The primary aim of this pilot study is to determine the acceptability of the intervention. The secondary aim is to elucidate factors that may facilitate or hinder the feasibility of the follow-up RCT (e.g., recruitment process) and to estimate the…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this pilot study is to test the acceptability of
imagery rescripting.
Secondary outcome
• To measure feasibility, we will assess recruitment/admission ratio, dropout
and (serious) adverse events.
• To estimate the variance of effects, group effects on depressive symptoms
measured with the BDI-II and SCID-5-s (module A)will be tested at
post-treatment and 3 months follow-up (corrected for baseline).
• Screening for other disorders (SCID-5 Dutch version); sections on depressive
disorder, substance use disorder, psychotic disorders, anxiety disorders
andposttraumatic disorder
• Behavioral activation (Behavioral Activation for Depression Scale - Dutch
version)
• Affect: The International Short-form of the Positive and Negative Affect
Schedule (I-PANAS-SF)
• Quality of life (EQ-5D-5L)
• Anxiety measured with Generalized Anxiety Disorder scale (GAD-7)
• Vividness and likelihood of prospective positive and negative scenarios with
prospective imagery task (PIT)
• Ratings of mental images on emotions (sad, guilty, ashamed, anxious, angry,
helpless), vivedness, uncontrollability, distress and core belief, using 0-100
visual analog scales ranging
• Monitoring of treatment as usual will be asked to the therapist at baseline
(*which treatment (including medication + dose; possible in-patient treatment)
does the patient receive currently?') and at posttreatment and follow-up
("which therapy has the patient received in the past 6/12 weeks (including
medication + dose; possible in-patient treatment)?")
Background summary
About 50% of patients with depressive disorders do not (sufficiently) respond
to treatments, hence optimizing treatment as usual is crucial. One explanation
for limited treatment effects is that patients with depression often suffer
from distressing negative mental imagery . Mental imagery can be defined as
*seeing with the mind*s eye, or hearing with the mind*s ear etc.* and, relative
to verbal cognitions, it typically has a greater impact on emotion, cognition,
and behavior. Several studies have shown that treating negative mental images
related to past experiences leads to decreased depressive symptoms. Yet, there
are several reasons why targeting future-oriented negative mental images is
also important. First, future-oriented mental imagery directly affects the
motivation to act upon the visualized event . This is in line with the
observation that *flashforwards* of suicide are related to higher suicidal
ideation, which in turn, has been associated with higher risk of suicide.
Reversely, patients with depressive disorders who repeatedly imagined positive
future events showed more behavioral activation . Second, future-oriented
mental imagery also influences current emotions. For example, patients with
anxiety disorders report distress of *flashforwards* of feared scenarios.
Indeed, positive future-oriented mental imagery can reduce anticipatory anxiety
and can increase positive affect. Third, individuals who envision future events
may perceive these events as more likely to occur . For example, when
individuals were asked to focus on factors that could impair their performance,
they evaluated their performance as poor, relative to individuals who
concentrated on factors that could facilitate their performance (while there
were no group differences in actual performance). This illustrates how
future-oriented negative imagery directly impacts the way you perceive your
behavior (e.g., reduced feelings of self-efficacy). Thus, to sum up,
future-oriented negative imagery may put individuals at risk for maladaptive
behavior, negative emotions and an availability heuristic for negative events.
Because future-oriented negative mental imagery, such as suicidal
flashforwards, is common in patients with depressive disorders it is vital to
successfully treat these images in this population.
Study objective
The primary aim of this pilot study is to determine the acceptability of the
intervention. The secondary aim is to elucidate factors that may facilitate or
hinder the feasibility of the follow-up RCT (e.g., recruitment process) and to
estimate the variance of the effect on reduction of depressive symptomatology,
which informs the sample size calculation of the follow-up RCT. To study
acceptability, we assess depressive symptoms (BDI-II and BADS) and treatment
satisfaction (SRS and CSQ-8). To measure feasibility, we will assess
recruitment/admission ratio and dropout. Finally, to estimate the variance of
effects, group effects on depressive symptoms measured with the BDI-II and
SCID-5-S (module A) will be tested at post-treatment and follow-up (corrected
for baseline).
Study design
The design is a randomized, controlled, pragmatic, multicentre, trial with five
Dutch participating sites: Amsterdam UMC, GGzE, Praktijk V, Psychologenpraktijk
De Amsterdamse, eppGGZ and Mental Care group (HSK/Mentaal Beter ).
Intervention
Future-oriented imaginary rescripting (ImRes): ImRes is an imagery technique in
which patients change a negative image in a positive way. These negative
future-oriented mental images (for example images of suicide) may maintain the
symptoms. This treatment should reduce depressive symptoms. Sessions are
scheduled weekly and the intervention lasts 6 weeks.
Treatment as usual (TAU): Participants in both arms will receive TAU. The
clinical practices of the sites involved rely heavily on the use of
antidepressants and/or cognitive behavioral therapy (CBT). These interventions
generally do not target (future-oriented) negative mental images, even though
this is proposed to be an important maintaining factor of depression. All
regular interventions are allowed in TAU, except eye movement desensitization
and reprocessing (EMDR) and imagery rescripting interventions. We monitor and
register what TAU entails.
Study burden and risks
There are no risks associated with imagery rescripting and treatment as usual.
However, a disadvantage of the research is that it takes up time. Participation
in the study will consist of interviews and questionnaires. There will be a
max. 55 minute screening interview. Following, there is a baseline measurement
and two follow-up measurements. The questionnaires and interviews are conducted
by telephone or online. Participants will be rewarded with a reimbursement for
their participation.
The project will contribute to improving care for people with depression. The
design of this pilot study allows us to set up a large intervention study in
the future with well-substantiated prior knowledge to determine the
effectiveness of imaginary rescripts on a large scale. The findings from this
pilot study will be presented at (inter)national conferences.
Meibergdreef 5
Amsterdam 1105AZ
NL
Meibergdreef 5
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
1) Aged 18 years or older ;
2) Meet DSM-5 criteria for major depressive disorder;
3) Be able to understand questionnaires and study information letter;
4) In case of medication use: are stable on medication for six weeks or longer;
5) Presence of at least one negative future-oriented mental imagery, which
causes distress.
Exclusion criteria
1) Psychosis and/or bipolarity
2) Severe cognitive impairment (e.g., mental retardation) as evidenced by
clinical impression;
3) Current EMDR or imagery rescripting therapy
4) Other circumstances that might affect participation (e.g., severe medical
disorder, relocation).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85551.018.23 |