None listed
Conditions
Brief summary
The purpose of this study is to determine whether a new psychological intervention for cancer-related anxiety is feasible and acceptable. Who is it for? You may be eligible for this study if you are attending the Kinghorn Cancer Centre, are aged over 18, have been diagnosed with a metastatic, recurrent or progressive cancer, and have clinically significant anxiety. Study details All participants will need to take part in 9 sessions, lasting 60-90 minutes of behaviour therapy with clinical psychologist. These 9 sessions will be weekly and will involve cognitive behaviour therapy, metacognitive therapy and acceptance and commitment therapy. This therapy program takes into account the specific concerns of patients with cancer, such as dealing with ongoing uncertainty and worries about the future. Participants will also be required to complete questionnaires at the beginning of the study, after each therapy session and 2 months after therapy has finished. It is hoped that this research will help determine whether this type of therapy is effective in reducing anxiety for participants and whether the content of the sessions is deemed by the participants to be essential and effective
Interventions
The intervention is 9 sessions of manualised psychological therapy which will be provided weekly for 60-90 minutes. The content of sessions is derived from previously validated therapies, such as Cognitive Behaviour Therapy, Metacognitive Therapy and Acceptance and Commitment Therapy. In particular, the session content will be as follows: Session 1. Psychological assessment and development of a formulation to identify targets for intervention and to provide psycho-education about anxiety in general and in this context in particular Session 2. Discuss the problem of uncontrollability in the cancer context, helpful vs unhelpful control attempts and provide a framework for helpful coping. (cf. Morling & Evered, 2006) and expand on helpful coping repertoire. Session 3. Begin to learn techniques for responding to difficult thoughts and emotions (i) Provide psycho-education about the nature of intrusions (ii) Discuss the utility of emotions and increasing awareness of one’s current experience (Barlow, 2011) (iii) Introduce a framework to aid decision making about when to process or disengage from unhelpful thoughts and emotions - the ReFleCT flowchart. (iv) Introduce Detached Mindfulness (Wells, 2005) as an alternative to rumination (v) Values clarification and goal setting Session 4. Introduce the cognitive model (Beck, 1995) and Attention Training (Wells, 2005) Session 5. Introduce cognitive reframing skills and practice an example in the session Session 6. Belief modification including providing psycho-education about underlying beliefs and practice modifying a belief identified in the individual’s formulation as contributing to their cancer-related anxiety using relevant cognitive and behavioural techniques. Session 7. Ongoing belief modification with a belief identified in the formulation. Introduce mindfulness and practice a short exercise in the session (Kabat-Zinn ,1990, Harris, 2009; Roemer & Orsillo, 2011). Session 8. Address any remaining avoidance or over-monitoring by identifying any remaining maladaptive coping behaviours and associated beliefs and distinguishing between over-monitoring / excessive health behaviours and reasonable surveillance /health behaviours. review mindfulness skills and practice a brief mindfulness exercise. Session 9. Review the program and introduce strategies to prevent relapse prevention by identifying potential future triggers and developing new plans for dealing with uncertainty and worry The intervention will be conducted individually in face to face consultations by a Clinical Psychologist who has a minimum of 5 years experience delivering psychological interventions to cancer patients. Adherence to the intervention will be monitored by 1) the therapist will complete a checklist at the end of each session to indicate if the components of the session plan where completed and 2) therapy sessions will be voice recorded and a proportion of sessions (11% or 15 therapy sessions) will be randomly audited by the Principal Investigator to ensure that the sessions adhere to the therapy manual. .
Sponsors
Study design
Eligibility
Inclusion criteria
• Patients with a diagnosis of metastatic cancer or patients who have experienced a recurrence or progression of their cancer or a second cancer diagnosis • Aged 18 or over • Fluent in English • Clinically significant anxiety as measured by a score of 8 or more on the Hospital Anxiety and Depression Scale– Anxiety subscale (HADS-A, Zigmond & Snaith, 1983) OR a score of 19 or more on the Impact of Events Scale - Revised (Weiss & Marmar, 1997) OR a score of 34 or more on the Fear of Progression questionnaire, Short version (Mehnert, Herschbach, Berg, Henrich, & Koch, 2006). • Willingness to give written informed consent and willingness to participate to and comply with the study.
Exclusion criteria
• Mental health condition predating cancer diagnosis requiring ongoing treatment, such as major depression, bipolar, psychosis, borderline personality disorder or substance dependence • Current suicidal risk. • Receiving concurrent psychological treatment • Taking psychotropic medication unless 1) the dose has been stable for at least 8 weeks 2) the medication was prescribed as a pre-medication before chemotherapy treatment or a medical procedure or 3) the medication was prescribed specifically to treat nausea. • Cognitive impairment as measured by a score of <27 on the Telephone Interview for Cognitive Status - modified (Brandt, Spencer, & Folstein, 1988; Welsh, Breitner, & Magruder-Habib, 1993)