Clinical trial NCT01681628: 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
Overall status: COMPLETED
Phase: NA
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.
Lead sponsor: Thought Field Therapy Foundation (UK) Ltd
Sponsor class: OTHER
Collaborators: name: Thought Field Therapy Foundation.
name: Mats Uldal Humanitarian Foundation
First posted: 2012-09-10
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Minimum age

Primary outcomes:
measure: Change in Post-traumatic Stress Disorder Check List for Civilians (PLC-C) Score.
timeFrame: Baseline (Time 1), One week later (Time 2) and Two weeks later (Time 3 for Wait-list: Thought field Therapy Arm)
Secondary outcomes:
measure: Percentage With Scores Diagnostic for Post Traumatic Stress Disorder (PCL-C > 50) Before and After Treatment in Treatment and Control Groups.
timeFrame: Baseline (Time 1), One week later (Time 2) and Two weeks later (Time 3 for Wait-list: Thought field Therapy Arm)
Other outcomes:
Locations:
city: Kasese
country: Uganda
facility: St Augustine's Catechist Training Centre, PO Box 155
Study officials:
affiliation: Thought Field Therapy Foundation (UK) Ltd
name: Robert H Robson, MA MB BChir
role: PRINCIPAL_INVESTIGATOR
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