Specific PhobiaNCT00184145
EMDR in the Treatment of Specific Phobia.
A study testing EMDR (Eye Movement Desensitization and Reprocessing) and Exposure therapy in people with Specific Phobia, run by Norwegian University of Science and Technology.
Trial summary
The purpose for this study is to determine whether EMDR is effective in the treatment of specific (animal) phobia. Read more about this study
- Who is it for?
- Ages 15 to 65 years
- Conditions the study is for
- Specific Phobia
- What is being tested?
- EMDR (Eye Movement Desensitization and Reprocessing) and Exposure therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2004to Sep 2004
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with Specific (Animal) Phobia
Who cannot join
- Current or past psychotic disorder
- Current substance dependence or abuse
- Serious physical illness
- Active suicidal behavior
- Bipolar affective disorder
- Pregnancy
About this study
Official title: EMDR (Eye Movement Desensitization and Reprocessing) in the Treatment of Specific Phobia. A Randomised Controlled Trial.
The purpose for this study is to determine whether EMDR is effective in the treatment of specific (animal) phobia.
Read the detailed description
Aims: To test the hypothesis that one session EMDR is more effective for the treatment of specific (animal) phobia than relaxation immediately after treatment and at follow-up. Secondly to test whether an additional one-session exposure therapy offered to both treatment groups (EMDR patients and relaxation patients) improves outcome in the EMDR-group and results in equal outcome for both treatment groups.
- Conditions
- Specific Phobia
- Being tested
- EMDR (Eye Movement Desensitization and Reprocessing), Exposure therapy
- Keywords
- Specific (Animal) Phobia, EMDR, Exposure therapy
- Medical subject headings
- Phobia, Specific, Phobic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMDR (Eye Movement Desensitization and Reprocessing)Other
Psychotherapy which is approved for PTSD.
Exposure therapyOther
All participants in the study received exposure therapy som second treatment. Exposure therapy is the therapy of choice for animal phobia.
| Study group | Role | What they receive |
|---|---|---|
| EMDR | Experimental | The experimental group was treated for animal phobia by EMDR, control group received an attention placebo (relaxation plus breathing exercises). Afterwards, both groups were treated by exposure therapy (therapy of choice for animal phobia). Receives: Other: EMDR (Eye Movement Desensitization and Reprocessing); Other: Exposure therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral Approach Test towards the feared animal.
Measured: Before and after each treatment
Secondary outcomes (3)
Scores on self-report questionnaires on phobic symptoms
Measured: Before and after both treatments
Neuropsychological function
Measured: Before first treatment, some measures also before second treatment
Cognitive strategies
Measured: Before both treatments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionSep 2004
- Study completionSep 2004
Why it stopped: approval of ethical committee was denied
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Specific PhobiaStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Ludger Kaiser, Doctor, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184145
- Sponsor's protocol ID
- EPLK-2004
- Status last verified
- Feb 2017
- First submitted
- 10 Sep 2005
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMDR (Eye Movement Desensitization and Reprocessing) in the Treatment of Specific Phobia. A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT00184145
- Acronym / sponsor ID
- EPLK-2004
- Conditions
- Specific Phobia
- Keywords
- Specific (Animal) Phobia, EMDR, Exposure therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: approval of ethical committee was denied
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Jun 2004 (actual)
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose for this study is to determine whether EMDR is effective in the treatment of specific (animal) phobia.
Detailed description
Aims: To test the hypothesis that one session EMDR is more effective for the treatment of specific (animal) phobia than relaxation immediately after treatment and at follow-up. Secondly to test whether an additional one-session exposure therapy offered to both treatment groups (EMDR patients and relaxation patients) improves outcome in the EMDR-group and results in equal outcome for both treatment groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMDR | Experimental | Other: EMDR (Eye Movement Desensitization and Reprocessing), Other: Exposure therapyThe experimental group was treated for animal phobia by EMDR, control group received an attention placebo (relaxation plus breathing exercises). Afterwards, both groups were treated by exposure therapy (therapy of choice for animal phobia). |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Specific (Animal) Phobia
Key exclusion criteria (6 listed)
- Current or past psychotic disorder
- Current substance dependence or abuse
- Serious physical illness
- Active suicidal behavior
- Bipolar affective disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMDR (Eye Movement Desensitization and Reprocessing)Psychotherapy which is approved for PTSD. | Other | EMDR |
| Exposure therapyAll participants in the study received exposure therapy som second treatment. Exposure therapy is the therapy of choice for animal phobia. | Other | EMDR |
Primary outcome
Behavioral Approach Test towards the feared animal.
Time frame: Before and after each treatment
3 secondary outcomes
Scores on self-report questionnaires on phobic symptoms
Time frame: Before and after both treatments
Neuropsychological function
Time frame: Before first treatment, some measures also before second treatment
Cognitive strategies
Time frame: Before both treatments
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ludger Kaiser, Doctor principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing EMDR (Eye Movement Desensitization and Reprocessing) and Exposure therapy in people with Specific Phobia, run by Norwegian University of Science and Technology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral Approach Test towards the feared animal. (time frame: Before and after each treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.