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Acceptance and Commitment Therapy for PTSD (ACT-SS Trial)
N/A
Waitlist Available
Led By Megan Marie Kelly, PhD MS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Competent to provide written informed consent
Current DSM-5 PTSD diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, end of treatment (12 weeks), 3-month follow-up, and 6-month follow-up
Awards & highlights
ACT-SS Trial Summary
This trial will test whether a treatment focused on helping veterans with PTSD to increase social support will be more effective than a common treatment for social support difficulties.
Who is the study for?
This trial is for Veterans aged 18+ with PTSD who struggle in social relationships. They must have a stable medication regimen for at least 2 months, be willing to be recorded, and score at least 31 on the PCL-5 scale. It's not open to those with recent suicidality, cognitive impairments, severe domestic violence issues, ongoing PTSD therapy or manic episodes, substance abuse within the last month, or any psychotic disorders.Check my eligibility
What is being tested?
The study compares Acceptance and Commitment Therapy (ACT-SS), aimed at improving social support among veterans with PTSD by addressing interpersonal difficulties and avoidance behaviors against Present-Centered Therapy (PCT). The trial involves randomly assigning participants into two groups of 75 each to test which therapy is more effective.See study design
What are the potential side effects?
While specific side effects are not listed for therapies like ACT-SS and PCT as they are psychological treatments rather than drugs; participants may experience emotional discomfort discussing traumatic events or changing long-standing behavior patterns.
ACT-SS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to understand and sign the consent form.
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I have been diagnosed with PTSD.
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I am 18 years old or older.
ACT-SS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, end of treatment (12 weeks), 3-month follow-up, and 6-month follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, end of treatment (12 weeks), 3-month follow-up, and 6-month follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the MOS Social Support Survey
Change in the Social Adjustment Scale-Self Report
Secondary outcome measures
Change in the Clinician Administered PTSD Scale (CAPS-5)
Change in the PTSD Checklist (PCL-5)
Change in the Quality of Life, Enjoyment, and Satisfaction Questionnaire
ACT-SS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Acceptance and Commitment Therapy to Improve Social SupportExperimental Treatment1 Intervention
This treatment is designed to help Veterans with PTSD increase social support in family, partner, and peer relationships by reducing experiential avoidance. ACT-SS is specifically designed to address deficits in the entire social support network for Veterans with PTSD.
Group II: Present-Centered TherapyActive Control1 Intervention
PCT is designed to provide the emotional support for individuals with PTSD that will assist with recovery. The focus of PCT is on the "here and now," including current life difficulties that are directly or indirectly related to the experience of trauma. PCT aims to help the patient consider ways to react to these difficulties.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,306,309 Total Patients Enrolled
Megan Marie Kelly, PhD MSPrincipal InvestigatorVA Bedford HealthCare System, Bedford, MA
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have a score of at least 31 on a specific questionnaire called the PCL-5.You have or had a serious mental illness called psychotic disorder.You have significant problems getting along with other people.I am currently experiencing a manic episode.My thinking or memory problems do not prevent me from participating in studies.I am able to understand and sign the consent form.You have had significant thoughts about harming yourself or suicide within the past 3 months.I have been diagnosed with PTSD.I am 18 years old or older.You have had problems with drugs or alcohol within the last month.You have a history of moderate to severe domestic violence, which is measured by a tool called the Conflict Tactics Scale-2.My mental health medication dose has been stable for the last 2 months.I am currently undergoing therapy for PTSD.I am okay with being audio-recorded.
Research Study Groups:
This trial has the following groups:- Group 1: Present-Centered Therapy
- Group 2: Acceptance and Commitment Therapy to Improve Social Support
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any availabilities left in this research endeavor?
"Affirmative, clinicaltrials.gov discloses that this medical trial is currently enrolling candidates. The listing was published on March 1st 2021 and has been updated as recent as March 21st 2022. Approximately 150 participants need to be recruited from 3 distinct centres of care."
Answered by AI
How many participants is the research team looking to include?
"Affirmative. The information posted on clinicaltrials.gov shows that this study, initially announced on March 1st 2021, is still enrolling patients. There are 150 positions available across 3 healthcare facilities."
Answered by AI
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