AgoraphobiaNCT00932919
Thought Field Therapy and Cognitive Therapy for Agoraphobia
A study testing Thought field therapy, Cognitive therapy and Wait list in people with Agoraphobia, run by Sorlandet Hospital HF at 1 site in Norway.
Trial summary
The purpose for this study is to find out if Thought field therapy has the same effect as, or better effect than, Cognitive therapy for Agoraphobia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Agoraphobia
- What is being tested?
- Thought field therapy, Cognitive therapy and Wait list
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2006to Nov 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ages 18 years or older,
- Patients with agoraphobia,
- Patients with a score on Mobility Inventory "Alone" of 2.5 or more,
- Patients who give a written consent to participate.
Who cannot join
- Psychosis (past or present),
- Drug abuse or dependency,
- Moderate or high score on suicidal behaviour on the M.I.N.I.,
- Patients who have another illness (other than panic disorder or agoraphobia) and are in need of immediate treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thought Field Therapy and Cognitive Therapy for Agoraphobia - a Randomized Controlled Intervention Study Where the Efficacy of Thought Field Therapy is to be Compared to Cognitive Therapy
The purpose for this study is to find out if Thought field therapy has the same effect as, or better effect than, Cognitive therapy for Agoraphobia.
Read the detailed description
Thought field therapy is an alternative treatment method that has shown, by casuistic reports, to give good results when applied for anxiety disorders. In this study 72 patients will be randomized to three groups. 24 patients will receive cognitive therapy as a control method, 24 patients will receive thought field therapy. The remaining 24 patients will wait three months, and then be randomized to either of the two therapies.
Before inclusion all patients will be diagnosed with M.I.N.I. and SCID II. They will fill out self evaluation forms for symptoms and quality of life, before and after treatment, and one year after treatment.
All patients will undergo an interview with ADIS on panic and agoraphobic diagnosis and symptoms before starting treatment, and on panic and agoraphobic symptoms immediately after and one year after treatment. These interviews will be done by psychologists who are blinded for which type of treatment the patients have got.
- Conditions
- Agoraphobia
- Being tested
- Thought field therapy, Cognitive therapy, Wait list
- Keywords
- Agoraphobia, Cognitive therapy, Thought field therapy, Psychotherapy research
- Medical subject headings
- Agoraphobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thought field therapyBehavioural
Also called TFT
5 sessions with Thought field therapy
Cognitive therapyBehavioural
Also called CBT
12 sessions of Cognitive therapy
Wait listBehavioural
Also called WL
3 months waiting, then randomized to either thought field therapy or cognitive therapy
| Study group | Role | What they receive |
|---|---|---|
| Thought field therapy | Experimental | 24 randomly selected patients will be treated with 5 sessions of standard Thought field therapy. Receives: Behavioral: Thought field therapy |
| Cognitive therapy | Active comparator | Treatment with Cognitive therapy, 12 sessions with manualized therapy according to David Clark's model. Receives: Behavioral: Cognitive therapy |
| Wait list | Other | 24 patients will be randomly selected to 3 months on a wait list, thereafter randomly selected to either Cognitive therapy or Thought field therapy. Receives: Behavioral: Wait list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in agoraphobic situation scores in ADIS.
Measured: Immedeately and 12 months after treatment
Secondary outcomes (10)
Interference score in ADIS
Measured: Immediately and 12 months after treatment
Mobility Inventory
Measured: Immediately and 12 months after treatment
Agoraphobic Cognitions Questionnaire
Measured: Immediately and 12 months after treatment
Body Sensations Questionnaire
Measured: Immediately and 12 months after treatment
BDI
Measured: Immediately and 12 months after treatment
BAI
Measured: Immediately and 12 months after treatment
WHOQOL-BREF
Measured: Immediately and 12 months after treatment
SF-36
Measured: Immediately and 12 months after treatment
Safety Seeking Behaviours Questionnaire.
Measured: Immediately and 12 months after treatment
Panic scale
Measured: Immediately and 12 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 posted7 Jul 2009 (estimated)
- Study startOct 2006
- Primary completionNov 2010
- Study completionNov 2010
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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorlandet Hospital HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Audun C Irgens, MD, Principal investigator, Sorlandet Hospital HF, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932919
- Sponsor's protocol ID
- SSHF-70343-AUIR-2
- Status last verified
- Apr 2014
- First submitted
- 3 Jul 2009
- Last updated
- 23 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Irgens AC, Hoffart A, Nysaeter TE, Haaland VO, Borge FM, Pripp AH, Martinsen EW, Dammen T. Thought Field Therapy Compared to Cognitive Behavioral Therapy and Wait-List for Agoraphobia: A Randomized, Controlled Study with a 12-Month Follow-up. Front Psychol. 2017 Jun 20;8:1027. doi: 10.3389/fpsyg.2017.01027. eCollection 2017.
PubMed 28676782
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thought Field Therapy and Cognitive Therapy for Agoraphobia - a Randomized Controlled Intervention Study Where the Efficacy of Thought Field Therapy is to be Compared to Cognitive Therapy
- ClinicalTrials.gov ID
- NCT00932919
- Acronym / sponsor ID
- SSHF-70343-AUIR-2
- Conditions
- Agoraphobia
- Keywords
- Agoraphobia, Cognitive therapy, Thought field therapy, Psychotherapy research
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Sorlandet Hospital HFOther government
- Study start
- Oct 2006
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 7 Jul 2009 (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 find out if Thought field therapy has the same effect as, or better effect than, Cognitive therapy for Agoraphobia.
Detailed description
Thought field therapy is an alternative treatment method that has shown, by casuistic reports, to give good results when applied for anxiety disorders. In this study 72 patients will be randomized to three groups. 24 patients will receive cognitive therapy as a control method, 24 patients will receive thought field therapy. The remaining 24 patients will wait three months, and then be randomized to either of the two therapies.
Before inclusion all patients will be diagnosed with M.I.N.I. and SCID II. They will fill out self evaluation forms for symptoms and quality of life, before and after treatment, and one year after treatment.
All patients will undergo an interview with ADIS on panic and agoraphobic diagnosis and symptoms before starting treatment, and on panic and agoraphobic symptoms immediately after and one year after treatment. These interviews will be done by psychologists who are blinded for which type of treatment the patients have got.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Thought field therapy | Experimental | Behavioral: Thought field therapy24 randomly selected patients will be treated with 5 sessions of standard Thought field therapy. |
| Cognitive therapy | Active comparator | Behavioral: Cognitive therapyTreatment with Cognitive therapy, 12 sessions with manualized therapy according to David Clark's model. |
| Wait list | Other | Behavioral: Wait list24 patients will be randomly selected to 3 months on a wait list, thereafter randomly selected to either Cognitive therapy or Thought field therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients ages 18 years or older,
- Patients with agoraphobia,
- Patients with a score on Mobility Inventory "Alone" of 2.5 or more,
- Patients who give a written consent to participate.
Key exclusion criteria (4 listed)
- Psychosis (past or present),
- Drug abuse or dependency,
- Moderate or high score on suicidal behaviour on the M.I.N.I.,
- Patients who have another illness (other than panic disorder or agoraphobia) and are in need of immediate treatment.
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 therapyAlso: TFT5 sessions with Thought field therapy | Behavioural | Thought field therapy |
| Cognitive therapyAlso: CBT12 sessions of Cognitive therapy | Behavioural | Cognitive therapy |
| Wait listAlso: WL3 months waiting, then randomized to either thought field therapy or cognitive therapy | Behavioural | Wait list |
Primary outcome
Change in agoraphobic situation scores in ADIS.
Time frame: Immedeately and 12 months after treatment
10 secondary outcomes
Interference score in ADIS
Time frame: Immediately and 12 months after treatment
Mobility Inventory
Time frame: Immediately and 12 months after treatment
Agoraphobic Cognitions Questionnaire
Time frame: Immediately and 12 months after treatment
Body Sensations Questionnaire
Time frame: Immediately and 12 months after treatment
BDI
Time frame: Immediately and 12 months after treatment
BAI
Time frame: Immediately and 12 months after treatment
WHOQOL-BREF
Time frame: Immediately and 12 months after treatment
SF-36
Time frame: Immediately and 12 months after treatment
Safety Seeking Behaviours Questionnaire.
Time frame: Immediately and 12 months after treatment
Panic scale
Time frame: Immediately and 12 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 23 Apr 2014.
- Derived from this study: PubMed 28676782Irgens AC, Hoffart A, Nysaeter TE, Haaland VO, Borge FM, Pripp AH, Martinsen EW, Dammen T. Thought Field Therapy Compared to Cognitive Behavioral Therapy and Wait-List for Agoraphobia: A Randomized, Controlled Study with a 12-Month Follow-up. Front Psychol. 2017 Jun 20;8:1027. doi: 10.3389/fpsyg.2017.01027. eCollection 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.
Audun C Irgens, MD principal investigator
Sorlandet Hospital HF, Norway
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, Cognitive therapy and Wait list in people with Agoraphobia, 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 4 inclusion and 4 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 23 Apr 2014. 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?
Change in agoraphobic situation scores in ADIS. (time frame: Immedeately and 12 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 NCT00932919, 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 23 Apr 2014.