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

Galovski 2016.

Study characteristics
Methods Study design: randomised controlled trial
Study grouping: parallel group
Duration of study: not given
Ethics approvals: all study procedures were approved by the IRB at the University of Missouri‐St. Louis.
Location of study: St. Louis, Missouri, USA
Randomisation method: using a 1:1 allocation ratio, a computer‐generated randomisation sequence randomised eligible participants to the ssmCPT condition or sleep‐directed hypnosis condition.
Participants Baseline characteristics
CBT (CPT)
  • Participants (at randomisation): 56

  • Gender: 100% female participants

  • Age: not given

  • Ethnicity: not given

  • Disability: not given

  • Time since trauma: not given

  • Income: not given

  • Education, M (SD) years: 13.5 (3.19)

  • Employment: not given

  • Sexual violence in adulthood: not given

  • Comorbid conditions: not given

  • Baseline PTSD, M (SD): 69.23 (15.74)

  • Partnered: not given

  • Randomised (N): 56

  • Completed post‐treatment assessment (N): 25

  • Dropped out or removed prior to analysis (N): 21

  • Numbers analysed at final applicable time point (N): 35

  • Number of sessions: not given

  • Treatment completion: 25 (52%)


CBT (CPT + hypnosis)
  • Participants (at randomisation): 52

  • Gender: 100% female participants

  • Age: not given

  • Ethnicity: not given

  • Disability: not given

  • Time since trauma: not given

  • Income: not given

  • Education, M (SD) years: 14.7 (2.46)

  • Employment: not given

  • Sexual violence in adulthood: not given

  • Comorbid conditions: not given

  • Baseline PTSD, M (SD): 72.48 (15.01)

  • Partnered: not given

  • Randomised (N): 52

  • Completed post‐treatment assessment (N): 29

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

  • Numbers analysed at final applicable time point (N): 30

  • Number of sessions: not given

  • Treatment completion: 26 (59%)


Overall
  • Participants (at randomisation): 108

  • Gender: 100% female participants

  • Age, M (SD): 36.87 years (11.8 years)

  • Ethnicity: 50% predominantly Black; 50% predominantly white; 20% mixed race; 3% Hispanic

  • Disability: not given

  • Time since trauma, M (SD): 196 months (170.4 months)

  • Income: 74% < USD 20,000

  • Education (% high school, college or apprentice, university or years of education; M (SD) years): 50% at least some post‐high school education; 14.16 years (2.89 years)

  • Employment: not given

  • Sexual violence in adulthood: 63% sexual violence in adulthood; complex trauma histories, with lifetime endorsements of child sexual abuse 71%, child physical abuse 58%, adult criminal victimisation 32% and domestic violence 56%

  • Comorbid conditions: not given

  • Baseline PTSD: not given

  • Partnered: 46%

  • Approached (N): 181

  • Ineligible (N): 62

  • Declined (N): 11

  • Other (N): 0

  • Randomised (N): 108

  • Completed post‐treatment assessment (N): 54

  • Dropped out or removed prior to analysis (N): 43

  • Numbers analysed at final applicable time point (N): 65

  • Number of sessions: not given

  • Treatment completion: 51 (47%)


Inclusion criteria
  • Female gender

  • Diagnosis of PTSD secondary to sexual or physical assault

  • Clinically significant sleep impairment as indicated by a severity score of 3 or more on the CAPS sleep impairment symptom

  • At least 3 months post‐trauma at initial assessment

  • Stable on any psychotropic medication for at least 1 month


Exclusion criteria
  • Psychosis

  • Learning disability

  • Active suicidality, parasuicidality

  • Current drug or alcohol dependence

  • Individuals currently in an abusive relationship or being stalked

  • No prior therapy with CPT, or current trauma‐ or sleep‐focused therapy


Pretreatment: years of education was the only difference detected, being slightly higher in the hypnosis group.
Interventions Intervention characteristics
CBT (cognitive processing theory)
  • Planned number of intervention sessions: 12

  • 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, questionable whether the therapists were sufficiently experienced to deliver the CPT and hypnosis, given the high level of dropout from treatment and average scores on independent ratings, although study was strong on supervision and fidelity checks.

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

  • Treatment fidelity (yes, no, unclear, with explanation): yes, the CPT and hypnosis manuals and relevant readings were provided in the training. Expert CPT clinicians not otherwise affiliated with the study reviewed and rated treatment sessions for adherence and competence. Scores were acceptable, although some concerns around the drop out rate for 1 therapist and unclear if detected in the fidelity assessment

  • Intervention aim and theoretical basis: following the 3 weeks of daily symptom monitoring, ssmCPT participants received CPT (see Resick 2010 for a complete protocol). CPT is predominantly a cognitive therapy in which patients are taught to identify, question, challenge and replace faulty assumptions and thoughts about the traumatic event and its implications in their current lives. While the patients engage with the traumatic memory, they are able to allow natural affect to run its course. CPT first targets specific, inaccurate interpretations of the trauma itself and then targets current and future maladaptive and inaccurate beliefs about world, self and others across a number of belief systems typically disrupted after experiencing a traumatic event.

  • Duration of intervention: 15 weeks; 3 weeks of symptom monitoring plus 12 weeks of CPT


CBT (CPT + hypnosis)
  • Planned number of intervention sessions: 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): as before

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

  • Treatment fidelity (yes, no, unclear, with explanation): as before

  • Intervention aim and theoretical basis: researchers hypothesised that improvements in sleep realised during hypnosis would augment CPT, such that PTSD symptom reduction (during CPT) would be greater in the CPT + hypnosis condition relative to the CPT condition. Hypnosis was conducted in accordance with a manual devised for the trial following Wright 1987.

  • Duration of intervention: 15 weeks

Outcomes PTSD
  • Outcome type: continuous outcome

  • Scale used: CAPS

  • Direction: lower is better

  • Score range: 0 to 80

  • Data value: endpoint, 3 months


Depression
  • Outcome type: continuous outcome

  • Scale used: BDI‐II

  • Direction: lower is better

  • Score range: 0 to 63

  • Data value: endpoint, 3 months


Treatment dropout
  • Outcome type: dichotomous outcome

Identification Sponsorship source: National Institutes of Health
Country: USA
Setting: community sample recruited through flyers, advertisements, referrals and word‐of‐mouth; academic setting for intervention
Authors name: Tara E Galovski
Institution: University of Missouri
Email: galovskit@msx.umsl.edu
Year: 2016
Notes Not included in meta‐analysis