Clinical trial NCT03154931: Efficacy of Compassion Focused Therapy in Group for Posttraumatic Stress Disorder
Official title: Group Compassion Focused Therapy for Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PTSD
Keywords: PTSD
CBT
CFT
compassion
shame
guilty
self-criticism
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Clinical Administered Posttraumatic Stress 5
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Davidson Trauma Scale
timeFrame: up to 8 weeks
measure: Beck Depression Inventory
timeFrame: up to 8 weeks
measure: Beck Anxiety Inventory
timeFrame: up to 8 weeks
measure: Beck Hopelessness Scale
timeFrame: up to 8 weeks
measure: Self Compassion Scale
timeFrame: up to 8 weeks
measure: Other as a Shame Scale
timeFrame: up to 8 weeks
measure: Functions of Self Critical Scale
timeFrame: up to 8 weeks
measure: Connor Davidson Resilience
timeFrame: up to 8 weeks
measure: Outcome Questionnaire 45
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: AMBAN - Anxiety Program at IPQ-HCFMUSP
state: SP
Study officials:
affiliation: University of Sao Paulo General Hospital
name: Francisco Lotufo Neto, PhD
role: STUDY_DIRECTOR
References: