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Completed

NCT Number: NCT03327259

A Pilot Study of Therapist Guided Activity Practice for Depressive Symptoms

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.

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Key information

Conditions

Depressive Symptoms Behavior Behavioral Symptoms Depression

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas at Austin

Austin, Texas, 78712, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Activity Planning

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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.

  2. Change in Self-Efficacy in Response to Therapist Guided Activity Practice

    Time frame: Baseline

    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.

Secondary outcomes

  1. Depressive Symptoms

    Time frame: Baseline and 1 week follow-up

    Severity of depressive symptoms will be measured at baseline and 1-week follow-up using the Beck Depression Inventory-II.

  2. Experiential Avoidance and Psychological Flexibility

    Time frame: Baseline and 1 week follow-up

    Experiential avoidance and psychological flexibility will be measured at baseline and 1-week follow-up using the Acceptance and Action Questionnaire-II.

  3. 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.

Other outcomes

  1. 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.

  2. Distress Intolerance

    Time frame: Baseline and 1 week follow-up

    Distress intolerance will be measured at baseline and 1-week follow-up using the Distress Intolerance Index.

  3. Anxiety Sensitivity and Distress Intolerance

    Time frame: Baseline and 1 week follow-up

    As an additional measure of distress intolerance, the Anxiety Sensitivity Index will be measured at baseline and 1-week follow-up.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 31, 2017
Registry last updated
Dec 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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