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Completed

NCT Number: NCT03826732

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

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Key information

Conditions

Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Solna, 17177, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Guided self-help based on ACT

Behavioral

ACT-based self-help book and regular support by trained facilitators

Primary outcomes

  1. 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.

Secondary outcomes

  1. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: 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

  2. General Anxiety Disorder-7 (GAD-7)

    Time frame: 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.

  3. Brunnsviken Brief Quality of Life Inventory (BBQ)

    Time frame: 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.

  4. Shirom Melamed Burnout Measure (SMBM)

    Time frame: 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.

  5. 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

    To Measure psychological flexibility (mediator of change). It ranges from 7-49. Lower values represent a better outcome.

  6. Mindful Attention Awareness Scale (MAAS)

    Time frame: 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.

  7. Client Satisfaction Questionnaire (CSQ)

    Time frame: 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.

  8. Negative Effects Questionnaire (NEQ)

    Time frame: 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).

Other outcomes

  1. Credibility/Expectancy Questionnaire (CEQ)

    Time frame: Pre-assessment

    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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

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

Acronym: ACT

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Feb 1, 2019
Registry last updated
Sep 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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