Terminé

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

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Ce qui est testé

Thought Field Therapy.

+ Thought Field Therapy.

Comportemental
Qui peut participer

Troubles liés aux traumatismes et aux facteurs de stress+1

+ Troubles Mentaux

+ Troubles liés au stress traumatique

À partir de 18 ans
+2 critères d'éligibilité
Voir tous les critères d'éligibilité
Comment se déroule l'étude

Étude thérapeutique

Interventionnel
Date de début : juin 2012
Voir le détail du protocole

Résumé

Sponsor principalThought Field Therapy Foundation (UK) Ltd
Dernière mise à jour : 1 mai 2017
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Date de début de l'étude : 1 juin 2012

Date à laquelle le premier participant a commencé l'étude.

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.

Sponsor principalThought Field Therapy Foundation (UK) Ltd
Dernière mise à jour : 1 mai 2017
Issu d'une base de données validée par les autorités. Revendiquer en tant que partenaire

Protocole

Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.
Détails du design

256 participants à inclure

Nombre total de participants que l'essai clinique vise à recruter.

Traitement

Cette étude teste un ou plusieurs traitements pour évaluer leur efficacité contre une maladie ou un problème de santé spécifique. L'objectif est de voir si un nouveau médicament ou une thérapie fonctionne mieux, ou provoque moins d'effets secondaires que les options existantes.



Éligibilité

Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.
Conditions
Critères

Tout sexe

Le sexe biologique des participants éligibles à s'inscrire.

À partir de 18 ans

Tranche d'âge des participants éligibles à participer.

Volontaires sains non autorisés

Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.

Conditions

Pathologie

Troubles liés aux traumatismes et aux facteurs de stressTroubles MentauxTroubles liés au stress traumatiqueTroubles de stress post-traumatique

Critères

Un critère d'inclusion nécessaire pour participer
Volunteers recruited from local communities, who feel that they are suffering from psychological trauma

Un critère d'exclusion empêche la participation
Minimum age

Plan de l'étude

Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.
Groupes de traitement
Objectifs de l'étude

2 groupes d'intervention sont désignés dans cette étude

Cette étude ne comporte pas de groupe placebo. 

Groupes de traitement

Groupe I

Expérimental
Thought Field Therapy delivered by trained community leaders.

Groupe II

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).

Objectifs de l'étude

Objectifs principaux

Objectifs secondaires

Centres d'étude

Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.

Cette étude comporte 1 site

St Augustine's Catechist Training Centre, PO Box 155

Kasese, UgandaOuvrir St Augustine's Catechist Training Centre, PO Box 155 dans Google Maps
Terminé1 Centres d'Étude