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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00932919
Other study ID # SSHF-70343-AUIR-2
Secondary ID
Status Completed
Phase N/A
First received July 3, 2009
Last updated April 22, 2014
Start date October 2006
Est. completion date November 2010

Study information

Verified date April 2014
Source Sorlandet Hospital HF
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Thought field therapy
5 sessions with Thought field therapy
Cognitive therapy
12 sessions of Cognitive therapy
Wait list
3 months waiting, then randomized to either thought field therapy or cognitive therapy

Locations

Country Name City State
Norway Sorlandet Hospital Arendal

Sponsors (1)

Lead Sponsor Collaborator
Sorlandet Hospital HF

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in agoraphobic situation scores in ADIS. Immedeately and 12 months after treatment No
Secondary Interference score in ADIS Immediately and 12 months after treatment No
Secondary Mobility Inventory Immediately and 12 months after treatment No
Secondary Agoraphobic Cognitions Questionnaire Immediately and 12 months after treatment No
Secondary Body Sensations Questionnaire Immediately and 12 months after treatment No
Secondary BDI Immediately and 12 months after treatment Yes
Secondary BAI Immediately and 12 months after treatment No
Secondary WHOQOL-BREF Immediately and 12 months after treatment No
Secondary SF-36 Immediately and 12 months after treatment No
Secondary Safety Seeking Behaviours Questionnaire. Immediately and 12 months after treatment No
Secondary Panic scale Immediately and 12 months after treatment No
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