Ignite Creation Date:
2025-12-24 @ 9:42 PM
Ignite Modification Date:
2026-01-04 @ 12:36 AM
Study NCT ID:
NCT03826732
Status:
COMPLETED
Last Update Posted:
2020-09-14
First Post:
2019-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acceptance and Commitment Therapy (ACT) Self-help to Reduce Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Given the nature of the intervention, and self-report as a main strategy for outcome assessment, nor masking is possible or necessary.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization into active treatment versus a wait-list control group'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-10', 'studyFirstSubmitDate': '2019-01-24', 'studyFirstSubmitQcDate': '2019-01-31', 'lastUpdatePostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Credibility/Expectancy Questionnaire (CEQ)', 'timeFrame': 'Pre-assessment', 'description': 'To measure the perceived credibility of the intervention as well as expectations. It has two subscales; 1) expectancy, and 2) credibility. The individual items are first standardized and then summed up in each subscale. Higher values represent a better outcome.'}], 'primaryOutcomes': [{'measure': 'Perceived Stress Scale-14 (PSS-14)', 'timeFrame': 'Pre-assessment, week 3 and 5 of intervention, post-assessment (week10), and 6 months follow-up', 'description': 'The PSS-14 is measure of stress. Its total score ranges from 0-56. Lower values represent a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'Pre- and post-assessment (10 weeks later) as well as 6 months follow-up', 'description': 'The PHQ-9 provides a measure of depressive symptomatology. It ranges from 0-27. Lower values represent a better outcome'}, {'measure': 'General Anxiety Disorder-7 (GAD-7)', 'timeFrame': 'Pre- and post-assessment (10 weeks later) as well as 6 months follow-up', 'description': 'The GAD-7 is used to measure anxiety. It ranges from 0-21. Lower values represent a better outcome.'}, {'measure': 'Brunnsviken Brief Quality of Life Inventory (BBQ)', 'timeFrame': 'Pre- and post-assessment (10 weeks later) as well as 6 months follow-up', 'description': 'The BBQ is a Swedish measure of quality of life. It ranges from 0-96. Higher values represent a better outcome.'}, {'measure': 'Shirom Melamed Burnout Measure (SMBM)', 'timeFrame': 'Pre- and post-assessment (10 weeks later) as well as 6 months follow-up', 'description': 'The SMBM provides a measure of burn-out. It has three sub-scales: 1) physical exhaustion, 2) cognitive fatigue, and 3) emotional exhaustion. The subscales are combined to compute a total score by summing the mean of the subscales. Scale ranges from 3-15. Higher values represent a better outcome.'}, {'measure': 'Acceptance and Action Questionnaire-2 (AAQ-2)', 'timeFrame': 'Pre-assessment, week 3 and 5 of intervention, post-assessment (week10), and 6 months follow-up', 'description': 'To Measure psychological flexibility (mediator of change). It ranges from 7-49. Lower values represent a better outcome.'}, {'measure': 'Mindful Attention Awareness Scale (MAAS)', 'timeFrame': 'Pre-assessment, week 3 and 5 of intervention, post-assessment (week10), and 6 months follow-up', 'description': 'To measure mindfulness (potential mediator of change). The score is computed by the mean of the 15 items and the resulting scale ranges from 1-6. Higher values represent a better outcome.'}, {'measure': 'Client Satisfaction Questionnaire (CSQ)', 'timeFrame': 'Post-assessment, and 6 month follow-up', 'description': 'To measure satisfaction and dissatisfaction with the intervention. It ranges from 8-32. Higher values indicate higher satisfaction.'}, {'measure': 'Negative Effects Questionnaire (NEQ)', 'timeFrame': 'Post-assessment, and 6 month follow-up', 'description': 'To identify iatrogenic events. It ranges from 0-128. Lower values represent a better outcome (i.e. fewer negative effects from the intervention).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stress']}, 'descriptionModule': {'briefSummary': 'The efficacy of guided self-help based on acceptance and commitment therapy (ACT) to reduce subjective sense of stress will be investigated in a randomised controlled trial with two condition: 1) ACT-based self-help, and 2) Wait-list control. The outcome at the end of the treatment (week 10) and 6-month follow-up will be assessed. The wail-list condition will be offered ACT-based self-help after the post-assessment.', 'detailedDescription': 'The efficacy of guided self-help based on acceptance and commitment therapy (ACT) to reduce subjective sense of stress will be investigated in a randomised controlled trial with two condition: 1) ACT-based self-help, and 2) Wait-list control. The outcome at the end of the treatment and 6-month follow-up will be assessed. The wail-list condition will be offered ACT-based self-help after 10 weeks (i.e. when the post-assessment is completed). Inclusion criteria are: Adults with a score above 14 on the stress sub scale of the Depression, Anxiety, Stress Scale (DASS) at screening, a score below 10 on the Patient Health Questionnaire (PHQ-9), no indication of suicidality on the PHQ-9, and no ongoing psychotherapeutic interventions, and no previous work with the self-help manual that has been published as a self-help book.\n\nA total of 140 participants will be recruited and randomised, using services on www.random.org. Informed consent will be obtained from all the participants ahead of screening. Participants will be asked to respond to the following questionnaires at pre-, post and follow-up assessments: Perceived Stress Scale-14 (PSS-14), General Anxiety Disorder-7 (GAD-7), Shirom Melamed Burnout Measure (SMBM), and Brunnsviken Brief Quality of Life Inventory (BBQ). Initially, they will also be asked to respond to the credibility/Expectancy Questionnaire (CEQ).\n\nAt the end of the intervention (week 10), participants will also be asked to respond to the Client Satisfaction Questionnaire (CSQ), and the Negative Effects Questionnaire (NEQ).\n\nThe following two scales will be used to study mediators: Acceptance and Action Questionnaire-2 (AAQ-2), and Attention Awareness Scale (MAAS), assess at pre-treatment, as well as at third and fifth week of treatment, at post-assessment (10 weeks later), and at the 6 months follow-up. A number of moderators, including demographics, will also be investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age above 18\n* DASS score above 14\n* PHQ-9 below 9\n\nExclusion Criteria:\n\n* Any indications of suicidality\n* Any indication of other psychiatric disorder in need of immediate attention/treatment\n* Concurrent psychotherapy or other treatments for stress\n* Previous work with the self-help book'}, 'identificationModule': {'nctId': 'NCT03826732', 'acronym': 'ACT', 'briefTitle': 'Acceptance and Commitment Therapy (ACT) Self-help to Reduce Stress', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Guided Self-help Based on Acceptance and Commitment Therapy to Reduce Perceived Stress', 'orgStudyIdInfo': {'id': 'AGFLDE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Guided self-help based on ACT', 'description': 'Participants follow a self-help program and receive weekly support by trained facilitators', 'interventionNames': ['Behavioral: Guided self-help based on ACT']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-list control', 'description': 'Participants are informed that they will receive the intervention after the 6-month follow-up assessment'}], 'interventions': [{'name': 'Guided self-help based on ACT', 'type': 'BEHAVIORAL', 'description': 'ACT-based self-help book and regular support by trained facilitators', 'armGroupLabels': ['Guided self-help based on ACT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17177', 'city': 'Solna', 'country': 'Sweden', 'facility': 'Karolinska Institutet', 'geoPoint': {'lat': 59.36004, 'lon': 18.00086}}], 'overallOfficials': [{'name': 'Ata Ghaderi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor'}]}, 'ipdSharingStatementModule': {'infoTypes': ['ICF', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'Unidentified data will be made available to other researchers upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ata Ghaderi', 'investigatorAffiliation': 'Karolinska Institutet'}}}}