Efficacy of Compassion Focused Therapy in Group for Posttraumatic Stress Disorder

PTSD Clinical Trial

— GCFT-PTSD  

Official title:

Group Compassion Focused Therapy for Posttraumatic Stress Disorder

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03154931
• Other study ID #: Group CFT treatment for PTSD
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 24, 2015
• Last updated: May 14, 2017
• Start date: October 2015
• Est. completion date: October 2018

Study information

• Verified date: May 2017
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: October 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Other:
• CBT-SG
To support the group.
• CFT-G
Teach compassionate skills.

Locations

Country	Name	City	State
Brazil	AMBAN - Anxiety Program at IPQ-HCFMUSP	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Administered Posttraumatic Stress 5	40% decrease	up to 8 weeks
Secondary	Davidson Trauma Scale	40% decrease	up to 8 weeks
Secondary	Beck Depression Inventory	final rating <20.	up to 8 weeks
Secondary	Beck Anxiety Inventory	final rating <19.	up to 8 weeks
Secondary	Beck Hopelessness Scale	final rating <9.	up to 8 weeks
Secondary	Self Compassion Scale	50% increase	up to 8 weeks
Secondary	Other as a Shame Scale	50% decrease	up to 8 weeks
Secondary	Functions of Self Critical Scale	50% decrease	up to 8 weeks
Secondary	Connor Davidson Resilience	50% increase	up to 8 weeks
Secondary	Outcome Questionnaire 45	50% decrease	up to 8 weeks