NCT01681628

Brief Summary

Thought Field Therapy (TFT) is a simple technique that involves tapping on points of the body corresponding to the meridians used in acupuncture. By using specific sequences, TFT can be used to treat a variety of psychological problems. Patients can be taught to treat themselves, and lay people can be trained to treat others in their community, as has been shown for narrative exposure therapy. Thought Field Therapy has been used to treat whole communities who have suffered psychological trauma following natural disasters and violent conflicts. In these circumstances, TFT can be used as a stand-alone therapy, or as an adjunct to other psychological therapies, by removing the pain of re-living the traumatic events. Studies in Rwanda have shown that individuals within a community can be treated with brief TFT sessions. Both short-term and longer-term improvements in scores of Post-Traumatic Stress Disorder (PTSD) measurement scales have been demonstrated. The Kasese District in Uganda has suffered from factional conflicts and the consequences of the ongoing struggles in neighbouring countries for many years. Although the government has controlled the situation and secured the borders, many are still haunted by the psychological consequences. The purpose of the study is to validate the model of addressing widespread psychological trauma following conflict by training community leaders to help others in their community using TFT. Thirty-six community leaders will be given a two-day training in algorithm level trauma-relief TFT. They will then treat 128 volunteers for their traumas, using TFT, who will be assessed before and one week after treatment by the post-traumatic stress disorder check-list questionnaire for civilians (PCL-C). As a control, a further 128 volunteers will join a wait-list group, who will be assessed at the same time, but treated later. PCL-C scores before and after treatment will be compared with the wait-list group scores before and after waiting, but before their treatment. A follow-up assessment of the participants will be undertaken 1 to 2 years later.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
256

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 10, 2012

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

May 1, 2017

Completed
Last Updated

May 1, 2017

Status Verified

March 1, 2017

Enrollment Period

1 month

First QC Date

September 2, 2012

Results QC Date

May 1, 2016

Last Update Submit

March 18, 2017

Conditions

Keywords

Thought Field Therapy.Post-traumatic stress disorder.Post-traumatic stress disorder check list for Civilians.UgandaUgandan therapists.Community treatment.

Outcome Measures

Primary Outcomes (1)

  • Change in Post-traumatic Stress Disorder Check List for Civilians (PLC-C) Score.

    PCL-C (post traumatic check list for civilians) is a measure of the severity of post traumatic stress disorder (PTSD), and can also be used for screening populations, It is a self-completed questionnaire with 17 questions scoring from 1 - 5. The scores of each question are added to create the total score for each participant. The highest possible score for any individual is 85, the lowest score being 17. A diagnostic score for PTSD is accepted as being more than 50. Participants completed the PCL-C just before treatment and one week later. The wait list group received no treatment at Time 1. In the treatment arm, measure immediately pre-treatment (baseline) (time 1) and one week later (time 2). In the wait-list no therapy arm, measure at baseline (time 1), and after one week (no treatment) (time 2). The wait-list group (Thought Field Therapy group) were then treated and reassessed after a further week (time 3).

    Baseline (Time 1), One week later (Time 2) and Two weeks later (Time 3 for Wait-list: Thought field Therapy Arm)

Secondary Outcomes (1)

  • Percentage With Scores Diagnostic for Post Traumatic Stress Disorder (PCL-C > 50) Before and After Treatment in Treatment and Control Groups.

    Baseline (Time 1), One week later (Time 2) and Two weeks later (Time 3 for Wait-list: Thought field Therapy Arm)

Study Arms (2)

Thought Field Therapy

EXPERIMENTAL

Thought Field Therapy delivered by trained community leaders.

Behavioral: Thought Field Therapy.

Wait list

OTHER

Delayed intervention. No intervention prior to assessment after one week (pre-test 2). Then treated with Thought Field Therapy, and re-assessed after a further week (post-test).

Behavioral: Thought Field Therapy.

Interventions

Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.

Thought Field TherapyWait list

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteers recruited from local communities, who feel that they are suffering from psychological trauma.

You may not qualify if:

  • Minimum age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Augustine's Catechist Training Centre, PO Box 155

Kasese, Kasese, Uganda

Location

Related Publications (24)

  • Callahan RJ. Tapping the healer within. New York, NY: McGraw-Hill, 2001

    BACKGROUND
  • Connolly S, Sakai C. Brief trauma intervention with Rwandan genocide-survivors using thought field therapy. Int J Emerg Ment Health. 2011;13(3):161-72.

    PMID: 22708146BACKGROUND
  • Ertl V, Pfeiffer A, Schauer E, Elbert T, Neuner F. Community-implemented trauma therapy for former child soldiers in Northern Uganda: a randomized controlled trial. JAMA. 2011 Aug 3;306(5):503-12. doi: 10.1001/jama.2011.1060.

    PMID: 21813428BACKGROUND
  • Feinstein D. Energy psychology in disaster relief. Traumatology 14: 127-129, 2008.

    BACKGROUND
  • Sakai CE, Connolly SM, Oas P. Treatment of PTSD in Rwandan child genocide survivors using thought field therapy. Int J Emerg Ment Health. 2010 Winter;12(1):41-9.

    PMID: 20828089BACKGROUND
  • Bisson JI, Roberts NP, Andrew M, Cooper R, Lewis C. Psychological therapies for chronic post-traumatic stress disorder (PTSD) in adults. Cochrane Database Syst Rev. 2013 Dec 13;2013(12):CD003388. doi: 10.1002/14651858.CD003388.pub4.

    PMID: 24338345BACKGROUND
  • Blanchard EB, Jones-Alexander J, Buckley TC, Forneris CA. Psychometric properties of the PTSD Checklist (PCL). Behav Res Ther. 1996 Aug;34(8):669-73. doi: 10.1016/0005-7967(96)00033-2.

    PMID: 8870294BACKGROUND
  • Church D, Hawk C, Brooks AJ, Toukolehto O, Wren M, Dinter I, Stein P. Psychological trauma symptom improvement in veterans using emotional freedom techniques: a randomized controlled trial. J Nerv Ment Dis. 2013 Feb;201(2):153-60. doi: 10.1097/NMD.0b013e31827f6351.

    PMID: 23364126BACKGROUND
  • Church D, Yount G, Brooks AJ. The effect of emotional freedom techniques on stress biochemistry: a randomized controlled trial. J Nerv Ment Dis. 2012 Oct;200(10):891-6. doi: 10.1097/NMD.0b013e31826b9fc1.

    PMID: 22986277BACKGROUND
  • Connolly SM, Roe-Sepowitz D, Sakai C, Edwards J. Utilizing community resources to treat PTSD: randomised controlled study using thought field therapy. African Journal of Traumatic Stress 3: 82-90, 2013.

    BACKGROUND
  • Feinstein D. Rapid treatment of PTSD: why psychological exposure with acupoint tapping may be effective. Psychotherapy (Chic). 2010 Sep;47(3):385-402. doi: 10.1037/a0021171.

    PMID: 22402094BACKGROUND
  • Feinstein D. Acupoint stimulation in treating psychological disorders. Review of general Psychology 16: 364-380, 2012. doi: 10.1037/a0021171

    BACKGROUND
  • Folkes CE. Thought field therapy and trauma recovery. Int J Emerg Ment Health. 2002 Spring;4(2):99-103.

    PMID: 12166020BACKGROUND
  • Galea S, Nandi A, Vlahov D. The epidemiology of post-traumatic stress disorder after disasters. Epidemiol Rev. 2005;27:78-91. doi: 10.1093/epirev/mxi003. No abstract available.

    PMID: 15958429BACKGROUND
  • Hui KK, Liu J, Makris N, Gollub RL, Chen AJ, Moore CI, Kennedy DN, Rosen BR, Kwong KK. Acupuncture modulates the limbic system and subcortical gray structures of the human brain: evidence from fMRI studies in normal subjects. Hum Brain Mapp. 2000;9(1):13-25. doi: 10.1002/(sici)1097-0193(2000)9:13.0.co;2-f.

    PMID: 10643726BACKGROUND
  • Jonas DE, Cusack K, Forneris CA, Wilkins TM, Sonis J, Middleton JC, Feltner C, Meredith D, Cavanaugh J, Brownley KA, Olmsted KR, Greenblatt A, Weil A, Gaynes BN. Psychological and Pharmacological Treatments for Adults With Posttraumatic Stress Disorder (PTSD) [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Apr. Report No.: 13-EHC011-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK137702/

    PMID: 23658937BACKGROUND
  • Kim YD, Heo I, Shin BC, Crawford C, Kang HW, Lim JH. Acupuncture for posttraumatic stress disorder: a systematic review of randomized controlled trials and prospective clinical trials. Evid Based Complement Alternat Med. 2013;2013:615857. doi: 10.1155/2013/615857. Epub 2013 Feb 6.

    PMID: 23476697BACKGROUND
  • Metcalf O, Varker T, Forbes D, Phelps A, Dell L, DiBattista A, Ralph N, O'Donnell M. Efficacy of Fifteen Emerging Interventions for the Treatment of Posttraumatic Stress Disorder: A Systematic Review. J Trauma Stress. 2016 Feb;29(1):88-92. doi: 10.1002/jts.22070. Epub 2016 Jan 7.

    PMID: 26749196BACKGROUND
  • Reed RV, Fazel M, Goldring L. Post-traumatic stress disorder. BMJ. 2012 Jun 25;344:e3790. doi: 10.1136/bmj.e3790. No abstract available.

    PMID: 22734075BACKGROUND
  • Stone B, Leyden L, Fellows B. Energy Psychology treatment for post traumatic stress in genocide survivors in a Rwandan orphanage: a pilot investigation. Energy Psychology 1: 73-81, 2009.

    BACKGROUND
  • Stone B, Leyden L, Fellows B. Energy Psychology treatment for orphan heads of households in Rwanda. Energy Psychology 2: 31-38, 2010.

    BACKGROUND
  • Watts BV, Schnurr PP, Mayo L, Young-Xu Y, Weeks WB, Friedman MJ. Meta-analysis of the efficacy of treatments for posttraumatic stress disorder. J Clin Psychiatry. 2013 Jun;74(6):e541-50. doi: 10.4088/JCP.12r08225.

    PMID: 23842024BACKGROUND
  • Dunnewold AL. Thought Field Therapy efficacy following large scale traumatic events. Current Research in Psychology 5: 34-39, 2014. DOI: 10.3844/crpsp.2014.34.39

    RESULT
  • Robson RH, Robson PM, Ludwig R, Mitabu C, Phillips C. Effectiveness of Thought Field Therapy Provided by Newly Instructed Community Workers to a Traumatized Population in Uganda: A Randomized Trial. Current Research in Psychology http://thescipub.com/PDF/ofsp.10454.pdf, 2016.

    RESULT

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Limitations and Caveats

Only one assessment tool for PTSD was used. The 19 month data interpretation was limited by the high drop-out rate.

Results Point of Contact

Title
Dr R H Robson
Organization
Thought field Therapy Foundation UK Ltd.

Study Officials

  • Robert H Robson, MA MB BChir

    Thought Field Therapy Foundation (UK) Ltd

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Robert Howard Robson

Study Record Dates

First Submitted

September 2, 2012

First Posted

September 10, 2012

Study Start

June 1, 2012

Primary Completion

July 1, 2012

Study Completion

January 1, 2014

Last Updated

May 1, 2017

Results First Posted

May 1, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

Spreadsheet available on request. Individual paper copies also available.

Locations