search
Back to results

Guided Imagery Training and Self-Referential Processing

Primary Purpose

Depression, Negative Thoughts

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Positive Self-Reference Training
Neutral Training Control
Sponsored by
University of Texas at Austin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Guided Imagery

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas at Austin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Positive Self-Reference Training

Neutral Training Control

Arm Description

Participants in this arm will complete the Positive Self-Reference Training (PSRT).

Participants in this arm will complete the neutral training paradigm.

Outcomes

Primary Outcome Measures

Change in response on the Self-Referent Encoding Task (SRET)
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

Depressive Symptomatology
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.

Full Information

First Posted
February 10, 2017
Last Updated
July 17, 2017
Sponsor
University of Texas at Austin
search

1. Study Identification

Unique Protocol Identification Number
NCT03056963
Brief Title
Guided Imagery Training and Self-Referential Processing
Official Title
Guided Imagery Training and Self-Referential Processing
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 17, 2017 (Actual)
Primary Completion Date
June 19, 2017 (Actual)
Study Completion Date
June 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Negative Thoughts
Keywords
Guided Imagery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive Self-Reference Training
Arm Type
Experimental
Arm Description
Participants in this arm will complete the Positive Self-Reference Training (PSRT).
Arm Title
Neutral Training Control
Arm Type
Placebo Comparator
Arm Description
Participants in this arm will complete the neutral training paradigm.
Intervention Type
Behavioral
Intervention Name(s)
Positive Self-Reference Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Neutral Training Control
Intervention Description
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 Measure Information:
Title
Change in response on the Self-Referent Encoding Task (SRET)
Description
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.
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.
Secondary Outcome Measure Information:
Title
Depressive Symptomatology
Description
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.
Time Frame
Participants will complete measures of depressive symptoms at baseline, after one week, and after two weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Dainer-Best
Organizational Affiliation
University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78703
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://redcap.prc.utexas.edu/redcap/surveys/?s=DCXW77HAF3
Description
Screening Questionnaire

Learn more about this trial

Guided Imagery Training and Self-Referential Processing

We'll reach out to this number within 24 hrs