Psychotherapy (Accelerated Resolution Therapy) for Cancer Related Trauma and Distress

Malignant Solid Neoplasm Clinical Trial

Official title:

Accelerated Resolution Therapy for Cancer Related Trauma and Distress: A Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04436835
• Other study ID #: 19-006093
• Secondary ID: NCI-2020-0413019
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 27, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial studies whether a form of psychotherapy called accelerated resolution therapy can help with cancer distress and psychological trauma. Accelerated resolution therapy is an evidence-based therapy for the treatment of depressive symptoms, trauma, and stress-related disorders. This study may provide evidence to support integration of accelerated resolution therapy into psychological treatment of cancer patients, which may decrease cancer related trauma and distress.

Description:

PRIMARY OBJECTIVES:

I. Calculate changes, and estimate mean changes, in primary outcomes of psychological trauma and cancer distress over a six week time period while receiving weekly accelerated resolution therapy (ART).

II. Calculate changes, and estimate mean changes, in secondary outcomes of anxiety and depression over a six week period while receiving weekly ART.

III. Will use a qualitative, descriptive design to explore contextual elements of the cancer experience that are consistently distressing and/or psychologically traumatic to more fully inform a future RCT testing in ART in cancer distress and psychological trauma.

IV. Calculate changes, and estimate mean changes, in secondary outcomes of resilience and symptom distress over a six week period while receiving weekly ART.

OUTLINE:

Patients undergo ART over 60-90 minutes once a week for up to 5 sessions.

After completion of study intervention, patients are followed up at 1 week and again at 1 month.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: December 31, 2024
• Est. primary completion date: August 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Able to read, write and understand English

• Undergone chemotherapy, radiation therapy, chimeric antigen receptor T cells (CAR-T), or bone marrow transplant for a cancer diagnosis within the previous 3 years or have metastatic cancer

• A mean score of at least 1.1 on the Cancer and Treatment Distress (CTxD) or at least one item rated at a 3 (often true) or 4 (nearly all the time)

• A minimum score of 3 on the Primary Care-Post Traumatic Stress Disorder Screen (PC-PTSD-5)

• Denial of suicidal ideation or intent, with no evidence of psychotic behavior

• Participants must be willing and able to utilize secure web conferencing software, phone calls, or to travel to Mayo Clinic outside of normally scheduled visits to participate in the study

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid System Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Behavioral:
• Psychotherapy
Undergo ART

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychological trauma	Symptoms of psychological trauma will be measured with both the Primary Care-Post Traumatic Stress Disorder Screening (PC-PTSD-5) and the Post Traumatic Stress Disorder Checklist (PCL-5). The PCL-5 (PTSD Patient Checklist) is a 20-item self-report instrument that will be used to assess the DSM-5 symptoms of PTSD (psychological trauma). The total symptom severity score ranges from 0 to 80.	Up to 6 weeks
Primary	Cancer distress	Cancer distress will be measured with the Cancer Treatment Distress Scale (CTxD). The CTxD is a 22 item Likert type scale that contains 6 subscales: uncertainty, health burden, identity, medical demands, finances, and family strain. Scores on individual items range from 0 (none) to 3 (severe) distress related to an aspect of the cancer experience.	Up to 6 weeks
Secondary	Anxiety	The General Anxiety Disorder (GAD-7) is a measure of anxiety scored from 0 (not at all)-3 (nearly every day) scale for each item with total scores ranging from 0-21. A score of 10 or more indicates high anxiety, although a cut-score of 7 or higher has been suggested for cancer populations.	Up to 6 weeks
Secondary	Depression	The Patient Health Questionnaire (PHQ-8) is an 8 item measure of depression scoring DSM -IV criteria for depression on a 0 (not at all) to 3 (nearly every day) scale for each item with total scores ranging from 0-24 (25). A score of 10 or more indicates depression.	Up to 6 weeks
Secondary	Resilience	The Connor-Davidson Resilience Scale (CD-RISC) is a 10 item scale in which participants rate statements on a scale of 0 (not at all true) to 4 (true nearly all the time). Higher scores indicate higher levels of resilience.	Up to 6 weeks
Secondary	Symptom distress	The Edmonton Symptom Assessment Scale (ESAS) consists of 11-point numerical rating scales for self-report of ten common symptoms of cancer. A summary score is calculated with higher scores representing greater symptom distress.	Up to 6 weeks

External Links

•   Mayo Clinic Clinical Trials