Thought Field Therapy and Cognitive Therapy for Agoraphobia

April 22, 2014 updated by: Sorlandet Hospital HF

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Arendal, Norway, 4809
        • Sorlandet hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Thought field therapy
24 randomly selected patients will be treated with 5 sessions of standard Thought field therapy.
Behavioral: Thought field therapy
5 sessions with Thought field therapy
Other Names:
  • TFT
ACTIVE_COMPARATOR: Cognitive therapy
Treatment with Cognitive therapy, 12 sessions with manualized therapy according to David Clark's model.
Behavioral: Cognitive therapy
12 sessions of Cognitive therapy
Other Names:
  • CBT
OTHER: Wait list
24 patients will be randomly selected to 3 months on a wait list, thereafter randomly selected to either Cognitive therapy or Thought field therapy.
Behavioral: Wait list
3 months waiting, then randomized to either thought field therapy or cognitive therapy
Other Names:
  • WL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in agoraphobic situation scores in ADIS.
Time Frame: Immedeately and 12 months after treatment
Immedeately and 12 months after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Interference score in ADIS
Time Frame: Immediately and 12 months after treatment
Immediately and 12 months after treatment
Mobility Inventory
Time Frame: Immediately and 12 months after treatment
Immediately and 12 months after treatment
Agoraphobic Cognitions Questionnaire
Time Frame: Immediately and 12 months after treatment
Immediately and 12 months after treatment
Body Sensations Questionnaire
Time Frame: Immediately and 12 months after treatment
Immediately and 12 months after treatment
BDI
Time Frame: Immediately and 12 months after treatment
Immediately and 12 months after treatment
BAI
Time Frame: Immediately and 12 months after treatment
Immediately and 12 months after treatment
WHOQOL-BREF
Time Frame: Immediately and 12 months after treatment
Immediately and 12 months after treatment
SF-36
Time Frame: Immediately and 12 months after treatment
Immediately and 12 months after treatment
Safety Seeking Behaviours Questionnaire.
Time Frame: Immediately and 12 months after treatment
Immediately and 12 months after treatment
Panic scale
Time Frame: Immediately and 12 months after treatment
Immediately and 12 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sorlandet Hospital HF

Investigators

  • Principal Investigator: Audun C Irgens, MD, Sorlandet Hospital HF, Norway

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

July 3, 2009

First Submitted That Met QC Criteria

July 6, 2009

First Posted (ESTIMATE)

July 7, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 23, 2014

Last Update Submitted That Met QC Criteria

April 22, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSHF-70343-AUIR-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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