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

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ClinicalTrials.gov Identifier: NCT01681628
Recruitment Status : Completed
First Posted : September 10, 2012
Results First Posted : May 1, 2017
Last Update Posted : May 1, 2017
Sponsor:
Collaborators:
Thought Field Therapy Foundation.
Mats Uldal Humanitarian Foundation
Information provided by (Responsible Party):
Robert Howard Robson, Thought Field Therapy Foundation (UK) Ltd

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Post-traumatic Stress Disorder
Intervention Behavioral: Thought Field Therapy.
Enrollment 256
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).
Arm/Group Title Thought Field Therapy Wait List
Hide Arm/Group Description

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.

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.

Period Title: Time 1 (Entry) to Time 2 One Week Later.
Started 128 128
Completed 114 122
Not Completed 14 6
Reason Not Completed
Lost to Follow-up             14             6
Period Title: Time 2 to Time 3 (One Week Later).
Started 0 [1] 122
Completed 0 [1] 107
Not Completed 0 15
Reason Not Completed
Lost to Follow-up             0             15
[1]
Only wait list group studied in this period.
Period Title: 19 Months Follow-up
Started 114 107
Completed 52 64
Not Completed 62 43
Reason Not Completed
Death             1             0
Lost to Follow-up             61             43
Arm/Group Title Thought Field Therapy (TFT) Wait List Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 114 122 236
Hide Baseline Analysis Population Description
Local population from Kasese district in Uganda who admitted to symptoms suggestive of PTSD and volunteered to participate. Non-attenders at Time 2 were not included in the analysis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 114 participants 122 participants 236 participants
44.3  (16) 45.1  (14.4) 44.5  (15.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 122 participants 236 participants
Female
100
  87.7%
102
  83.6%
202
  85.6%
Male
14
  12.3%
20
  16.4%
34
  14.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
African (Western Uganda) Number Analyzed 114 participants 122 participants 236 participants
114 122 236
PCL-C   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 114 participants 122 participants 236 participants
58.0  (12.6) 61.2  (10.1) 59.6  (11.3)
[1]
Measure 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.
1.Primary Outcome
Title Change in Post-traumatic Stress Disorder Check List for Civilians (PLC-C) Score.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Thought Field Therapy Wait List: no Therapy Wait-list: Thought Field Therapy
Hide Arm/Group Description:

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.

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.

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.

Overall Number of Participants Analyzed 114 122 107
Mean (Standard Deviation)
Unit of Measure: units on a scale
32.4  (14.7) 12.4  (14.2) 20.6  (13.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Thought Field Therapy, Wait List: no Therapy
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments This was an a priori threshold.
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 20.9
Confidence Interval (2-Sided) 95%
16.1 to 24.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.0
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Thought Field Therapy
Comments Change in PCL-C scores from before to after treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 32.4
Confidence Interval (2-Sided) 95%
29.1 to 34.7
Parameter Dispersion
Type: Standard Deviation
Value: 14.7
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Wait List: no Therapy
Comments Changes in PCL-C scores for control group after no treatment.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 12.4
Confidence Interval (2-Sided) 95%
11.4 to 17.1
Parameter Dispersion
Type: Standard Deviation
Value: 14.2
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Wait-list: Thought Field Therapy
Comments Change in control group PCL-C scores after treatment, that is from time 2 to time 3.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments Degrees of freedom 94
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 20.6
Confidence Interval (2-Sided) 95%
17.1 to 22.5
Parameter Dispersion
Type: Standard Deviation
Value: 13.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage With Scores Diagnostic for Post Traumatic Stress Disorder (PCL-C > 50) Before and After Treatment in Treatment and Control Groups.
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Thought Field Therapy Wait List no Treatment Wait List: Thought Field Therapy
Hide Arm/Group Description:

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.

No 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.

After two control assessments at times 1 and 2, the wait list group were treated and re-assessed one week later at time 3. Non-attenders at time 3 were excluded from analysis.
Overall Number of Participants Analyzed 114 122 107
Measure Type: Number
Unit of Measure: percentage with PCL-C score > 50
Time 1 Number Analyzed 114 participants 122 participants 0 participants
67.5 82.8
Time 2 Number Analyzed 114 participants 122 participants 107 participants
1.8 41.8 41.8
Time 3 Number Analyzed 0 participants 0 participants 107 participants
1.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Thought Field Therapy
Comments Chi-squared test of any change in PCL-C from time 1 to time 2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter percentage of participants
Estimated Value 65.7
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Wait List no Treatment
Comments Comparison of the percentage with diagnostic scores in the wait list group after no treatment at times 1 and 2.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter % of participants with PCL score > 50
Estimated Value 41.0
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Wait List: Thought Field Therapy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Percentage
Estimated Value 39.9
Estimation Comments [Not Specified]
3.Post-Hoc Outcome
Title Assessment of Any Persisting Benefit of TFT (Thought Field Therapy) After 19 Months.
Hide 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 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All those who had scores one week after treatment and at 19 months. Similar gender and age proportions to original groups.
Arm/Group Title Thought Field Therapy
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 116
Mean (Standard Deviation)
Unit of Measure: units on a scale (PCL-C score)
one week following treatment 25.8  (7.8)
19 months later 43.6  (13.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Thought Field Therapy
Comments 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.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 17.8
Confidence Interval (2-Sided) 95%
15.2 to 20.5
Estimation Comments [Not Specified]
4.Post-Hoc Outcome
Title 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.
Hide 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. 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.
Hide Outcome Measure Data
Hide Analysis Population Description
83% female average age 43 years, 17% male average age 46.7 years.
Arm/Group Title Wait List Group
Hide Arm/Group Description:
Those in the wait list, who had attended for their second immediate pre-treatment assessment and attended for assessment 19 months later.
Overall Number of Participants Analyzed 71
Measure Type: Number
Unit of Measure: percentage of PCL-C scores >50.
PCL-C score pre-treatment (time 2) >50 41.8
% with PCL-C score >50 at 19 months 26.6
Time Frame Complete up to time 3, that is one week after treatment. Incomplete up to 19 months later.
Adverse Event Reporting Description 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.
 
Arm/Group Title Thought Field Therapy
Hide Arm/Group Description

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

All-Cause Mortality
Thought Field Therapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Thought Field Therapy
Affected / at Risk (%) # Events
Total   1/250 (0.40%)    
Social circumstances   
Death * [1]  1/250 (0.40%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Cause unknown
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Thought Field Therapy
Affected / at Risk (%) # Events
Total   2/250 (0.80%)    
Psychiatric disorders   
Functional seizure * [1]  1/250 (0.40%)  1
Hysterical reaction * [2]  1/250 (0.40%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Known history of blackouts, likely to be non-organic. One occurred during therapy with complete recovery.
[2]
Uncontrollable shaking and rapid speech
Only one assessment tool for PTSD was used. The 19 month data interpretation was limited by the high drop-out rate.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr R H Robson
Organization: Thought field Therapy Foundation UK Ltd.
Phone: +44 (0)1952550688
Publications of Results:
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
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.
Other Publications:
Callahan RJ. Tapping the healer within. New York, NY: McGraw-Hill, 2001
Feinstein D. Energy psychology in disaster relief. Traumatology 14: 127-129, 2008.
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.
Feinstein D. Acupoint stimulation in treating psychological disorders. Review of general Psychology 16: 364-380, 2012. doi: 10.1037/a0021171
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.
Stone B, Leyden L, Fellows B. Energy Psychology treatment for orphan heads of households in Rwanda. Energy Psychology 2: 31-38, 2010.
Responsible Party: Robert Howard Robson, Thought Field Therapy Foundation (UK) Ltd
ClinicalTrials.gov Identifier: NCT01681628     History of Changes
Other Study ID Numbers: Uganda2012
First Submitted: September 2, 2012
First Posted: September 10, 2012
Results First Submitted: May 1, 2016
Results First Posted: May 1, 2017
Last Update Posted: May 1, 2017