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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03056963
Other study ID # UTEXAS-2016-07-0080
Secondary ID
Status Completed
Phase N/A
First received February 10, 2017
Last updated July 17, 2017
Start date March 17, 2017
Est. completion date June 19, 2017

Study information

Verified date July 2017
Source University of Texas at Austin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date June 19, 2017
Est. primary completion date June 19, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 45 Years
Eligibility 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:

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States University of Texas at Austin Austin Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 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 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. Participants will complete measures of depressive symptoms at baseline, after one week, and after two weeks.
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