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AnxietyACTNCT02449759

An ACT Manual-based, Guided Self-help Intervention Pilot

A study testing ACT Intervention Group in people with Anxiety and Depression, run by University of Edinburgh at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aims to evaluate the effectiveness of a guided self-help intervention using Acceptance and Commitment Therapy (ACT). Half of the participants will receive the self-help manual whilst on a waiting list for individual therapy, while the other half will remain on a waiting list and not receive the manual. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Anxiety, Depression
What is being tested?
ACT Intervention Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteUnited Kingdom
Study dates
Apr 2015to May 2017
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • On the primary care waiting list for individual therapy
  • Anxiety or depression/low mood assessed using the Depression, Anxiety and Stress Scales (DASS21). Those with mild to moderate (≥ 4 and ≤ 7) mixed anxiety (including panic, agoraphobia, obsessive compulsive disorder, generalised anxiety disorder and phobias) or depressive/low mood (including dysthymia; ≥ 5 and ≤ 10) will be included.
  • For those participants presenting with both anxiety and depression, at least one must reach the minimum cut off score and neither should exceed the maximum cut-off score.
  • Adequate English ability
  • Able to give informed consent

Who cannot join

  • High suicide risk (as indicated with a risk score of >0.3 on the Clinical Outcomes in Routine Evaluation questionnaire; CORE-34
  • Participants that have been flagged at the referral meeting to receive specialised individual therapy (e.g. schema-focussed therapy)
  • Medication change within the last three months*
  • Currently receiving or received psychological help within the last 6 months using a Cognitive Behavioural Therapy or ACT modality (e.g. Beating the Blues, Anxiety Management Groups, Mindfulness, Individual therapy)
  • Currently taking part in another research study
  • Intellectual impairment (e.g. a learning disability)
  • Referral for a primary diagnosis, other than anxiety/depression, that would significantly over arch any work focusing on anxiety/depression even if the above criteria is met for anxiety/depression (e.g. an eating disorder whereby the stated symptoms: cognitions, physical sensations, emotions and behaviours, are orientated solely around food).
  • Those individuals who have started or changed medication within the last 3 months will still be eligible to participate, but will be put on hold until this time period has elapsed. They will be informed of this and told that they may not be entered into the trial if recruitment targets are met or individual treatment becomes available (the waiting list will be reviewed at the time).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Adult Psychology Department

    Falkirk, Stirlingshire, FK1 5QE

Other trials in United Kingdom

About this study

Official title: Evaluating Acceptance and Commitment Therapy as a Low-intensity, Manual-based, Guided Self-help Intervention for Anxiety and Depression: A Pilot Study

This study aims to evaluate the effectiveness of a guided self-help intervention using Acceptance and Commitment Therapy (ACT). Half of the participants will receive the self-help manual whilst on a waiting list for individual therapy, while the other half will remain on a waiting list and not receive the manual. This study is looking specifically at individuals with mild to moderate anxiety and/or depression.

Read the detailed description

Many patients are offered written self-help material as a stage 1 (low intensity) intervention for anxiety and/or depression, as recommended by the United Kingdom's National Institute for Clinical Excellence's pathways framework (http://pathways.nice.org.uk/).

Acceptance and Commitment Therapy (ACT) is an emerging therapy that has been shown to help patients with mild to moderate anxiety and/or depression in therapist-led individual and group treatments. However, few studies have shown how effective ACT is in the form of a low-intensity, guided self-help intervention.

This study seeks to find out whether an ACT-based manual, sent to patients with anxiety and/or depression, increases their ability to effectively manage their difficulties and improve their quality of life. Participants on a primary care mental health waiting list will be invited to take part in this study.

Eligible participants will be randomly allocated to one of two groups: the ACT intervention or waiting list as usual. Participants receiving the ACT intervention will be posted a manual and will be asked to read a chapter each week for six weeks. A member of the research team will also phone them on two occasions to support their use of the manual, trouble shoot any difficulties and provide encouragement. All participants will be asked to complete nine, short questionnaires sent through the post prior to and after six weeks of self-help.

By comparing the results the study will demonstrate whether the ACT intervention is effective compared to wait list as usual.

Conditions
Anxiety, Depression
Being tested
ACT Intervention Group
Medical subject headings
Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACT Intervention GroupBehavioural

    A six chapter, 58 page self-help manual based on the principles of Acceptance and Commitment Therapy

Study groups in NCT02449759
Study groupRoleWhat they receive
ACT Intervention GroupExperimentalThis group will receive an ACT self-help manual to be completed over the course of 6 weeks. They will also receive two brief telephone calls during the reading of the manual by a member of the research team.
Receives: Behavioral: ACT Intervention Group
Control GroupNo interventionThis group will receive no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change is being assessed using the Quality of Life BREF (WHOQOLBREF; Skevington et al., 2004) questionnaire

    26-item self-report questionnaire

    Measured: Baseline and 6 weeks

Secondary outcomes (1)

  1. Change is being assessed using the Acceptance and Action Questionnaire II (AAQII; Bond, Hayes & Baer et. al, 2011).

    A 7-item, unidimensional, self-report questionnaire which measures the construct of experiential avoidance/psychological inflexibility

    Measured: Baseline and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionMay 2017
  4. Study completionMay 2017

Resources

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
Masking
Single blind
Who is masked
Investigator
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02449759
Sponsor's protocol ID
166325
Acronym
ACT
Status last verified
Nov 2017
First submitted
29 Apr 2015
Last updated
6 Nov 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.

    PubMed 15085902

  • Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, Waltz T, Zettle RD. Preliminary psychometric properties of the Acceptance and Action Questionnaire-II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011 Dec;42(4):676-88. doi: 10.1016/j.beth.2011.03.007. Epub 2011 May 25.

    PubMed 22035996

Questions about this trial

What is this clinical trial studying?

A study testing ACT Intervention Group in people with Anxiety and Depression, run by University of Edinburgh at 1 site in United Kingdom.

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 5 inclusion and 8 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 6 Nov 2017. 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 United Kingdom. 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?

Change is being assessed using the Quality of Life BREF (WHOQOLBREF; Skevington et al., 2004) questionnaire (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02449759, which also lists 2 linked publications.

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 6 Nov 2017.

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