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

NCT ID: NCT03826732

Last Updated: 2020-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-25

Study Completion Date

2020-05-29

Brief Summary

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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

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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

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Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization into active treatment versus a wait-list control group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Given the nature of the intervention, and self-report as a main strategy for outcome assessment, nor masking is possible or necessary.

Study Groups

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Guided self-help based on ACT

Participants follow a self-help program and receive weekly support by trained facilitators

Group Type EXPERIMENTAL

Guided self-help based on ACT

Intervention Type BEHAVIORAL

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

Wait-list control

Participants are informed that they will receive the intervention after the 6-month follow-up assessment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Guided self-help based on ACT

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Ata Ghaderi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ata Ghaderi, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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Karolinska Institutet

Solna, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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AGFLDE

Identifier Type: -

Identifier Source: org_study_id

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