Trials (Feb 2024)
Outpatient follow-up of tumour diseases through video-based value-oriented behavioural activation (ViVA): study protocol for a randomised controlled trial
Abstract
Abstract Background In Germany, approximately half a million people are diagnosed with cancer annually; this can be traumatic and lead to depression, anxiety, and adjustment disorders necessitating psycho-oncological intervention. Value-oriented behavioural activation, adopted from depression psychotherapy, aims to provide structured support to help patients adjust their personal values, goals, and activities within the context of their changed life situation. This trial aims to evaluate the effectiveness of video-based value-oriented behavioural activation against German S3-Guideline-compliant aftercare for cancer patients dealing with psychological distress. Methods This trial will use covariate-adaptive randomisation according to gender and type of tumour disease to assign participants to one of two study arms (value-oriented behavioural activation consisting of 12 manualised follow-up sessions delivered via video consultation vs. S3-Guideline-compliant aftercare comprising three supportive talks). Psychological strain, psychosocial distress, quality of life, work-related outcomes, fear of cancer recurrence, goal adjustment, satisfaction with the consultant-participant relationship, and rumination will be measured at baseline, twice during treatment, posttreatment, and at the 6-month follow-up. The target sample of 146 tumour patients experiencing high psychosocial distress will be recruited at the Rehazentrum Oberharz, Germany. Discussion This trial aims to test the effectiveness of value-oriented behavioural activation in aftercare for tumour patients, focusing on its capacity to reduce distress and the potential for long-term effects evaluated through a 6-month follow-up. The study’s possible challenges include enrolling a sufficient sample and ensuring adherence to treatment, mitigated through in-person recruitment and rigorous training of staff. If successful, the results will be of high public health relevance, especially for psychotherapeutic care in rural areas and among patients with limited mobility considering the video-based approach of the trial. Trial registration This study was registered at the German Clinical Trials Register: DRKS00031900 on Sep 19, 2023.
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