- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03154931
Efficacy of Compassion Focused Therapy in Group for Posttraumatic Stress Disorder (GCFT-PTSD)
Group Compassion Focused Therapy for Posttraumatic Stress Disorder
Studieöversikt
Detaljerad beskrivning
This study will be a randomized clinical trial with two parallel groups, with two models of treatment: Group 1 - Control Group - will receive CBT Supportive Group (CBT-SG) and Group 2 - Experimental Group - will receive Compassion Focused Therapy (CFT-G). Will be attended in total, the maximum of 80 patients, with 40 patients in each arm (CBT-SG versus CFT-G). Both groups will be formed by at least eight patients and a maximum of twelve patients who receive eight weekly sessions with an hour and a half each session, and the total duration of treatment will be eight weeks. The groups will be closed, that is, after the start will not be permitted to input any more participants. The experimental group (CFT-G) will be structured and the control group (CBT-SG) will be unstructured, and free format.
All patients will be assessed through self-report scales, within three distinct phases: Assessment I - Initial (before therapy); Assessment II - Final (after therapy); Assessment III - Follow-up (after 3 months of therapy ending).
All groups will be led by a principal therapist and co-therapist. All sessions will be recorded for later evaluation of the researcher responsible for the research.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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SP
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Sao Paulo, SP, Brasilien, 05403-903
- AMBAN - Anxiety Program at IPQ-HCFMUSP
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Clinical Administered PTSD Scale 5 Monthly version Criteria A and >30 points
Exclusion Criteria:
- Suicidal patients and/or severe automutilation behavior and/or psychotic symptoms and/or lack of event memory.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: CBT-SG
This CBT-Supportive group will focus on the interaction here-and-now, realizing that the group acts as a secure place, driven by interactions among its participants and therapist and co-therapist.
The main objective is to welcome and support the participation of all patients and stimulate the group's initiatives, encouraging interpersonal interactions and mutual aid.
There will be no specific therapeutic intervention in relation to any PTSD related content.
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To support the group.
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Experimentell: CFT-G
This CFT-group will focus on activities using specific therapeutic strategies, to learn and training compassionate skills - psychoeducation and exercises developed for use in session and at home.They will learn What is compassion and shame?
Steps to the training of compassion and how Building a compassionate image.
Will use Thoughts Daily Record - self critical and self compassionate.
Explanation of Formulation of Strategy Threats and Security, The Three Emotional regulation systems and PTSD formulation - based on shame and guilt.
They will learn how to incorporate these skills to everyday situations.
At the end, will write an Autobiography writing about this experience and share with the group.
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Teach compassionate skills.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Clinical Administered Posttraumatic Stress 5
Tidsram: up to 8 weeks
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40% decrease
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up to 8 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Davidson Trauma Scale
Tidsram: up to 8 weeks
|
40% decrease
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up to 8 weeks
|
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Beck Depression Inventory
Tidsram: up to 8 weeks
|
final rating <20.
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up to 8 weeks
|
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Beck Anxiety Inventory
Tidsram: up to 8 weeks
|
final rating <19.
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up to 8 weeks
|
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Beck Hopelessness Scale
Tidsram: up to 8 weeks
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final rating <9.
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up to 8 weeks
|
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Self Compassion Scale
Tidsram: up to 8 weeks
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50% increase
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up to 8 weeks
|
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Other as a Shame Scale
Tidsram: up to 8 weeks
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50% decrease
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up to 8 weeks
|
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Functions of Self Critical Scale
Tidsram: up to 8 weeks
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50% decrease
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up to 8 weeks
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Connor Davidson Resilience
Tidsram: up to 8 weeks
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50% increase
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up to 8 weeks
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Outcome Questionnaire 45
Tidsram: up to 8 weeks
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50% decrease
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up to 8 weeks
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Samarbetspartners och utredare
Utredare
- Studierektor: Francisco Lotufo Neto, PhD, University of Sao Paulo General Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Group CFT treatment for PTSD
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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