Krebber, A.M., Jansen, F., Witte, B.I., Cuijpers, P., de Bree, R., Becker-Commissaris, A., . . . Verdonck-de Leeuw, I.M. (2016). Stepped care targeting psychological distress in head and neck cancer and lung cancer patients: A randomized controlled trial. Annals of Oncology, 27, 1754–1760. 

To evaluate the effects of a stepped psychotherapeutic intervention on patients with baseline anxiety

Patients who had completed curative therapy, were referred for follow-up, found to have relevant levels of distress, and consented to participation had a telephone interview at baseline. After the interview, they were randomized to usual care or the stepped program, which included watchful waiting, guided self-help via the Internet or a booklet, face-to-face problem-solving therapy, and psychological interventions and/or medications. Time frames for data collection varied depending upon the duration of the stepped program. General measures were obtained at 3, 6, 9, and 12 months after study entry. Usual care consisted of no psychosocial care in 64% of the group.

• N = 156, 106 at 12-month follow-up   
• MEAN AGE = 62 years (SD = 9.4 years)
• MALES: 60.9%, FEMALES: 39.1%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Patients with head and neck or lung cancer in various stages
• OTHER KEY SAMPLE CHARACTERISTICS: Of the patients, 77.6% had anxiety or a depressive disorder.

• SITE: Single site   
• SETTING TYPE: Multiple settings    
• LOCATION: Netherlands

PHASE OF CARE: Transition phase after active treatment

Single-blind, randomized, controlled trial

• Hospital Anxiety and Depression Scale (HADS)
• European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLC-C30)
• EORTC IN-PATSAT32 for inpatient satisfaction with care 
• Composite International Diagnostic Interview (CIDI) for the presence of depression or an anxiety disorder

The course of anxiety (p = 0.046) and depression (p = 0.007) was better for the intervention group than for the controls. When corrected for baseline anxiety and depression, depression was better for the intervention group over time (p < 0.001), but anxiety was not significantly different (p = 0.061). The stepped program had more influence over the course of symptoms among patients with a depression or anxiety disorder compared to those without a psychiatric disorder (p = 0.001). Among those without a psychiatric disorder, no differences in anxiety or depression scores were observed after a six-month measurement.

The stepped psychological intervention approach was shown to be effective to reduce anxiety and depression in the short-term, and had particular effectiveness for individuals with psychiatric disorders.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Subject withdrawals ≥ 10% 
• About 40% were lost to follow-up at six months.
• Patients were not blinded.  
• No information was provided regarding medication use, etc.
• More patients in the intervention group used alcohol.
• Although all patients had clinically relevant anxiety at study entry, the majority of patients in the usual care group had no interventions.
• Patients had completed initial treatment at highly varied time points prior to the study.

Psychiatric and stepped psychological interventions resulted in relatively short-term improvement in anxiety and depression among patients with cancer and anxiety. Interventions were most helpful for individuals with anxiety or depressive disorders over a longer period of time as well.