Traumatic Stress DisorderNCT05272553
Narrative Exposure Therapy to Reduce Symptoms of Traumatic Stress in Cancer Survivors
A study testing Narrative Exposure Therapy in people with Traumatic Stress Disorder and Cancer, run by University of Nottingham at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Stress Disorder, Cancer
- What is being tested?
- Narrative Exposure Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Mar 2022to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The University of Nottingham
Nottingham, Nottinghamshire, NG8 1BB
About this study
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
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?
Read the 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.
- Conditions
- Traumatic Stress Disorder, Cancer
- Being tested
- Narrative Exposure Therapy
- Keywords
- narrative exposure therapy
- Medical subject headings
- Stress Disorders, Traumatic, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Narrative Exposure TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Narrative Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
The HADS is the most extensively studied mood scale in cancer services (as well as in other medical settings) (Mitchell et al., 2010). It is a fourteen item self-report measure of anxiety and depression that has demonstrated to be psychometrically robust showing good internal consistency (Anxiety Cronbach's alpha = .83; Depression Cronbach's alpha = .82) (Bjelland et al., 2002) and good test-retest reliability (Anxiety r = .82; Depression r = .52) (Martin \& Thompson, 2002). Scores of 8 and above are indicative of clinical concerns.
Measured: 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)
The FACT-G7 is a brief, cancer-specific quality-of-life measure comprising 7 items from the 27-item Functional Assessment of Cancer Therapy-General Scale (FACT-G; Cella et al., 1993) that were endorsed by cancer patients as being of highest priority. Its items comprise physical, emotional and functional domains. Total scores range between 0 and 28, and higher scores indicate better quality of life. The FACT-G7 has shown good internal consistency (Cronbach's alpha = between .72 and .80) (Mah et al., 2020) and good test-retest reliability (scores between .52 and .74) (King et al., 2020).
Measured: Throughout the study, for approximately 31 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start4 Mar 2022
- Primary completionFeb 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Naturalistic, mixed-method, explanatory sequential measurement single case series design
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Thomas Schröder, Principal investigator, The University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272553
- Sponsor's protocol ID
- 21083
- Status last verified
- Mar 2022
- First submitted
- 6 Jan 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05272553
- Acronym / sponsor ID
- 21083
- Conditions
- Traumatic Stress Disorder, Cancer
- Keywords
- narrative exposure therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Naturalistic, mixed-method, explanatory sequential measurement single case series design
| Arm | Type | Receives |
|---|---|---|
| Narrative Exposure Therapy | Experimental | Other: Narrative Exposure TherapyThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Narrative Exposure TherapyNET (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. | Other | Narrative Exposure Therapy |
Primary outcome
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)
Time frame: Throughout the study, for approximately 31 weeks
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).
2 secondary outcomes
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)
Time frame: 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)
Time frame: Throughout the study, for approximately 31 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Schröder principal investigator
The University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Narrative Exposure Therapy in people with Traumatic Stress Disorder and Cancer, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Throughout the study, for approximately 31 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.