NCT03327259

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

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

Study Start

First participant enrolled

October 9, 2017

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 31, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2019

Completed
Last Updated

December 10, 2019

Status Verified

December 1, 2019

Enrollment Period

1.5 years

First QC Date

October 23, 2017

Last Update Submit

December 6, 2019

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Depressive Symptoms

    Baseline and 1 week follow-up

  • Experiential Avoidance and Psychological Flexibility

    Baseline and 1 week follow-up

  • Multidimensional Experiential Avoidance

    Baseline and 1 week follow-up

Other Outcomes (4)

  • Behavioral Activation

    Baseline and 1 week follow-up

  • Distress Intolerance

    Baseline and 1 week follow-up

  • Anxiety Sensitivity and Distress Intolerance

    Baseline and 1 week follow-up

  • +1 more other outcomes

Study Arms (2)

Activity Planning Only

ACTIVE COMPARATOR
Behavioral: Activity Planning

Enhanced Activity Planning

EXPERIMENTAL

Activity planning with therapist guided activity practice.

Behavioral: Activity PlanningBehavioral: Therapist Guided Activity Practice

Interventions

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.

Activity Planning OnlyEnhanced Activity Planning

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.

Enhanced Activity Planning

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Initiated psychotherapy or psychotropic medication in past 6 weeks
  • Recent change (past 6 weeks) in psychotropic medication
  • Current or past psychosis or mania

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Ambulatory Care Facilities

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Health FacilitiesHealth Care Facilities Workforce and Services

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
PRINCIPAL INVESTIGATOR
PI Title
Doctoral Student

Study Record Dates

First Submitted

October 23, 2017

First Posted

October 31, 2017

Study Start

October 9, 2017

Primary Completion

April 5, 2019

Study Completion

April 5, 2019

Last Updated

December 10, 2019

Record last verified: 2019-12

Locations