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

Group Compassion Focused Therapy for Posttraumatic Stress Disorder

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.

Study Overview

• Status: Unknown
• Conditions: PTSD
• Intervention / Treatment: Other: CBT-SG; Other: CFT-G

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 05403-903
      • AMBAN - Anxiety Program at IPQ-HCFMUSP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: CBT-SG; To support the group.
Experimental: 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.	Other: CFT-G; Teach compassionate skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Administered Posttraumatic Stress 5	40% decrease	up to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Davidson Trauma Scale	40% decrease	up to 8 weeks
Beck Depression Inventory	final rating <20.	up to 8 weeks
Beck Anxiety Inventory	final rating <19.	up to 8 weeks
Beck Hopelessness Scale	final rating <9.	up to 8 weeks
Self Compassion Scale	50% increase	up to 8 weeks
Other as a Shame Scale	50% decrease	up to 8 weeks
Functions of Self Critical Scale	50% decrease	up to 8 weeks
Connor Davidson Resilience	50% increase	up to 8 weeks
Outcome Questionnaire 45	50% decrease	up to 8 weeks

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Investigators: Study Director: Francisco Lotufo Neto, PhD, University of Sao Paulo General Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: September 24, 2015
• First Submitted That Met QC Criteria: May 14, 2017
• First Posted (Actual): May 16, 2017

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 14, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: PTSD; CBT; compassion; CFT; self-criticism; shame; guilty
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: Group CFT treatment for PTSD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED