NCT03154931

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 24, 2015

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.6 years until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

May 16, 2017

Status Verified

May 1, 2017

Enrollment Period

2 years

First QC Date

September 24, 2015

Last Update Submit

May 14, 2017

Conditions

Keywords

PTSDCBTCFTcompassionshameguiltyself-criticism

Outcome Measures

Primary Outcomes (1)

  • Clinical Administered Posttraumatic Stress 5

    40% decrease

    up to 8 weeks

Secondary Outcomes (9)

  • Davidson Trauma Scale

    up to 8 weeks

  • Beck Depression Inventory

    up to 8 weeks

  • Beck Anxiety Inventory

    up to 8 weeks

  • Beck Hopelessness Scale

    up to 8 weeks

  • Self Compassion Scale

    up to 8 weeks

  • +4 more secondary outcomes

Study Arms (2)

CBT-SG

ACTIVE COMPARATOR

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

CFT-G

EXPERIMENTAL

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

Interventions

CBT-SGOTHER

To support the group.

CBT-SG
CFT-GOTHER

Teach compassionate skills.

CFT-G

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical Administered PTSD Scale 5 Monthly version Criteria A and \>30 points

You may not qualify if:

  • Suicidal patients and/or severe automutilation behavior and/or psychotic symptoms and/or lack of event memory.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AMBAN - Anxiety Program at IPQ-HCFMUSP

São Paulo, São Paulo, 05403-903, Brazil

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Francisco Lotufo Neto, PhD

    University of Sao Paulo General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 24, 2015

First Posted

May 16, 2017

Study Start

October 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2018

Last Updated

May 16, 2017

Record last verified: 2017-05

Locations