Narrative Exposure Therapy to Reduce Symptoms of Traumatic Stress in Cancer Survivors

NCT05272553 | Unknown

• 1 other identifier: 21083
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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?

Conditions

Traumatic Stress Disorder; Cancer

Keywords

narrative exposure therapy

Outcome Measures

Primary Outcomes (1)

• 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)

  The PCL-C explores items related to individuals' past stressful experiences using a 17-item self-report checklist (Weathers et al., 1994). The PCL-C has been widely used in cancer research (such as DuHamel et al., 2010; Levine et al., 2005; Lleras de Frutos et al., 2020; Ochoa-Arnedo et al., 2020) and was assessed as a screening instrument by Andrykowski and colleagues in their study with breast cancer survivors in 1998. The PCL-C has shown good internal consistency (Cronbach's alpha \>.75) (Wilkins et al., 2011) and good test-retest reliability with scores ranging from 0.68 and 0.92 (Hahn et al., 2015). Scores above 29 are indicative of clinical concerns; the US Department of Veterans Affairs recommends a cut-off score of 30 to 38 for diagnosis of PTSD (www.ptsd.va.gov).

  Throughout the study, for approximately 31 weeks

Secondary Outcomes (2)

• 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)

  Throughout the study, for approximately 31 weeks

• 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)

  Throughout the study, for approximately 31 weeks

Other Outcomes (5)

• Process measure of habituation: Subjective Unit of Distress (SUD; Wolpe, 1969)

  For approximately ten weeks

• 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)

  On week two, week 15, week 19, and week 31

• 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)

  On week two, week 15, week 19, and week 31

Study Arms (1)

Narrative Exposure Therapy

EXPERIMENTAL

This is a single case series design which focuses on assessing whether Narrative Exposure Therapy could reduce symptoms of traumatic stress in cancer survivors; no comparator will be included.

Other: Narrative Exposure Therapy

Interventions

Narrative Exposure Therapy OTHER

NET (Schauer et al., 2011) is an evidence-based, short-term, manualised treatment for trauma-spectrum disorders; it aims to reduce symptoms of traumatic stress in individuals who continue to suffer from past experiences of traumatic stressors; NET combines principles of CBT, Testimony Therapy, and Exposure Therapy.

Narrative Exposure Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead
• National Health Service, United Kingdom: collaborator

Study Sites (1)

The University of Nottingham

Nottingham, Nottinghamshire, NG8 1BB, United Kingdom

Location

MeSH Terms

Conditions

Stress Disorders, Traumatic; Neoplasms

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Thomas Schröder

  The University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Naturalistic, mixed-method, explanatory sequential measurement single case series design

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: March 9, 2022
• Study Start: March 4, 2022
• Primary Completion: February 1, 2023
• Study Completion: September 1, 2023
• Last Updated: May 19, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)