in which a relapse prevention plan is formulated. The intervention will consist
of approximately 2-5 sessions. The primary research question is whether such an intervention
is effective in terms of causal change in problem areas identified as personally meaningful
by the individual patient.
Description:
The most severely ill psychiatric patients are treated on inpatient wards. On most Swedish
inpatient wards, psychological treatment is not routinely offered. At the same time, research
show that psychological treatment often adds a clinically significant effect to routine care.
However, it is a great challenge to handle the diagnostically complex picture present in this
context. Often, diagnoses are unclear or preliminary, or there are many co-morbid conditions
to be treated simultaneously. Available treatment protocols are often developed for an
outpatient population, and for a specific diagnostic group. This, combined with cultural and
organizational challenges inherent to the inpatient context, makes the implementation of
psychological treatment for these patients a great challenge. Factors such as form of care
(voluntary or mandatory), the patient's motivation, and other unforeseen events add to the
fact that the length of any given episode of inpatient care is difficult to estimate. This is
also a fact that a psychological treatment model must adapt to.
There seems to be a need for developing psychological treatment models in a way that makes
them suitable for the special challenges that psychiatric inpatient care present. Looking at
the existing research so far, combined with clinical experience, transdiagnostic
applicability and flexibility in terms of time frame, context and level of functioning in the
individual patient seem to be key factors for a potentially successful model. One way of
developing such a model is to individually tailor each treatment, with the support of a few
well establish principles. Some form of clinical functional analysis is fundamental for most
treatment models based on cognitive behavior therapy (CBT), which is in general the form of
therapy that has the broadest evidence base for the most common psychiatric conditions.
Functional analysis is idiographic in nature, and takes the individual patient's problems as
its starting point, no matter the diagnosis. It is a tool that, at least in theory, is
applicable to all behavior. This means that even complex psychopathology such as psychosis or
suicidality is potentially amenable to analysis and change.
The challenge with using psychological treatment in an inpatient context is to identify and
treat some part of a complex condition, in a way that is possible to combine with other forms
of care given on the ward. Functional analysis is a flexible tool in this respect. For
example, it would be possible to formulate a meaningful plan for behavioral activation or
limited exposure, in the context of a complex psychiatric condition such as schizophrenia.
Besides functional analysis as a basic tool, there are interventions from various therapy
models that have been shown effective in an inpatient context. One CBT-based treatment model
that has been investigated in an inpatient context with promising results is Acceptance &
Commitment Therapy (ACT). In short, ACT aims to promote psychological flexibility in relation
to disturbing experiences, for example symptoms of a psychiatric disorder. One of the central
processes that ACT targets are so called values. Values are defined as freely chosen concepts
that are connected to patterns of action that give a sense of meaning, and that are able to
coordinate behavior over time. One example of such a concept might be being a present parent.
This is connected to a pattern of various behaviors, with each one giving the person a sense
of meaning, because they are connected to an overarching quality of action. Values, in this
respect, are different from concrete and reachable goals. Values are not reachable but point
to a direction for action more generally.
Generally, some form of maintenance plan is also central for change in psychotherapy to last
over time. One method for constructing a maintenance plan is to summarize central principles
in a form that the patient can take with them when treatment is completed.
Looking at the challenges that have been identified in terms of implementing psychological
treatment models in a psychiatric inpatient context, and clinical experiences with using
flexible interventions in this context, the purpose of the present project is to investigate
the effect of a transdiagnostic short-term psychotherapy for psychiatric inpatients.
The main research question is:
Is individually tailored transdiagnostic short-term psychotherapy based on functional
analysis, clarification of values, and the establishment of a maintenance plan effective in
an inpatient context, in terms of causal change in personally meaningful problem areas
defined by the individual patient?
Method Design The study is designed as an experimental sincle case study, with a multiple
baseline across participants. Data will be collected during a baseline period (A) of
approximately two days (2-3 data points will be collected daily) in order to establish a
stable baseline of at least 5 data points. Thereafter, the intervention (B) will be
introduced, and data will be continuously collected 2-3 times daily during treatment.
Approximately 5 data points will be collected after treatment is complete. In order to
control for measurement effects, the length of the baseline will be varied so that it will be
prolonged for some participants.
Participants Approximately 5-10 participants will be included. The number needed is dependent
on the variability of the dependent variable, the length of the baselines, possible trends in
baseline and intervention phases, the size of the change that can be expected, and how fast
the effect on the dependent variable can be reached after introducing treatment.
Meta-analyses of the effect of psychological treatment for inpatients have shown small to
medium effects. Even if the modality of treatment and diagnoses vary in studies included in
meta-analyses, and compared to the project being described here, it seems reasonable when
including patients to expect a quite limited (while clinically significant) effect. It is
estimated that at least five patients will be needed to establish sufficient experimental
control in the project being described here. However, more might be needed, or fewer if the
baselines are stable enough, and the effect of treatment is clear.
Context Data will be collected on the inpatient wards of the Hospital of Västmanland,
Västerås, Sweden, where the main researcher Mårten Tyrberg has his clinical position. In the
hospital, there are 6 inpatient wards, each with 10-15 beds. Patients suitable for inclusion
will be identified on routine rounds, where the main researcher participates regularly.
Outcome measures Outcome measures and dependent variables are the Personal Questionnaire
(PQ), the Bull's-Eye Values Survey (BEVS) and objectively observable behaviors such as
as-needed medication, amount of self-harm or degree of activity. PQ is a procedure for
constructing reliable and personally relevant questionnaires for rating mental health. In an
assessment interview, one or more so called illness statements are formulated, that describe
the central problem with the patient's own words (for example, "I can't stand my anxiety").
For each illness statement an improvement statement is formulated, that is meant to describe
some degree of improvement (for example "At times, I can handle my anxiety"), and a recovery
statement that is meant to describe a situation where treatment is no longer needed (for
example "I can handle my anxiety in a good way most of the time"). Every statement is paired
with each other statement on a total of three cards. The order in which the statements are
presented is varied on the three cards. The cards are presented for the patient, and for each
card they get to choose the statement that best describes their present condition. 1-4 points
are obtained for each illness statement, higher points representing worse mental health. BEVS
is an instrument that measures, on a scale from 0-28, to what extent a patient is living
according to their values. On a visually presented dart board, the patient marks with a cross
somewhere on the board to indicate degree of values-based living, a cross closer to the
middle (the bull's-eye) representing better health. BEVS has shown satisfying reliability and
validity. Objectively observable behaviors such as use of as-needed medication can be tracked
in the patients charts, degree of activity can be measured using an actigraph, and amount of
self-harm can be tracked in patient charts.
Intervention, transdiagnostic short-term psychotherapy The treatment is a flexible
application of clinical functional analysis and a few chosen interventions that in clinical
experience have shown to work well with the patient group under study (psychiatric inpatients
with complex symptoms), each being adjustable to suit the kind and degree of problems being
presented. The first step is functional analysis and case conceptualization, in the form of a
clinical interview. This is based on four focus questions that are helpful in conducting a
quick analysis and isolating a treatable problem: What are you seeking? What have you tried?
How has it worked? What has it cost you? The questions aim to focus in on the patient's main
problem, as well as previous strategies that they have tried, in terms of their long- and
short-term functionality, and in relation to central values. The second step is a simplified
version of an experiential exercise called the lifeline. Potentially, this exercise can
function as a concretization, where the findings of the functional analysis can be put into
action, resulting in a plan for behavior change that is connected to personally meaningful
life areas. The lifeline exercise is conducted as an exercise where both therapist and
patient stand up and use the physical properties of the room to clarify life directions in a
concrete way. Aids such as post-its are often used to concretize obstacles in one's valued
direction, where key words describing symptoms are noted. According to clinical experience,
this concrete way of working has been particularly helpful for patients with complex
diagnoses, including some cognitive deficits, as it helps them register and remember central
principles of the treatment (such as the need for acceptance in relation to experiences that
can't be changed). The exercise has also proven adjustable to different kinds of problems.
The third step is a repetition and a summary of the previous two steps, where an exercise
called the pause is given to the patient, in the form of a printed card that the patient gets
to keep. This is used as a maintenance plan. The exercise consists of the following steps:
pause and slow your breathing; use the observer perspective; experience thoughts and feelings
as they are; formulate a direction and act.
Data analysis Data will be analyzed using visual analysis, focusing on differences in outcome
measures between A and B phases concerning central location, trend and variability.
Statistical analysis will be used in the form of Kendall's Tau to analyze trends in A and B
phases, and non-overlap of all pairs (NAP) to analyze differences between A and B phases.
