Kangas, M., Milross, C., Taylor, A., & Bryant, R.A. (2013). A pilot randomized controlled trial of a brief early intervention for reducing posttraumatic stress disorder, anxiety and depressive symptoms in newly diagnosed head and neck cancer patients. Psycho-Oncology, 22,1665–1673.

To conduct a controlled pilot trial evaluating the efficacy of a brief early cognitive behavior therapy intervention (CBT) to reduce symptoms of post-traumatic stress disorder (PTSD), depression, and anxiety and to prevent chronic psychological problems within the first year following diagnosis of head and neck cancer

Patients with elevated levels of PTSD, anxiety, or depression were randomized to seven individual sessions of either CBT or nondirective supportive counseling (SC). The interventions were concurrent with radiation therapy. The primary outcomes (PTSD, anxiety, and depression) and secondary outcomes (cancer-related appraisals, quality of life)  were assessed at baseline, one month, six months, and one year postintervention. Researchers assessed participants by using diagnostic clinical interviews and self-report questionnaires. Participants completed the screening assessment conducted by trained psychologists and were then randomized to either a CBT or SC group. Assessors blinded to treatment group conducted follow-up assessments. Researchers conducted a random evaluation of 25% of participants to ensure clinician adherence to protocol.

• The study reported on a sample of 35 participants.
• Mean patient age was 54.8 years, with a range of 18–70 years.
• The sample was 80% male and 20% female.
• Patients had primary head and neck cancer, first onset.
• Patients were recommended to receive primary radiation therapy (XRT) or adjuvant XRT, had an expected prognosis of more than 12 months, and were English speaking.
• There were no differences in sociodemographic or medical variables.

• Single site
• Setting type unspecified
• Royal Prince Alfred Hospital, Sydney, Australia

• Patients were undergoing active antitumor treatment.
• The study has clinical applicability for elder care and palliative care.

A pilot randomized controlled trial design was used.

Assessors administered the following at each assessment:

• Clinician-administered PTSD scale
• Structured Clinical Interview for DSM-IV Axis IV disorders (SCID-IV)
• Posttraumatic Stress Disorder Checklist (PCL), stress-specific version
• Beck Depression Inventory (BDI)
• Posttraumatic Cognitions Inventory (PTCI)
• Functional Assessment of Cancer Therapy–General
• Treatment Credibility Scale (TCS), adapted to measure patient’s beliefs about treatment efficacy contingent on the intervention to which patient was randomized (CBT or SC)

In spite of randomization, the CBT group, compared to the SC group, had significantly elevated scores on the PTCI self-blame subscale. This finding was included as a covariate. Participants in both treatment interventions reported a decline in anxiety and symptoms of depression over time. The study found no significant interaction effects between the two groups in regard to world outlook and negative appraisals. However, a main effect of time was evident for the PTCI negative scale, with both groups reporting a reduction in negative self-referent appraisal scores at one and six months. Significant main effects of time were also evident for improvements in quality of life and on all four subscales in both treatment groups. This was most evident at 6 and 12 months post-therapy. There were no significant differences between groups, and effect size (Cohen’s d) was not significantly different for anxiety or depression outcomes.

The findings of this study indicate that early intervention with psychotherapy is useful in reducing anxiety and symptoms of depression and PTSD and for preventing chronic psychopathology in symptomatic patients with head and neck cancer.

• The study had a small sample size, with less than 100 participants.
• The study had risks of bias due to no control group, no appropriate attentional control condition, and limiting sample characteristics.
• Findings are not generalizable.
• The intervention is expensive or impractical and is accompanied by need for training.
• The study involved English-speaking patients only, and mainly Caucasian males.
• Cancer type was limited to head and neck cancer.

Early identification and intervention for patients who are newly diagnosed with head and neck cancer may be beneficial in reducing symptoms resulting from PTSD, anxiety, and symptoms of depression related to diagnosis. Early identification and intervention may prevent chronic psychological issues in the patient population studied. This study showed that both CBT and SC had similar effects. Findings are limited by lack of a control group and the fact that, with or without treatment, all patients' anxiety levels tend to decline over time.