<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03826732</url>
  </required_header>
  <id_info>
    <org_study_id>AGFLDE</org_study_id>
    <nct_id>NCT03826732</nct_id>
  </id_info>
  <brief_title>Acceptance and Commitment Therapy (ACT) Self-help to Reduce Stress</brief_title>
  <acronym>ACT</acronym>
  <official_title>Guided Self-help Based on Acceptance and Commitment Therapy to Reduce Perceived Stress</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The efficacy of guided self-help based on acceptance and commitment therapy (ACT) to reduce&#xD;
      subjective sense of stress will be investigated in a randomised controlled trial with two&#xD;
      condition: 1) ACT-based self-help, and 2) Wait-list control. The outcome at the end of the&#xD;
      treatment (week 10) and 6-month follow-up will be assessed. The wail-list condition will be&#xD;
      offered ACT-based self-help after the post-assessment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The efficacy of guided self-help based on acceptance and commitment therapy (ACT) to reduce&#xD;
      subjective sense of stress will be investigated in a randomised controlled trial with two&#xD;
      condition: 1) ACT-based self-help, and 2) Wait-list control. The outcome at the end of the&#xD;
      treatment and 6-month follow-up will be assessed. The wail-list condition will be offered&#xD;
      ACT-based self-help after 10 weeks (i.e. when the post-assessment is completed). Inclusion&#xD;
      criteria are: Adults with a score above 14 on the stress sub scale of the Depression,&#xD;
      Anxiety, Stress Scale (DASS) at screening, a score below 10 on the Patient Health&#xD;
      Questionnaire (PHQ-9), no indication of suicidality on the PHQ-9, and no ongoing&#xD;
      psychotherapeutic interventions, and no previous work with the self-help manual that has been&#xD;
      published as a self-help book.&#xD;
&#xD;
      A total of 140 participants will be recruited and randomised, using services on&#xD;
      www.random.org. Informed consent will be obtained from all the participants ahead of&#xD;
      screening. Participants will be asked to respond to the following questionnaires at pre-,&#xD;
      post and follow-up assessments: Perceived Stress Scale-14 (PSS-14), General Anxiety&#xD;
      Disorder-7 (GAD-7), Shirom Melamed Burnout Measure (SMBM), and Brunnsviken Brief Quality of&#xD;
      Life Inventory (BBQ). Initially, they will also be asked to respond to the&#xD;
      credibility/Expectancy Questionnaire (CEQ).&#xD;
&#xD;
      At the end of the intervention (week 10), participants will also be asked to respond to the&#xD;
      Client Satisfaction Questionnaire (CSQ), and the Negative Effects Questionnaire (NEQ).&#xD;
&#xD;
      The following two scales will be used to study mediators: Acceptance and Action&#xD;
      Questionnaire-2 (AAQ-2), and Attention Awareness Scale (MAAS), assess at pre-treatment, as&#xD;
      well as at third and fifth week of treatment, at post-assessment (10 weeks later), and at the&#xD;
      6 months follow-up. A number of moderators, including demographics, will also be&#xD;
      investigated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 25, 2019</start_date>
  <completion_date type="Actual">May 29, 2020</completion_date>
  <primary_completion_date type="Actual">September 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Randomization into active treatment versus a wait-list control group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Given the nature of the intervention, and self-report as a main strategy for outcome assessment, nor masking is possible or necessary.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Perceived Stress Scale-14 (PSS-14)</measure>
    <time_frame>Pre-assessment, week 3 and 5 of intervention, post-assessment (week10), and 6 months follow-up</time_frame>
    <description>The PSS-14 is measure of stress. Its total score ranges from 0-56. Lower values represent a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>Pre- and post-assessment (10 weeks later) as well as 6 months follow-up</time_frame>
    <description>The PHQ-9 provides a measure of depressive symptomatology. It ranges from 0-27. Lower values represent a better outcome</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Anxiety Disorder-7 (GAD-7)</measure>
    <time_frame>Pre- and post-assessment (10 weeks later) as well as 6 months follow-up</time_frame>
    <description>The GAD-7 is used to measure anxiety. It ranges from 0-21. Lower values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brunnsviken Brief Quality of Life Inventory (BBQ)</measure>
    <time_frame>Pre- and post-assessment (10 weeks later) as well as 6 months follow-up</time_frame>
    <description>The BBQ is a Swedish measure of quality of life. It ranges from 0-96. Higher values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shirom Melamed Burnout Measure (SMBM)</measure>
    <time_frame>Pre- and post-assessment (10 weeks later) as well as 6 months follow-up</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptance and Action Questionnaire-2 (AAQ-2)</measure>
    <time_frame>Pre-assessment, week 3 and 5 of intervention, post-assessment (week10), and 6 months follow-up</time_frame>
    <description>To Measure psychological flexibility (mediator of change). It ranges from 7-49. Lower values represent a better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindful Attention Awareness Scale (MAAS)</measure>
    <time_frame>Pre-assessment, week 3 and 5 of intervention, post-assessment (week10), and 6 months follow-up</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Client Satisfaction Questionnaire (CSQ)</measure>
    <time_frame>Post-assessment, and 6 month follow-up</time_frame>
    <description>To measure satisfaction and dissatisfaction with the intervention. It ranges from 8-32. Higher values indicate higher satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative Effects Questionnaire (NEQ)</measure>
    <time_frame>Post-assessment, and 6 month follow-up</time_frame>
    <description>To identify iatrogenic events. It ranges from 0-128. Lower values represent a better outcome (i.e. fewer negative effects from the intervention).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Credibility/Expectancy Questionnaire (CEQ)</measure>
    <time_frame>Pre-assessment</time_frame>
    <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.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">133</enrollment>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>Guided self-help based on ACT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants follow a self-help program and receive weekly support by trained facilitators</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants are informed that they will receive the intervention after the 6-month follow-up assessment</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Guided self-help based on ACT</intervention_name>
    <description>ACT-based self-help book and regular support by trained facilitators</description>
    <arm_group_label>Guided self-help based on ACT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age above 18&#xD;
&#xD;
          -  DASS score above 14&#xD;
&#xD;
          -  PHQ-9 below 9&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any indications of suicidality&#xD;
&#xD;
          -  Any indication of other psychiatric disorder in need of immediate attention/treatment&#xD;
&#xD;
          -  Concurrent psychotherapy or other treatments for stress&#xD;
&#xD;
          -  Previous work with the self-help book&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ata Ghaderi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karolinska Institutet</name>
      <address>
        <city>Solna</city>
        <zip>17177</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>January 24, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>September 10, 2020</last_update_submitted>
  <last_update_submitted_qc>September 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Ata Ghaderi</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Unidentified data will be made available to other researchers upon request.</ipd_description>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03826732
org study id: AGFLDE
nct id: NCT03826732
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.

      A 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).

      At 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).

      The 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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomization into active treatment versus a wait-list control group
primary purpose: Treatment
masking: None (Open Label)
masking description: Given the nature of the intervention, and self-report as a main strategy for outcome assessment, nor masking is possible or necessary.
measure: Perceived Stress Scale-14 (PSS-14)
time frame: 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.
measure: Patient Health Questionnaire-9 (PHQ-9)
time frame: 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)
time frame: 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)
time frame: 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)
time frame: 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)
time frame: 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)
time frame: 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)
time frame: 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)
time frame: 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).
measure: Credibility/Expectancy Questionnaire (CEQ)
time frame: 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.
arm group label: Guided self-help based on ACT
arm group type: Experimental
description: Participants follow a self-help program and receive weekly support by trained facilitators
arm group label: Wait-list control
arm group type: No Intervention
description: Participants are informed that they will receive the intervention after the 6-month follow-up assessment
intervention type: Behavioral
intervention name: Guided self-help based on ACT
description: ACT-based self-help book and regular support by trained facilitators
arm group label: Guided self-help based on ACT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ata Ghaderi, PhD
role: Principal Investigator
affiliation: Professor
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Ata Ghaderi
investigator title: Professor
sharing ipd: Yes
ipd description: Unidentified data will be made available to other researchers upon request.
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code