Posttraumatic Stress DisorderNCT06047691
Intensive Multi-Couple Therapy for PTSD Versus Relationship Education in Military Couples
A study testing Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD and Prevention and Relationship Education Program in people with Posttraumatic Stress Disorder, run by Penn State University at 1 site in United States.
Trial summary
The goal of this clinical trial is to test an abbreviated, intensive, multi-couple group version of cognitive-behavioral conjoint therapy for PTSD (AIM-CBCT for PTSD) in an active military and veteran population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD and Prevention and Relationship Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2023to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Service member or veteran and a romantic partner willing to participate.
- Couple is married or cohabiting for at least 3 months. Couple can be either different or same sex.
- Service member/veteran diagnosis of PTSD as determined by the CAPS-5.
- Each partner is at least 18 years old.
- Both partners able to speak and read English.
Who cannot join
- Either partner reports current suicidal ideation severe enough to warrant immediate attention
- Current homicide risk meriting crisis intervention for either partner
- Current and severe alcohol misuse in either partner warranting immediate intervention
- Symptoms of moderate to severe other substance use warranting immediate intervention
- Recent (past month) manic episode or psychotic disorder symptoms in either partner
- Other psychiatric disorders severe enough to warrant designation as the primary disorder
Show all 10Show fewer
- Evidence of a moderate or severe traumatic brain injury or other cognitive impairment in either partner
- Couple is separated or have taken steps to dissolve their relationship
- Either partner is currently participating in evidence-based treatment for PTSD (e.g., Prolonged Exposure, Cognitive Processing Therapy, Present-Centered Therapy for PTSD, Eye Movement Desensitization and Reprocessing, Cognitive-Behavioral Conjoint Therapy for PTSD, or Structured Approach Therapy).
- Evidence or admission of severe intimate aggression by either partner occurring within the past 6-months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Alan Peterson, Ph.D., 210-562-6703, petersona3@uthscsa.edu
About this study
Official title: Randomized Controlled Trial of Intensive Multi-Couple Therapy for PTSD Versus Relationship Education in Military Couples
The goal of this clinical trial is to test an abbreviated, intensive, multi-couple group version of cognitive-behavioral conjoint therapy for PTSD (AIM-CBCT for PTSD) in an active military and veteran population. The main questions it aims to answer are:
- Does AIM-CBCT for PTSD improve PTSD symptoms?
- Does AIM-CBCT for PTSD improve associated symptoms (e.g., depression), romantic partner distress, and couple relationship satisfaction?
Participants will participate in a two-day retreat in which they are taught and practice skills to decrease PTSD symptoms and enhance their relationships. Researchers will compare AIM-CBCT for PTSD to the Prevention and Relationship Education Program (PREP) to determine whether it is superior to an evidence-based relationship education curriculum that is also delivered in a two-day multi-couple group format.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD, Prevention and Relationship Education Program
- Keywords
- PTSD
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSDBehavioural
Approximately 12 hours of programming delivered over 2 consecutive days in a multi-couple group retreat format. Couples are provided with psychoeducation about PTSD and relationship functioning and are taught cognitive and behavioral skills to address the manifestation of PTSD in the couple relationship. Couples will also meet once individually with one of the group leaders 1-2 weeks before the retreat and once 1-2 weeks after the retreat.
Prevention and Relationship Education ProgramBehavioural
Approximately 12 hours of programming delivered over 2 consecutive days in a multi-couple group retreat format.The content of PREP and workshop experiences focuses on helping couples communicate effectively, manage conflict without harming their relationship, preserve and act on commitment, improve relationship decision-making, increase understanding of differences between partners, and protect positive connections between partners. Approximately 12 hours of PREP content will be delivered over 2 consecutive days in a multi-couple group retreat format. Couples will also meet once individually with one of the group leaders 1-2 weeks before the retreat and will check in with a member of the study staff 1-2 weeks after the retreat.
| Study group | Role | What they receive |
|---|---|---|
| Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD | Experimental | AIM-CBCT for PTSD is an abbreviated, intensive, multi-couple group version of cognitive-behavioral conjoint therapy for PTSD, an evidence-based treatment for PTSD delivered in a conjoint format. Receives: Behavioral: Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD |
| Prevention and Relationship Education Program | Active comparator | PREP is an evidence-based relationship education program delivered in a multi-couple group format. Receives: Behavioral: Prevention and Relationship Education Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Administered PTSD Scale for DSM-5
Interviewer ratings of posttraumatic stress disorder (PTSD) symptoms identified in the Diagnostic and Statistical Manual for Mental Disorders, Fifth Edition. Scores range from 0-80, with higher scores indicating more severe PTSD symptoms.
Measured: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Secondary outcomes (5)
PTSD Checklist for DSM-5
Participant's self-report of posttraumatic stress disorder (PTSD) symptoms identified in the Diagnostic and Statistical Manual for Mental Disorders, Fifth Edition. Scores range from 0-80, with higher scores indicating more severe PTSD symptoms.
Measured: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Patient Health Questionnaire-9
Self-reported depressive symptoms. Scores range from 0 to 27, with higher scores indicating greater depressive symptom severity.
Measured: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Generalized Anxiety Disorder-Screener
Self-reported general anxiety symptoms. Scores range from 0 to 21, with higher scores indicating greater anxiety.
Measured: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Dimensions of Anger Reactions-5
Self-reported anger symptoms. Scores range from 5 to 25, with higher scores indicating greater anger.
Measured: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Couples Satisfaction Index-32
Self-reported relationship satisfaction. Scores range from 0 to 161, with higher scores indicating higher relationship satisfaction.
Measured: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start15 Sep 2023
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with parallel group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio, University of Denver
- Responsible party
- Principal investigator, Steffany J Fredman, Ph.D., Penn State University
- Investigators
- Steffany J Fredman, Ph.D., Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047691
- Sponsor's protocol ID
- SITE00001245
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Intensive Multi-Couple Therapy for PTSD Versus Relationship Education in Military Couples
- ClinicalTrials.gov ID
- NCT06047691
- Acronym / sponsor ID
- SITE00001245
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- PTSD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio, University of Denver
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test an abbreviated, intensive, multi-couple group version of cognitive-behavioral conjoint therapy for PTSD (AIM-CBCT for PTSD) in an active military and veteran population. The main questions it aims to answer are:
- Does AIM-CBCT for PTSD improve PTSD symptoms?
- Does AIM-CBCT for PTSD improve associated symptoms (e.g., depression), romantic partner distress, and couple relationship satisfaction?
Participants will participate in a two-day retreat in which they are taught and practice skills to decrease PTSD symptoms and enhance their relationships. Researchers will compare AIM-CBCT for PTSD to the Prevention and Relationship Education Program (PREP) to determine whether it is superior to an evidence-based relationship education curriculum that is also delivered in a two-day multi-couple group format.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial with parallel group design
| Arm | Type | Receives |
|---|---|---|
| Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD | Experimental | Behavioral: Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSDAIM-CBCT for PTSD is an abbreviated, intensive, multi-couple group version of cognitive-behavioral conjoint therapy for PTSD, an evidence-based treatment for PTSD delivered in a conjoint format. |
| Prevention and Relationship Education Program | Active comparator | Behavioral: Prevention and Relationship Education ProgramPREP is an evidence-based relationship education program delivered in a multi-couple group format. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Service member or veteran and a romantic partner willing to participate.
- Couple is married or cohabiting for at least 3 months. Couple can be either different or same sex.
- Service member/veteran diagnosis of PTSD as determined by the CAPS-5.
- Each partner is at least 18 years old.
- Both partners able to speak and read English.
Key exclusion criteria (10 listed)
- Either partner reports current suicidal ideation severe enough to warrant immediate attention
- Current homicide risk meriting crisis intervention for either partner
- Current and severe alcohol misuse in either partner warranting immediate intervention
- Symptoms of moderate to severe other substance use warranting immediate intervention
- Recent (past month) manic episode or psychotic disorder symptoms in either partner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSDApproximately 12 hours of programming delivered over 2 consecutive days in a multi-couple group retreat format. Couples are provided with psychoeducation about PTSD and relationship functioning and are taught cognitive and behavioral skills to address the manifestation of PTSD in the couple relationship. Couples will also meet once individually with one of the group leaders 1-2 weeks before the retreat and once 1-2 weeks after the retreat. | Behavioural | Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD |
| Prevention and Relationship Education ProgramApproximately 12 hours of programming delivered over 2 consecutive days in a multi-couple group retreat format.The content of PREP and workshop experiences focuses on helping couples communicate effectively, manage conflict without harming their relationship, preserve and act on commitment, improve relationship decision-making, increase understanding of differences between partners, and protect positive connections between partners. Approximately 12 hours of PREP content will be delivered over 2 consecutive days in a multi-couple group retreat format. Couples will also meet once individually with one of the group leaders 1-2 weeks before the retreat and will check in with a member of the study staff 1-2 weeks after the retreat. | Behavioural | Prevention and Relationship Education Program |
Primary outcome
Clinician-Administered PTSD Scale for DSM-5
Time frame: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Interviewer ratings of posttraumatic stress disorder (PTSD) symptoms identified in the Diagnostic and Statistical Manual for Mental Disorders, Fifth Edition. Scores range from 0-80, with higher scores indicating more severe PTSD symptoms.
5 secondary outcomes
PTSD Checklist for DSM-5
Time frame: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Patient Health Questionnaire-9
Time frame: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Generalized Anxiety Disorder-Screener
Time frame: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Dimensions of Anger Reactions-5
Time frame: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Couples Satisfaction Index-32
Time frame: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steffany J Fredman, Ph.D. principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD and Prevention and Relationship Education Program in people with Posttraumatic Stress Disorder, run by Penn State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steffany J Fredman, Ph.D. (781-879-9758, sjf23@psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician-Administered PTSD Scale for DSM-5 (time frame: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.