Trial Outcomes & Findings for Community Self-help Using Thought Field Therapy in a Traumatised Population in Uganda: a Randomised Trial (NCT NCT01681628)
NCT ID: NCT01681628
Last Updated: 2017-05-01
Results Overview
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).
COMPLETED
NA
256 participants
Baseline (Time 1), One week later (Time 2) and Two weeks later (Time 3 for Wait-list: Thought field Therapy Arm)
2017-05-01
Participant Flow
Public announcement throughout Kasese district of Uganda for those with symptoms of PTSD (described in announcement).
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).
Participant milestones
| Measure |
Thought Field Therapy
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.
|
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.
|
|---|---|---|
|
Time 1 (Entry) to Time 2 One Week Later.
STARTED
|
128
|
128
|
|
Time 1 (Entry) to Time 2 One Week Later.
COMPLETED
|
114
|
122
|
|
Time 1 (Entry) to Time 2 One Week Later.
NOT COMPLETED
|
14
|
6
|
|
Time 2 to Time 3 (One Week Later).
STARTED
|
0
|
122
|
|
Time 2 to Time 3 (One Week Later).
COMPLETED
|
0
|
107
|
|
Time 2 to Time 3 (One Week Later).
NOT COMPLETED
|
0
|
15
|
|
19 Months Follow-up
STARTED
|
114
|
107
|
|
19 Months Follow-up
COMPLETED
|
52
|
64
|
|
19 Months Follow-up
NOT COMPLETED
|
62
|
43
|
Reasons for withdrawal
| Measure |
Thought Field Therapy
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.
|
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.
|
|---|---|---|
|
Time 1 (Entry) to Time 2 One Week Later.
Lost to Follow-up
|
14
|
6
|
|
Time 2 to Time 3 (One Week Later).
Lost to Follow-up
|
0
|
15
|
|
19 Months Follow-up
Death
|
1
|
0
|
|
19 Months Follow-up
Lost to Follow-up
|
61
|
43
|
Baseline Characteristics
Community Self-help Using Thought Field Therapy in a Traumatised Population in Uganda: a Randomised Trial
Baseline characteristics by cohort
| Measure |
Thought Field Therapy (TFT)
n=114 Participants
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
|
Wait List
n=122 Participants
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.
|
Total
n=236 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.3 years
STANDARD_DEVIATION 16 • n=93 Participants
|
45.1 years
STANDARD_DEVIATION 14.4 • n=4 Participants
|
44.5 years
STANDARD_DEVIATION 15.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=93 Participants
|
102 Participants
n=4 Participants
|
202 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African (Western Uganda)
|
114 participants
n=93 Participants
|
122 participants
n=4 Participants
|
236 participants
n=27 Participants
|
|
PCL-C
|
58.0 units on a scale
STANDARD_DEVIATION 12.6 • n=93 Participants
|
61.2 units on a scale
STANDARD_DEVIATION 10.1 • n=4 Participants
|
59.6 units on a scale
STANDARD_DEVIATION 11.3 • n=27 Participants
|
PRIMARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Thought Field Therapy
n=114 Participants
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.
|
Wait List: no Therapy
n=122 Participants
No thought field therapy intervention prior to assessment after one week (pre-test 2).
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.
|
Wait-list: Thought Field Therapy
n=107 Participants
Received thought field therapy after second assessment (time 2) and re-assessed one week later (time 3).
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.
|
|---|---|---|---|
|
Change in Post-traumatic Stress Disorder Check List for Civilians (PLC-C) Score.
|
32.4 units on a scale
Standard Deviation 14.7
|
12.4 units on a scale
Standard Deviation 14.2
|
20.6 units on a scale
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Thought Field Therapy
n=114 Participants
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.
|
Wait List: no Therapy
n=122 Participants
No thought field therapy intervention prior to assessment after one week (pre-test 2).
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.
|
Wait-list: Thought Field Therapy
n=107 Participants
Received thought field therapy after second assessment (time 2) and re-assessed one week later (time 3).
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.
|
|---|---|---|---|
|
Percentage With Scores Diagnostic for Post Traumatic Stress Disorder (PCL-C > 50) Before and After Treatment in Treatment and Control Groups.
Time 1
|
67.5 percentage with PCL-C score > 50
|
82.8 percentage with PCL-C score > 50
|
—
|
|
Percentage With Scores Diagnostic for Post Traumatic Stress Disorder (PCL-C > 50) Before and After Treatment in Treatment and Control Groups.
Time 2
|
1.8 percentage with PCL-C score > 50
|
41.8 percentage with PCL-C score > 50
|
41.8 percentage with PCL-C score > 50
|
|
Percentage With Scores Diagnostic for Post Traumatic Stress Disorder (PCL-C > 50) Before and After Treatment in Treatment and Control Groups.
Time 3
|
—
|
—
|
1.9 percentage with PCL-C score > 50
|
POST_HOC outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Thought Field Therapy
n=116 Participants
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.
|
Wait List: no Therapy
No thought field therapy intervention prior to assessment after one week (pre-test 2).
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.
|
Wait-list: Thought Field Therapy
Received thought field therapy after second assessment (time 2) and re-assessed one week later (time 3).
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.
|
|---|---|---|---|
|
Assessment of Any Persisting Benefit of TFT (Thought Field Therapy) After 19 Months.
one week following treatment
|
25.8 units on a scale (PCL-C score)
Standard Deviation 7.8
|
—
|
—
|
|
Assessment of Any Persisting Benefit of TFT (Thought Field Therapy) After 19 Months.
19 months later
|
43.6 units on a scale (PCL-C score)
Standard Deviation 13.1
|
—
|
—
|
POST_HOC outcome
Timeframe: Time 2 and 19 months later.Population: 83% female average age 43 years, 17% male average age 46.7 years.
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.
Outcome measures
| Measure |
Thought Field Therapy
n=71 Participants
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.
|
Wait List: no Therapy
No thought field therapy intervention prior to assessment after one week (pre-test 2).
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.
|
Wait-list: Thought Field Therapy
Received thought field therapy after second assessment (time 2) and re-assessed one week later (time 3).
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.
|
|---|---|---|---|
|
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 score pre-treatment (time 2) >50
|
41.8 percentage of PCL-C scores >50.
|
—
|
—
|
|
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.
% with PCL-C score >50 at 19 months
|
26.6 percentage of PCL-C scores >50.
|
—
|
—
|
Adverse Events
Thought Field Therapy
Serious adverse events
| Measure |
Thought Field Therapy
n=250 participants at risk
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
|
|---|---|
|
Social circumstances
Death
|
0.40%
1/250 • Number of events 1 • Complete up to time 3, that is one week after treatment. Incomplete up to 19 months later.
Adverse events were reported for all those who were treated. There were 128 in the treatment group, but only 122 in the waitlist group as four did not attend for treatment at time 2, making 250 in total.
|
Other adverse events
| Measure |
Thought Field Therapy
n=250 participants at risk
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
|
|---|---|
|
Psychiatric disorders
Functional seizure
|
0.40%
1/250 • Number of events 1 • Complete up to time 3, that is one week after treatment. Incomplete up to 19 months later.
Adverse events were reported for all those who were treated. There were 128 in the treatment group, but only 122 in the waitlist group as four did not attend for treatment at time 2, making 250 in total.
|
|
Psychiatric disorders
Hysterical reaction
|
0.40%
1/250 • Number of events 1 • Complete up to time 3, that is one week after treatment. Incomplete up to 19 months later.
Adverse events were reported for all those who were treated. There were 128 in the treatment group, but only 122 in the waitlist group as four did not attend for treatment at time 2, making 250 in total.
|
Additional Information
Dr R H Robson
Thought field Therapy Foundation UK Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place