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

2 november 2017 uppdaterad av: University of Edinburgh

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

52

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Stirlingshire
      • Falkirk, Stirlingshire, Storbritannien, FK1 5QE
        • Adult Psychology Department

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: ACT Intervention Group
This 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.
A six chapter, 58 page self-help manual based on the principles of Acceptance and Commitment Therapy
Inget ingripande: Control Group
This group will receive no intervention

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change is being assessed using the Quality of Life BREF (WHOQOLBREF; Skevington et al., 2004) questionnaire
Tidsram: Baseline and 6 weeks
26-item self-report questionnaire
Baseline and 6 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change is being assessed using the Acceptance and Action Questionnaire II (AAQII; Bond, Hayes & Baer et. al, 2011).
Tidsram: Baseline and 6 weeks
A 7-item, unidimensional, self-report questionnaire which measures the construct of experiential avoidance/psychological inflexibility
Baseline and 6 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Shane A Ford, National Health Service, United Kingdom

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2015

Primärt slutförande (Faktisk)

1 maj 2017

Avslutad studie (Faktisk)

1 maj 2017

Studieregistreringsdatum

Först inskickad

29 april 2015

Först inskickad som uppfyllde QC-kriterierna

15 maj 2015

Första postat (Uppskatta)

20 maj 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 november 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 november 2017

Senast verifierad

1 november 2017

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 166325

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Depression

Kliniska prövningar på ACT Intervention Group

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