Clinical trial NCT03826732: Acceptance and Commitment Therapy (ACT) Self-help to Reduce Stress
Official title: Guided Self-help Based on Acceptance and Commitment Therapy to Reduce Perceived Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2019-02-01
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization into active treatment versus a wait-list control group
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Perceived Stress Scale-14 (PSS-14)
timeFrame: Pre-assessment, week 3 and 5 of intervention, post-assessment (week10), and 6 months follow-up
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Pre- and post-assessment (10 weeks later) as well as 6 months follow-up
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: Pre- and post-assessment (10 weeks later) as well as 6 months follow-up
measure: Brunnsviken Brief Quality of Life Inventory (BBQ)
timeFrame: Pre- and post-assessment (10 weeks later) as well as 6 months follow-up
measure: Shirom Melamed Burnout Measure (SMBM)
timeFrame: Pre- and post-assessment (10 weeks later) as well as 6 months follow-up
measure: Acceptance and Action Questionnaire-2 (AAQ-2)
timeFrame: Pre-assessment, week 3 and 5 of intervention, post-assessment (week10), and 6 months follow-up
measure: Mindful Attention Awareness Scale (MAAS)
timeFrame: Pre-assessment, week 3 and 5 of intervention, post-assessment (week10), and 6 months follow-up
measure: Client Satisfaction Questionnaire (CSQ)
timeFrame: Post-assessment, and 6 month follow-up
measure: Negative Effects Questionnaire (NEQ)
timeFrame: Post-assessment, and 6 month follow-up
Other outcomes:
measure: Credibility/Expectancy Questionnaire (CEQ)
timeFrame: Pre-assessment
Locations:
city: Solna
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Professor
name: Ata Ghaderi, PhD
role: PRINCIPAL_INVESTIGATOR
References: