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

NCT03826732 | Completed

• 1 other identifier: AGFLDE
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

• Perceived Stress Scale-14 (PSS-14)

  The PSS-14 is measure of stress. Its total score ranges from 0-56. Lower values represent a better outcome.

  Pre-assessment, week 3 and 5 of intervention, post-assessment (week10), and 6 months follow-up

Secondary Outcomes (8)

• Patient Health Questionnaire-9 (PHQ-9)

  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

• Brunnsviken Brief Quality of Life Inventory (BBQ)

  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

• Acceptance and Action Questionnaire-2 (AAQ-2)

  Pre-assessment, week 3 and 5 of intervention, post-assessment (week10), and 6 months follow-up

Other Outcomes (1)

• Credibility/Expectancy Questionnaire (CEQ)

  Pre-assessment

Study Arms (2)

Guided self-help based on ACT

EXPERIMENTAL

Participants follow a self-help program and receive weekly support by trained facilitators

Behavioral: Guided self-help based on ACT

Wait-list control

NO INTERVENTION

Participants are informed that they will receive the intervention after the 6-month follow-up assessment

Interventions

Guided self-help based on ACT BEHAVIORAL

ACT-based self-help book and regular support by trained facilitators

Guided self-help based on ACT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet

Solna, 17177, Sweden

Location

Study Officials

• Ata Ghaderi, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Given the nature of the intervention, and self-report as a main strategy for outcome assessment, nor masking is possible or necessary.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomization into active treatment versus a wait-list control group

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: February 1, 2019
• Study Start: January 25, 2019
• Primary Completion: September 1, 2019
• Study Completion: May 29, 2020
• Last Updated: September 14, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, ANALYTIC CODE

Locations

SE (1)