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Undersøgelse af virkningerne af et terapeutisk fokus på positive minder på posttraumatisk sundhed

6. august 2026 opdateret af: Ateka Contractor, University of North Texas, Denton, TX

Undersøgelse og forfining af en ny behandling for posttraumatisk stresslidelse: Processing of Positive Memories Technique (PPMT)

Posttraumatisk stresslidelse (PTSD) har ødelæggende helbredsmæssige konsekvenser. Evidensbaserede PTSD-interventioner adresserer den betydelige byrde af PTSD på individers og samfunds sundhed; flere personer, der modtager disse interventioner, falder dog fra, og ikke alle personer oplever bedring af PTSD-symptomer. Desuden er disse nuværende PTSD-interventioner primært rettet mod traumeminder. Navnlig tyder voksende beviser på, at PTSD-symptomer også er relateret til vanskeligheder med at indkode og hente positive minder.

Således vil den foreslåede undersøgelse undersøge effekter af og mål, der ligger til grund for en ny PTSD-teknik med fokus på at fortælle og detaljere positive minder - Processing of Positive Memories Technique (PPMT). Metodisk vil 70 personer blive tilfældigt tildelt PPMT vs. Supportive Counseling (SC) for denne undersøgelse.

Formålet med den foreslåede undersøgelse omfatter (1) at undersøge PPMT's virkninger på PTSD-symptomernes sværhedsgrad og stresssystemers dysregulering (dvs. opvågning af spyt alfa-amylase [sAA] og cortisol); (2) at undersøge mekanismer, der ligger til grund for PPMT's virkninger; og (3) raffinering af PPMT. Det antages, at PPMT-armen vil rapportere større fald i PTSD-sværhedsgrad og sAA/cortisol-forhold. Ydermere antages det, at PPMT-relateret forbedret affekt vil mediere sammenhængen mellem undersøgelsesarm (PPMT vs. SC) og ændringer i PTSD-sværhedsgrad. Til sidst vil der blive indhentet feedback fra undersøgelsens deltagere om PPMTs gennemførlighed, format og indhold for at forfine PPMT.

Den foreslåede undersøgelse kan bidrage med foreløbige beviser på den potentielle betydning af at målrette positive minder i PTSD-interventioner.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

70

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Texas
      • Denton, Texas, Forenede Stater, 76203
        • University of North Texas

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • 18-65 år
  • Villig/i stand til at give informeret samtykke
  • Sidste måned DSM-5 posttraumatisk stresslidelse (PTSD) diagnose
  • Arbejdskendskab til engelsk

Ekskluderingskriterier:

  • Aktive selvmordshensigter eller -forsøg
  • Aktiv psykose
  • Modtager i øjeblikket mental sundhedsterapi (sidste 3 måneder)
  • Dosisændringer i psykiatrisk medicin (seneste 3 måneder)
  • I øjeblikket gravid

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Processing of Positive Memories Technique (PPMT)
Deltagerne modtager 5 60-minutters behandling af positive erindringer Technique (PPMT) sessioner for PTSD efter behandlingsprocedurerne som beskrevet i PPMT-terapimanualen.
Adfærdsmæssigt: Processing of Positive Memories Technique (PPMT)
PPMT består af 5 sessioner med fokus på at identificere og behandle positive minder. I session 1-5 fortæller deltagerne detaljer om én positiv hukommelse og bearbejder den positive hukommelse for at fremkalde positive værdier, affekt, styrker og tanker.
Aktiv komparator: Understøttende rådgivning (SC)
Deltagerne modtager 5 60-minutters støttende rådgivning (SC) sessioner. SC inkluderer en diskussion af den daglige overvågningsdagbog og udforskning af aktuelle spørgsmål og bekymringer.
Adfærdsmæssigt: Understøttende rådgivning (SC)
SC er en 5-session, aktiv og uspecifik behandling administreret ugentligt, som inkluderer en diskussion af den daglige overvågningsdagbog og udforskning af aktuelle problemer og bekymringer.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) Scores
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Awakening Salivary Alpha Amylase to Cortisol Ratio
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of North Texas, Denton, TX

Efterforskere

  • Ledende efterforsker: Ateka Contractor, PHD, University of North Texas Health Science Center

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

23. marts 2023

Primær færdiggørelse (Faktiske)

19. februar 2025

Studieafslutning (Faktiske)

19. februar 2025

Datoer for studieregistrering

Først indsendt

24. august 2022

Først indsendt, der opfyldte QC-kriterier

29. august 2022

Først opslået (Faktiske)

31. august 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R15MH129773-01A1 (U.S. NIH-bevilling/kontrakt)

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