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Thought Field Therapy and Cognitive Therapy for Agoraphobia

Primary Purpose

Agoraphobia

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Thought field therapy
Cognitive therapy
Wait list
Sponsored by
Sorlandet Hospital HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Agoraphobia focused on measuring Agoraphobia, Cognitive therapy, Thought field therapy, Psychotherapy research

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sorlandet Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Thought field therapy

Cognitive therapy

Wait list

Arm Description

24 randomly selected patients will be treated with 5 sessions of standard Thought field therapy.

Treatment with Cognitive therapy, 12 sessions with manualized therapy according to David Clark's model.

24 patients will be randomly selected to 3 months on a wait list, thereafter randomly selected to either Cognitive therapy or Thought field therapy.

Outcomes

Primary Outcome Measures

Change in agoraphobic situation scores in ADIS.

Secondary Outcome Measures

Interference score in ADIS
Mobility Inventory
Agoraphobic Cognitions Questionnaire
Body Sensations Questionnaire
BDI
BAI
WHOQOL-BREF
SF-36
Safety Seeking Behaviours Questionnaire.
Panic scale

Full Information

First Posted
July 3, 2009
Last Updated
April 22, 2014
Sponsor
Sorlandet Hospital HF
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1. Study Identification

Unique Protocol Identification Number
NCT00932919
Brief Title
Thought Field Therapy and Cognitive Therapy for Agoraphobia
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorlandet Hospital HF

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agoraphobia
Keywords
Agoraphobia, Cognitive therapy, Thought field therapy, Psychotherapy research

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thought field therapy
Arm Type
Experimental
Arm Description
24 randomly selected patients will be treated with 5 sessions of standard Thought field therapy.
Arm Title
Cognitive therapy
Arm Type
Active Comparator
Arm Description
Treatment with Cognitive therapy, 12 sessions with manualized therapy according to David Clark's model.
Arm Title
Wait list
Arm Type
Other
Arm Description
24 patients will be randomly selected to 3 months on a wait list, thereafter randomly selected to either Cognitive therapy or Thought field therapy.
Intervention Type
Behavioral
Intervention Name(s)
Thought field therapy
Other Intervention Name(s)
TFT
Intervention Description
5 sessions with Thought field therapy
Intervention Type
Behavioral
Intervention Name(s)
Cognitive therapy
Other Intervention Name(s)
CBT
Intervention Description
12 sessions of Cognitive therapy
Intervention Type
Behavioral
Intervention Name(s)
Wait list
Other Intervention Name(s)
WL
Intervention Description
3 months waiting, then randomized to either thought field therapy or cognitive therapy
Primary Outcome Measure Information:
Title
Change in agoraphobic situation scores in ADIS.
Time Frame
Immedeately and 12 months after treatment
Secondary Outcome Measure Information:
Title
Interference score in ADIS
Time Frame
Immediately and 12 months after treatment
Title
Mobility Inventory
Time Frame
Immediately and 12 months after treatment
Title
Agoraphobic Cognitions Questionnaire
Time Frame
Immediately and 12 months after treatment
Title
Body Sensations Questionnaire
Time Frame
Immediately and 12 months after treatment
Title
BDI
Time Frame
Immediately and 12 months after treatment
Title
BAI
Time Frame
Immediately and 12 months after treatment
Title
WHOQOL-BREF
Time Frame
Immediately and 12 months after treatment
Title
SF-36
Time Frame
Immediately and 12 months after treatment
Title
Safety Seeking Behaviours Questionnaire.
Time Frame
Immediately and 12 months after treatment
Title
Panic scale
Time Frame
Immediately and 12 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Audun C Irgens, MD
Organizational Affiliation
Sorlandet Hospital HF, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sorlandet Hospital
City
Arendal
ZIP/Postal Code
4809
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
28676782
Citation
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.
Results Reference
derived

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Thought Field Therapy and Cognitive Therapy for Agoraphobia

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