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Thought Field Therapy and Cognitive Therapy for Agoraphobia

This study has been completed.
Sponsor:
Information provided by:
Sorlandet Hospital HF
ClinicalTrials.gov Identifier:
NCT00932919
First received: July 3, 2009
Last updated: July 27, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention
Agoraphobia
 Behavioral: Thought field therapy
Behavioral: Cognitive therapy
Behavioral: Wait list

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

Further study details as provided by Sorlandet Hospital HF:

Primary Outcome Measures:
  • Change in agoraphobic situation scores in ADIS. [ Time Frame: Immedeately and 12 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Interference score in ADIS [ Time Frame: Immediately and 12 months after treatment ] [ Designated as safety issue: No ]
  • Mobility Inventory [ Time Frame: Immediately and 12 months after treatment ] [ Designated as safety issue: No ]
  • Agoraphobic Cognitions Questionnaire [ Time Frame: Immediately and 12 months after treatment ] [ Designated as safety issue: No ]
  • Body Sensations Questionnaire [ Time Frame: Immediately and 12 months after treatment ] [ Designated as safety issue: No ]
  • BDI [ Time Frame: Immediately and 12 months after treatment ] [ Designated as safety issue: Yes ]
  • BAI [ Time Frame: Immediately and 12 months after treatment ] [ Designated as safety issue: No ]
  • WHOQOL-BREF [ Time Frame: Immediately and 12 months after treatment ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: Immediately and 12 months after treatment ] [ Designated as safety issue: No ]
  • Safety Seeking Behaviours Questionnaire. [ Time Frame: Immediately and 12 months after treatment ] [ Designated as safety issue: No ]
  • Panic scale [ Time Frame: Immediately and 12 months after treatment ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: October 2006
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: CBT
No Intervention: 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 Name: WL

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932919

Locations
Norway
Sorlandet Hospital
Arendal, Norway, 4809
Sponsors and Collaborators
Sorlandet Hospital HF
Investigators
Principal Investigator: Audun C Irgens, MD Sorlandet Hospital HF, Norway
  More Information

No publications provided

Responsible Party: Svein Gunnar Gundersen, Sorlandet sykehus HF
ClinicalTrials.gov Identifier: NCT00932919     History of Changes
Other Study ID Numbers: SSHF-70343-AUIR-2
Study First Received: July 3, 2009
Last Updated: July 27, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Sorlandet Hospital HF:
Agoraphobia
Cognitive therapy
Thought field therapy
Psychotherapy research

Additional relevant MeSH terms:
Agoraphobia
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013