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Efficacy of Compassion Focused Therapy in Group for Posttraumatic Stress Disorder (GCFT-PTSD)

Primary Purpose

PTSD

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CBT-SG
CFT-G
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, CBT, CFT, compassion, shame, guilty, self-criticism

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • AMBAN - Anxiety Program at IPQ-HCFMUSP

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CBT-SG

CFT-G

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Clinical Administered Posttraumatic Stress 5
40% decrease

Secondary Outcome Measures

Davidson Trauma Scale
40% decrease
Beck Depression Inventory
final rating <20.
Beck Anxiety Inventory
final rating <19.
Beck Hopelessness Scale
final rating <9.
Self Compassion Scale
50% increase
Other as a Shame Scale
50% decrease
Functions of Self Critical Scale
50% decrease
Connor Davidson Resilience
50% increase
Outcome Questionnaire 45
50% decrease

Full Information

First Posted
September 24, 2015
Last Updated
May 14, 2017
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03154931
Brief Title
Efficacy of Compassion Focused Therapy in Group for Posttraumatic Stress Disorder
Acronym
GCFT-PTSD
Official Title
Group Compassion Focused Therapy for Posttraumatic Stress Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD
Keywords
PTSD, CBT, CFT, compassion, shame, guilty, self-criticism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT-SG
Arm Type
Active Comparator
Arm Description
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.
Arm Title
CFT-G
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
CBT-SG
Intervention Description
To support the group.
Intervention Type
Other
Intervention Name(s)
CFT-G
Intervention Description
Teach compassionate skills.
Primary Outcome Measure Information:
Title
Clinical Administered Posttraumatic Stress 5
Description
40% decrease
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Davidson Trauma Scale
Description
40% decrease
Time Frame
up to 8 weeks
Title
Beck Depression Inventory
Description
final rating <20.
Time Frame
up to 8 weeks
Title
Beck Anxiety Inventory
Description
final rating <19.
Time Frame
up to 8 weeks
Title
Beck Hopelessness Scale
Description
final rating <9.
Time Frame
up to 8 weeks
Title
Self Compassion Scale
Description
50% increase
Time Frame
up to 8 weeks
Title
Other as a Shame Scale
Description
50% decrease
Time Frame
up to 8 weeks
Title
Functions of Self Critical Scale
Description
50% decrease
Time Frame
up to 8 weeks
Title
Connor Davidson Resilience
Description
50% increase
Time Frame
up to 8 weeks
Title
Outcome Questionnaire 45
Description
50% decrease
Time Frame
up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Lotufo Neto, PhD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
AMBAN - Anxiety Program at IPQ-HCFMUSP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-903
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Efficacy of Compassion Focused Therapy in Group for Posttraumatic Stress Disorder

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