Efficacy of Compassion Focused Therapy in Group for Posttraumatic Stress Disorder

NCT ID: NCT03154931

Last Updated: 2017-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-10-31

Brief Summary

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The purpose of this study is to determine the efficacy of a 8-week program of Compassion Focused Therapy in Group comparing to Supportive Cognitive Behavioral Therapy in Group for patients with Posttraumatic Stress Disorder.

Detailed Description

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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.

Conditions

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PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

CBT-SG

Intervention Type OTHER

To support the group.

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.

Group Type EXPERIMENTAL

CFT-G

Intervention Type OTHER

Teach compassionate skills.

Interventions

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CBT-SG

To support the group.

Intervention Type OTHER

CFT-G

Teach compassionate skills.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Francisco Lotufo Neto

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francisco Lotufo Neto, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo General Hospital

Locations

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AMBAN - Anxiety Program at IPQ-HCFMUSP

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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Group CFT treatment for PTSD

Identifier Type: -

Identifier Source: org_study_id

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