AgoraphobiaNCT00202709
Can Thought Field Therapy (TFT) be Helpful for Patients With an Anxiety Disorder?
A study testing Thought Field Therapy (TFT) in people with Agoraphobia and Social Phobia, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
The purpose of this study is to find out if Thought Field Therapy has effect on certain anxiety disorders; agoraphobia, social phobia, and post traumatic stress disorder (PTSD). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Agoraphobia, Social Phobia, PTSD
- What is being tested?
- Thought Field Therapy (TFT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteNorway
- Study dates
- May 2002to Aug 2003
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- One or more of the study diagnoses agoraphobia, social phobia and/or PTSD
Who cannot join
- Ongoing psychosis
- Ongoing serious drug problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Thought Field Therapy (TFT) be Helpful for Patients With an Anxiety Disorder, a Prospective, Randomized Pilot Study With Wait List as Control Group.
The purpose of this study is to find out if Thought Field Therapy has effect on certain anxiety disorders; agoraphobia, social phobia, and post traumatic stress disorder (PTSD).
Read the detailed description
Thought Field Therapy is an alternative treatment method that has been shown, by casuistic reports, to give good results when applied for anxiety disorders. In this study 52 patients, with one or more of the diagnoses agoraphobia, social phobia and/or PTSD, where randomized to either treatment with TFT or a wait list. The treatment group all got treatment in one week. 2 1/2 months later both the treatment group and the control group were tested on the same items as before the treatment started. After this evaluation phase the control group got the same treatment as the treatment or study group. Both groups were evaluated 3 and 12 months after treatment, the study group also 6 months after treatment. 4 patients were omitted because they changed groups. The study were performed from May 2002 until June 2003.
- Conditions
- Agoraphobia, Social Phobia, PTSD
- Being tested
- Thought Field Therapy (TFT)
- Keywords
- Anxiety disorder, Thought Field Therapy, Psychotherapy, Agoraphobia, Social Phobia, Post Traumatic Stress Disorder
- Medical subject headings
- Agoraphobia, Phobia, Social, Stress Disorders, Post-Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thought Field Therapy (TFT)Behavioural
Also called Wait list control
Treatment with TFT twice in one week
| Study group | Role | What they receive |
|---|---|---|
| Thought Field Therapy (TFT) | Experimental | Treatment with TFT, first one hour, then 1/2 hour. Receives: Behavioral: Thought Field Therapy (TFT) |
| Wait list control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global symptom index (gsi) on the Symptom checklist 90 revised (SCL-90-R)
Measured: Before treatment/wait list period, just after treatment, 3 months and 12 months after treatment. Group A also 6 months after treatment.
Secondary outcomes (5)
Davidson Trauma Scale
Measured: Before treatment/wait list period, just after treatment, 3 months and 12 months after treatment. Group A also 6 months after treatment.
Liebowitz Social Anxiety Scale
Measured: Before treatment/wait list period, just after treatment, 3 months and 12 months after treatment. Group A also 6 months after treatment.
Hospital Anxiety and Depression Scale (HADS)
Measured: Before treatment/wait list period, just after treatment, 3 months and 12 months after treatment. Group A also 6 months after treatment.
Fear Questionnaire (FQ)
Measured: Before treatment/wait list period, just after treatment, 3 months and 12 months after treatment. Group A also 6 months after treatment.
Sheehan Disability Scale
Measured: Before treatment/wait list period, just after treatment, 3 months and 12 months after treatment. Group A also 6 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startMay 2002
- Primary completionAug 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgoraphobiaStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Investigators
- Audun C Irgens, MD, Principal investigator, Sorlandet Hospital HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202709
- Sponsor's protocol ID
- SSHF-AUIR-1
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 28 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Irgens A, Dammen T, Nysaeter TE, Hoffart A. Thought Field Therapy (TFT) as a treatment for anxiety symptoms: a randomized controlled trial. Explore (NY). 2012 Nov-Dec;8(6):331-8. doi: 10.1016/j.explore.2012.08.002.
PubMed 23141789
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Thought Field Therapy (TFT) be Helpful for Patients With an Anxiety Disorder, a Prospective, Randomized Pilot Study With Wait List as Control Group.
- ClinicalTrials.gov ID
- NCT00202709
- Acronym / sponsor ID
- SSHF-AUIR-1
- Conditions
- Agoraphobia, Social Phobia, PTSD
- Keywords
- Anxiety disorder, Thought Field Therapy, Psychotherapy, Agoraphobia, Social Phobia, Post Traumatic Stress Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- May 2002
- Primary completion
- Aug 2003 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 20 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 of this study is to find out if Thought Field Therapy has effect on certain anxiety disorders; agoraphobia, social phobia, and post traumatic stress disorder (PTSD).
Detailed description
Thought Field Therapy is an alternative treatment method that has been shown, by casuistic reports, to give good results when applied for anxiety disorders. In this study 52 patients, with one or more of the diagnoses agoraphobia, social phobia and/or PTSD, where randomized to either treatment with TFT or a wait list. The treatment group all got treatment in one week. 2 1/2 months later both the treatment group and the control group were tested on the same items as before the treatment started. After this evaluation phase the control group got the same treatment as the treatment or study group. Both groups were evaluated 3 and 12 months after treatment, the study group also 6 months after treatment. 4 patients were omitted because they changed groups. The study were performed from May 2002 until June 2003.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thought Field Therapy (TFT) | Experimental | Behavioral: Thought Field Therapy (TFT)Treatment with TFT, first one hour, then 1/2 hour. |
| Wait list control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- One or more of the study diagnoses agoraphobia, social phobia and/or PTSD
Key exclusion criteria (2 listed)
- Ongoing psychosis
- Ongoing serious drug problems
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 |
|---|---|---|
| Thought Field Therapy (TFT)Also: Wait list controlTreatment with TFT twice in one week | Behavioural | Thought Field Therapy (TFT) |
Primary outcome
Global symptom index (gsi) on the Symptom checklist 90 revised (SCL-90-R)
Time frame: Before treatment/wait list period, just after treatment, 3 months and 12 months after treatment. Group A also 6 months after treatment.
5 secondary outcomes
Davidson Trauma Scale
Time frame: Before treatment/wait list period, just after treatment, 3 months and 12 months after treatment. Group A also 6 months after treatment.
Liebowitz Social Anxiety Scale
Time frame: Before treatment/wait list period, just after treatment, 3 months and 12 months after treatment. Group A also 6 months after treatment.
Hospital Anxiety and Depression Scale (HADS)
Time frame: Before treatment/wait list period, just after treatment, 3 months and 12 months after treatment. Group A also 6 months after treatment.
Fear Questionnaire (FQ)
Time frame: Before treatment/wait list period, just after treatment, 3 months and 12 months after treatment. Group A also 6 months after treatment.
Sheehan Disability Scale
Time frame: Before treatment/wait list period, just after treatment, 3 months and 12 months after treatment. Group A also 6 months after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2011.
- Derived from this study: PubMed 23141789Irgens A, Dammen T, Nysaeter TE, Hoffart A. Thought Field Therapy (TFT) as a treatment for anxiety symptoms: a randomized controlled trial. Explore (NY). 2012 Nov-Dec;8(6):331-8. doi: 10.1016/j.explore.2012.08.002.
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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.
Audun C Irgens, MD principal investigator
Sorlandet Hospital HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thought Field Therapy (TFT) in people with Agoraphobia and Social Phobia, run by Sorlandet Hospital HF at 1 site in Norway.
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 2 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: finished, as of the sponsor's last update on 28 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Global symptom index (gsi) on the Symptom checklist 90 revised (SCL-90-R) (time frame: Before treatment/wait list period, just after treatment, 3 months and 12 months after treatment. Group A also 6 months after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00202709, which also lists 1 linked publication.
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 Jul 2011.