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Clinical Trials/NCT03154931
NCT03154931
Unknown
Not Applicable

Group Compassion Focused Therapy for Posttraumatic Stress Disorder

University of Sao Paulo General Hospital1 site in 1 country80 target enrollmentOctober 2015
ConditionsPTSD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
PTSD
Sponsor
University of Sao Paulo General Hospital
Enrollment
80
Locations
1
Primary Endpoint
Clinical Administered Posttraumatic Stress 5
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
October 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Francisco Lotufo Neto

PhD

University of Sao Paulo General Hospital

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.

Outcomes

Primary Outcomes

Clinical Administered Posttraumatic Stress 5

Time Frame: up to 8 weeks

40% decrease

Secondary Outcomes

  • Beck Hopelessness Scale(up to 8 weeks)
  • Davidson Trauma Scale(up to 8 weeks)
  • Beck Depression Inventory(up to 8 weeks)
  • Beck Anxiety Inventory(up to 8 weeks)
  • Self Compassion Scale(up to 8 weeks)
  • Other as a Shame Scale(up to 8 weeks)
  • Functions of Self Critical Scale(up to 8 weeks)
  • Connor Davidson Resilience(up to 8 weeks)
  • Outcome Questionnaire 45(up to 8 weeks)

Study Sites (1)

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