| Study characteristics |
| Methods |
Study design: randomised controlled trial
Study grouping: parallel group
Duration of study: 4 years (1995 to 1999)
Ethics approvals: University of New Mexico Health Sciences Center IRB
Location of study: New Mexico, USA
Randomisation method: participants mailed a postcard, and the postcard's time and date were logged into a computer and entered into a previously generated list of numbers that randomly assigned participants. |
| Participants |
Baseline characteristics
CBT (imagery rehearsal therapy)
Participants (at randomisation): 88 Gender: 100% female participants Age, M (SD): completer 40 years (11.2 years), non‐completer 37 years (12.7 years) Ethnicity: 69% non‐Hispanic white, 31% other (mostly Hispanic) Disability: not given Time since trauma: not given Income: 49% < USD 10,000, 51% > USD 10,000 Education (% high school, college or apprentice, university or years of education): 38% college degree Employment: not given Sexual violence in adulthood: 100% Comorbid conditions: not given Baseline PTSD, M (SD): 81.88 (16.96) Partnered: 38% Randomised (N): 88 Completed post‐treatment assessment (N): 44 Dropped out or removed prior to analysis (N): 34 Numbers analysed at final applicable time point (N): 54 Number of sessions: not given Treatment completion: 66 (75%)
Wait‐list
Participants (select at randomisation if available): 80 Gender: 100% female participants Age, M (SD): completer 36 years (9.3 years), non‐completer 31 years (10.5 years) Ethnicity: 55% non‐Hispanic white, 45% other (mostly Hispanic) Disability: not given Time since trauma: not given Income: 40% < USD 10,000, 60% > USD 10,000 Education (% high school, college or apprentice, university or years of education): 39% college degree Employment: not given Sexual violence in adulthood: 100% Comorbid conditions: not given Baseline PTSD, M (SD): 79.62 (24.37) Partnered: 43% Randomised (N): 80 Completed post‐treatment assessment (N): 52 Dropped out or removed prior to analysis (N): 20 Numbers analysed at final applicable time point (N): 60 Number of sessions: N/A Treatment completion: N/A
Overall
Participants (at randomisation): 168 Gender: 100% female participants Age: not given Ethnicity: 62.5% non‐Hispanic white, 37.5% other (mostly Hispanic) Disability: not given Time since trauma: not given Income: 44% < USD 10,000, 56% > USD 10,000 Education (% high school, college or apprentice, university or years of education): 38% college degree Employment: not given Sexual violence in adulthood: 100% sexual violence in adulthood, 58% multiple exposures, 90% abused as children Comorbid conditions: not given Baseline PTSD: 85% reported CAPS score > 65 Partnered: 40% Approached (N): 203 Ineligible (N): 0 Declined (N): 35 Other (N): 0 Randomised (N): 168 Completed post‐treatment assessment (N): 96 Dropped out or removed prior to analysis (N): 54 Numbers analysed at final applicable time point (N): 114 Number of sessions: N/A Treatment completion: N/A
Inclusion criteria
Female sexual assault survivors 18 years or older Self‐reported nightmares (at least once a week for more than 6 months) Insomnia PTSD coupled with criterion A trauma link (DSM‐IV)
Exclusion criteria
Acute intoxication Withdrawal Psychosis
Pretreatment: no statistically significant baseline differences with exception of age, whereby control non‐completers were younger than treatment completers |
| Interventions |
Intervention characteristics
CBT (imagery rehearsal therapy)
Planned number of intervention sessions: 3 (2 × 3‐hour sessions spaced 1 week apart with a 1‐hour follow‐up 3 weeks later) Mode of delivery (face‐to‐face, online, video, telephone, blend, with explanation): face‐to‐face Format (group, individual, blend): group Therapist qualifications and training appropriate (yes, no, unclear, with explanation): yes, although not described in any great detail, the lead author is an expert in the field of IRT for PTSD and sleep disorders. There was minimal reference to supervision and training. Treatment followed a manual and focused on nightmares within the framework of an imagery and CR paradigm. Research allegiance or conflict of interest (yes, no, unclear, with explanation): yes, cognitive‐imagery treatment was previously tested in studies of the authors. Author links to both not‐for‐profit and for‐profit sleep centres. Treatment fidelity (yes, no, unclear, with explanation): no, information for assessing fidelity not provided Intervention aim and theoretical basis: to determine if treating chronic nightmares with imagery rehearsal therapy reduces the frequency of disturbing dreams, improves sleep quality and decreases PTSD symptom severity. Involves story line alteration of the nightmare while awake, followed by rehearsal of a new set of images Duration of intervention: 4 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: contact with control participants was limited to brief telephone calls and letters to remind them of future appointments. All controls continued any treatment they were already receiving and were offered treatment at no charge on completion of their 6‐month wait‐list period. Duration of intervention: N/A
|
| Outcomes |
Adverse events
Outcome type: adverse event Notes: IRT can produce imagery adverse effects, and 4 participants reported increased negative imagery and eventually withdrew; 12 of 66 who completed treatment did not complete follow‐up for unknown reasons.
Treatment dropout (intervention only)
PTSD
|
| Identification |
Sponsorship source: NIMH (MH53239) and University of New Mexico Health Sciences Centre Research Allocation Committee
Country: USA
Setting: academic setting for intervention delivery; sample was community, rape crisis and mental health services
Authors name: Barry Krakow
Institution: University of New Mexico Health Sciences Centre
Email: bkrakow@salud.unm.edu
Year: 2001 |
| Notes |
Included in meta‐analysis |
