Summarize the research design and methods used in the study. At a minimum, this summary should include (but not necessarily

A Randomized Controlled Trial of 7-Day Intensive and Standard Weekly Cognitive Therapy for PTSD and Emotion-Focused Supportive Therapy

Anke Ehlers, Ph.D.1,2, Ann Hackmann, D.Clin.Psy.3, Nick Grey, D.Clin.Psy.2, Jennifer Wild, D.Clin.Psy.1,2, Sheena Liness, M.A.2, Idit Albert, D.Clin.Psy.2, Alicia Deale, Ph.D.2, Richard Stott, D.Clin.Psy.2, and David M. Clark, DPhil1,2

1Department of Experimental Psychology, University of Oxford, UK and NIHR Oxford cognitive health Clinical Research Facility

2NIHR Biomedical Research Centre for Mental Health, South London and Maudsley NHS Trust and King’s College London, UK

3Department of Psychiatry, University of Oxford, UK

Abstract

Objective—Psychological treatments for posttraumatic stress disorder (PTSD) are usually delivered once or twice weekly over several months. It is unclear whether they can be successfully

delivered over a shorter period of time. This clinical trial had two goals, (1) to investigate the

acceptability and efficacy of a 7-day intensive version of cognitive therapy for PTSD, and (2) to

investigate whether cognitive therapy has specific treatment effects by comparing intensive and

standard weekly cognitive therapy with an equally credible alternative treatment.

Method—Patients with chronic PTSD (N=121) were randomly allocated to 7-day intensive or standard 3-month weekly cognitive therapy for PTSD, 3-month weekly emotion-focused

supportive therapy, or a 14-week waitlist condition. Primary outcomes were PTSD symptoms and

diagnosis as assessed by independent assessors and self-report. Secondary outcomes were

disability, anxiety, depression, and quality of life. Measures were taken at initial assessment, 6

weeks and 14 weeks (post-treatment/wait). For groups receiving treatment, measures were also

taken at 3 weeks, and follow-ups at 27 and 40 weeks after randomization. All analyses were

intent-to-treat.

Results—At post-treatment/wait assessment, 73%, 77%, 43%, 7% of the intensive cognitive therapy, standard cognitive therapy, supportive therapy, and waitlist groups, respectively, had

recovered from PTSD. All treatments were well tolerated and were superior to waitlist on all

outcome measures, with the exception of no difference between supportive therapy and waitlist on

quality of life. For primary outcomes, disability and general anxiety, intensive and standard

Location of work and address for reprints: The work was conducted at the University of Oxford and Oxford Cognitive Health NIHR Clinical Research Facility and the NIHR Biomedical Research Centre for Mental Health, South London and Maudsley NHS Trust and King’s College London, UK. Please address correspondence to Anke Ehlers, Ph.D., Department of Experimental Psychology, University of Oxford, South Parks Road, Oxford OX1 3UD, UK, [email protected]

The trial was registered as ISRCTN 48524925.

Europe PMC Funders Group Author Manuscript Am J Psychiatry. Author manuscript; available in PMC 2014 September 01.

Published in final edited form as: Am J Psychiatry. 2014 March 1; 171(3): 294–304. doi:10.1176/appi.ajp.2013.13040552.

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cognitive therapy were superior to supportive therapy. Intensive cognitive therapy achieved faster

symptom reduction and comparable overall outcomes to standard cognitive therapy.

Conclusions—Cognitive therapy for PTSD delivered intensively over little more than a week is as effective as cognitive therapy delivered over 3 months. Both had specific effects and were

superior to supportive therapy. Intensive cognitive therapy for PTSD is a feasible and promising

alternative to traditional weekly treatment.

Keywords

Posttraumatic stress disorder; clinical trial; randomized controlled trial; cognitive behavior therapy; cognitive therapy; intensive treatment; treatment outcome; treatment acceptability

Introduction

A range of trauma-focused psychological treatment programs are effective for posttraumatic

stress disorder (PTSD) (1-3). Such treatments are usually delivered once or twice per week

over the course of several months. While this is a conventional psychotherapy format, it has

some potential disadvantages from a patient perspective. PTSD interferes with social and

occupational functioning and it could be desirable to make more rapid progress.

Furthermore, some patients find it difficult to commit to protracted psychological treatment

(2). This raises the question of whether trauma-focused psychological treatment for PTSD is

effective and acceptable if condensed into a shorter period of time. There is some evidence

that intensive cognitive behavior therapy is effective in other anxiety disorders (4-5), but it

remains unclear whether it is feasible for PTSD. Some clinicians are concerned about the

risk of symptom exacerbation in the treatment of PTSD (6-7), and it is conceivable that a

concentrated treatment delivery could enhance the risk of possible adverse effects.

This clinical trial had two goals. First, we investigated the acceptability and efficacy of an

intensive 7-day version of cognitive therapy or PTSD (8). Standard once-weekly cognitive

therapy for PTSD over three months has been shown to be highly effective and acceptable to

patients (9-13). A pilot study suggested that intensive cognitive therapy for PTSD may also

be effective (8). Second, we tested whether cognitive therapy for PTSD has specific

treatment effects by comparing intensive and standard weekly cognitive therapy with an

alternative active treatment, emotion-focused supportive psychotherapy, using a broad range

of outcomes including PTSD symptoms, disability, anxiety, depression, and quality of life.

Cognitive therapy for PTSD has been shown to be superior to self-help interventions with

limited therapist contact (9), but has not yet been compared with an equally credible

alternative psychological treatment involving the same amount of therapist contact.

Method

Participants

Participants (N=121) were recruited between 2003 and 2008 from consecutive referrals to a

National Health Service outpatient clinic for anxiety disorders in South London, UK (n=81),

or a research clinic at the University of Oxford, UK (n=40). Patients were invited to

participate if they met the following inclusion criteria: they were between 18-65 years old;

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met diagnostic criteria for chronic PTSD as determined by the Structured Clinical Interview

for DSM-IV (14); their current intrusive memories were linked to one or two discrete

traumatic events in adulthood; and PTSD was the main problem. Exclusion criteria were:

history of psychosis; current substance dependence; borderline personality disorder; acute

serious suicide risk; treatment could not be conducted without the aid of an interpreter.

Figure 1 shows the patient flow chart and Table 1 presents details on trauma, clinical,

demographic and treatment characteristics. There were no group differences in any of the

variables. Seventy-one patients (58.7%) were female, and 36 (29.8%) were from ethnic

minorities. The most common index traumas were interpersonal violence (physical/sexual

assault, 37.2%), accidents or disaster (38.0%), or traumatic death of others (7.4%). Most

patients (71.9%) had a history of other traumas besides their index traumas. The majority

(63.6%) had comorbid other Axis I disorders (mainly mood and anxiety disorders, substance

abuse), and 19.8% had Axis II disorders (mainly obsessive-compulsive, depressive,

paranoid, avoidant). Around a third (36.7%) had had previous treatment for PTSD. Patients

taking psychotropic medication (29.8%) were required to be on a stable dose for two months

before random allocation.

Random Allocation and Masking

If suitable for the trial and willing to participate, patients signed the informed consent form.

They were then randomly allocated to one of the four trial conditions by an independent

researcher who was not involved in assessing patients, using the minimization procedure

(15) to stratify for sex and severity of PTSD symptoms. Assessors determining the

suitability of a patient for inclusion were not informed about the stratification variables and

algorithm. Assessments of treatment outcome were conducted by independent evaluators

without knowledge of the patient’s treatment condition. Patients were asked not to reveal

their group assignment to the evaluators. Participants were not blind to the nature of the

treatment, but care was taken to create similarly positive expectations in each treatment

group, by informing them that several psychological treatments were effective in PTSD and

it was unknown which worked best, and by giving a detailed rationale for the treatment

condition to which the patient was allocated. Patient ratings of treatment credibility (16) and

therapeutic alliance scores (17) were high in all treatment conditions and did not differ

(Table 1).

Treatment Conditions

Patients in all treatment conditions received up to 20 hours of treatment by the 14 week

(post-treatment/wait) assessment. Sessions were spread evenly over 3 months for standard

cognitive therapy and supportive therapy, whereas the main part of treatment occurred

within the first 7 to 10 days of intensive cognitive therapy. The number of treatment or

booster sessions received did not differ between the treatment groups (Table 1).

Standard Cognitive Therapy for PTSD—This treatment was delivered as in previous trials (9, 10), in up to 12 weekly individual sessions over the course of three months, with an

optional three monthly booster sessions over the following three months. The treatment

follows Ehlers and Clark’s model of PTSD (19) and aims to reduce the patient’s sense of

current threat by (i) identifying and modifying excessively negative appraisals of the trauma

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and/or its sequelae, (ii) elaborating the trauma memory and discriminating triggers of

intrusive reexperiencing, and (iii) reducing the use of cognitive strategies and behaviors

(such as thought suppression, rumination, safety-seeking behaviors) that maintain the

problem. Therapists followed a treatment manual (20). A description of treatment

procedures is found at http://oxcadat.psy.ox.ac.uk/downloads/CT-PTSD%20Treatment

%20Procedures.pdf/view. Patients were given homework assignments to complete between

sessions.

7-Day Intensive Cognitive Therapy for PTSD—This treatment followed the same protocol as standard cognitive therapy, but the main part of the treatment was delivered over

a much shorter period of time. In the intensive treatment phase, patients received up to 18

hours of therapy over a period of 5 to 7 working days. Treatment days usually comprised a

morning and an afternoon session lasting 90 min to 2 hours, with a break for lunch. There

were up to two further sessions one week and one month after the intensive period to discuss

progress and homework assignments, and up to three optional monthly booster sessions.

Patients receiving intensive cognitive therapy completed homework assignments parallel to

those in standard cognitive therapy. However, during the intensive phase homework was

more limited due to time constraints.

Emotion-focused Supportive Therapy—This non-directive treatment focused on patients’ emotional reactions rather than their cognitions. It was designed to provide a

credible therapeutic alternative to control for nonspecific therapeutic factors so that observed

effects of cognitive therapy could be attributed to its specific effects beyond the benefits of

good therapy. Like standard cognitive therapy, it comprised up to 12 weekly individual

sessions (up to 20 hours in total) over three months and optional three monthly booster

sessions. Therapists followed a manual that specified procedures, building on similar

treatment programs (20-21). After normalizing PTSD symptoms, the therapist gave the

rationale that the trauma had left the patient with unprocessed emotions and that therapy

would provide them with support and a safe context to address their unresolved emotions.

Patients could freely choose what problems to discuss in the session, including any aspect of

the trauma. Therapists helped patients clarify their emotions and solve problems. They did

not restructure the patient’s appraisals, attempt to elaborate their trauma memories or

discriminate triggers, or direct them in how to change their behavior. As homework, patients

kept a daily diary of their emotional responses to the events of the week that was discussed

in the following session (20).

Waitlist—Patients allocated to waitlist waited for 14 weeks before receiving treatment.

Outcome measures

Data were collected from all participants, including dropouts. Primary assessment points

were at pre-treatment/wait, 6 weeks (self-reports only), and 14 weeks (post-treatment/wait).

Follow-ups for treated patients were at 27 and 40 weeks after randomization. Figure 1 shows

the number of patients who provided data at each assessment point. In addition, patients

receiving therapy also completed self-reports of PTSD symptoms, anxiety and depression at

3 weeks.

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Primary Outcome Measures

Clinician-rated PTSD symptoms: Independent assessors (trained psychologists) interviewed patients with the Clinician-Administered PTSD scale (CAPS) (22). The CAPS

assesses the frequency and severity of each of the PTSD symptoms specified in DSM-IV.

Interrater reliability was kappa=.95 for a PTSD diagnosis, and r=.98 for the total severity

score (37 interviews, 14 interviewers, 14 raters).

Severity of PTSD symptoms: Patients completed the Posttraumatic Diagnostic Scale (23), a self-report questionnaire measuring the overall severity of PTSD symptoms (range 0-51)

that has shown good reliability and concurrent validity with other PTSD measures.

Secondary Outcome Measures

Disability: Patients completed the Sheehan Disability Scale (24) and rated the interference caused by their symptoms in their work, social life/leisure activities, and family life/home.

The disability score was the sum of the ratings (range 0-30).

General Anxiety and Depression: Symptoms of anxiety and depression were assessed with the Beck Anxiety Inventory (25) and the Beck Depression Inventory (BDI) (26), standard

21-item self-report measures with high reliability and validity (range 0-63).

Quality of Life: Perceived quality of life was assessed with the Quality of Life Enjoyment and Satisfaction Questionnaire (27). This scale assesses the patient’s satisfaction in 14 life

domains and has been shown to be reliable and valid in clinical and community samples

(28).

Therapist Training and Treatment Fidelity

Therapists were qualified clinicians who had completed a clinical psychology or nurse

therapist degree, and had received further training in all treatments used in this study. They

had treated at least two cases with each of the therapy protocols under supervision before

treating trial patients. They received weekly supervision from a senior clinician trained in all

treatment modalities for weekly cases, and daily supervision for intensive cases to ensure

compliance with the treatment protocols.

To further evaluate treatment integrity, a randomly selected recording from each patient was

reviewed by a trained assessor for compliance with the treatment protocol, using a detailed

checklist of procedures used. Only one minor deviation was discovered: one of the

supportive therapy patients worked on spotting memory triggers for a few minutes. Another

randomly selected session from each patient was rated for therapist competency. Cognitive

therapy sessions were rated by a psychologist experienced in cognitive therapy, using an

adapted version of the Cognitive Therapy Scale (29), on a scale from 0 to 6. A score of 3 is

considered satisfactory, and scores of 4 and above indicate good to excellent competency.

The mean score was 4.7 (SD=0.41) for standard cognitive therapy and 4.8 (SD=0.35) for

intensive cognitive therapy (p>.18). Supportive Therapy sessions were evaluated for

therapist competency by a counseling psychologist experienced in supportive therapy (on a

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scale from 0 to 6 with anchors as above, informed by ratings of dimensions of good non-

directive therapy such an empathic understanding, 30). The mean rating was 4.7 (SD=0.49).

Data Analysis

All analyses were intent-to-treat, using all 121 randomly assigned participants. Dichotomous

outcomes were compared with χ2 tests. Continuous outcomes were analyzed with

hierarchical linear modeling (31). This analysis models random slopes and intercepts for

participants, and tests the fixed effects of treatment condition and repeated assessments over

time, using data from all participants. Differential treatment efficacy shows in significant

interactions between treatment condition and time. Significant overall effects were followed

up with contrasts between conditions. All variables were centered for the analysis (32).

Significance levels were set at p<.05 (two-tailed). To test whether the 3 treatment conditions

led to better outcome than waitlist, linear trends for symptom change over assessments

points from baseline to 6 weeks and 14 weeks post-treatment/wait assessments were

compared between the 4 trial conditions. To compare the efficacy of the 3 treatment

conditions, hierarchical linear modeling compared symptom scores from baseline to the 40-

weeks follow-up, fitting linear and quadratic trends for symptom change over the five

assessments (pre treatment, 6, 14, 27 and 40 weeks). Interactions of site, sex, medication

status, and trauma type with condition and time were explored in additional analyses, but as

effects were far from significant, these were omitted from the final models.

For comparison with meta-analyses, we also report effect sizes Cohen’s d (33) for adjusted

between-group differences (controlling for pre-treatment scores) and confidence intervals at

post-treatment. Effect sizes of 0.5 and above are considered medium effects and those of 0.8

and above large effects. To compare the speed of recovery between the treated groups, a

further analysis compared symptom scores on the Posttraumatic Diagnostic Scale, and Beck

Anxiety and Depression Inventories at 3 weeks for the treated groups, controlling for initial

symptom severity. Effect sizes for within-group changes in symptom scores between the

pre- and post-treatment/wait assessments were calculated as Cohen’s d statistic (33), using

the pooled standard deviation as reference, which is more conservative in estimating

improvement than using pre-treatment standard deviations.

Recovery from PTSD diagnosis according to the CAPS was coded if the patient no longer

met the minimum number of symptoms in each symptom cluster required by DSM-IV with

a score of at least “1” for both frequency and intensity, and a global severity score of at least

“2”, as in (9-11). This was determined for all randomly assigned participants. The status of a

few subjects with missing CAPS observations was based on the Posttraumatic Diagnostic

Scale (if available for this time-point) or the last available value on the CAPS. In addition,

for comparisons with other papers (21), we calculated the percentages of patients who were

totally remitted according to assessor ratings and self-report, using cut-offs recommended in

the respective manual, (1) a CAPS score of below 20 (“asymptomatic”), and (2) a

Posttraumatic Diagnostic Scale score below 11. PTSD symptom deterioration was defined

using established cut-offs for statistically reliable change, i.e. increases in symptoms greater

than 6.15 on the Posttraumatic Diagnostic Scale (34) and increases greater than 10 on the

CAPS (21).

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Sample size was determined by power analysis on the basis of effect sizes for cognitive

therapy observed in previous trials. A group size of n=30 per condition yields 85% power

for ES=0.8.

Results

Adverse Effects, Dropouts and Symptom Deterioration

No adverse effects (i.e., negative reactions to treatment procedures such as significant

increases in dissociation, suicidal intent or hyperarousal) were reported in any of the groups.

Dropouts were defined as attending fewer than 8 sessions (35), unless the earlier completion

was agreed with the therapist. Dropout rates were low and did not differ between conditions

(Table 2). Only one patient in the supportive therapy group reported symptom deterioration

on the Posttraumatic Diagnostic Scale (Table 2). On the CAPS, fewer patients treated with

intensive and cognitive therapy were rated as having deteriorated than those in the waitlist

condition. The supportive therapy group did not statistically differ from the other groups.

Comparison of Treatment Conditions with Waitlist

Table 2 shows the recovery rates for the treatment and wait conditions. All treatment

conditions were more likely to lead to recovery from PTSD diagnosis than waitlist. Intensive

and standard cognitive therapy had excellent number-needed-to-treat statistics of 1.50

(95%CI 1.18; 2.06) and 1.41 (95%CI 1.14; 1.87). For supportive therapy, the number-

needed-to-treat was 2.73 (95%CI 1.77; 5.95). Similar results were obtained for assessor-

rated and self-reported total remission. Table 3 shows the results for the continuous outcome

measures. There were significant condition × time interactions (all p<.002) for all primary

and secondary outcome measures, PTSD symptoms: CAPS F(3,135.35)=21.50 and

Posttraumatic Diagnostic Scale F(3,106.56)=21.16; disability F(3,109.86)=14.01; anxiety

F(3,106.85)=13.57; depression F(3,122.20)=5.16; quality of life F(3,106.85)=6.96. All

contrasts between treatment conditions and waitlist were significant, indicating greater

improvement for intensive and standard cognitive therapy and supportive therapy compared

to waitlist, except for a nonsignificant difference between supportive therapy and waitlist on

quality of life. As shown in Table 4, pre-post effect sizes d for both intensive and standard

cognitive therapy showed very large improvement in PTSD symptoms and disability, and

large improvement in anxiety, depression, and quality of life.

Comparison of Treatment Conditions

At the post-treatment and follow-up assessments, more patients receiving intensive and

standard cognitive therapy had recovered from a PTSD diagnosis than those receiving

supportive therapy (Table 2). Similar results were obtained for assessor-rated and self-

reported total remission. For all primary and secondary continuous outcomes except for

depression (Table 3), hierarchical linear modeling showed significant interactions between

condition and linear time effects; PTSD symptoms: CAPS F(2,154.13)=7.83, p=.001, and

Posttraumatic Diagnostic Scale F(2,215.14)=4.42, p=.01; disability F(2,220.14)=7.45, p=.

001; anxiety F(2,176.80)=5.40, p=.005; depression F(2,213.98)=0.79, p>.23; quality of life

F(2, 231.98)=3.27, p=.04. Contrasts showed that both intensive and standard cognitive

therapy led to greater improvement than supportive therapy on the primary outcome

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measures (CAPS, Posttraumatic Diagnostic Scale), disability and anxiety. For quality of life,

standard cognitive therapy was superior to supportive therapy, and there was a trend for

intensive cognitive therapy to be superior (p<.10). Baseline-adjusted mean group differences

at post-treatment and effect sizes are shown in Table 4.

Speed of Recovery

Comparison of the treatment groups at 3 weeks, controlling for initial severity, showed

significant differences on the Posttraumatic Diagnostic Scale, F(2,87)=10.35, p<.001;

anxiety, F(2,87)=4.23, p=.018; and depression, F(2, 87)=5.27, p=.007. The intensive

cognitive therapy group scored lower on PTSD symptoms than the standard cognitive

therapy and supportive therapy groups, baseline-adjusted means 16.65 (95%CI 13.19;

20.12), 24.05 (95%CI 20.64; 27.46), 27.65 (95%CI 24.18; 31.12), respectively. They also

had lower depression scores at 3 weeks than both other treatment groups, and lower anxiety

scores than supportive therapy.

Additional Comparison of Intensive and Standard Weekly Cognitive Therapy Including Post-Wait Patients

To further test the comparability of outcomes between the intensive and standard cognitive

therapy groups, waitlist patients who still had PTSD at the post-wait assessment and still

wished treatment were randomly assigned to either standard (n=13) or intensive (n=11)

cognitive therapy. The comparison of all patients treated with intensive (n=41) and standard

cognitive therapy (n=44) had 80% power in detecting a difference of 4.4 points on the

Posttraumatic Diagnostic Scale. There were no interactions between treatment condition and

time on any measure, indicating comparable outcomes. Baseline-adjusted differences at 14

weeks between all standard weekly and intensive cognitive therapy patients were: CAPS

−2.19 (95%CI −12.97;8.60), d=0.08, and Posttraumatic Diagnostic Scale −1.48 (95%CI

−5.35;2.39), d=0.15; disability 0.51 (95%CI −2.74;3.75), d=0.06; anxiety −2.59 (95%CI

−6.79;1.63), d=0.24; depression 0.27 (95%CI −3.59;4.13), d=0.03; quality of life 4.8(95%CI

−3.18;12.72), d=0.23.

Discussion

The main findings were (1) that a novel 7-day intensive version of cognitive therapy for

PTSD was well tolerated, achieved faster symptom reduction and led to comparable overall

outcomes as standard once-weekly cognitive therapy delivered over three months, and (2)

that both intensive and standard cognitive therapy had specific effects and were more

efficacious in treating PTSD than emotion-focused supportive therapy. The intent-to-treat

pre-post effect sizes for improvement in PTSD symptoms with both intensive and standard

cognitive therapy were very large, and patients’ mean scores after treatment were in the

nonclinical range. There were no site effects, suggesting that the treatment worked as well in

patients recruited from a routine clinical setting as in those referred to a research clinic. The

study replicated the excellent outcomes observed for cognitive therapy for PTSD in previous

trials (9-10), and is the first study to demonstrate that this treatment not only leads to a large

reductions in symptoms of PTSD, disability, anxiety and depression, but also to large

increases in quality of life.

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Some authors have expressed concerns about a risk of symptom exacerbation with trauma-

focused psychological treatments (6-7), and it is therefore noteworthy that both standard and

intensive cognitive therapy were well tolerated, in line with initial case reports of intensive

trauma-focused treatments (8, 36). Delivering cognitive therapy in an intensive format did

not increase dropout rates or symptom deterioration. Both the standard and intensive

cognitive therapy groups were less likely to be rated as having deteriorated on the CAPS

than those waiting for treatment. The present study thus underlines the safety of this

treatment approach. The feasibility of intensive cognitive therapy is of interest for

therapeutic settings where treatment needs to be conducted over a short period of time, such

as residential therapy units or occupational groups exposed to trauma, or where patients

have to get better quickly to avoid secondary complications such as job loss or marital

problems. The feasibility of intensive treatment is also of interest for patient choice, as some

patients m

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