Desensitizing Distressing Recollections in Cancer Patients

Study Overview
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Brief Summary
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The major goal of this study is to determine whether Neuro-Emotional Technique is a viable treatment option for decreasing distress in cancer patients. The potential advantages of NET are: 1) it is designed specifically to address distressing stimuli and unresolved emotional memories; 2) it is a brief, time-limited intervention; and 3) its multi-modal design may appeal to and benefit a broader range of patients than a single mode intervention

Official Title
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Desensitizing Distressing Recollections in Cancer Patients

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: NET Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years of age Distressing cancer-related recollection that has persisted for at least six months Distressing cancer-related recollection that causes physiological reactivity (i.e., increased heart rate and/or increased skin conductance level - SCL), as described in section 4.2.3. Received a cancer diagnosis at least 6 months prior to being contacted for participation in this study Exclusion Criteria: Any current Major Mental Disorder, as assessed by Structured Clinical Interview for DSM IV Axis I Disorders (SCID - Clinical Version, First et al, 1997) History of Post-traumatic Stress Disorder Current active mood primary disorder prior to the cancer diagnosis (as per PI or designate) History or current diagnosis of substance or alcohol abuse or dependence (as per PI or designate) Use of psychotropic medications within the past month or current use of medications that would interfere with autonomic nervous system measures (benzodiazepines, barbiturates, major tranquilizers). Use of some psychotropic medications are allowed such as SSRIs and certain sleep aids, but dosages must be stable from six weeks prior to enrollment and throughout study period Any psychological or musculoskeletal problems that would interfere with psychophysiological assessments and treatment Currently receiving chemotherapy or radiation Are in the terminal stages of illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Subjects will receive NET intervention treatment immediately | Behavioral: NET Intervention<br>* Neuro-emotional Technique<br>|
| Active Comparator: Control<br>Subjects will receive NET intervention treatment and serve as a wait-list control | Behavioral: NET Intervention<br>* Neuro-emotional Technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post traumatic Cognitions Inventory | change from baseline Post Traumatic Cognitions Inventory score | baseline/ 4 weeks/6 months follow up | 
| State Trait Anxiety Inventory | change from baseline State Trait Anxiety Inventory score | baseline/4 weeks/6 months follow up | 
| Brief Symptom Inventory | change from baseline Brief Symptom Inventory | baseline/4 weeks/6 month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autonomal response to distressing recollections | change from baseline in autonomal response to distressing recollections | baseline/4 weeks follow up | 
| Genomic testing | change from baseline genomic testing before and after intervention | baseline/ 4 weeks follow up |