StressACTNCT03826732
Acceptance and Commitment Therapy (ACT) Self-help to Reduce Stress
A study testing Guided self-help based on ACT in people with Stress, run by Karolinska Institutet at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Guided self-help based on ACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteSweden
- Study dates
- 25 Jan 2019to 29 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age above 18
- DASS score above 14
- PHQ-9 below 9
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Guided Self-help Based on Acceptance and Commitment Therapy to Reduce Perceived Stress
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.
Read the 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.
- Conditions
- Stress
- Being tested
- Guided self-help based on ACT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided self-help based on ACTBehavioural
ACT-based self-help book and regular support by trained facilitators
| Study group | Role | What they receive |
|---|---|---|
| Guided self-help based on ACT | Experimental | Participants follow a self-help program and receive weekly support by trained facilitators Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The PHQ-9 provides a measure of depressive symptomatology. It ranges from 0-27. Lower values represent a better outcome
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Post-assessment, and 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start25 Jan 2019
- Primary completion1 Sep 2019
- Study completion29 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization into active treatment versus a wait-list control group
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ata Ghaderi, Karolinska Institutet
- Investigators
- Ata Ghaderi, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826732
- Sponsor's protocol ID
- AGFLDE
- Acronym
- ACT
- Status last verified
- Sep 2020
- First submitted
- 24 Jan 2019
- Last updated
- 14 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Unidentified data will be made available to other researchers upon request.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guided Self-help Based on Acceptance and Commitment Therapy to Reduce Perceived Stress
- ClinicalTrials.gov ID
- NCT03826732
- Acronym / sponsor ID
- ACT / AGFLDE
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 29 May 2020 (actual)
- First posted
- 1 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization into active treatment versus a wait-list control group
| Arm | Type | Receives |
|---|---|---|
| Guided self-help based on ACT | Experimental | Behavioral: Guided self-help based on ACTParticipants follow a self-help program and receive weekly support by trained facilitators |
| Wait-list control | No intervention | –Participants are informed that they will receive the intervention after the 6-month follow-up assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age above 18
- DASS score above 14
- PHQ-9 below 9
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided self-help based on ACTACT-based self-help book and regular support by trained facilitators | Behavioural | Guided self-help based on ACT |
Primary outcome
Perceived Stress Scale-14 (PSS-14)
Time frame: 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.
8 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Pre- and post-assessment (10 weeks later) as well as 6 months follow-up
General Anxiety Disorder-7 (GAD-7)
Time frame: Pre- and post-assessment (10 weeks later) as well as 6 months follow-up
Brunnsviken Brief Quality of Life Inventory (BBQ)
Time frame: Pre- and post-assessment (10 weeks later) as well as 6 months follow-up
Shirom Melamed Burnout Measure (SMBM)
Time frame: Pre- and post-assessment (10 weeks later) as well as 6 months follow-up
Acceptance and Action Questionnaire-2 (AAQ-2)
Time frame: Pre-assessment, week 3 and 5 of intervention, post-assessment (week10), and 6 months follow-up
Mindful Attention Awareness Scale (MAAS)
Time frame: Pre-assessment, week 3 and 5 of intervention, post-assessment (week10), and 6 months follow-up
Client Satisfaction Questionnaire (CSQ)
Time frame: Post-assessment, and 6 month follow-up
Negative Effects Questionnaire (NEQ)
Time frame: Post-assessment, and 6 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2020.
- Individual participant dataSharing planned: Yes. Unidentified data will be made available to other researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ata Ghaderi, PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided self-help based on ACT in people with Stress, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale-14 (PSS-14) (time frame: Pre-assessment, week 3 and 5 of intervention, post-assessment (week10), and 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2020.