Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Guided Imagery Training and Self-Referential Processing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03056963
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
University of Texas at Austin

Brief Summary:

The purpose of this study is to examine the efficacy of a guided imagery paradigm for reducing negative ways of thinking about the self. There will be at least 60 participants enrolled at the University of Texas at Austin. Participants will be randomly selected to receive one of two types of trainings, each over the course of two weeks. Participants will undergo the training exercises at home. The training exercises will help them to think differently about themselves.

Participants will be able to determine if they are eligible, and then participate, by filling out a screening questionnaire online.


Condition or disease Intervention/treatment Phase
Depression Negative Thoughts Behavioral: Positive Self-Reference Training Behavioral: Neutral Training Control Not Applicable

Detailed Description:

This study uses a randomized controlled trial to compare two types of guided imagery. One intervention is an active intervention; the other is intended to be inert. These interventions were developed based on extensive research indicating the efficacy of using imagery in depression, and a perceived lack of treatments targeting biased self-referential processing.

This protocol aims to develop a novel intervention which can be used on its own or as an adjunct to existing treatments. Common treatments for Major Depressive Disorder (MDD) are diffuse; this paradigm instead aims to specifically target negative self-schema, a part of the cognitive model of MDD. This study focuses on participants with elevated depressive symptoms.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Guided Imagery Training and Self-Referential Processing
Actual Study Start Date : March 17, 2017
Actual Primary Completion Date : June 19, 2017
Actual Study Completion Date : June 19, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Positive Self-Reference Training
Participants in this arm will complete the Positive Self-Reference Training (PSRT).
Behavioral: Positive Self-Reference Training
Participants in this intervention will review a brief psychoeducational video describing the training, and then be given cues every other day designed to practice skills. Participants will then practice visualizing and describing scenes based on these cues. This training will be focused on positive self-referent material.

Placebo Comparator: Neutral Training Control
Participants in this arm will complete the neutral training paradigm.
Behavioral: Neutral Training Control
Participants in this intervention will review a brief psychoeducational video describing the training, and then be given cues every other day designed to practice skills. Participants will then practice visualizing and describing scenes based on these cues. This training will be focused on neutral, non-self-referent material.




Primary Outcome Measures :
  1. Change in response on the Self-Referent Encoding Task (SRET) [ Time Frame: Participants will complete the SRET at baseline, after one week, and after two weeks. Change will be assessed primarily as SRET at two weeks MINUS SRET at baseline. ]
    The SRET is a task that asks participants to categorize words as self-referential or not. Its outcomes are focused on behavioral response and reaction time. We have shown that it has good test-retest reliability over the course of one week.


Secondary Outcome Measures :
  1. Depressive Symptomatology [ Time Frame: Participants will complete measures of depressive symptoms at baseline, after one week, and after two weeks. ]
    Measures of depressive symptoms will be measured with the CESD, a self-report questionnaire used in the literature to measure levels of depression. This questionnaire has good test-retest reliability, and reliably changes with symptoms.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • willing and able to provide informed consent
  • elevated depressive symptoms -- i.e., a score above a 13 on the Center for Epidemiologic Studies Depression Scale (CESD)

Exclusion Criteria:

  • N/A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056963


Locations
Layout table for location information
United States, Texas
University of Texas at Austin
Austin, Texas, United States, 78703
Sponsors and Collaborators
University of Texas at Austin
Investigators
Layout table for investigator information
Principal Investigator: Justin Dainer-Best University of Texas at Austin
Additional Information:
Layout table for additonal information
Responsible Party: University of Texas at Austin
ClinicalTrials.gov Identifier: NCT03056963    
Other Study ID Numbers: UTEXAS-2016-07-0080
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Texas at Austin:
Guided Imagery
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Behavioral Symptoms