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

Rothbaum 2005.

Study characteristics
Methods Study design: randomised controlled trial
Study grouping: parallel group
Duration of study: not given
Ethics approvals: the informed consent form and this study were approved by an IRB (Emory).
Location of study: Atlanta, Georgia, USA
Randomisation method: not given
Participants Baseline characteristics
Behavioural (EMDR)
  • Participants (completers): 20

  • Gender: 100% female participants

  • Age: not given

  • Ethnicity: not given

  • Disability: not given

  • Time since trauma, M (SD): 145.9 months (146.8 months)

  • Income: not given

  • Education: not given

  • Employment: not given

  • Sexual violence in adulthood: not given

  • Comorbid conditions: not given

  • Baseline PTSD, M: 80

  • Partnered: not given

  • Randomised (N): 25

  • Completed post‐treatment assessment (N): 20

  • Dropped out or removed prior to analysis (N): 5

  • Numbers analysed at final applicable time point (N): 19

  • Number of sessions: not given

  • Treatment completion: 20 (80%)


CBT (PE)
  • Participants (completers): 20

  • Gender: 100% female participants

  • Age: not given

  • Ethnicity: not given

  • Disability: not given

  • Time since trauma, M (SD): 120.9 months (94.1 months)

  • Income: not given

  • Education: not given

  • Employment: not given

  • Sexual violence in adulthood: not given

  • Comorbid conditions: not given

  • Baseline PTSD, M: 61

  • Partnered: not given

  • Randomised (N): 23

  • Completed post‐treatment assessment (N): 20

  • Dropped out or removed prior to analysis (N): 5

  • Numbers analysed at final applicable time point (N): 18

  • Number of sessions: not given

  • Treatment completion: 20 (87%)


Wait‐list
  • Participants (completers): 20

  • Gender: 100% female participants

  • Age: not given

  • Ethnicity: not given

  • Disability: not given

  • Time since trauma, M (SD): 162.9 months (136.9 months)

  • Income: not given

  • Education: not given

  • Employment: not given

  • Sexual violence in adulthood: not given

  • Comorbid conditions: not given

  • Baseline PTSD, M: 78

  • Partnered: not given

  • Randomised (N): 24

  • Completed post‐treatment assessment (N): 20

  • Dropped out or removed prior to analysis (N): 20

  • Numbers analysed at final applicable time point (N): 0


Overall
  • Participants (select at randomisation if available): 60

  • Gender: 100% female participants

  • Age, M (SD): 33.8 years (11.0 years)

  • Ethnicity: 68% white

  • Disability: not given

  • Time since trauma: not given

  • Income: 30% household income USD 40,000 or higher

  • Education (% high school, college or apprentice, university or years of education): 48% college degree or higher

  • Employment (% employed; unemployed, other): 77% employed or full‐time students

  • Sexual violence in adulthood: 100% sexual violence > 12 years; including the index assault, participants experienced a mean of 6.0 traumas (SD = 4.1) prior to study entry

  • Comorbid conditions: 65% had 1 or more comorbid mental health diagnosis.

  • Baseline PTSD: not given

  • Partnered: 26.7%

  • Approached (N): not given

  • Ineligible (N): 1

  • Declined (N): not given

  • Other (N): 1

  • Randomised (N): 72

  • Completed post‐treatment assessment (N): 60

  • Dropped out or removed prior to analysis (N): 35

  • Numbers analysed at final applicable time point (N): 37


Inclusion criteria
  • A rape or attempted rape in adulthood (age 12 years or older) or a single incident of rape in childhood (age 0 years to 11 years) by either a family or a non‐family member

  • If taking psychotropic medication, participants were required to be stable on the medication at the same dosage for 30 d prior to study entry and to agree not to change medication or dosage for duration of the study.


Exclusion criteria
  • History of schizophrenia or other psychoses

  • Current suicidal risk or practised self‐mutilation

  • Illiterate and thus unable to complete self‐reports

  • Current alcohol or drug dependence as determined by the Structured Clinical Interview for the DSM‐IV

  • Blind or had a history of serious eye disease (e.g. detached retina) that would cause risk with rapid eye movement

  • Use of cocaine in any form within 60 d of treatment administration

  • In an ongoing threatening situation (e.g. domestic violence)


Pretreatment: participants in the EMDR condition exhibited significantly higher overall PTSD symptoms; higher levels of intrusive symptoms on the PSS; and higher levels of depression, dissociation and trait anxiety than the PE group.
Interventions Intervention characteristics
Behavioural (EMDR)
  • Planned number of intervention sessions: 9 (× 90 min)

  • 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, there was not much information other than that participants were assigned to 1 of 3 doctoral‐level psychologists who were trained in both therapies.

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

  • Treatment fidelity (yes, no, unclear, with explanation): yes, 92.09% of sessions adherent for essential and unique items; therapist skill was rated 6.04 (SD 0.58)

  • Intervention aim and theoretical basis: EMDR involves having the patient imagine a scene that represents the worst part of the trauma, focusing on the sensations of distress in her body, and rehearsing negative thoughts that match the picture. The patient simultaneously follows the therapist’s fingers moving back and forth approximately 18 inches in front of her, a minimum of 20 times each repetition. Distress ratings are gathered using a SUDs from 0 to 10. Once the distress about this scene from the memory drops to 0 or 1, the patient is asked to track the therapist’s finger while rehearsing a new, preferred belief, repeating this sequence until the new statement feels true to the patient. Cognitive work is accomplished through the use of cognitive interweaves.

  • Duration of intervention: 5 weeks


CBT (PE)
  • Planned number of intervention sessions: 9 (× 90 min)

  • 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): as previous

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

  • Treatment fidelity (yes, no, unclear, with explanation): yes, 90.46% of sessions adherent for essential and unique items; therapist skill was rated 5.80 (SD = 0.66)

  • Intervention aim and theoretical basis: PE treatment (Foa 1998; Foa 1991) – a hierarchy of avoided situations is constructed for in vivo exposure homework. The next 7 sessions are devoted to reliving the rape scene in imagination. Participants are instructed to try to imagine the assault scene as vividly as possible and describe it aloud in the present tense. Anxiety levels (SUDs 0 to 100) are monitored every 5 min during exposure. Participants are encouraged to describe the rape in its entirety, repeating it several times for 45 min to 60 min per session. Following exposure, the participant’s reaction to the exposure situation is discussed, and a homework assignment is assigned. Participants' narratives are tape‐recorded, and they are instructed to listen to the tapes at home at least once daily.

  • Duration of intervention: 5 weeks


Wait‐list
  • Planned number of intervention sessions: N/A

  • Mode of delivery: N/A

  • Format: N/A

  • Therapist qualifications and training appropriate: N/A

  • Research allegiance or conflict of interest: N/A

  • Treatment fidelity: N/A

  • Intervention aim and theoretical basis: N/A

  • Duration of intervention: N/A

Outcomes Depression
  • Outcome type: continuous outcome

  • Scale used: BDI

  • Direction: lower is better

  • Score range: 0 to 63

  • Data value: endpoint and 6 months


Treatment dropout
  • Outcome type: dichotomous outcome


Anxiety
  • Outcome type: continuous outcome

  • Scale used: STAI‐State

  • Direction: lower is better

  • Score range: 0 to 80

  • Data value: endpoint and 6 months


Dissociation
  • Outcome type: continuous outcome

  • Scale used: Dissociative Experiences Scale‐II

  • Direction: lower is better

  • Score range: 0 to 100

  • Data value: endpoint and 6 months

Identification Sponsorship source: NIMH grant 1 R01 MH56351‐01A1
Country: USA
Setting: women with rape‐related PTSD; interventions delivered in clinical academic setting
Authors name: Barbara O Rothbaum
Institution: Emory University
Email: brothba@emory.edu
Year: 2005
Notes No explanation on where sample was derived from. The 60 in the population characteristics is the intervention completer sample. Final time point is 6 months with 18 PE and 19 EMDR participants and no control.