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Clinical Trials/NCT03826732
NCT03826732
Completed
Not Applicable

Guided Self-help Based on Acceptance and Commitment Therapy to Reduce Perceived Stress

Karolinska Institutet1 site in 1 country133 target enrollmentJanuary 25, 2019
ConditionsStress

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stress
Sponsor
Karolinska Institutet
Enrollment
133
Locations
1
Primary Endpoint
Perceived Stress Scale-14 (PSS-14)
Status
Completed
Last Updated
5 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 25, 2019
End Date
May 29, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ata Ghaderi

Professor

Karolinska Institutet

Eligibility 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

Outcomes

Primary Outcomes

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 Outcomes

  • Brunnsviken Brief Quality of Life Inventory (BBQ)(Pre- and post-assessment (10 weeks later) as well as 6 months follow-up)
  • Patient Health Questionnaire-9 (PHQ-9)(Pre- and post-assessment (10 weeks later) as well as 6 months follow-up)
  • Shirom Melamed Burnout Measure (SMBM)(Pre- and post-assessment (10 weeks later) as well as 6 months follow-up)
  • General Anxiety Disorder-7 (GAD-7)(Pre- and post-assessment (10 weeks later) as well as 6 months follow-up)
  • Mindful Attention Awareness Scale (MAAS)(Pre-assessment, week 3 and 5 of intervention, post-assessment (week10), and 6 months follow-up)
  • Client Satisfaction Questionnaire (CSQ)(Post-assessment, and 6 month follow-up)
  • Negative Effects Questionnaire (NEQ)(Post-assessment, and 6 month follow-up)
  • Acceptance and Action Questionnaire-2 (AAQ-2)(Pre-assessment, week 3 and 5 of intervention, post-assessment (week10), and 6 months follow-up)

Study Sites (1)

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