Guided Imagery Training and Self-Referential Processing

July 17, 2017 updated by: University of Texas at Austin

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

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

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Austin, Texas, United States, 78703
        • University of Texas at Austin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Justin Dainer-Best, University of Texas at Austin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2017

Primary Completion (Actual)

June 19, 2017

Study Completion (Actual)

June 19, 2017

Study Registration Dates

First Submitted

February 10, 2017

First Submitted That Met QC Criteria

February 14, 2017

First Posted (Actual)

February 17, 2017

Study Record Updates

Last Update Posted (Actual)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 17, 2017

Last Verified

July 1, 2017

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)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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