Post-traumatic Stress DisorderNCT01681628
Community Self-help Using Thought Field Therapy in a Traumatised Population in Uganda: a Randomised Trial
A study testing Thought Field Therapy. in people with Post-traumatic Stress Disorder, run by Thought Field Therapy Foundation (UK) Ltd at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Thought Field Therapy.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUganda
- Study dates
- Jun 2012to Jan 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteers recruited from local communities, who feel that they are suffering from psychological trauma.
Who cannot join
- Minimum age
Trial locations and contacts
1 site in 1 country.
Uganda1 site
St Augustine's Catechist Training Centre, PO Box 155
Kasese, Kasese
About this study
Official title: Effectiveness of Thought Field Therapy Provided by Newly Instructed Community Workers to a Traumatized Population in Uganda: A Randomised Trial
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.
Read more
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.
Read the detailed description
Six TFT practitioners from the USA, Great Britain, and Norway will train 36 community leaders during a two-day trauma-relief training programme. These newly-trained practitioners will then treat 256 volunteers who feel that they are suffering from psychological trauma. The six visiting practitioners, together with two additional TFT practitioners from Rwanda, will supervise and support the study following the training.
A Catholic Priest, Father Peter Mubunga Basaliza, on behalf of the Kasese Diocese, will organise the recruitment of the local trainers and volunteer participants, including publicising by local radio. All faiths will be welcome, but volunteers must be 18 years of age or older. Volunteers will be informed of their allocated date and time to attend for inclusion in the study. Any volunteer who cannot be accommodated in the study because the pre-requisite number has been met, will be offered TFT by the visiting practitioners and trained community leaders.
Signed consent will be obtained prior to commencing the study. Participants will be provided with an information sheet and duplicate consent forms in Lhukonzo (the local language), and assistance will be provided by Ugandan therapists for those who have difficulty reading. Consent forms will also be available in English for those for whom it is the preferred language. Each participant will also complete a demographic questionnaire.
Participants will be free to withdraw at any time, and any who do so will still be offered TFT, if desired.
Sixty-four participants will be seen each day, 32 in the morning, and 32 in the afternoon, for four consecutive days. They will be allocated according to a previously computer generated random number sequence, to Group A and provided with a blue folder, or Group B and provided with a red folder. Their names will be recorded on a sign-in sheet. They will be identified by a number, which will be written on their folder and documents. Both groups will initially complete the post-trauma checklist (PCL-C) questionnaire (www.pdhealth.mil) available in Lhukonzo, referring to symptoms within the previous week. Therapists, who will be unaware of the individual's group allocation, will assist if necessary. The PCL-C has been translated from English into Lhukonzo and back into English to ensure that the translation is accurate.
The PCL-C consists of 17 questions, each question scoring from 1 - 5. Thus the minimum score is 17 and maximum score 85. A score of 17 has no features of PTSD and 85 the highest score for PTSD. When used as a screening tool, a score of more than 50 is considered to be diagnostic of PTSD.
Completed questionnaires and consent forms will be kept in their folders and retained by the researchers.
Following completion of their PCL-C forms, Group A participants will be treated using Thought Field Therapy by the newly trained therapists for their traumas, supervised by the researchers. The therapists will keep a record for each participant of the problem that was treated, algorithms used, the time taken, and the Subjective Units of Distress (SUD) scores (0-10).
Group B will be a control (wait-list group) and will receive no treatment following their first visit. This model has been successfully utilised in Rwanda.
One week later, at the same time and day of the week as they first attended, the participants in group A and group B will return and repeat their PCL. On this occasion, testing will be followed by treatment for Group B.
After a further week, Group B only will return for repeat testing using PCL.
In summary, the protocol to be followed will be:
- Two-day training of new therapists
- Day one of study: 9am - PCL test of 16 Group A and 16 Group B 11am -Treat the 16 Group A 1pm - Test a new group of 16 A and 16 B 3pm - Treat the new 16 group A
- Days 2-4: Same as for day one, but with new participants. Each therapist will treat the same number in each group.
- Days 8-11 9am -PCL test of 16 Group A and 16 Group B 11am -Treat the 16 Group B 1pm - Test another 16 of each Group 3pm -Treat the new Group B
- Day 18 Test all Group B, 16 every two hours from 9am
Mean + SD PCL test scores will be calculated for each group during their four days of each week, and of Group B on day 18. That is:
Group A days 1-4 (A pre-treatment) Group B days 1-4 (B pre-treatment) Group A days 8-11 (A post-treatment) Group B days 8-11 (B post-no treatment) Group B day 18 (B post-treatment)
The statistical significance of differences of mean scores will be analysed by analysis of variance and paired samples t tests. Significances of differences in group proportions with diagnostic scores for PTSD will be assessed by a non-parametric test.
Statistically significant differences were found in a similar study in Rwanda, with smaller numbers, so the study will be adequately powered.
A follow-up assessment will be done 19 months later.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- Thought Field Therapy.
- Keywords
- Thought Field Therapy., Post-traumatic stress disorder., Post-traumatic stress disorder check list for Civilians., Uganda, Ugandan therapists., Community treatment.
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thought Field Therapy.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Thought Field Therapy | Experimental | Thought Field Therapy delivered by trained community leaders. Receives: 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). Receives: Behavioral: Thought Field Therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
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.
Measured: Baseline (Time 1), One week later (Time 2) and Two weeks later (Time 3 for Wait-list: Thought field Therapy Arm)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startJun 2012
- Primary completionJul 2012
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Post-traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thought Field Therapy Foundation (UK) Ltd
- Sponsor type
- University, hospital or other
- Collaborators
- Thought Field Therapy Foundation., Mats Uldal Humanitarian Foundation
- Responsible party
- Principal investigator, Robert Howard Robson, Thought Field Therapy Foundation (UK) Ltd
- Investigators
- Robert H Robson, MA MB BChir, Principal investigator, Thought Field Therapy Foundation (UK) Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681628
- Sponsor's protocol ID
- Uganda2012
- Status last verified
- Mar 2017
- First submitted
- 2 Sep 2012
- Last updated
- 1 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Spreadsheet available on request. Individual paper copies also available.
Publications
Callahan RJ. Tapping the healer within. New York, NY: McGraw-Hill, 2001
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.
PubMed 22708146Ertl 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.
PubMed 21813428Feinstein D. Energy psychology in disaster relief. Traumatology 14: 127-129, 2008.
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.
PubMed 20828089Bisson 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.
PubMed 24338345Blanchard 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.
PubMed 8870294Church 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.
PubMed 23364126Church 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.
PubMed 22986277Connolly 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.
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.
PubMed 22402094Feinstein D. Acupoint stimulation in treating psychological disorders. Review of general Psychology 16: 364-380, 2012. doi: 10.1037/a0021171
Folkes CE. Thought field therapy and trauma recovery. Int J Emerg Ment Health. 2002 Spring;4(2):99-103.
PubMed 12166020Galea 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.
PubMed 15958429Hui 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.
PubMed 10643726
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Thought Field Therapy Provided by Newly Instructed Community Workers to a Traumatized Population in Uganda: A Randomised Trial
- ClinicalTrials.gov ID
- NCT01681628
- Acronym / sponsor ID
- Uganda2012
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- Thought Field Therapy., Post-traumatic stress disorder., Post-traumatic stress disorder check list for Civilians., Uganda, Ugandan therapists., Community treatment.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Thought Field Therapy Foundation (UK) LtdUniversity, hospital or other
- Collaborators
- Thought Field Therapy Foundation., Mats Uldal Humanitarian Foundation
- Study start
- Jun 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 10 Sep 2012 (estimated)
- Results
- Posted 1 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Six TFT practitioners from the USA, Great Britain, and Norway will train 36 community leaders during a two-day trauma-relief training programme. These newly-trained practitioners will then treat 256 volunteers who feel that they are suffering from psychological trauma. The six visiting practitioners, together with two additional TFT practitioners from Rwanda, will supervise and support the study following the training.
A Catholic Priest, Father Peter Mubunga Basaliza, on behalf of the Kasese Diocese, will organise the recruitment of the local trainers and volunteer participants, including publicising by local radio. All faiths will be welcome, but volunteers must be 18 years of age or older. Volunteers will be informed of their allocated date and time to attend for inclusion in the study. Any volunteer who cannot be accommodated in the study because the pre-requisite number has been met, will be offered TFT by the visiting practitioners and trained community leaders.
Signed consent will be obtained prior to commencing the study. Participants will be provided with an information sheet and duplicate consent forms in Lhukonzo (the local language), and assistance will be provided by Ugandan therapists for those who have difficulty reading. Consent forms will also be available in English for those for whom it is the preferred language. Each participant will also complete a demographic questionnaire.
Participants will be free to withdraw at any time, and any who do so will still be offered TFT, if desired.
Sixty-four participants will be seen each day, 32 in the morning, and 32 in the afternoon, for four consecutive days. They will be allocated according to a previously computer generated random number sequence, to Group A and provided with a blue folder, or Group B and provided with a red folder. Their names will be recorded on a sign-in sheet. They will be identified by a number, which will be written on their folder and documents. Both groups will initially complete the post-trauma checklist (PCL-C) questionnaire (www.pdhealth.mil) available in Lhukonzo, referring to symptoms within the previous week. Therapists, who will be unaware of the individual's group allocation, will assist if necessary. The PCL-C has been translated from English into Lhukonzo and back into English to ensure that the translation is accurate.
The PCL-C consists of 17 questions, each question scoring from 1 - 5. Thus the minimum score is 17 and maximum score 85. A score of 17 has no features of PTSD and 85 the highest score for PTSD. When used as a screening tool, a score of more than 50 is considered to be diagnostic of PTSD.
Completed questionnaires and consent forms will be kept in their folders and retained by the researchers.
Following completion of their PCL-C forms, Group A participants will be treated using Thought Field Therapy by the newly trained therapists for their traumas, supervised by the researchers. The therapists will keep a record for each participant of the problem that was treated, algorithms used, the time taken, and the Subjective Units of Distress (SUD) scores (0-10).
Group B will be a control (wait-list group) and will receive no treatment following their first visit. This model has been successfully utilised in Rwanda.
One week later, at the same time and day of the week as they first attended, the participants in group A and group B will return and repeat their PCL. On this occasion, testing will be followed by treatment for Group B.
After a further week, Group B only will return for repeat testing using PCL.
In summary, the protocol to be followed will be:
- Two-day training of new therapists
- Day one of study: 9am - PCL test of 16 Group A and 16 Group B 11am -Treat the 16 Group A 1pm - Test a new group of 16 A and 16 B 3pm - Treat the new 16 group A
- Days 2-4: Same as for day one, but with new participants. Each therapist will treat the same number in each group.
- Days 8-11 9am -PCL test of 16 Group A and 16 Group B 11am -Treat the 16 Group B 1pm - Test another 16 of each Group 3pm -Treat the new Group B
- Day 18 Test all Group B, 16 every two hours from 9am
Mean + SD PCL test scores will be calculated for each group during their four days of each week, and of Group B on day 18. That is:
Group A days 1-4 (A pre-treatment) Group B days 1-4 (B pre-treatment) Group A days 8-11 (A post-treatment) Group B days 8-11 (B post-no treatment) Group B day 18 (B post-treatment)
The statistical significance of differences of mean scores will be analysed by analysis of variance and paired samples t tests. Significances of differences in group proportions with diagnostic scores for PTSD will be assessed by a non-parametric test.
Statistically significant differences were found in a similar study in Rwanda, with smaller numbers, so the study will be adequately powered.
A follow-up assessment will be done 19 months later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thought Field Therapy | Experimental | Behavioral: Thought Field Therapy.Thought Field Therapy delivered by trained community leaders. |
| Wait list | Other | Behavioral: Thought Field Therapy.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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Volunteers recruited from local communities, who feel that they are suffering from psychological trauma.
Key exclusion criteria (1 listed)
- Minimum age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thought Field Therapy.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. | Behavioural | Thought Field Therapy, Wait list |
Primary outcome
Change in Post-traumatic Stress Disorder Check List for Civilians (PLC-C) Score.
Time frame: Baseline (Time 1), One week later (Time 2) and Two weeks later (Time 3 for Wait-list: Thought field Therapy Arm)
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).
1 secondary outcome
Percentage With Scores Diagnostic for Post Traumatic Stress Disorder (PCL-C > 50) Before and After Treatment in Treatment and Control Groups.
Time frame: Baseline (Time 1), One week later (Time 2) and Two weeks later (Time 3 for Wait-list: Thought field Therapy Arm)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundCallahan RJ. Tapping the healer within. New York, NY: McGraw-Hill, 2001
- Background: PubMed 22708146Connolly S, Sakai C. Brief trauma intervention with Rwandan genocide-survivors using thought field therapy. Int J Emerg Ment Health. 2011;13(3):161-72.
- Background: PubMed 21813428Ertl 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.
- BackgroundFeinstein D. Energy psychology in disaster relief. Traumatology 14: 127-129, 2008.
- Background: PubMed 20828089Sakai 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.
- Background: PubMed 24338345Bisson 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.
- Background: PubMed 8870294Blanchard 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.
- Background: PubMed 23364126Church 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.
- Background: PubMed 22986277Church 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.
- BackgroundConnolly 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: PubMed 22402094Feinstein 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.
- BackgroundFeinstein D. Acupoint stimulation in treating psychological disorders. Review of general Psychology 16: 364-380, 2012. doi: 10.1037/a0021171
- Background to local conflicts potentially causing post-traumatic stress disorder.Link provided by the sponsor.
- Co-sponsorLink provided by the sponsor.
- Co-sponsorLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Spreadsheet available on request. Individual paper copies also available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert H Robson, MA MB BChir principal investigator
Thought Field Therapy Foundation (UK) Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thought Field Therapy. in people with Post-traumatic Stress Disorder, run by Thought Field Therapy Foundation (UK) Ltd at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Post-traumatic Stress Disorder Check List for Civilians (PLC-C) Score. (time frame: Baseline (Time 1), One week later (Time 2) and Two weeks later (Time 3 for Wait-list: Thought field Therapy Arm)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01681628, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2017.