- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT05523453
Untersuchung der Auswirkungen eines therapeutischen Fokus auf positive Erinnerungen auf die posttraumatische Gesundheit
Untersuchung und Verfeinerung einer neuartigen Behandlung für posttraumatische Belastungsstörung: Processing of Positive Memories Technique (PPMT)
Posttraumatische Belastungsstörung (PTSD) hat verheerende gesundheitliche Folgen. Evidenzbasierte PTBS-Interventionen befassen sich mit der erheblichen Belastung durch PTBS für die Gesundheit von Einzelpersonen und Gesellschaften; Einige Personen, die diese Interventionen erhalten, brechen jedoch ab, und nicht alle Personen erfahren eine Verbesserung der PTBS-Symptome. Darüber hinaus zielen diese aktuellen PTBS-Interventionen hauptsächlich auf Traumaerinnerungen ab. Bemerkenswerterweise deuten zunehmende Beweise darauf hin, dass PTSD-Symptome auch mit Schwierigkeiten beim Kodieren und Abrufen positiver Erinnerungen zusammenhängen.
Daher wird die vorgeschlagene Studie die Wirkungen und Ziele einer neuartigen PTBS-Technik untersuchen, die sich auf das Erzählen und Detaillieren positiver Erinnerungen konzentriert – die Processing of Positive Memories Technique (PPMT). Methodisch werden 70 Personen für diese Studie zufällig PPMT vs. Supportive Counseling (SC) zugeteilt.
Die Ziele der vorgeschlagenen Studie umfassen (1) die Untersuchung der Auswirkungen von PPMT auf die Schwere der PTBS-Symptome und die Dysregulation von Stresssystemen (d. h. Erwachen von Speichel-Alpha-Amylase [sAA] und Cortisol); (2) Untersuchung der Mechanismen, die den Wirkungen von PPMT zugrunde liegen; und (3) Raffinieren von PPMT. Es wird die Hypothese aufgestellt, dass der PPMT-Arm eine stärkere Abnahme des PTBS-Schweregrads und des sAA/Cortisol-Verhältnisses aufweisen wird. Darüber hinaus wird die Hypothese aufgestellt, dass der PPMT-bezogene verbesserte Affekt die Assoziation zwischen dem Studienarm (PPMT vs. SC) und Änderungen im Schweregrad der PTBS vermitteln wird. Schließlich wird von den Studienteilnehmern Feedback zur Machbarkeit, zum Format und zum Inhalt von PPMT eingeholt, um PPMT zu verfeinern.
Die vorgeschlagene Studie kann vorläufige Beweise für die potenzielle Bedeutung der gezielten Behandlung positiver Erinnerungen bei PTBS-Interventionen liefern.
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Texas
-
Denton, Texas, Vereinigte Staaten, 76203
- University of North Texas
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Beschreibung
Einschlusskriterien:
- 18-65 Jahre alt
- Bereit / in der Lage, eine informierte Einwilligung zu erteilen
- Diagnose einer posttraumatischen Belastungsstörung (PTSD) im vergangenen Monat DSM-5
- Arbeitskenntnisse in Englisch
Ausschlusskriterien:
- Aktive Selbstmordabsichten oder -versuche
- Aktive Psychose
- Derzeit in psychiatrischer Therapie (letzte 3 Monate)
- Dosisänderungen bei Psychopharmaka (letzte 3 Monate)
- Aktuell schwanger
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver Komparator: Verarbeitung positiver Erinnerungen Technik (PPMT)
Die Teilnehmer erhalten 5 60-minütige PPMT-Sitzungen (Processing of Positive Memories Technique) für PTBS nach den im PPMT-Therapiehandbuch beschriebenen Behandlungsverfahren.
|
PPMT besteht aus 5 Sitzungen, die sich auf die Identifizierung und Verarbeitung positiver Erinnerungen konzentrieren.
In Sitzung 1-5 erzählen die Teilnehmer Einzelheiten einer positiven Erinnerung und verarbeiten die positive Erinnerung, um positive Werte, Affekte, Stärken und Gedanken hervorzurufen.
|
|
Aktiver Komparator: Unterstützende Beratung (SC)
Die Teilnehmer erhalten 5 60-minütige unterstützende Beratungssitzungen (SC).
SC beinhaltet eine Diskussion des täglichen Überwachungstagebuchs und die Untersuchung aktueller Probleme und Bedenken.
|
SC ist eine aktive und unspezifische Behandlung mit 5 Sitzungen, die wöchentlich durchgeführt wird und eine Diskussion des täglichen Überwachungstagebuchs und die Erforschung aktueller Probleme und Bedenken umfasst.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Awakening Salivary Alpha Amylase to Cortisol Ratio
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Ateka Contractor, PHD, University of North Texas Health Science Center
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- R15MH129773-01A1 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .