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

Not Applicable

Completed

• Conditions: Stress
• Interventions: Behavioral: Guided self-help based on ACT

• Registration Number: NCT03826732
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2019-01-24
• Study Start: 2019-01-25
• Study First Submitted QC: 2019-01-31
• Study First Posted: 2019-02-01
• Primary Completion: 2019-09-01
• Study Completion: 2020-05-29
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guided self-help based on ACT	Guided self-help based on ACT	Participants follow a self-help program and receive weekly support by trained facilitators

Primary Outcome Measures

Name	Time	Method
Perceived Stress Scale-14 (PSS-14)	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

Name	Time	Method
Brunnsviken Brief Quality of Life Inventory (BBQ)	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.
Patient Health Questionnaire-9 (PHQ-9)	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
Shirom Melamed Burnout Measure (SMBM)	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.
General Anxiety Disorder-7 (GAD-7)	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.
Mindful Attention Awareness Scale (MAAS)	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.
Client Satisfaction Questionnaire (CSQ)	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.
Negative Effects Questionnaire (NEQ)	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).
Acceptance and Action Questionnaire-2 (AAQ-2)	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.

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Solna, Sweden