Posttraumatic Stress DisorderPTSDNCT05274061
Couple's Retreats for Posttraumatic Stress Disorder
A study testing Accelerated, Intensive, Multi-Couple Cognitive Behavioral Couples Therapy in people with Posttraumatic Stress Disorder, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Posttraumatic stress disorder (PTSD) increases the risk for conflict and dissatisfaction in romantic relationships. Accelerated, Intensive, Multi-Couples Cognitive Behavioral Conjoint Therapy (AIM-CBCT) is a behavioral treatment that targets reducing PTSD symptoms and improving relationship functioning. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Accelerated, Intensive, Multi-Couple Cognitive Behavioral Couples Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2022to 27 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cohabitating couples (ages 18 to 65 years old), who have been together for at least 4 months who reside in Texas.
- At least one partner in the relationship is a Texas Veteran with significant PTSD symptoms as determined by the endorsement of at least one Criterion A event on the Life Event Checklist, the endorsement of at least one re-experiencing on the PCL-5 (i.e., a score of 2 or higher on Items 1, 2, 3, 4, or 5), the endorsement of at least one avoidance symptom on the PCL-5 (i.e., a score of 2 or higher on Items 6 or 7), and a total symptom score of 31 or higher on the PCL-5.
- Both individuals must be willing to participate in the study.
- Both individuals must be able to speak and read English.
Who cannot join
- Couple is separated and/or is taking steps to dissolve their relationship (e.g., divorce).
- Veteran or partner are currently participating in an evidence-based treatment for PTSD (Prolonged Exposure, Cognitive Processing Therapy, or Cognitive-Behavioral Conjoint Therapy for PTSD).
- Veteran or partner exhibit current psychiatric symptoms warranting immediate intervention that is beyond the scope of the treatment provided in this study.
- Veteran or partner exhibit evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires)
- Veteran or partner report current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index - Suicidality Subscale; DSI-SS)
- Evidence or admission of severe intimate aggression as indicated by a "yes" endorsement to the one-question Screen for Conflict Question by Veteran or partner occurring within the past 6-months.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: Couple's Retreats for PTSD: Healing the Impacts of Trauma in Texas Veteran Families
Posttraumatic stress disorder (PTSD) increases the risk for conflict and dissatisfaction in romantic relationships. Accelerated, Intensive, Multi-Couples Cognitive Behavioral Conjoint Therapy (AIM-CBCT) is a behavioral treatment that targets reducing PTSD symptoms and improving relationship functioning. The treatment is delivered over two days using an intensive, outpatient group (between 2 to 6 couples) format. Previous research has found that AIM-CBCT for PTSD decrease PTSD symptoms and improves relationship functioning in military veterans and service members with combat-related PTSD. The present study examines whether these original findings can be replicated in a broader military/Veteran sample of up to 80 couples. The investigators predict that AIM-CBCT for PTSD will be associated with significant decreases in PTSD symptoms, depression, and anxiety in Veteran/military service members, significant decreases in mental health symptoms in their romantic partners, and an increase in couple's satisfaction for both the Veteran/service members and their partners.
Couples who agree to participate in the research study will be asked to participate in a 60-mintute pre-retreat meeting, the two-day retreat in which AIM-CBCT for PTSD will be delivered, and a 60-minute post-retreat check-in meeting. Additionally, each member of the couple will be asked to complete measures on their trauma history, mental health symptoms, and relationship functioning at baseline and at two and four weeks after the retreat.
Read the detailed description
Numerous studies have documented an association between posttraumatic stress disorder (PTSD) symptoms and intimate relationship problems in Veterans and their partners, including relationship distress, physical and psychological aggression, and psychological distress in partners. Prior studies support the use of Cognitive-Behavioral Conjoint Therapy for PTSD (CBCT for PTSD) to treat PTSD and comorbid symptoms while simultaneously improving intimate relationship functioning. However, the standard outpatient format of CBCT for PTSD (i.e., fifteen 75-minute sessions over 15 weeks) presents challenges for many couples as well as for large-scale dissemination. To address these concerns, Dr. Steffany Fredman in collaboration with the STRONG STAR Consortium to Alleviate PTSD adapted CBCT for PTSD into an accelerated, intensive, multiple-couple format (AIM-CBCT for PTSD). The initial data of AIM-CBCT for PTSD tested in 24 couples was promising suggesting that this two-day retreat can reduce PTSD symptoms and improve mental health and relationship functioning in post-9/11 service members/veteran couples.
In September 2021, the South Texas Research Organizational Network Guiding Studies on Trauma and Resilience (STRONG STAR) initiated a clinical program which provides AIM-CBCT for PTSD to Texas Veteran couples impacted by PTSD symptoms. Within the clinical program, couples are asked to participate in an intake assessment to determine eligibility for treatment, a 60-minute pre-retreat meeting, a two-day retreat, a two-week post-retreat assessment, and a two-week post-retreat check-in. Couples who are eligible for the clinical program will be invited to participate in this replication study, which examines whether AIM-CBCT for PTSD is associated with reductions in PTSD and improvements in relationship functioning in a broader Veteran sample of up to 80 couples.
Research Questions and Hypotheses:
- Will Accelerated, Intensive, Multi-Couple Cognitive Behavioral Couples Therapy delivered in a 2-day retreat (AIM-CBCT for PTSD) be associated with significant improvements in patient-rated PTSD symptom severity, as measured by the PTSD Checklist-DSM-5 (PCL-5), when assessed two-weeks and one month after treatment? Hypothesis 1: Participation in AIM-CBCT for PTSD will be associated with a significant reduction of self-reported PTSD symptoms on the Posttraumatic Checklist-DSM 5 (PCL-5) at the one-month follow-up assessment.
- Will AIM-CBCT for PTSD be associated with significant improvements in secondary outcomes (e.g., patient self-reported comorbid symptom severity, relationship satisfaction) when assessed two-weeks and one month after treatment?
Hypothesis 2: Participation in AIM-CBCT for PTSD will be associated with a significant reduction of Veteran/Service members' self-reported mental health symptoms (Patient Health Questionnaire-9; General Anxiety Disorder-7) at the one-month follow-up assessment.
Hypothesis 3: Participation in AIM-CBCT for PTSD will be associated with a significant reduction of partners'' self-reported mental health symptoms (Patient Health Questionnaire-9; General Anxiety Disorder-7) at the one-month follow-up assessment.
Hypothesis 4: Participation in AIM-CBCT for PTSD will be associated with a significant increase in self-reported relationship satisfaction on the Couples Satisfaction Index-32) at the one-month follow-up assessment for both partners.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Accelerated, Intensive, Multi-Couple Cognitive Behavioral Couples Therapy
- Keywords
- Posttraumatic stress disorder, Conjoint Therapy, Cognitive Behavioral Treatment, Intensive Treatments, Couples, Cognitive Behavioral Conjoint Therapy
- 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.
Accelerated, Intensive, Multi-Couple Cognitive Behavioral Couples TherapyBehavioural
Also called AIM-CBCT for PTSD
AIM-CBCT consists of an accelerated, 2-day delivery of the first 7 sessions of CBCT for PTSD and is comprised of (a) psychoeducation about PTSD and relationship functioning; (b) instruction in conflict management skills; (c) instruction in effective communication skills with an emphasis on the identification and sharing of emotions to decrease emotional numbing and increase emotional intimacy; (d) discussion of the importance of approaching, rather than avoiding, difficult situations and identification of places, situations, people, and feelings that the couple has heretofore avoided as a result of PTSD; (e) instruction in identification of thoughts and related feelings that can maintain PTSD and relationship distress and strategies to increase cognitive flexibility, and (f) instruction in problem-solving skills to generate couple-level approach behaviors and guidance in how to select activities that double as opportunities to approach feared situations and engage in positive bonding.
| Study group | Role | What they receive |
|---|---|---|
| Accelerated, Intensive, Multi-Couple Cognitive Behavioral Couples Therapy (AIM-CBCT for PTSD) | Experimental | This is a single-arm study in which each couple will receive AIM-CBCT. The intervention is described in the section below. Receives: Behavioral: Accelerated, Intensive, Multi-Couple Cognitive Behavioral Couples Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Checklist - DSM-5 (PCL-5)
Change in scale measurements by the PTSD CheckList-5. The PCL-5 is a 20-item, self-report measure of PTSD symptoms experienced in the past month. Each item is rated on a severity scale ranging from 0 (Not at all) to 4 (Extremely). The measure provides a total severity score that ranges from 0 to 80, with higher scores representing more PTSD symptoms.
Measured: Baseline, two-week post-retreat assessment, one-month post-retreat assessment
Secondary outcomes (3)
Patient Health Questionnaire-9 (PHQ-9)
Change in scale measurements by the Patient Health Questionnaire-9. The PHQ-9 is 9-item, self-report screener for current depressive symptoms. Each item is rated on a frequency scale ranging from 0 (Not at all) to 3 (Nearly Every day). The measure provides a total severity score that ranges from 0 to 27, with higher scores representing more severe depressive symptoms.
Measured: Baseline, two-week post-retreat assessment, one-month post-retreat assessment
General Anxiety Disorder - 7 (GAD-7)
Change in scale measurements by the Generalized Anxiety Disorder Screener: The GAD-7 is 7-item, self-report screener for current anxiety symptoms. Each item is rated on a frequency scale ranging from 0 (Not at all) to 3 (Nearly Every day). The measure provides a total severity score that ranges from 0 to 21, with higher scores representing more severe anxiety symptoms.
Measured: Baseline, two-week post-retreat assessment, one-month post-retreat assessment
Couples Satisfaction Index-32 (CSI-32)
Change in scale measurements by the Couples' Satisfaction Index. The CSI-32 is 32-item, self-report measure of couple's satisfaction. Each item is rated on a 0 to 5 scale for a total score range of 0 to 161. Higher scores represent greater levels of relationship satisfaction with scores below 96 generally considered to reflect significant distress within the relationship.
Measured: Baseline, two-week post-retreat assessment, one-month post-retreat assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start18 Mar 2022
- Primary completion27 Jun 2023
- Study completion27 Jun 2023
Why it stopped: Nonrandomized, open-label study terminated at the end of the program's funding cycle.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open-label, single group treatment study in which every couple will receive the intervention (AIM-CBCT).
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan L Peterson, PhD, Principal investigator, UT Health Science Center San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05274061
- Sponsor's protocol ID
- HSC20210843H
- Acronym
- PTSD
- Status last verified
- Jul 2023
- First submitted
- 1 Mar 2022
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fredman SJ, Le Y, Macdonald A, Monson CM, Rhoades GK, Dondanville KA, Blount TH, Hall-Clark BN, Fina BA, Mintz J, Litz BT, Young-McCaughan S, Jenkins AIC, Yarvis JS, Keane TM, Peterson AL; Consortium to Alleviate PTSD. A Closer Examination of Relational Outcomes from a Pilot Study of Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD with Military Dyads. Fam Process. 2021 Sep;60(3):712-726. doi: 10.1111/famp.12654. Epub 2021 Apr 20.
PubMed 33876831Fredman SJ, Macdonald A, Monson CM, Dondanville KA, Blount TH, Hall-Clark BN, Fina BA, Mintz J, Litz BT, Young-McCaughan S, Hancock AK, Rhoades GK, Yarvis JS, Resick PA, Roache JD, Le Y, Wachen JS, Niles BL, McGeary CA, Keane TM, Peterson AL; Consortium to Alleviate PTSD. Intensive, Multi-Couple Group Therapy for PTSD: A Nonrandomized Pilot Study With Military and Veteran Dyads. Behav Ther. 2020 Sep;51(5):700-714. doi: 10.1016/j.beth.2019.10.003. Epub 2019 Nov 27.
PubMed 32800299Macdonald A, Fredman SJ, Taylor DJ, Pruiksma KE, Blount TH, Hall-Clark BN, Fina BA, Dondanville KA, Mintz J, Litz BT, Young-McCaughan S, Le Y, Jenkins AIC, Monson CM, Yarvis JS, Keane TM, Peterson AL; Consortium to Alleviate PTSD. Secondary individual outcomes following multicouple group therapy for posttraumatic stress disorder: An uncontrolled pilot study with military dyads. J Trauma Stress. 2022 Feb;35(1):321-329. doi: 10.1002/jts.22729. Epub 2021 Nov 20.
PubMed 34800060Monson CM, Taft CT, Fredman SJ. Military-related PTSD and intimate relationships: from description to theory-driven research and intervention development. Clin Psychol Rev. 2009 Dec;29(8):707-14. doi: 10.1016/j.cpr.2009.09.002. Epub 2009 Sep 10.
PubMed 19781836Monson CM, Fredman SJ. Cognitive-behavioral conjoint therapy for posttraumatic stress disorder: Harnessing the healing power of relationships. New York: Guilford. 2012
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093.
PubMed 18388841
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Couple's Retreats for PTSD: Healing the Impacts of Trauma in Texas Veteran Families
- ClinicalTrials.gov ID
- NCT05274061
- Acronym / sponsor ID
- PTSD / HSC20210843H
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Posttraumatic stress disorder, Conjoint Therapy, Cognitive Behavioral Treatment, Intensive Treatments, Couples, Cognitive Behavioral Conjoint Therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Nonrandomized, open-label study terminated at the end of the program's funding cycle.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 10 Mar 2022 (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.
Posttraumatic stress disorder (PTSD) increases the risk for conflict and dissatisfaction in romantic relationships. Accelerated, Intensive, Multi-Couples Cognitive Behavioral Conjoint Therapy (AIM-CBCT) is a behavioral treatment that targets reducing PTSD symptoms and improving relationship functioning. The treatment is delivered over two days using an intensive, outpatient group (between 2 to 6 couples) format. Previous research has found that AIM-CBCT for PTSD decrease PTSD symptoms and improves relationship functioning in military veterans and service members with combat-related PTSD. The present study examines whether these original findings can be replicated in a broader military/Veteran sample of up to 80 couples. The investigators predict that AIM-CBCT for PTSD will be associated with significant decreases in PTSD symptoms, depression, and anxiety in Veteran/military service members, significant decreases in mental health symptoms in their romantic partners, and an increase in couple's satisfaction for both the Veteran/service members and their partners.
Couples who agree to participate in the research study will be asked to participate in a 60-mintute pre-retreat meeting, the two-day retreat in which AIM-CBCT for PTSD will be delivered, and a 60-minute post-retreat check-in meeting. Additionally, each member of the couple will be asked to complete measures on their trauma history, mental health symptoms, and relationship functioning at baseline and at two and four weeks after the retreat.
Detailed description
Numerous studies have documented an association between posttraumatic stress disorder (PTSD) symptoms and intimate relationship problems in Veterans and their partners, including relationship distress, physical and psychological aggression, and psychological distress in partners. Prior studies support the use of Cognitive-Behavioral Conjoint Therapy for PTSD (CBCT for PTSD) to treat PTSD and comorbid symptoms while simultaneously improving intimate relationship functioning. However, the standard outpatient format of CBCT for PTSD (i.e., fifteen 75-minute sessions over 15 weeks) presents challenges for many couples as well as for large-scale dissemination. To address these concerns, Dr. Steffany Fredman in collaboration with the STRONG STAR Consortium to Alleviate PTSD adapted CBCT for PTSD into an accelerated, intensive, multiple-couple format (AIM-CBCT for PTSD). The initial data of AIM-CBCT for PTSD tested in 24 couples was promising suggesting that this two-day retreat can reduce PTSD symptoms and improve mental health and relationship functioning in post-9/11 service members/veteran couples.
In September 2021, the South Texas Research Organizational Network Guiding Studies on Trauma and Resilience (STRONG STAR) initiated a clinical program which provides AIM-CBCT for PTSD to Texas Veteran couples impacted by PTSD symptoms. Within the clinical program, couples are asked to participate in an intake assessment to determine eligibility for treatment, a 60-minute pre-retreat meeting, a two-day retreat, a two-week post-retreat assessment, and a two-week post-retreat check-in. Couples who are eligible for the clinical program will be invited to participate in this replication study, which examines whether AIM-CBCT for PTSD is associated with reductions in PTSD and improvements in relationship functioning in a broader Veteran sample of up to 80 couples.
Research Questions and Hypotheses:
- Will Accelerated, Intensive, Multi-Couple Cognitive Behavioral Couples Therapy delivered in a 2-day retreat (AIM-CBCT for PTSD) be associated with significant improvements in patient-rated PTSD symptom severity, as measured by the PTSD Checklist-DSM-5 (PCL-5), when assessed two-weeks and one month after treatment? Hypothesis 1: Participation in AIM-CBCT for PTSD will be associated with a significant reduction of self-reported PTSD symptoms on the Posttraumatic Checklist-DSM 5 (PCL-5) at the one-month follow-up assessment.
- Will AIM-CBCT for PTSD be associated with significant improvements in secondary outcomes (e.g., patient self-reported comorbid symptom severity, relationship satisfaction) when assessed two-weeks and one month after treatment?
Hypothesis 2: Participation in AIM-CBCT for PTSD will be associated with a significant reduction of Veteran/Service members' self-reported mental health symptoms (Patient Health Questionnaire-9; General Anxiety Disorder-7) at the one-month follow-up assessment.
Hypothesis 3: Participation in AIM-CBCT for PTSD will be associated with a significant reduction of partners'' self-reported mental health symptoms (Patient Health Questionnaire-9; General Anxiety Disorder-7) at the one-month follow-up assessment.
Hypothesis 4: Participation in AIM-CBCT for PTSD will be associated with a significant increase in self-reported relationship satisfaction on the Couples Satisfaction Index-32) at the one-month follow-up assessment for both partners.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open-label, single group treatment study in which every couple will receive the intervention (AIM-CBCT).
| Arm | Type | Receives |
|---|---|---|
| Accelerated, Intensive, Multi-Couple Cognitive Behavioral Couples Therapy (AIM-CBCT for PTSD) | Experimental | Behavioral: Accelerated, Intensive, Multi-Couple Cognitive Behavioral Couples TherapyThis is a single-arm study in which each couple will receive AIM-CBCT. The intervention is described in the section below. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Cohabitating couples (ages 18 to 65 years old), who have been together for at least 4 months who reside in Texas.
- At least one partner in the relationship is a Texas Veteran with significant PTSD symptoms as determined by the endorsement of at least one Criterion A event on the Life Event Checklist, the endorsement of at least one re-experiencing on the PCL-5 (i.e., a score of 2 or higher on Items 1, 2, 3, 4, or 5), the endorsement of at least one avoidance symptom on the PCL-5 (i.e., a score of 2 or higher on Items 6 or 7), and a total symptom score of 31 or higher on the PCL-5.
- Both individuals must be willing to participate in the study.
- Both individuals must be able to speak and read English.
Key exclusion criteria (6 listed)
- Couple is separated and/or is taking steps to dissolve their relationship (e.g., divorce).
- Veteran or partner are currently participating in an evidence-based treatment for PTSD (Prolonged Exposure, Cognitive Processing Therapy, or Cognitive-Behavioral Conjoint Therapy for PTSD).
- Veteran or partner exhibit current psychiatric symptoms warranting immediate intervention that is beyond the scope of the treatment provided in this study.
- Veteran or partner exhibit evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires)
- Veteran or partner report current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index - Suicidality Subscale; DSI-SS)
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 |
|---|---|---|
| Accelerated, Intensive, Multi-Couple Cognitive Behavioral Couples TherapyAlso: AIM-CBCT for PTSDAIM-CBCT consists of an accelerated, 2-day delivery of the first 7 sessions of CBCT for PTSD and is comprised of (a) psychoeducation about PTSD and relationship functioning; (b) instruction in conflict management skills; (c) instruction in effective communication skills with an emphasis on the identification and sharing of emotions to decrease emotional numbing and increase emotional intimacy; (d) discussion of the importance of approaching, rather than avoiding, difficult situations and identification of places, situations, people, and feelings that the couple has heretofore avoided as a result of PTSD; (e) instruction in identification of thoughts and related feelings that can maintain PTSD and relationship distress and strategies to increase cognitive flexibility, and (f) instruction in problem-solving skills to generate couple-level approach behaviors and guidance in how to select activities that double as opportunities to approach feared situations and engage in positive bonding. | Behavioural | Accelerated, Intensive, Multi-Couple Cognitive Behavioral Couples Therapy (AIM-CBCT for PTSD) |
Primary outcome
PTSD Checklist - DSM-5 (PCL-5)
Time frame: Baseline, two-week post-retreat assessment, one-month post-retreat assessment
Change in scale measurements by the PTSD CheckList-5. The PCL-5 is a 20-item, self-report measure of PTSD symptoms experienced in the past month. Each item is rated on a severity scale ranging from 0 (Not at all) to 4 (Extremely). The measure provides a total severity score that ranges from 0 to 80, with higher scores representing more PTSD symptoms.
3 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, two-week post-retreat assessment, one-month post-retreat assessment
General Anxiety Disorder - 7 (GAD-7)
Time frame: Baseline, two-week post-retreat assessment, one-month post-retreat assessment
Couples Satisfaction Index-32 (CSI-32)
Time frame: Baseline, two-week post-retreat assessment, one-month post-retreat assessment
Results and safety
The study was stopped early (reason given: Nonrandomized, open-label study terminated at the end of the program's funding cycle.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Background: PubMed 33876831Fredman SJ, Le Y, Macdonald A, Monson CM, Rhoades GK, Dondanville KA, Blount TH, Hall-Clark BN, Fina BA, Mintz J, Litz BT, Young-McCaughan S, Jenkins AIC, Yarvis JS, Keane TM, Peterson AL; Consortium to Alleviate PTSD. A Closer Examination of Relational Outcomes from a Pilot Study of Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD with Military Dyads. Fam Process. 2021 Sep;60(3):712-726. doi: 10.1111/famp.12654. Epub 2021 Apr 20.
- Background: PubMed 32800299Fredman SJ, Macdonald A, Monson CM, Dondanville KA, Blount TH, Hall-Clark BN, Fina BA, Mintz J, Litz BT, Young-McCaughan S, Hancock AK, Rhoades GK, Yarvis JS, Resick PA, Roache JD, Le Y, Wachen JS, Niles BL, McGeary CA, Keane TM, Peterson AL; Consortium to Alleviate PTSD. Intensive, Multi-Couple Group Therapy for PTSD: A Nonrandomized Pilot Study With Military and Veteran Dyads. Behav Ther. 2020 Sep;51(5):700-714. doi: 10.1016/j.beth.2019.10.003. Epub 2019 Nov 27.
- Background: PubMed 34800060Macdonald A, Fredman SJ, Taylor DJ, Pruiksma KE, Blount TH, Hall-Clark BN, Fina BA, Dondanville KA, Mintz J, Litz BT, Young-McCaughan S, Le Y, Jenkins AIC, Monson CM, Yarvis JS, Keane TM, Peterson AL; Consortium to Alleviate PTSD. Secondary individual outcomes following multicouple group therapy for posttraumatic stress disorder: An uncontrolled pilot study with military dyads. J Trauma Stress. 2022 Feb;35(1):321-329. doi: 10.1002/jts.22729. Epub 2021 Nov 20.
- Background: PubMed 19781836Monson CM, Taft CT, Fredman SJ. Military-related PTSD and intimate relationships: from description to theory-driven research and intervention development. Clin Psychol Rev. 2009 Dec;29(8):707-14. doi: 10.1016/j.cpr.2009.09.002. Epub 2009 Sep 10.
- BackgroundMonson CM, Fredman SJ. Cognitive-behavioral conjoint therapy for posttraumatic stress disorder: Harnessing the healing power of relationships. New York: Guilford. 2012
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 18388841Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093.
- 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. This study is not recruiting at the moment.
Alan L Peterson, PhD principal investigator
UT Health Science Center San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated, Intensive, Multi-Couple Cognitive Behavioral Couples Therapy in people with Posttraumatic Stress Disorder, run by The University of Texas Health Science Center at San Antonio 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 12 Jul 2023. 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?
The study was stopped early (reason given: Nonrandomized, open-label study terminated at the end of the program's funding cycle.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Checklist - DSM-5 (PCL-5) (time frame: Baseline, two-week post-retreat assessment, one-month post-retreat assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05274061, which also lists 7 linked publications.
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 12 Jul 2023.