- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03056963
Guided Imagery Training and Self-Referential Processing
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78703
- University of Texas at Austin
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Positive Self-Reference Training
Participants in this arm will complete the Positive Self-Reference Training (PSRT).
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Participants will complete measures of depressive symptoms at baseline, after one week, and after two weeks.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Justin Dainer-Best, University of Texas at Austin
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UTEXAS-2016-07-0080
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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