N/A
N=274
Cognitive-Behavioral Conjoint Therapy (CBCT) Project
Post Traumatic Stress Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02720016 ↗Enrolled (actual)
274
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Clinician Administered PTSD Scale (CAPS) — 38.456522; 37.239130; 36.933333 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CBCT-Home Based (CBCT-HB) (Behavioral); CBCT-Office Based (CBCT-OB) (Behavioral); PTSD Family Education (PFE) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinician Administered PTSD Scale (CAPS) |
25.225243; 24.869300; 28.281612 | — |
| PRIMARY Clinician Administered PTSD Scale (CAPS) |
25.225243; 24.869300; 28.281612 | — |
| PRIMARY Clinician Administered PTSD Scale (CAPS) |
25.225243; 24.869300; 28.281612 | — |
| PRIMARY Clinician Administered PTSD Scale (CAPS) |
25.225243; 24.869300; 28.281612 | — |
| PRIMARY Couples Satisfaction Index (CSI) |
109.384934; 110.919753; 118.410443 | — |
| PRIMARY Couples Satisfaction Index (CSI) |
109.384934; 110.919753; 118.410443 | — |
| PRIMARY Couples Satisfaction Index (CSI) |
109.384934; 110.919753; 118.410443 | — |
| PRIMARY Couples Satisfaction Index (CSI) |
109.384934; 110.919753; 118.410443 | — |
| PRIMARY Couples Satisfaction Index (CSI) |
109.384934; 110.919753; 118.410443 | — |
| PRIMARY Inventory of Psychosocial Functioning (IPF) |
38.3285; 34.5207; 37.2820 | — |
| PRIMARY Inventory of Psychosocial Functioning (IPF) |
38.3285; 34.5207; 37.2820 | — |
| PRIMARY Inventory of Psychosocial Functioning (IPF) |
38.3285; 34.5207; 37.2820 | — |
| PRIMARY Inventory of Psychosocial Functioning (IPF) |
38.3285; 34.5207; 37.2820 | — |
| PRIMARY Inventory of Psychosocial Functioning (IPF) |
38.3285; 34.5207; 37.2820 | — |
| PRIMARY Client Satisfaction Questionnaire (CSQ) |
3.389157; 3.423814; 3.421993 | — |
| PRIMARY Working Alliance Inventory- Short Form (WAI-S) |
72.099053; 73.882508; 75.647561 | — |
| PRIMARY Working Alliance Inventory- Short Form (WAI-S) |
72.099053; 73.882508; 75.647561 | — |
| SECONDARY PTSD Checklist-5 (PCL-5) |
35.6725; 31.0392; 39.8824; 27.8900; 25.1507; 27.9336 | — |
| SECONDARY PTSD Checklist-5 (PCL-5) |
35.6725; 31.0392; 39.8824; 27.8900; 25.1507; 27.9336 | — |
| SECONDARY PTSD Checklist-5 (PCL-5) |
35.6725; 31.0392; 39.8824; 27.8900; 25.1507; 27.9336 | — |
| SECONDARY PTSD Checklist-5 (PCL-5) |
35.6725; 31.0392; 39.8824; 27.8900; 25.1507; 27.9336 | — |
| SECONDARY PTSD Checklist-5 (PCL-5) |
35.6725; 31.0392; 39.8824; 27.8900; 25.1507; 27.9336 | — |
| SECONDARY Beck Depression Inventory-II (BDI-2) |
18.0075; 14.9098; 20.0467; 12.1675; 11.5881; 11.1593 | — |
| SECONDARY Beck Depression Inventory-II (BDI-2) |
18.0075; 14.9098; 20.0467; 12.1675; 11.5881; 11.1593 | — |
| SECONDARY Beck Depression Inventory-II (BDI-2) |
18.0075; 14.9098; 20.0467; 12.1675; 11.5881; 11.1593 | — |
| SECONDARY Beck Depression Inventory-II (BDI-2) |
18.0075; 14.9098; 20.0467; 12.1675; 11.5881; 11.1593 | — |
| SECONDARY Beck Depression Inventory-II (BDI-2) |
18.0075; 14.9098; 20.0467; 12.1675; 11.5881; 11.1593 | — |
| SECONDARY State-Trait Anger Inventory (STAXI) |
19.9870; 20.0932; 20.8182; 17.5131; 17.2149; 17.7645 | — |
| SECONDARY State-Trait Anger Inventory (STAXI) |
19.9870; 20.0932; 20.8182; 17.5131; 17.2149; 17.7645 | — |
| SECONDARY State-Trait Anger Inventory (STAXI) |
19.9870; 20.0932; 20.8182; 17.5131; 17.2149; 17.7645 | — |
| SECONDARY State-Trait Anger Inventory (STAXI) |
19.9870; 20.0932; 20.8182; 17.5131; 17.2149; 17.7645 | — |
| SECONDARY State-Trait Anger Inventory (STAXI) |
19.9870; 20.0932; 20.8182; 17.5131; 17.2149; 17.7645 | — |
| SECONDARY Conflict Tactics Scale Short Form- (CTS-2S) |
4.2911; 4.1617; 3.1872; 3.9574; 4.5597; 3.5832 | — |
| SECONDARY Conflict Tactics Scale Short Form- (CTS-2S) |
4.2911; 4.1617; 3.1872; 3.9574; 4.5597; 3.5832 | — |
| SECONDARY Conflict Tactics Scale Short Form- (CTS-2S) |
4.2911; 4.1617; 3.1872; 3.9574; 4.5597; 3.5832 | — |
| SECONDARY Conflict Tactics Scale Short Form- (CTS-2S) |
4.2911; 4.1617; 3.1872; 3.9574; 4.5597; 3.5832 | — |
| SECONDARY Conflict Tactics Scale Short Form- (CTS-2S) |
4.2911; 4.1617; 3.1872; 3.9574; 4.5597; 3.5832 | — |
Summary
Untreated posttraumatic stress disorder (PTSD) is a costly condition associated with impairment in functioning across a host of psychosocial domains including occupational and academic functioning, marital and family functioning, parenting, and socialization. Impairment is not limited to Veterans with PTSD because the entire family is affected, particularly the Veteran's intimate partner. PTSD symptoms can produce negative effects on both members of the dyad. Despite the need for treatment, many Veterans and their families do not access PTSD-related services due to a number of barriers to accessing care (e.g., living in rural or remote areas where no specialty services exist, concerns about stigma around using mental health services, limited clinic hours to accommodate patient schedules). The objective of this study is to assess whether providing Cognitive-Behavioral Conjoint Therapy, in which PTSD symptoms and intimate relationship functioning are addressed, to Veterans and their romantic partners in their homes via clinical video teleconferencing leads to better outcomes compared to office based treatment.
Eligibility Criteria
Inclusion Criteria
- Be a Veteran (age 18 or older) with a current Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of PTSD (as assessed by the CAPS) no less than 3 months after the index trauma occurred (to allow for potential natural recovery)
- Be on a stable psychoactive medication regimen for at least 2 months (if eligible)
- Be an intimate partner (age 18 or older) who is willing to participate in the intervention.
- Be randomized into any of the three treatment conditions
- Have assessment and treatment sessions audio recorded
- Agree not to receive other individual or conjoint psychotherapy for PTSD during the treatment portion of the study
- Consistent with home-based clinical trials and actual clinical practice
- Participants enrolled into the study will need to have access to internet via Digital Subscriber Line (DSL) or a cable provider in case they are randomized into the home-based condition.
- The frequency of occurrence of no internet service will be tracked
- If the PTSD-positive Veteran is currently receiving treatment at the VA, study staff will consult with their primary clinician prior to their inclusion in the study
Exclusion Criteria
- Current substance dependence in either member of the couple not in remission for at least 3 months, as assessed by the Alcohol Use Disorders Identification Test (AUDIT)108 and Drug Abuse Screening Test (DAST)
- Any current uncontrolled psychotic disorder in either member of the couple
- Imminent suicidality or homicidality in either member of the couple
- Any severe cognitive impairment in either member of the couple
- Any perpetration of severe physical or sexual relationship aggression in the past year (as assessed by the Conflict Tactics Scale-2 [CTS-2]).
- Participants who do not meet study criteria will be offered referrals to alternate services, as well as assistance in contacting the referral sites as needed
Data sourced from ClinicalTrials.gov (NCT02720016). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.