Feasibility and efficacy of an emotion-based online intervention for the treatment of anxiety and depression in people with cancer - Results of a randomized controlled trial.

BACKGROUND: Psycho-oncological support for cancer patients is routinely offered in acute hospital care in Germany. The purposes of the study were to assess the feasibility and efficacy of a newly developed emotion-based psycho-oncological online self-help (epos) integrating a psychodynamic and emotion-focused approach. METHOD: Eligibility requirements were age ≥ 18 years, any type of cancer, current treatment or aftercare, German language proficiency and internet access. Patients were randomized to 10-week epos vs. TAU plus informational website. Primary outcome was a combined score of anxiety and depression (PHQ-ADS). Secondary outcomes included measures of post-traumatic growth and attitudes towards online interventions. RESULTS: N = 155 patients were randomly assigned to the intervention and N = 153 to the control group; 85% were female, mean age was 50.8 years. Symptom severity (PHQ-ADS) at baseline was low in 62%. In the IG, 55% worked through the introductory and at least one more unit. In the ITT analyses, PHQ-ADS decreased in both groups but not statistically significant comparing IG vs. CG. In per protocol analyses IG benefitted statistically significant compared to CG in the PHQ-ADS, in posttraumatic growth and attitudes towards online interventions. CONCLUSIONS: Recruitment for epos was feasible but uptake of units was low. While we could not confirm our primary hypothesis, intervention participants benefitted in per protocol analyses. Better posttraumatic growth and attitudes towards online interventions represent beneficial secondary outcomes.