A Pilot Study of Therapist Guided Activity Practice for Depressive Symptoms

Depressive Symptoms Clinical Trial

Official title:

A Pilot Study of Therapist Guided Activity Practice for Depressive Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03327259
• Other study ID #: 2017-02-0043
• Status: Completed
• Phase: N/A
• Start date: October 9, 2017
• Est. completion date: April 5, 2019

Study information

• Verified date: December 2019
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 5, 2019
• Est. primary completion date: April 5, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

Behavioral:
• Activity Planning
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.
• Therapist Guided Activity Practice
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.

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
Other	Behavioral Activation	Behavioral Activation will be measured at baseline and 1-week follow-up using the Behavioral Activation for Depression Scale.	Baseline and 1 week follow-up
Other	Distress Intolerance	Distress intolerance will be measured at baseline and 1-week follow-up using the Distress Intolerance Index.	Baseline and 1 week follow-up
Other	Anxiety Sensitivity and Distress Intolerance	As an additional measure of distress intolerance, the Anxiety Sensitivity Index will be measured at baseline and 1-week follow-up.	Baseline and 1 week follow-up
Other	Anxiety Symptoms	Anxiety symptoms will be measured at baseline and 1-week follow-up using the Beck Anxiety Inventory.	Baseline and 1 week follow-up
Primary	Percent Activity Completion Between Conditions	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.	Daily for 7 days
Primary	Change in Self-Efficacy in Response to Therapist Guided Activity Practice	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.	Baseline
Secondary	Depressive Symptoms	Severity of depressive symptoms will be measured at baseline and 1-week follow-up using the Beck Depression Inventory-II.	Baseline and 1 week follow-up
Secondary	Experiential Avoidance and Psychological Flexibility	Experiential avoidance and psychological flexibility will be measured at baseline and 1-week follow-up using the Acceptance and Action Questionnaire-II.	Baseline and 1 week follow-up
Secondary	Multidimensional Experiential Avoidance	Multidimensional experiential avoidance will be measured at baseline and 1-week follow-up using the Multidimensional Experiential Avoidance Questionnaire.	Baseline and 1 week follow-up