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

Stress Clinical Trial

— ACT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03826732
• Other study ID #: AGFLDE
• Status: Completed
• Phase: N/A
• Start date: January 25, 2019
• Est. completion date: May 29, 2020

Study information

• Verified date: September 2020
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: May 29, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stress

Intervention

Behavioral:
• Guided self-help based on ACT
ACT-based self-help book and regular support by trained facilitators

Locations

Country	Name	City	State
Sweden	Karolinska Institutet	Solna

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Credibility/Expectancy Questionnaire (CEQ)	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.	Pre-assessment
Primary	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	Patient Health Questionnaire-9 (PHQ-9)	The PHQ-9 provides a measure of depressive symptomatology. It ranges from 0-27. Lower values represent a better outcome	Pre- and post-assessment (10 weeks later) as well as 6 months follow-up
Secondary	General Anxiety Disorder-7 (GAD-7)	The GAD-7 is used to measure anxiety. It ranges from 0-21. Lower values represent a better outcome.	Pre- and post-assessment (10 weeks later) as well as 6 months follow-up
Secondary	Brunnsviken Brief Quality of Life Inventory (BBQ)	The BBQ is a Swedish measure of quality of life. It ranges from 0-96. Higher values represent a better outcome.	Pre- and post-assessment (10 weeks later) as well as 6 months follow-up
Secondary	Shirom Melamed Burnout Measure (SMBM)	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.	Pre- and post-assessment (10 weeks later) as well as 6 months follow-up
Secondary	Acceptance and Action Questionnaire-2 (AAQ-2)	To Measure psychological flexibility (mediator of change). It ranges from 7-49. Lower values represent a better outcome.	Pre-assessment, week 3 and 5 of intervention, post-assessment (week10), and 6 months follow-up
Secondary	Mindful Attention Awareness Scale (MAAS)	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.	Pre-assessment, week 3 and 5 of intervention, post-assessment (week10), and 6 months follow-up
Secondary	Client Satisfaction Questionnaire (CSQ)	To measure satisfaction and dissatisfaction with the intervention. It ranges from 8-32. Higher values indicate higher satisfaction.	Post-assessment, and 6 month follow-up
Secondary	Negative Effects Questionnaire (NEQ)	To identify iatrogenic events. It ranges from 0-128. Lower values represent a better outcome (i.e. fewer negative effects from the intervention).	Post-assessment, and 6 month follow-up