Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Acceptance and Commitment Therapy (ACT) Self-help to Reduce Stress (ACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826732
Recruitment Status : Completed
First Posted : February 1, 2019
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Ata Ghaderi, Karolinska Institutet

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stress Behavioral: Guided self-help based on ACT Not Applicable

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization into active treatment versus a wait-list control group
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.
Primary Purpose: Treatment
Official Title: Guided Self-help Based on Acceptance and Commitment Therapy to Reduce Perceived Stress
Actual Study Start Date : January 25, 2019
Actual Primary Completion Date : September 1, 2019
Actual Study Completion Date : May 29, 2020

Arm Intervention/treatment
Experimental: Guided self-help based on ACT
Participants follow a self-help program and receive weekly support by trained facilitators
Behavioral: Guided self-help based on ACT
ACT-based self-help book and regular support by trained facilitators

No Intervention: Wait-list control
Participants are informed that they will receive the intervention after the 6-month follow-up assessment



Primary Outcome Measures :
  1. Perceived Stress Scale-14 (PSS-14) [ Time Frame: Pre-assessment, week 3 and 5 of intervention, post-assessment (week10), and 6 months follow-up ]
    The PSS-14 is measure of stress. Its total score ranges from 0-56. Lower values represent a better outcome.


Secondary Outcome Measures :
  1. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Pre- and post-assessment (10 weeks later) as well as 6 months follow-up ]
    The PHQ-9 provides a measure of depressive symptomatology. It ranges from 0-27. Lower values represent a better outcome

  2. General Anxiety Disorder-7 (GAD-7) [ Time Frame: Pre- and post-assessment (10 weeks later) as well as 6 months follow-up ]
    The GAD-7 is used to measure anxiety. It ranges from 0-21. Lower values represent a better outcome.

  3. Brunnsviken Brief Quality of Life Inventory (BBQ) [ Time Frame: Pre- and post-assessment (10 weeks later) as well as 6 months follow-up ]
    The BBQ is a Swedish measure of quality of life. It ranges from 0-96. Higher values represent a better outcome.

  4. Shirom Melamed Burnout Measure (SMBM) [ Time Frame: Pre- and post-assessment (10 weeks later) as well as 6 months follow-up ]
    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.

  5. 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 ]
    To Measure psychological flexibility (mediator of change). It ranges from 7-49. Lower values represent a better outcome.

  6. Mindful Attention Awareness Scale (MAAS) [ Time Frame: Pre-assessment, week 3 and 5 of intervention, post-assessment (week10), and 6 months follow-up ]
    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.

  7. Client Satisfaction Questionnaire (CSQ) [ Time Frame: Post-assessment, and 6 month follow-up ]
    To measure satisfaction and dissatisfaction with the intervention. It ranges from 8-32. Higher values indicate higher satisfaction.

  8. Negative Effects Questionnaire (NEQ) [ Time Frame: Post-assessment, and 6 month follow-up ]
    To identify iatrogenic events. It ranges from 0-128. Lower values represent a better outcome (i.e. fewer negative effects from the intervention).


Other Outcome Measures:
  1. Credibility/Expectancy Questionnaire (CEQ) [ Time Frame: Pre-assessment ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age above 18
  • DASS score above 14
  • PHQ-9 below 9

Exclusion Criteria:

  • Any indications of suicidality
  • Any indication of other psychiatric disorder in need of immediate attention/treatment
  • Concurrent psychotherapy or other treatments for stress
  • Previous work with the self-help book

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826732


Locations
Layout table for location information
Sweden
Karolinska Institutet
Solna, Sweden, 17177
Sponsors and Collaborators
Karolinska Institutet
Investigators
Layout table for investigator information
Principal Investigator: Ata Ghaderi, PhD Professor
Layout table for additonal information
Responsible Party: Ata Ghaderi, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03826732    
Other Study ID Numbers: AGFLDE
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Unidentified data will be made available to other researchers upon request.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No