Community Self-help Using Thought Field Therapy in a Traumatised Population in Uganda: a Randomised Trial
Primary Purpose
Post-traumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Thought Field Therapy.
Sponsored by
About this trial
This is an interventional treatment trial for Post-traumatic Stress Disorder focused on measuring Thought Field Therapy., Post-traumatic stress disorder., Post-traumatic stress disorder check list for Civilians., Uganda, Ugandan therapists., Community treatment.
Eligibility Criteria
Inclusion Criteria:
- Volunteers recruited from local communities, who feel that they are suffering from psychological trauma.
Exclusion Criteria:
- Minimum age
Sites / Locations
- St Augustine's Catechist Training Centre, PO Box 155
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Thought Field Therapy
Wait list
Arm Description
Thought Field Therapy delivered by trained community leaders.
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).
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01681628
First Posted
September 2, 2012
Last Updated
March 18, 2017
Sponsor
Thought Field Therapy Foundation (UK) Ltd
Collaborators
Thought Field Therapy Foundation., Mats Uldal Humanitarian Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01681628
Brief Title
Community Self-help Using Thought Field Therapy in a Traumatised Population in Uganda: a Randomised Trial
Official Title
Effectiveness of Thought Field Therapy Provided by Newly Instructed Community Workers to a Traumatized Population in Uganda: A Randomised Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thought Field Therapy Foundation (UK) Ltd
Collaborators
Thought Field Therapy Foundation., Mats Uldal Humanitarian Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
256 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Thought Field Therapy
Arm Type
Experimental
Arm Description
Thought Field Therapy delivered by trained community leaders.
Arm Title
Wait list
Arm Type
Other
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Thought Field Therapy.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Post-traumatic Stress Disorder Check List for Civilians (PLC-C) Score.
Description
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).
Time Frame
Baseline (Time 1), One week later (Time 2) and Two weeks later (Time 3 for Wait-list: Thought field Therapy Arm)
Secondary Outcome Measure Information:
Title
Percentage With Scores Diagnostic for Post Traumatic Stress Disorder (PCL-C > 50) Before and After Treatment in Treatment and Control Groups.
Description
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.
Time Frame
Baseline (Time 1), One week later (Time 2) and Two weeks later (Time 3 for Wait-list: Thought field Therapy Arm)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Volunteers recruited from local communities, who feel that they are suffering from psychological trauma.
Exclusion Criteria:
Minimum age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert H Robson, MA MB BChir
Organizational Affiliation
Thought Field Therapy Foundation (UK) Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Augustine's Catechist Training Centre, PO Box 155
City
Kasese
Country
Uganda
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Spreadsheet available on request. Individual paper copies also available.
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Links:
URL
http://en.wikipedia.org/wiki/Rwenzururu
Description
Background to local conflicts potentially causing post-traumatic stress disorder.
URL
http://www.tftfoundation.org
Description
Co-sponsor
URL
http://matsuldalhumanitarianfondation.wordpress.com/
Description
Co-sponsor
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Community Self-help Using Thought Field Therapy in a Traumatised Population in Uganda: a Randomised Trial
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