Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-04-17 @ 4:40 AM
Study NCT ID:
NCT03327259
Status:
COMPLETED
Last Update Posted:
2019-12-10
First Post:
2017-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study of Therapist Guided Activity Practice for Depressive Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000554', 'term': 'Ambulatory Care Facilities'}], 'ancestors': [{'id': 'D006268', 'term': 'Health Facilities'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-06', 'studyFirstSubmitDate': '2017-10-23', 'studyFirstSubmitQcDate': '2017-10-25', 'lastUpdatePostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Behavioral Activation', 'timeFrame': 'Baseline and 1 week follow-up', 'description': 'Behavioral Activation will be measured at baseline and 1-week follow-up using the Behavioral Activation for Depression Scale.'}, {'measure': 'Distress Intolerance', 'timeFrame': 'Baseline and 1 week follow-up', 'description': 'Distress intolerance will be measured at baseline and 1-week follow-up using the Distress Intolerance Index.'}, {'measure': 'Anxiety Sensitivity and Distress Intolerance', 'timeFrame': 'Baseline and 1 week follow-up', 'description': 'As an additional measure of distress intolerance, the Anxiety Sensitivity Index will be measured at baseline and 1-week follow-up.'}, {'measure': 'Anxiety Symptoms', 'timeFrame': 'Baseline and 1 week follow-up', 'description': 'Anxiety symptoms will be measured at baseline and 1-week follow-up using the Beck Anxiety Inventory.'}], 'primaryOutcomes': [{'measure': 'Percent Activity Completion Between Conditions', 'timeFrame': 'Daily for 7 days', 'description': '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.'}, {'measure': 'Change in Self-Efficacy in Response to Therapist Guided Activity Practice', 'timeFrame': 'Baseline', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Depressive Symptoms', 'timeFrame': 'Baseline and 1 week follow-up', 'description': 'Severity of depressive symptoms will be measured at baseline and 1-week follow-up using the Beck Depression Inventory-II.'}, {'measure': 'Experiential Avoidance and Psychological Flexibility', 'timeFrame': 'Baseline and 1 week follow-up', 'description': 'Experiential avoidance and psychological flexibility will be measured at baseline and 1-week follow-up using the Acceptance and Action Questionnaire-II.'}, {'measure': 'Multidimensional Experiential Avoidance', 'timeFrame': 'Baseline and 1 week follow-up', 'description': 'Multidimensional experiential avoidance will be measured at baseline and 1-week follow-up using the Multidimensional Experiential Avoidance Questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Depressive Symptoms']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 18-65\n* University of Texas at Austin students currently enrolled in Introductory Psychology (PSY 301)\n* Score \\>14 on Beck Depression Inventory during both pre-screening and baseline screen\n* Avoidance rating \\>59 and Distress rating \\>39 on at least one item of the Avoidance Screen.\n\nExclusion Criteria:\n\n* Initiated psychotherapy or psychotropic medication in past 6 weeks\n* Recent change (past 6 weeks) in psychotropic medication\n* Current or past psychosis or mania'}, 'identificationModule': {'nctId': 'NCT03327259', 'briefTitle': 'A Pilot Study of Therapist Guided Activity Practice for Depressive Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'A Pilot Study of Therapist Guided Activity Practice for Depressive Symptoms', 'orgStudyIdInfo': {'id': '2017-02-0043'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Activity Planning Only', 'interventionNames': ['Behavioral: Activity Planning']}, {'type': 'EXPERIMENTAL', 'label': 'Enhanced Activity Planning', 'description': 'Activity planning with therapist guided activity practice.', 'interventionNames': ['Behavioral: Activity Planning', 'Behavioral: Therapist Guided Activity Practice']}], 'interventions': [{'name': 'Activity Planning', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Activity Planning Only', 'Enhanced Activity Planning']}, {'name': 'Therapist Guided Activity Practice', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Enhanced Activity Planning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78712', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas at Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctoral Student', 'investigatorFullName': 'Aliza T. Stein', 'investigatorAffiliation': 'University of Texas at Austin'}}}}