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Community Self-help Using Thought Field Therapy in a Traumatised Population in Uganda: a Randomised Trial

Effectiveness of Thought Field Therapy Provided by Newly Instructed Community Workers to a Traumatized Population in Uganda: A Randomised Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01681628
Enrollment
256
Registered
2012-09-10
Start date
2012-06-30
Completion date
2014-01-31
Last updated
2017-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

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.

Interventions

BEHAVIORALThought 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.

Sponsors

Thought Field Therapy Foundation.
CollaboratorUNKNOWN
Mats Uldal Humanitarian Foundation
CollaboratorUNKNOWN
Thought Field Therapy Foundation (UK) Ltd
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Minimum age

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
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)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.

Countries

Uganda

Participant flow

Recruitment details

Public announcement throughout Kasese district of Uganda for those with symptoms of PTSD (described in announcement).

Pre-assignment details

Participants had been previously identified. As an excess number presented, only sufficient for the trial were assigned. One participant was excluded as not meeting age criteria (had to be 18 years old or over).

Participants by arm

ArmCount
Thought Field Therapy (TFT)
Thought Field Therapy delivered by trained community leaders. 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. Both groups were invited to attend 19 months later
114
Wait List
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). 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. Both groups were invited to attend 19 mo the later.
122
Total236

Withdrawals & dropouts

PeriodReasonFG000FG001
19 Months Follow-upDeath10
19 Months Follow-upLost to Follow-up6143
Time 1 (Entry) to Time 2 One Week Later.Lost to Follow-up146
Time 2 to Time 3 (One Week Later).Lost to Follow-up015

Baseline characteristics

CharacteristicThought Field Therapy (TFT)Wait ListTotal
Age, Continuous44.3 years
STANDARD_DEVIATION 16
45.1 years
STANDARD_DEVIATION 14.4
44.5 years
STANDARD_DEVIATION 15
PCL-C58.0 units on a scale
STANDARD_DEVIATION 12.6
61.2 units on a scale
STANDARD_DEVIATION 10.1
59.6 units on a scale
STANDARD_DEVIATION 11.3
Race/Ethnicity, Customized
African (Western Uganda)
114 participants122 participants236 participants
Sex: Female, Male
Female
100 Participants102 Participants202 Participants
Sex: Female, Male
Male
14 Participants20 Participants34 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
2 / 250
serious
Total, serious adverse events
1 / 250

Outcome results

Primary

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).

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

Population: Participants with symptoms suggestive of PTSD, excluding non-attenders at Time 2. Non-attenders at time 3 were excluded from the wait-list (Thought Field Therapy) arm.

ArmMeasureValue (MEAN)Dispersion
Thought Field TherapyChange in Post-traumatic Stress Disorder Check List for Civilians (PLC-C) Score.32.4 units on a scaleStandard Deviation 14.7
Wait List: no TherapyChange in Post-traumatic Stress Disorder Check List for Civilians (PLC-C) Score.12.4 units on a scaleStandard Deviation 14.2
Wait-list: Thought Field TherapyChange in Post-traumatic Stress Disorder Check List for Civilians (PLC-C) Score.20.6 units on a scaleStandard Deviation 13.5
Comparison: Means and differences were calculated for both groups before (time 1) and after treatment (or no treatment) (time 2). Also, the differences in mean scores from time 1 to 2 were compared between the two groups, the primary outcome. The numbers in the groups were considered adequate based on previous similar studies. The null hypothesis was that there would be no difference in any mean change in scores from time 1 to 2, between both groups.p-value: <0.00195% CI: [16.1, 24]t-test, 2 sided
Comparison: Change in PCL-C scores from before to after treatment.p-value: <0.00195% CI: [29.1, 34.7]t-test, 2 sided
Comparison: Changes in PCL-C scores for control group after no treatment.p-value: <0.00195% CI: [11.4, 17.1]t-test, 2 sided
Comparison: Change in control group PCL-C scores after treatment, that is from time 2 to time 3.p-value: <0.00195% CI: [17.1, 22.5]t-test, 2 sided
Secondary

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.

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

Population: Participants with symptoms suggestive of PTSD, thought field therapy group treated, wait list group not treated, and wait-list group treated. All assessed one week after initial assessment and treatment, and the percentage with a score \> 50 compared before and after treatment, or control.

ArmMeasureGroupValue (NUMBER)
Thought Field TherapyPercentage With Scores Diagnostic for Post Traumatic Stress Disorder (PCL-C > 50) Before and After Treatment in Treatment and Control Groups.Time 167.5 percentage with PCL-C score > 50
Thought Field TherapyPercentage With Scores Diagnostic for Post Traumatic Stress Disorder (PCL-C > 50) Before and After Treatment in Treatment and Control Groups.Time 21.8 percentage with PCL-C score > 50
Wait List: no TherapyPercentage With Scores Diagnostic for Post Traumatic Stress Disorder (PCL-C > 50) Before and After Treatment in Treatment and Control Groups.Time 182.8 percentage with PCL-C score > 50
Wait List: no TherapyPercentage With Scores Diagnostic for Post Traumatic Stress Disorder (PCL-C > 50) Before and After Treatment in Treatment and Control Groups.Time 241.8 percentage with PCL-C score > 50
Wait-list: Thought Field TherapyPercentage With Scores Diagnostic for Post Traumatic Stress Disorder (PCL-C > 50) Before and After Treatment in Treatment and Control Groups.Time 241.8 percentage with PCL-C score > 50
Wait-list: Thought Field TherapyPercentage With Scores Diagnostic for Post Traumatic Stress Disorder (PCL-C > 50) Before and After Treatment in Treatment and Control Groups.Time 31.9 percentage with PCL-C score > 50
Comparison: Chi-squared test of any change in PCL-C from time 1 to time 2.p-value: <0.001Chi-squared
Comparison: Comparison of the percentage with diagnostic scores in the wait list group after no treatment at times 1 and 2.p-value: <0.001Chi-squared
p-value: <0.001Chi-squared
Post Hoc

Assessment of Any Persisting Benefit of TFT (Thought Field Therapy) After 19 Months.

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 one week following treatment and nineteen months later. Comparison of PCL-C scores at nineteen months compared to one week following treatment.

Time frame: 1 week post-treatment (Time 2, TFT; Time 3, WL) and 19 months later.

Population: All those who had scores one week after treatment and at 19 months. Similar gender and age proportions to original groups.

ArmMeasureGroupValue (MEAN)Dispersion
Thought Field TherapyAssessment of Any Persisting Benefit of TFT (Thought Field Therapy) After 19 Months.one week following treatment25.8 units on a scale (PCL-C score)Standard Deviation 7.8
Thought Field TherapyAssessment of Any Persisting Benefit of TFT (Thought Field Therapy) After 19 Months.19 months later43.6 units on a scale (PCL-C score)Standard Deviation 13.1
Comparison: Both the original treatment and control groups were combined as both groups had been treated at a similar time before the nineteen month assessment. The null hypothesis was that there had been no change in the PCL-C scores at nineteen months compared to one week following treatment.p-value: <0.00195% CI: [15.2, 20.5]t-test, 2 sided
Post Hoc

Assessment of Continuing Benefit of TFT After 19 Months, in Control Group, as Measured by a Diagnosis of PTSD According to a PCL-C Score of >50.

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. Only the wait-list control group was used as the treatment group did not not have a run-in score, and would have given inappropriately positive results.

Time frame: Time 2 and 19 months later.

Population: 83% female average age 43 years, 17% male average age 46.7 years.

ArmMeasureGroupValue (NUMBER)
Thought Field TherapyAssessment of Continuing Benefit of TFT After 19 Months, in Control Group, as Measured by a Diagnosis of PTSD According to a PCL-C Score of >50.PCL-C score pre-treatment (time 2) >5041.8 percentage of PCL-C scores >50.
Thought Field TherapyAssessment of Continuing Benefit of TFT After 19 Months, in Control Group, as Measured by a Diagnosis of PTSD According to a PCL-C Score of >50.% with PCL-C score >50 at 19 months26.6 percentage of PCL-C scores >50.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026