- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT05523453
Onderzoek naar de effecten van een therapeutische focus op positieve herinneringen op posttraumatische gezondheid
Onderzoek en verfijning van een nieuwe behandeling voor posttraumatische stressstoornis: Processing of Positive Memories Technique (PPMT)
Posttraumatische stressstoornis (PTSS) heeft verwoestende gevolgen voor de gezondheid. Evidence-based PTSS-interventies pakken de aanzienlijke belasting van PTSS op de gezondheid van individuen en samenlevingen aan; verschillende personen die deze interventies krijgen, haken echter af en niet alle personen ervaren verbetering van PTSS-symptomen. Bovendien richten deze huidige PTSS-interventies zich vooral op traumaherinneringen. Met name suggereert groeiend bewijs dat PTSS-symptomen ook verband houden met moeilijkheden bij het coderen en ophalen van positieve herinneringen.
De voorgestelde studie zal dus de effecten onderzoeken van en doelen die ten grondslag liggen aan een nieuwe PTSS-techniek gericht op het vertellen en detailleren van positieve herinneringen - Processing of Positive Memories Technique (PPMT). Methodologisch zullen 70 personen willekeurig worden toegewezen aan PPMT versus ondersteunende counseling (SC) voor deze studie.
De doelstellingen van de voorgestelde studie omvatten (1) het onderzoeken van de effecten van PPMT op de ernst van PTSS-symptomen en de ontregeling van stresssystemen (d.w.z. ontwaken van speeksel alfa-amylase [sAA] en cortisol); (2) mechanismen onderzoeken die ten grondslag liggen aan de effecten van PPMT; en (3) het verfijnen van PPMT. Er wordt verondersteld dat de PPMT-arm grotere afnames in PTSD-ernst en sAA/cortisol-ratio's zal rapporteren. Verder wordt verondersteld dat PPMT-gerelateerd verbeterd affect de associatie tussen studiearm (PPMT vs. SC) en veranderingen in de ernst van PTSS zal mediëren. Ten slotte zal feedback worden verkregen van studiedeelnemers over de haalbaarheid, het formaat en de inhoud van PPMT om PPMT te verfijnen.
De voorgestelde studie kan voorlopig bewijs leveren over de potentiële betekenis van het richten op positieve herinneringen bij PTSS-interventies.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Texas
-
Denton, Texas, Verenigde Staten, 76203
- University of North Texas
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Beschrijving
Inclusiecriteria:
- 18-65 jaar oud
- Bereid/in staat om geïnformeerde toestemming te geven
- Vorige maand DSM-5 posttraumatische stressstoornis (PTSS) diagnose
- Praktische kennis van het Engels
Uitsluitingscriteria:
- Actieve zelfmoordintentie of -pogingen
- Actieve psychose
- Ondergaat momenteel geestelijke gezondheidstherapie (afgelopen 3 maanden)
- Doseringsveranderingen in psychiatrische medicijnen (afgelopen 3 maanden)
- Momenteel zwanger
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Verwerking van Positive Memories Technique (PPMT)
Deelnemers krijgen 5 60 minuten durende Processing of Positive Memories Technique (PPMT) -sessies voor PTSS volgens de behandelingsprocedures zoals beschreven in de PPMT-therapiehandleiding.
|
PPMT bestaat uit 5 sessies gericht op het identificeren en verwerken van positieve herinneringen.
In sessie 1-5 vertellen de deelnemers details van één positieve herinnering en verwerken ze de positieve herinnering om positieve waarden, gevoelens, sterke punten en gedachten op te roepen.
|
|
Actieve vergelijker: Ondersteunende Counseling (SC)
Deelnemers krijgen 5 ondersteunende counselingsessies van 60 minuten.
SC omvat een bespreking van het dagelijkse monitoringdagboek en een verkenning van actuele kwesties en zorgen.
|
SC is een actieve en niet-specifieke behandeling van 5 sessies die wekelijks wordt toegediend, inclusief een bespreking van het dagelijkse monitoringdagboek en een verkenning van actuele problemen en zorgen.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Tijdsspanne: Baseline
|
The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
|
Baseline
|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Tijdsspanne: Week 1 post-baseline during therapy session
|
The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
|
Week 1 post-baseline during therapy session
|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Tijdsspanne: Week 2 post-baseline during therapy session
|
The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
|
Week 2 post-baseline during therapy session
|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Tijdsspanne: Week 3 post-baseline during therapy session
|
The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
|
Week 3 post-baseline during therapy session
|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Tijdsspanne: Week 4 post-baseline during therapy session
|
The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
|
Week 4 post-baseline during therapy session
|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Tijdsspanne: Week 5 post-baseline during therapy session
|
The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
|
Week 5 post-baseline during therapy session
|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Tijdsspanne: 1 week after the last therapy session, at week 6 post-baseline
|
The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
|
1 week after the last therapy session, at week 6 post-baseline
|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Tijdsspanne: 3-months posttreatment completion, at week 18 post-baseline
|
The 20-item self-report PTSD Checklist for DSM-5 (PCL-5) assessed past-week posttraumatic stress disorder (PTSD) severity.
Response options ranged from 0 (not at all) to 4 (extremely), with the possible range being from 0 to 80. Higher scores indicate more PTSD symptom severity.
|
3-months posttreatment completion, at week 18 post-baseline
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Awakening Salivary Alpha Amylase to Cortisol Ratio
Tijdsspanne: 3 times each day for 2 consecutive days prior to first therapy session
|
Via a passive drool procedure, participants provided 3 whole saliva samples each day for 2 consecutive days both prior to PPMT/SC: (1) immediately upon awakening, (2) 30 minutes post-awakening, and (3) 60 minutes post-awakening.
For each marker, for each day, area under the curve with respect to ground (AUCg) was calculated.
The two-day average AUCg of sAA was then divided by the two-day average AUCg of cortisol to create the ratio variable.
Higher sAA/cortisol ratio indicates greater stress system dysregulation and sympathetic nervous system dominance.
|
3 times each day for 2 consecutive days prior to first therapy session
|
|
Awakening Salivary Alpha Amylase to Cortisol Ratio
Tijdsspanne: 3 times each day for 2 consecutive days after the last therapy session
|
Via a passive drool procedure, participants provided 3 whole saliva samples each day for 2 consecutive days one week following PPMT/SC: (1) immediately upon awakening, (2) 30 minutes post-awakening, and (3) 60 minutes post-awakening.
For each marker, for each day, area under the curve with respect to ground (AUCg) was calculated.
The two-day average AUCg of sAA was then divided by the two-day average AUCg of cortisol to create the ratio variable.
Higher sAA/cortisol ratio indicates greater stress system dysregulation and sympathetic nervous system dominance.
|
3 times each day for 2 consecutive days after the last therapy session
|
|
Positive and Negative Affect Schedule
Tijdsspanne: Baseline
|
The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Baseline
|
|
Positive and Negative Affect Schedule
Tijdsspanne: Week 1 post-baseline during therapy session
|
The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Week 1 post-baseline during therapy session
|
|
Positive and Negative Affect Schedule
Tijdsspanne: Week 2 post-baseline during therapy session
|
The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Week 2 post-baseline during therapy session
|
|
Positive and Negative Affect Schedule
Tijdsspanne: Week 3 post-baseline during therapy session
|
The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Week 3 post-baseline during therapy session
|
|
Positive and Negative Affect Schedule
Tijdsspanne: Week 4 post-baseline during therapy session
|
The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Week 4 post-baseline during therapy session
|
|
Positive and Negative Affect Schedule
Tijdsspanne: Week 5 post-baseline during therapy session
|
The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
Week 5 post-baseline during therapy session
|
|
Positive and Negative Affect Schedule
Tijdsspanne: 1 week after the last therapy session, at week 6 post-baseline
|
The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
1 week after the last therapy session, at week 6 post-baseline
|
|
Positive and Negative Affect Schedule
Tijdsspanne: 3-months posttreatment completion, at week 18 post-baseline
|
The 20-item Positive and Negative Affect Schedule (PANAS) examined past-week positive and negative affect levels. There were 10 items for each of the PANAS-Positive and PANAS-Negative subscales, which measure past-week positive and negative affect respectively. Response options ranged from 1 (not at all/very slightly) to 5 (extremely), with the possible range being from 10 to 50 for each subscale. Higher scores mean more self-reported positive affect and negative affect for the PANAS-Positive and PANAS-Negative subscales respectively. |
3-months posttreatment completion, at week 18 post-baseline
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Ateka Contractor, PHD, University of North Texas Health Science Center
Publicaties en nuttige links
Algemene publicaties
- Contractor AA, Blumenthal H, Rosenfield D, Shea MT, Taylor DJ, Fentem A, Vingren JL. Study protocol and rationale for a pilot randomized clinical trial comparing processing of positive memories technique with supportive counseling for PTSD. Contemp Clin Trials. 2024 Mar;138:107455. doi: 10.1016/j.cct.2024.107455. Epub 2024 Jan 20.
- Rodenbaugh MM, Almeida I, Solakoglu L, Jin L, Contractor AA. Client and therapist experiences with the Processing of Positive Memories Technique (PPMT) in a randomized controlled trial: insights for protocol refinement. Eur J Psychotraumatol. 2026 Dec;17(1):2692887. doi: 10.1080/20008066.2026.2692887. Epub 2026 Jul 29.
- Contractor AA, Rosenfield D, Almeida IM, Wang S, Taylor DJ, Weiss NH, Shea MT. Comparison of the processing of positive memories technique and supportive counseling for posttraumatic stress disorder: A randomized controlled trial. Behav Res Ther. 2026 Aug;203:105087. doi: 10.1016/j.brat.2026.105087. Epub 2026 May 19.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- R15MH129773-01A1 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .