Guided Imagery Training and Self-Referential Processing

• Sponsor: University of Texas at Austin (Other)
• Overall Status: Completed
• CT.gov ID: NCT03056963
• Collaborator: (none)
• Enrollment: 86
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.1
• Patients Per Site Per Month: 27.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression; Negative Thoughts	Behavioral: Positive Self-Reference Training; Behavioral: Neutral Training Control	N/A

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 Design

• Study Type: Interventional
• 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: Mar 17, 2017
• Actual Primary Completion Date: Jun 19, 2017
• Actual Study Completion Date: Jun 19, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas at Austin	Austin	Texas	United States	78703

Sponsors and Collaborators

• University of Texas at Austin

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Screening Questionnaire

Publications

None provided.

• Responsible Party: University of Texas at Austin
• ClinicalTrials.gov Identifier: NCT03056963
• Other Study ID Numbers: UTEXAS-2016-07-0080
• First Posted: Feb 17, 2017
• Last Update Posted: Jul 19, 2017
• Last Verified: Jul 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Depression

Study Results

No Results Posted as of Jul 19, 2017