| Study characteristics |
| Methods |
Study design: randomised controlled trial
Study grouping: parallel group
Duration of study: not given
Location of study: Dallas, Texas, USA
Randomisation method: for the purpose of randomisation, participants were assigned sequential PIN numbers as they entered the study. Blocks of random numbers were generated for each therapist and were allocated to either CPT or PCT using a conditional statement. The random number sequence was maintained on an Excel spreadsheet, and as participants’ PINs were entered into the spreadsheet, the preassigned condition was revealed. Assignment to therapist was based on therapist availability.
Ethics approvals: all study‐related procedures were conducted in compliance with the IRB of the VA North Texas Health Care System, Dallas VA Medical Center. |
| Participants |
Baseline characteristics
CBT (CPT)
Participants (completers): 52 Gender: 83% female participants; 17% (9) male participants Age, M (SD): 44.6 years (10.5 years) Ethnicity: 44% white, non‐Hispanic, 39% Black, 17% other Disability: 61% (based on disability status approved), 20% (based on PTSD disability status approved) Time since trauma: not given Income: not given Education (% high school, college or apprentice, university or years of education): 17% high school, 67% college, 16% post‐college Employment (% employed, unemployed, other): 44% employed, 35% unemployed, 21% other Sexual violence in adulthood: 100% Comorbid conditions: 61% VA disability status Baseline PTSD, M (SD): 85.07 (2.69) Partnered: 29% Randomised (N): 72 Completed post‐treatment assessment (N): 45 Dropped out or removed prior to analysis (N): 20 Numbers analysed at final applicable time point (N): 52 Number of sessions, M (SD): 9.7 (3.5) Treatment completion: 34 (47%)
Other psychologically orientated interventions (PCT)
Participants (completers): 34 Gender: 88% female participants, 12% (4) male participants Age, M (SD): 48.4 years (8.2 years) Ethnicity: 44% white, non‐Hispanic, 44% Black, 12% other Disability: 65% (based on disability status approved), 24% (based on PTSD disability status approved) Time since trauma: not given Income: not given Education (% high school, college or apprentice, university or years of education): 26% high school, 62% college, 12% post‐college Employment (% employed, unemployed, other): 32% employed, 41% unemployed, 27% other Sexual violence in adulthood: 100% Comorbid conditions: 65% VA disability status Baseline PTSD, M (SD): 83.81 (3.29) Partnered: 32% Randomised (N): 57 Completed post‐treatment assessment (N): 44 Dropped out or removed prior to analysis (N): 23 Numbers analysed at final applicable time point (N): 34 Number of sessions, M (SD): 10.7 (3.1) Treatment completion: 28 (49%)
Overall
Participants (select at randomisation if available): 86 Gender: 85% female participants, 15% male participants Age, M (SD): 46.1 years (9.8 years) Ethnicity: 44% white, non‐Hispanic; 41% Black; 15% other Disability: 62% (based on disability status approved), 21% (based on PTSD disability status approved) Time since trauma: not given Income: not given Education (% high school, college or apprentice, university or years of education): 21% high school, 65% college, 14% post‐college Employment (% employed, unemployed, other): 39% employed, 37% unemployed, 24% other Sexual violence in adulthood: 100% Comorbid conditions: 62% VA disability status Baseline PTSD: not given Partnered: 30% Approached (N): 481 Ineligible (N): 147 Declined (N): 119 Other (N): 86 Randomised (N): 129 Completed post‐treatment assessment (N): 89 Dropped out or removed prior to analysis (N): 43 Numbers analysed at final applicable time point (N): 86
Inclusion criteria
Veteran status with a current diagnosis of PTSD related to MST MST event occurred ≥ 3 months prior to study entry MST was the veteran’s lifetime trauma associated with the most severe current distress Veteran had > 1 clear memory of the trauma Any psychiatric medication regimen was stable for ≥ 6 weeks
Exclusion criteria
Active substance dependence within the last 3 months Current psychotic symptoms Current unstable bipolar disorder Current prominent suicidal or homicidal intent Severe cognitive impairment Currently receiving other psychotherapy specifically for PTSD Current involvement in a violent relationship
Pretreatment: although the 2 treatment groups did not significantly differ in any demographic characteristics, the baseline CAPS re‐experiencing subscale (CAPS B) was significantly higher for the CPT than for the PCT group. This difference was addressed in relevant statistical analyses. |
| Interventions |
Intervention characteristics
CBT (CPT)
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): yes, 4 master's‐ or doctoral‐level mental health providers were trained in both the CPT and PCT protocols. Research allegiance or conflict of interest (yes, no, unclear, with explanation): unclear, as Chard, a co‐author of the current paper, is one of the authors of the adapted CPT tested in this randomised controlled trial. Thus, there may have been an incentive to see the therapy work. On the other hand, Alina Suris led the current paper and is based at different institution, and there were good efforts to monitor fidelity. Treatment fidelity (yes, no, unclear, with explanation): yes, all therapy sessions were videotaped after obtaining informed consent. A minimum of 2 practice cases were required for each treatment modality. Therapists received weekly supervision, including videotape review. Twelve per cent of therapy tapes from each condition were randomly selected for rating by an independent expert. Ratings were made on a scale of 1 = poor to 7 = excellent, with 4 = satisfactory. Ratings were made for unique and essential elements specific to each session of each therapy approach, as well as essential but not unique elements (i.e. rapport‐related) that were the same for every session across both approaches. Ratings were averaged across sessions for each therapist, for each condition. Treatment fidelity analysis indicated a below‐satisfactory competency rating in the CPT condition for 1 therapist. This therapist’s data were excluded from study analyses (129 to 86). Intervention aim and theoretical basis: CPT is a manualised CBT developed by Resick 1993 for the treatment of rape‐related PTSD and further adapted for the treatment of PTSD in veterans and military personnel (Resick 2008b). CPT provides a framework for conceptualising PTSD as a disorder of nonrecovery from trauma. Interventions include education, CR and writing trauma narratives. The first 7 sessions address education, examination of thoughts through Socratic dialogue and skill building; the remaining 5 sessions challenge beliefs surrounding themes of safety, trust, power, self‐esteem and intimacy. Duration of intervention: 6 weeks to 12 weeks
Other psychologically orientated interventions (PCT)
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): yes, as previous Research allegiance or conflict of interest (yes, no, unclear, with explanation): no Treatment fidelity (yes, no, unclear, with explanation): yes, as previous Intervention aim and theoretical basis: PCT is a manualised therapy for the treatment of PTSD, but without the cognitive‐behavioural or trauma‐focused components of CPT. In PCT, therapeutic focus is deliberately redirected away from discussion of traumatic events. PCT provides general support and education focused on current issues in the participant’s life. Emphasis is on problem‐solving and improving relationships, with connections made between current problems and PTSD symptoms. Like CPT, PCT utilises a written component, but in the form of daily journaling as opposed to written trauma accounts. In the current study, the number of sessions of PCT was extended from 10 to 12 to match the time and attention components of CPT. The PCT manual has not been published. Duration of intervention: 6 weeks to 12 weeks
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| Outcomes |
PTSD (PCL‐C)
Outcome type: continuous outcome Scale: PCL‐C Direction: lower is better Score range: 17 to 85 Data value: endpoint, 3 months and 6 months
PTSD
Outcome type: continuous outcome Scale: CAPS Direction: lower is better Score range: 0 to 80 Data value: endpoint, 3 months and 6 months
Depression
Outcome type: continuous outcome Scale: Quick Inventory of Depressive Symptomology Direction: lower is better Score range: 0 to 27 Data value: endpoint, 3 months and 6 months
PTSD
Outcome type: continuous outcome Scale: PCL‐5 Direction: lower is better Score range: 0 to 80 Data value: endpoint, 3 months and 6 months
PTSD
Outcome type: continuous outcome Scale: PSS‐I Direction: lower is better Score range: 0 to 51 Data value: endpoint, 3 months and 6 months
PTSD
Outcome type: continuous outcome Scale: PSS‐SR Direction: lower is better Score range: 0 to 119 Data value: endpoint, 3 months and 6 months
Depression
Outcome type: continuous outcome Scale: BDI Direction: lower is better Score range: 0 to 63 Data value: endpoint, 3 months and 6 months
PTSD
Outcome type: continuous outcome Scale: IES‐R Intrusion Direction: lower is better Score range: 0 to 4 Data value: endpoint, 3 months and 6 months
PTSD
Outcome type: continuous outcome Scale: IES‐R Avoidance Direction: lower is better Score range: 0 to 4 Data value: endpoint, 3 months and 6 months
PTSD
Outcome type: continuous outcome Scale: IES‐R Hyperarousal Direction: lower is better Score range: 0 to 4 Data value: endpoint, 3 months and 6 months
PTSD
Outcome type: continuous outcome Scale: MPSS‐SR Direction: lower is better Score range: 0 to 119 Data value: endpoint, 3 months and 6 months
Adverse events
Outcome type: adverse event Notes: during the course of the study, there were 3 adverse events in the CPT condition (1 suicide attempt by overdose and 2 psychiatric hospitalisations) and 2 adverse events in the PCT condition (1 suicide attempt by overdose and 1 psychiatric hospitalisation). No events were deemed definitely study‐related; however, 1 psychiatric hospitalisation in the CPT condition was deemed possibly related. "Although we did not collect data on causes of dropout, we hypothesize that this is related to the fact that participants write their trauma narratives as homework for sessions 3 and 4. The writing of trauma narratives can be an especially challenging component of this therapy approach in terms of the emotional demands involved. Dropping out of therapy is one method of avoidance coping when faced with distressing emotions, or even the possibility of distressing emotions. In addition to the emotional demands of directly confronting one’s trauma, CPT is also more demanding in terms of the mental focus and the homework required (as opposed to the trauma‐free journaling of PCT), which may have also contributed to the differential dropout between the treatment groups." (Discussion, p. 35)
Treatment dropout
|
| Identification |
Sponsorship source: Veterans Administration Rehabilitation Research & Development Service (US government)
Country: USA
Setting: outpatients clinic at a VA Medical Centre
Comments: Clinical trial NCT00371644 at http://clinicaltrials.gov/. There were 13 male participants in this study. We included the 4‐month outcome data as our 3‐month time point. There were no significant differences between the randomised sample of 129 and the final sample of 86 on demographic or baseline measures, and the study only reported the latter group.
Authors name: Alina Suris
Institution: VA North Texas Health Care System
Email: alina.suris@va.gov
Year: 2013 |
| Notes |
Included in meta‐analysis |
