Clinical trial NCT05272553: Narrative Exposure Therapy to Reduce Symptoms of Traumatic Stress in Cancer Survivors
Official title: Investigating the Application of Narrative Exposure Therapy (NET) to Reduce Symptoms of Traumatic Stress in Cancer Patients Not in Active Treatment: a Naturalistic Single Case Study Series
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Traumatic Stress Disorder
Cancer
Keywords: narrative exposure therapy
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: National Health Service, United Kingdom
First posted: 2022-03-09
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Naturalistic, mixed-method, explanatory sequential measurement single case series design
Primary purpose: TREATMENT

Brief summary: The main purpose of the study is to evaluate the feasibility, acceptability, and potential effectiveness of NET in reducing symptoms of traumatic stress (e.g., hyperarousal, avoidance, and intrusion) in cancer patients who are not in active treatment.

Further aims include:

* Can NET be effective in reducing symptoms of existential anxiety, anxiety, and depression in cancer patients who are not in active treatment?
* Can NET improve the Quality of Life (QoL) of cancer patients who are not in active treatment? And are improvements in QoL associated to reduction of traumatic stress?
* Can NET lead to post-traumatic growth?
* Does the NET protocol need to be adapted to meet cancer patients' needs?

Detailed description: Research has shown that cancer can lead to significant emotional and social distress. Many elements of the cancer experience can be perceived as traumatic by cancer patients, including diagnostic testing, waiting periods, prolonged and invasive treatment procedures, follow-up scans, and fear of recurrence.

Unlike single traumatic events, cancer behaves as an ongoing and chronic stressor. Emotional and social distress (including anxiety, depression, and post-traumatic stress disorders), can lead to reduced treatment compliance and less adherence to a healthy lifestyle which might compromise chances of survival.

Research has shown that due to the psychological distress experienced during diagnosis, treatment, and survivorship, cancer patients are interested in receiving psychosocial support; unfortunately, their distress is often perceived as "normal" and "manageable" by professionals. The result is that 30-40% of cancer patients are not supported.

This study aims to evaluate whether Narrative Exposure Therapy (NET) can be a feasible, acceptable, and effective intervention to reduce symptoms of traumatic stress in adult cancer patients who are not in active treatment. NET is a time-limited, structured, and evidenced-based intervention designed to reduce symptoms of traumatic stress through two main processes: fear habituation and integration of the traumas within the autobiographical memory. Six participants will be recruited with the support of Clinical Psychologists working in cancer services across Nottinghamshire and Lincolnshire, they will receive around twelve weekly interventions sessions. Changes will be explored through outcome measures administered before, during, and after the intervention and through interviews about their experience at the end.

The study is founded by The University of Nottingham. Potential benefits include providing initial evidence to address traumatic stress in cancer patients, providing an intervention which could be suitable for psycho-oncology services which might lack resources to offer long-term psychosocial support, and contributing to the evidence for the use of NET in a new group.

Eligibility criteria: Inclusion Criteria:

* Adults (18 and over)
* Diagnosed with cancer in adulthood
* Able to provide informed consent
* Able to communicate verbally and speak English
* Not in active treatment (at any stage post-treatment)
* Suffer from symptoms of traumatic stress caused or triggered by the cancer experience. A diagnosis of PTSD is not required (PTSD Checklist Civilian, PCL-C cut-off score: 29 and above).
* No specific form of cancer

Exclusion Criteria:

Participants have a known diagnosis of Intellectual Disability (ID)

* Participants must not be receiving other forms of psychosocial support whilst engaging in NET
* They are substance dependent
* They are actively psychotic

Primary outcomes:
measure: Change in PTS symptoms between the baseline, NET intervention, and 1 month and up to three months follow-up phases - as assessed by thePTSD Checklist - Civilian (PCL-C; Weathers et al., 1994)
timeFrame: Throughout the study, for approximately 31 weeks
Secondary outcomes:
measure: Change in depression and anxiety symptoms between the baseline, NET intervention, and 1 month and up to three months follow-up phases - as assessed byHospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983)
timeFrame: Throughout the study, for approximately 31 weeks
measure: Change in cancer-specific quality of life between the baseline, NET intervention, and 1 month and up to three months follow-up phases - as assessed by the Functional Assessment of Cancer Therapy - General 7 items (FACT-G7; Yanez et al., 2013)
timeFrame: Throughout the study, for approximately 31 weeks
Other outcomes:
measure: Process measure of habituation: Subjective Unit of Distress (SUD; Wolpe, 1969)
timeFrame: For approximately ten weeks
measure: Change in post traumatic growth between the baseline, the last NET session, and 1 month and up to three months follow up phases - as assessed by the Post-traumatic growth inventory (PTGI; Tedeschi & Calhoun, 1996)
timeFrame: On week two, week 15, week 19, and week 31
measure: Change in existential anxiety symptoms between the baseline, the last NET session, and 1 month and up to three months follow up phases - as assessed by theExistential Concerns Questionnaire (ECQ; van Bruggen, 2018)
timeFrame: On week two, week 15, week 19, and week 31
measure: Change in body awareness and autonomic reactivity between the baseline, the last NET session, and 1 month and up to 3 months follow-up phases - as assessed by the Body Perception Questionnaire Short Form - Autonomic Nervous System (Porges, 1993, 2015)
timeFrame: On week two, week 15, week 19, and week 31
measure: Change Interviews (Elliot et al., 2001)
timeFrame: At 1 month follow up
Locations:
city: Nottingham
country: United Kingdom
facility: The University of Nottingham
state: Nottinghamshire
Study officials:
affiliation: The University of Nottingham
name: Thomas Schröder
role: PRINCIPAL_INVESTIGATOR
References: