BACKGROUND: A diagnosis of head and neck cancer, like many other cancers, can lead to significant psychosocial distress. Patients with head and neck cancer can have very specific needs, due to both the location of their disease and the impact of treatment, which can interfere with basic day-to-day activities such as eating, speaking and breathing. There is a lack of clarity on the effectiveness of the interventions developed to address the psychosocial distress experienced by patients living with head and neck cancer. OBJECTIVES: To assess the effectiveness of psychosocial interventions to improve quality of life and psychosocial well-being for patients with head and neck cancer. SEARCH METHODS: We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; BIOSIS Previews; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials. The date of the most recent search was 17 December 2012. SELECTION CRITERIA: We selected randomised controlled trials and quasi-randomised controlled trials of psychosocial interventions for adults with head and neck cancer. For trials to be included the psychosocial intervention had to involve a supportive relationship between a trained helper and individuals diagnosed with head and neck cancer. Outcomes had to be assessed using a validated quality of life or psychological distress measure, or both. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, extracted data and assessed the risk of bias, with mediation from a third author where required. Where possible, we extracted outcome measures for combining in meta-analyses. We compared continuous outcomes using either mean differences (MD) or standardised mean differences (SMD) and 95% confidence intervals (CI), with a random-effects model. We conducted meta-analyses for the primary outcome measure of quality of life and secondary outcome measures of psychological distress, including anxiety and depression. We subjected the remaining outcome measures (self esteem, coping, adjustment to cancer, body image) to a narrative synthesis, due to the limited number of studies evaluating these specific outcomes and the wide divergence of assessment tools used. MAIN RESULTS: Seven trials, totaling 542 participants, met the eligibility criteria. Studies varied widely on risk of bias, interventions used and outcome measures reported. From these studies, there was no evidence to suggest that psychosocial intervention promotes global quality of life for patients with head and neck cancer at end of intervention (MD 1.23, 95% CI -5.82 to 8.27) as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This quality of life tool includes five functional scales, namely cognitive, physical, emotional, social and role. There was no evidence to demonstrate that psychosocial intervention provides an immediate or medium-term improvement on any of these five functional scales. From the data available, there was no significant change in levels of anxiety (SMD -0.09, 95% CI -0.40 to 0.23) or depression following intervention (SMD -0.03, 95% CI -0.24 to 0.19). At present, there is insufficient evidence to refute or support the effectiveness of psychosocial intervention for patients with head and neck cancer. AUTHORS' CONCLUSIONS: The evidence for psychosocial intervention is limited by the small number of studies, methodological shortcomings such as lack of power, difficulties with comparability between types of interventions and a wide divergence in outcome measures used. Future research should be targeted at patients who screen positive for distress and use validated outcome measures, such as the EORTC scale, as a measure of quality of life. These studies should implement interventions that are theoretically derived. Other shortcomings should be addressed in future studies, including using power calculations that may encourage multi-centred collaboration to ensure adequate sample sizes are recruited.