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. 2023 Oct 5;2023(10):CD013456. doi: 10.1002/14651858.CD013456.pub2

Acierno 2021.

Study characteristics
Methods Study design: randomised controlled trial
Study grouping: parallel group
Duration of study: 30 October 2014 to 10 September 2019
Location of study: Southeastern USA
Randomisation method: eligible veterans were randomised by the project co‐ordinator using REDCap 1:1 to PE using HBT or in‐person PE, and REDCap generated assignments that were saved as they were made and reviewed by the study statistician; thereby, no modification or skipping of assignments was possible.
Ethics approvals: not given
Participants Baseline characteristics
CBT (PE via HBT)
  • Participants: 69

  • Gender: 100% female participants

  • Age, M (SD): 41.55 years (12.10 years)

  • Ethnicity: 30.43% white, 62.32% African American, 7.25% other

  • Disability: not given

  • Time since trauma: not given

  • Income: not given

  • Education: not given

  • Employment: not given

  • Sexual violence in adulthood: 100%

  • Comorbid conditions: not given

  • Baseline PTSD, M (SD): 52.90 (12.91)

  • Partnered: not given

  • Randomised (N): 69

  • Completed post‐treatment assessment (N): 46

  • Dropped out or removed prior to analysis (N): 27

  • Numbers analysed at final applicable time point (N): 42

  • Number of sessions, M (SD): 6.80 (4.14)

  • Treatment completion: 34 (49.27%)


CBT (PE via in‐person)
  • Participants: 67

  • Gender (% female, male, other): 100% female participants

  • Age in years (M, SD): 45.31 (10.63)

  • Ethnicity: 28.36% white, 65.67% African American, 5.97% other

  • Disability: not given

  • Time since trauma: not given

  • Income: not given

  • Education: not given

  • Employment: not given

  • Sexual violence in adulthood: 100%

  • Comorbid conditions: not given

  • Baseline PTSD, M (SD): 52.30 (12.42)

  • Partnered: not given

  • Randomised (N): 67

  • Completed post‐treatment assessment (N): 49

  • Dropped out or removed prior to analysis (N): 22

  • Numbers analysed at final applicable time point (N): 45

  • Number of sessions, M (SD): 6.28 (4.33)

  • Treatment completion: 33 (49.25%)


Overall
  • Participants: 136

  • Gender: 100% female participants

  • Age, M (SD): 43.40 years (11.51 years)

  • Ethnicity: 29.41% white, 63.97% African American, 6.62% other

  • Disability: not given

  • Time since trauma: not given

  • Income: not given

  • Education: not given

  • Employment: not given

  • Sexual violence in adulthood: 100%

  • Comorbid conditions: not given

  • Baseline PTSD, M (SD): 52.60 (12.63)

  • Partnered: not given

  • Approached (N): 172

  • Ineligible (N): 19

  • Declined (N): 16

  • Other (N): 1

  • Randomised (N): 136

  • Completed post‐treatment assessment (N): 95

  • Dropped out or removed prior to analysis (N): 49

  • Numbers analysed at final applicable time point (N): 87

  • Number of sessions, M (SD): 6.54 (4.23)

  • Treatment completion: 67 (49.26%)


Inclusion criteria
  • An MST‐related index event as identified on the Stressful Events for Veterans Questionnaire

  • Met criteria for PTSD related to MST based on the Clinician‐Administered PTSD Scale


Exclusion criteria
  • Active psychosis or dementia at screening

  • Current suicidal ideation with clear intent

  • Current severe substance use disorder

  • Concurrently enrolled in a clinical trial for PTSD or depression or if they had a household member in the study

  • Further, medication stabilisation was ensured with a 4‐week waiting period after recent medication change prior to enrolling in the study for more information about study design.


Pretreatment: those assigned to the in‐person delivery condition were more likely to be Hispanic, but no other group differences were identified.
Interventions Intervention characteristics
CBT (PE via HBT)
  • Planned number of intervention sessions: 12 to 15

  • Mode of delivery (face‐to‐face, online, video, telephone, blend, with explanation): teleconference (video/audio)

  • Format (group, individual, blend): individual

  • Therapist qualifications and training appropriate (yes, no, unclear, with explanation): unclear, no information given

  • Research allegiance or conflict of interest (yes, no, unclear, with explanation): no, team is committed to establishing if HBT delivery brings benefits and has used the technology in several other trials, but there is no clear evidence of a conflict of interest.

  • Treatment fidelity (yes, no, unclear, with explanation): no, information not given

  • Intervention aim and theoretical basis: PE is a manualised treatment (Foa 2007) that includes the following components: 1) psychoeducation and treatment rationale (Sessions 1 and 2); 2) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during Sessions 3 through 11); 3) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during Sessions 3 through 11, and participants listen to session audiotapes for homework between sessions), and 4) relapse prevention strategies and further treatment planning (Session 12).

  • Duration of intervention: 12 weeks to 15 weeks


CBT (PE via in‐person)
  • Planned number of intervention sessions: 12 to 15

  • Mode of delivery (face‐to‐face, online, video, telephone, blend, with explanation): face‐to‐face

  • Format (group, individual, blend): individual

  • Therapist qualifications and training appropriate (yes, no, unclear, with explanation): unclear, no information given

  • Research allegiance or conflict of interest (yes, no, unclear, with explanation): no

  • Treatment fidelity (yes, no, unclear, with explanation): unclear, no information given

  • Intervention aim and theoretical basis: in the case of women with a history of MST, accessibility will be enhanced by removing a barrier to care associated with the treatment environment that can potentially elicit an anxiety and avoidance response in the target population. HBT care is delivered using via Movi/Jabber software packages installed on standard tablet devices or home computers with standard internet connections to teleconference (video and audio) in real time.

  • Duration of intervention: 12 weeks to 15 weeks

Outcomes PTSD
  • Outcome type: continuous outcome

  • Scale used: PCL‐5

  • Direction: lower is better

  • Score range: 0 to 80

  • Data value: endpoint


Depression
  • Outcome type: continuous outcome

  • Scale used: BDI‐II

  • Direction: lower is better

  • Score range: 0 to 63

  • Data value: endpoint


Treatment dropout
  • Outcome type: dichotomous outcome

Identification Sponsorship source: Department of Defense (W81XWH‐14‐1‐0264; PI: Acierno) and from the NIMH (T32 MH18869, PIs: Kilpatrick and Danielson)
Country: USA
Setting: VA Medical Centre; individuals from range of VA support services and affiliated community clinics screening positive for MST‐related PTSD
Authors name: Ronald Acierno
Institution: McGovern Medical School, University of Texas
Email: ronald.acierno@uth.tmc.edu
Address: N/A
Year: unpublished
Notes Unpublished data. This study is under review. This paper should not be used for any other purpose or shared with anyone else.
Data not included in meta‐analysis
Communicated with the author(s) for purpose of review