The first goal of the current research is to investigate whether EMDR prior to CBT, compared to an active psychological control condition (*supportive counseling*), improves treatment tolerability, adherence, and effectiveness. The second goal is to…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Treatment tolerability and adherence: actual drop-out during treatment (i.e.,
EMDR/SC and CBT) and no show in CBT sessions, as well subjective measures:
willingness to start exposure treatment, behavioral avoidance, and considered
drop out (assessed after treatment).
- Reductions in symptoms: anxiety (symptoms/diagnosis), related psychological
problems (e.g., depression), functional impairments, quality of life, need for
additional treatment after the trial.
Secondary outcome
1. Predictors
- Study parameters for patients are: extinction learning, intrusive memories
from past and future events, clinical profiles, treatment expectancy,
therapeutic alliance, intolerance of uncertainty, anxiety sensitivity, and
worry.
- Study parameters for therapists are: demographics, trait anxiety, intolerance
of uncertainty, attitudes towards evidence based practice and treatment
manuals, treatment credibility, therapist prediction of clinical change and
working alliance.
2. Mechanisms
- Exposure process variables: threat expectancy and threat severity.
3. Cost-effectiveness
- Direct and indirect cost within the healthcare system, as well as health
related expenses for the patient and productivity losses.
Background summary
Cognitive behavioral therapy (CBT), with its key element exposure in vivo, 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.
Previous research has revealed that many patients with anxiety disorders report
vivid and distressing mental images of threat related to the content of their
anxiety disorder and these images possibly impede exposure therapy. These
images are however not targeted in standard CBT for anxiety disorders. An
effective treatment that focuses on mental images of threat and the
desensitization of aversive memories is Eye movement Desensitization and
Reprocessing (EMDR). 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 memories combined with CBT enhances
treatment effects in patients with anxiety disorders.
Study objective
The first goal of the current research is to investigate whether EMDR prior to
CBT, compared to an active psychological control condition (*supportive
counseling*), improves treatment tolerability, adherence, and effectiveness.
The second goal is to unravel theory-driven variables as well as non-specific
patient and therapist factors that predict treatment outcome and optimal
treatment allocation. The third goal is to elucidate mechanisms of change of
this novel approach (EMDR+CBT) in the treatment of anxiety disorders. Lastly,
cost-effectiveness of the new approach (EMDR+CBT) will be assessed.
Study design
A multicenter RCT with two groups (EMDR and SC) repeated measures design
(T1-Baseline, T2-Between, T3-Post, follow-up1, followup2).
Intervention
Two standardized interventions will be used before CBT: EMDR and SC. We will
use the standard Dutch EMDR 2020 protocol from the Dutch EMDR society. SC will
serve as a credible intervention that controls for non-specific treatment
effects and will be based on the protocol by Bryant, Harvey, Dang and Basten
(1998). It focuses on a discussion of topics that are relevant to the patient
and the therapist offers support but does not use CBT techniques. Patients will
receive a 90 minute EMDR or SC case formulation session. Followed by 4x90
minute sessions of EMDR or SC once weekly before starting CBT. All patients
will then receive 8x90 minute sessions of CBT once weekly. CBT will be based on
the current treatment guidelines for panic disorder, which involves exposure
therapy. All assessments will be provided online. Treatment sessions will be
provided face to face or online depending on the preference of the patient and
clinician.
Study burden and risks
Earlier studies showed symptom reductions in all treatments (SC, EMDR and CBT),
therefore participants will potentially profit from either treatment condition.
Worsening of symptoms or adverse events as a result of the interventions are
not expected. A potential benefit for all participants is an well-controlled
treatment with longer sessions compared to the treatment as usual protocol.
Compared to treatment as usual (TAU), no additional risks are involved. As in
TAU, a clinician will be present during treatment sessions. In the unlikely
event of any negative consequence of treatment, the principal and main
investigators will be informed directly. Time investment for treatment in the
study is roughly equal to normal treatment procedures. Additional time
investment includes completing an extinction learning task and questionnaires
before, during and after treatment, two follow-up assessment. When additional
care is needed, TAU will be provided. Time investment can be justified by the
clinical and scientific relevance of the study. Benefits could consist of a
more tolerable and effective treatment compared to TAU. Patients can withdraw
at any time from the study without further consequences.
Heidelberglaan 1
Utrecht 3584 CS
NL
Heidelberglaan 1
Utrecht 3584 CS
NL
Listed location countries
Age
Inclusion criteria
- Patients of >18 years of age
- Sufficient mastery of the Dutch language to complete questionnaires
- Ability to understand questionnaires and written informed consent
- Meeting DSM-5 criteria for primary panic disorder (with or without
agoraphobia) (assessed with MINI-S-DSM-5)
- Stable medication for at least six weeks and willingness by the patient and
physician to keep the medication stable during the study period (until FU1).
The use of sedating medication (e.g. benzodiazepines) is no contraindication,
however participants are strongly advised not to use sedating medication prior
to- or after treatment sessions and subsequent days. Use of sedating medication
will be registered
- Willingness and ability not to be under the influence of alcohol or drugs
twenty-four hours before and after each session, general use will be
discouraged as much as possible
Exclusion criteria
- Neurological disorder
- Acute or recent history of suicide attempts according to the M.I.N.I. section
C
- Self-reported visual or auditory impairments that could hinder treatment
- Self-reported epilepsy, pregnancy, or heart disease (these are common
exclusion criteria for using a fear conditioning task, see 8.3.3)
- Not willing or able to fill in (online) questionnaires.
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 |
|---|---|
| ISRCTN | ISRCTN29668369 |
| CCMO | NL73918.041.20 |