Issue link: https://read.uberflip.com/i/1503820
1 | INTRODUCTION Breast cancer is the most commonly diagnosed cancer among women globally and long‐term survival rates are high. 1 Depression and anxiety are the two most common problems among people living with and beyond cancer. 2–6 However, many cannot access psychotherapy due to the under‐recognition of psychological symptoms, lack of trained clinicians, stigma, and lack of evidence around effective treatments. 7,8 Fear of recurrence, 9 use of avoidant coping, 10 and low perceived social support 11 are important determinants of distress and decreased life quality in breast cancer survivors. An intervention providing education on depression and anxiety symptoms within the context of breast cancer and teaching active coping skills can help individuals effectively deal with uncertainty, decrease their fear of recurrence, depression and anxiety, and improve health‐related quality of life. Guided internet‐delivered cognitive behavioural therapy (iCBT) is an easily accessible and accepted best practice that results in moderate to large reductions in depression and anxiety in the general population. 12–17 Data on the iCBT interventions on depression and anxiety in cancer survivors is emerging with studies conducted with Australian and Canadian survivors. 18–20 Despite the limited number of studies, research with cancer survivors demonstrated promising results with significant reductions in depression and anxiety at post‐ intervention and 3‐month follow‐up. 18,21 Both guided and self‐guided iCBT were shown more cost‐effective compared to the waiting list for breast cancer survivors. 22 Qualitative research found that cancer survivors and iCBT providers find it acceptable for alleviating distress. 19 Survivors also supported combining depression and anxi- ety in an iCBT intervention for early‐stage cancer. 20 Evidence‐based self‐management and e‐Health interventions tailored to the needs of specific populations can meet the majority of cancer survivors' needs at lower costs, allowing resource‐intensive interventions to those most in need. 23 The present study is novel as it is the first randomised controlled trial (RCT) of an iCBT inter- vention for depression and anxiety in breast cancer survivors in Ireland and the UK. We hypothesised that iCBT recipients would have lower distress at post‐intervention and follow‐up compared to treatment‐as‐usual (TAU). iCBT group was also expected to have a greater quality of life and active coping and lower fear of recurrence than TAU at post‐intervention and follow‐up. We further hypoth- esised that change in active and avoidant coping strategies would mediate the effects of iCBT on distress and quality of life. 2 | METHODS 2.1 | Participants Participants were included if they were female, finished primary cancer treatment, and were at least mildly confident using the Internet, and reading and writing in English. There was no time limit for participants who were many years out from finishing treatment due to the pilot nature of this trial. Exclusion criteria were current suicidal ideation or intent, current alcohol or drug misuse, enduring mental health disorders (schizophrenia, psychosis), and currently receiving psychological treatment for depression and/or anxiety. 2.2 | Design and procedure The trial was registered (ISRCTN96180849) and approved by the university research ethics committee. The study was originally designed as a three‐arm study where participants are randomised to iCBT or TAU, and the iCBT group is asked to choose between iCBT alone or iCBT + carer access (with a separate account). Since only four participants preferred carer access, the proposed design was changed to a two‐arm pilot RCT comparing iCBT with TAU. Participants were recruited online between October 2020 and May 2021 through research email listings of cancer charities and social media in Ireland and the UK (Facebook, Twitter, LinkedIn). A Qualtrics link explaining the study details was shared. Participants self‐screened as their responses determined their eligibility. Qual- trics automatically randomised participants. 2.3 | Intervention The iCBT programme is a 7‐module intervention (see Supporting Information S1) based on a transdiagnostic approach for depression and anxiety provided through the SilverCloud platform. It aimed to improve survivors' knowledge about their experience and symptom management skills. The intervention consisted of various tools such as quizzes, goal setting, mood monitoring, activity scheduling, thoughts‐feelings‐behaviours cycle, worry tree, and relaxation exercises. The programme content was adapted using an integrative approach combining steps from three adaptation frameworks. 24–26 Adaptation was based on the literature on CBT for people with cancer 19,20,27 and interviews with breast cancer survivors and carers to include both general and cancer‐specific CBT information. The adapted content was reviewed by a psycho‐oncologist, clinical psy- chologist, and health psychologist. Intervention participants were assigned a supporter, who pro- vided guidance and post‐session feedback on a weekly basis over 8 weeks. There were 10 supporters, who were graduate psycholo- gists doing their masters. Supporters received training on the de- livery of online support and weekly supervision provided by SA and DH. TAU group continued their usual care recommended by their healthcare team. 2.4 | Measures Sociodemographic and Clinical History Questionnaire was used to assess demographic and health‐related characteristics, and for AKKOL‐SOLAKOGLU AND HEVEY - 447 10991611, 2023, 3, Downloaded from https://onlinelibrary.wiley.com/doi/10.1002/pon.6097, Wiley Online Library on [28/06/2023]. 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