NCT03056963

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 17, 2017

Completed
28 days until next milestone

Study Start

First participant enrolled

March 17, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2017

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

3 months

First QC Date

February 10, 2017

Last Update Submit

July 17, 2017

Conditions

Keywords

Guided Imagery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Depressive Symptomatology

    Participants will complete measures of depressive symptoms at baseline, after one week, and after two weeks.

Study Arms (2)

Positive Self-Reference Training

EXPERIMENTAL

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

Behavioral: Positive Self-Reference Training

Neutral Training Control

PLACEBO COMPARATOR

Participants in this arm will complete the neutral training paradigm.

Behavioral: Neutral Training Control

Interventions

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.

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 neutral, non-self-referent material.

Neutral Training Control

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78703, United States

Location

Related Links

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Justin Dainer-Best

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2017

First Posted

February 17, 2017

Study Start

March 17, 2017

Primary Completion

June 19, 2017

Study Completion

June 19, 2017

Last Updated

July 19, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations