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NET: Desensitizing Distressing Recollections in Cancer Patients

Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University (Other)
Overall Status
Completed
CT.gov ID
NCT02760524
Collaborator
(none)
44
Enrollment
1
Location
2
Arms
89.6
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: NET Intervention
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Desensitizing Distressing Recollections in Cancer Patients
Actual Study Start Date :
Apr 11, 2010
Actual Primary Completion Date :
Aug 1, 2015
Actual Study Completion Date :
Sep 28, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

Subjects will receive NET intervention treatment immediately

Behavioral: NET Intervention
Neuro-emotional Technique
Active Comparator: Control

Subjects will receive NET intervention treatment and serve as a wait-list control

Behavioral: NET Intervention
Neuro-emotional Technique

Outcome Measures

Primary Outcome Measures

  1. Post traumatic Cognitions Inventory [baseline/ 4 weeks/6 months follow up]

    change from baseline Post Traumatic Cognitions Inventory score

  2. State Trait Anxiety Inventory [baseline/4 weeks/6 months follow up]

    change from baseline State Trait Anxiety Inventory score

  3. Brief Symptom Inventory [baseline/4 weeks/6 month follow up]

    change from baseline Brief Symptom Inventory

Secondary Outcome Measures

  1. Autonomal response to distressing recollections [baseline/4 weeks follow up]

    change from baseline in autonomal response to distressing recollections

  2. Genomic testing [baseline/ 4 weeks follow up]

    change from baseline genomic testing before and after intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Thomas Jefferson University Philadelphia Pennsylvania United States 19107

Sponsors and Collaborators

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

Investigators

  • Principal Investigator: Daniel A Monti, MD, Thomas Jefferson University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Sidney Kimmel Cancer Center at Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT02760524
Other Study ID Numbers:
  • 09D.182
First Posted:
May 3, 2016
Last Update Posted:
Jun 13, 2018
Last Verified:
Jun 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No

Study Results

No Results Posted as of Jun 13, 2018