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

Study 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.

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

Conditions
-----------------
Stress

Intervention / Treatment
-----------------
* Behavioral: Guided self-help based on ACT


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization into active treatment versus a wait-list control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guided self-help based on ACT<br>Participants follow a self-help program and receive weekly support by trained facilitators | Behavioral: Guided self-help based on ACT<br>* ACT-based self-help book and regular support by trained facilitators<br>|
| No Intervention: Wait-list control<br>Participants are informed that they will receive the intervention after the 6-month follow-up assessment | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |