- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03327259
A Pilot Study of Therapist Guided Activity Practice for Depressive Symptoms
December 6, 2019 updated by: Aliza T. Stein, University of Texas at Austin
There is literature to support both the need for and efficacy of brief interventions for depressive symptoms, particularly among college students.Brief behavioral activation interventions (BATD) have gained recognition as efficacious treatments for depression; yet a recent study evidenced a substantial (39%) non-response rate (Kuyken et al., 2017).
In accordance with behavioral models of depression, the treatment involves increasing activity and positive experience, to break the negative reinforcement cycle maintaining depressed mood.
Thus, strategies that may facilitate increasing activity may improve BATD outcomes.
The objective of the current study is to examine whether briefly practicing a target activity during an activity planning session (modified single session of BATD) increases the likelihood of completing the activity during the upcoming week.
We hypothesized that guided activity practice may improve self-efficacy within session and activity completion in the upcoming week.
We further aim to explore whether activity completion mediates depressive symptom change.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
100
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
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Texas
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Austin, Texas, United States, 78712
- University of Texas at Austin
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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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ages 18-65
- University of Texas at Austin students currently enrolled in Introductory Psychology (PSY 301)
- Score >14 on Beck Depression Inventory during both pre-screening and baseline screen
- Avoidance rating >59 and Distress rating >39 on at least one item of the Avoidance Screen.
Exclusion Criteria:
- Initiated psychotherapy or psychotropic medication in past 6 weeks
- Recent change (past 6 weeks) in psychotropic medication
- Current or past psychosis or mania
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 |
|---|---|
|
Active Comparator: Activity Planning Only
|
The therapist will work with the participant to select a challenging, yet rewarding or value-driven activity that he/she can engage in 5x and monitor daily over the upcoming week.
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Experimental: Enhanced Activity Planning
Activity planning with therapist guided activity practice.
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The therapist will work with the participant to select a challenging, yet rewarding or value-driven activity that he/she can engage in 5x and monitor daily over the upcoming week.
The therapist will work with the participant to plan and carry out a brief in-vivo version of their goal/target activity.
The therapist will guide the participant through the activity for approximately 15 minutes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percent Activity Completion Between Conditions
Time Frame: Daily for 7 days
|
Participants will complete daily surveys for seven days following the initial visit.
Participants will answer whether or not the activity was completed that day.
Data will be collected using Qualtrics survey software.
The outcome variable is the percentage of days the participant completed the activity.
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Daily for 7 days
|
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Change in Self-Efficacy in Response to Therapist Guided Activity Practice
Time Frame: Baseline
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Following the activity planning portion of the initial visit, participants rate the degree of self-efficacy (confidence in ability to complete the goal) on a scale from 0 (no confidence) to 100 (complete confidence).
Participants randomized to Enhanced Activity Practice condition will complete a second rating following the activity practice.
The pre-to-post difference score in self-efficacy will be examined as a primary outcome.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depressive Symptoms
Time Frame: Baseline and 1 week follow-up
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Severity of depressive symptoms will be measured at baseline and 1-week follow-up using the Beck Depression Inventory-II.
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Baseline and 1 week follow-up
|
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Experiential Avoidance and Psychological Flexibility
Time Frame: Baseline and 1 week follow-up
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Experiential avoidance and psychological flexibility will be measured at baseline and 1-week follow-up using the Acceptance and Action Questionnaire-II.
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Baseline and 1 week follow-up
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Multidimensional Experiential Avoidance
Time Frame: Baseline and 1 week follow-up
|
Multidimensional experiential avoidance will be measured at baseline and 1-week follow-up using the Multidimensional Experiential Avoidance Questionnaire.
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Baseline and 1 week follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Behavioral Activation
Time Frame: Baseline and 1 week follow-up
|
Behavioral Activation will be measured at baseline and 1-week follow-up using the Behavioral Activation for Depression Scale.
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Baseline and 1 week follow-up
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Distress Intolerance
Time Frame: Baseline and 1 week follow-up
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Distress intolerance will be measured at baseline and 1-week follow-up using the Distress Intolerance Index.
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Baseline and 1 week follow-up
|
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Anxiety Sensitivity and Distress Intolerance
Time Frame: Baseline and 1 week follow-up
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As an additional measure of distress intolerance, the Anxiety Sensitivity Index will be measured at baseline and 1-week follow-up.
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Baseline and 1 week follow-up
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Anxiety Symptoms
Time Frame: Baseline and 1 week follow-up
|
Anxiety symptoms will be measured at baseline and 1-week follow-up using the Beck Anxiety Inventory.
|
Baseline and 1 week follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
October 9, 2017
Primary Completion (Actual)
April 5, 2019
Study Completion (Actual)
April 5, 2019
Study Registration Dates
First Submitted
October 23, 2017
First Submitted That Met QC Criteria
October 25, 2017
First Posted (Actual)
October 31, 2017
Study Record Updates
Last Update Posted (Actual)
December 10, 2019
Last Update Submitted That Met QC Criteria
December 6, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-02-0043
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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