IMPROVE - improving anxiety treatments by modulating emotional memories prior to in vivo exposure: a multiple baseline study

Cognitive behavioral therapy (CBT), is the most effective treatment for anxiety
disorders but many patients do not benefit sufficiently from it, so there is an
urgent need for improvement. Negative mental imagery involving future events is
common in individuals suffering from anxiety disorders and can appear like
*flashforwards*. However, these images are not targeted in standard CBT for
anxiety disorders. Laboratory research has shown that such imagery can be
modulated by a dual-tasking intervention, which is used in Eye Movement
Desensitization and Reprocessing (EMDR) therapy. Though a clinical EMDR
protocol for anxiety has been developed and used in clinical practice for
years, no research to date has tested whether modulation of fear-related
imagery reduces anxiety symptoms and reduces social avoidance symptoms.

The aim of this this study, is to test whether EMDR therapy, relative to a
baseline phase, results in: 1) less social anxiety symptoms, and 2) less social
avoidance symptoms

In this replicated non-concurrent single-case multiple baseline study, eight
participants will be randomized to various lengths of baseline phase (A; 2-5
weeks), followed by an intervention phase (B; 5 weeks). Participants will be
randomized to groups (I-IV) with different lengths of the baseline duration (I;
two weeks, II; three weeks etc.). The intervention phase consists of three
weekly 90-minute EMDR sessions, followed by two weeks without any sessions to
assess post-intervention effects.

A standardized intervention will be used: EMDR therapy. The same intervention
was used in a randomized controlled trial in social anxiety disorder
(NL73918.041) that was terminated prematurely due to a low influx of patients.

All participants will likely benefit from the provided therapy. Worsening of
symptoms or adverse events as a result of the intervention is not expected. No
adverse events related to the intervention occurred in a randomized clinical
trial in social anxiety disorder and panic disorder (NL73918.041) using the
same intervention. A potential benefit for all participants is that they will
receive a well-controlled treatment during the time they are waiting for
treatment as usual (TAU). Therefore, no additional waiting time during the
baseline for participants is needed. Compared to treatment as usual (TAU), no
additional risks are involved. Additional time investment includes completing
questionnaires during baseline (A) and intervention (B or C). Time investment
can be justified by the clinical and scientific relevance of the study.
Benefits could consist of treatment during a regular waiting list period.
Patients can withdraw at any time from the study without further consequences.