- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02449759
An ACT Manual-based, Guided Self-help Intervention Pilot (ACT)
Evaluating Acceptance and Commitment Therapy as a Low-intensity, Manual-based, Guided Self-help Intervention for Anxiety and Depression: A Pilot Study
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Stirlingshire
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Falkirk, Stirlingshire, Regno Unito, FK1 5QE
- Adult Psychology Department
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
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A six chapter, 58 page self-help manual based on the principles of Acceptance and Commitment Therapy
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Nessun intervento: Control Group
This group will receive no intervention
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change is being assessed using the Quality of Life BREF (WHOQOLBREF; Skevington et al., 2004) questionnaire
Lasso di tempo: Baseline and 6 weeks
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26-item self-report questionnaire
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Baseline and 6 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change is being assessed using the Acceptance and Action Questionnaire II (AAQII; Bond, Hayes & Baer et. al, 2011).
Lasso di tempo: Baseline and 6 weeks
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A 7-item, unidimensional, self-report questionnaire which measures the construct of experiential avoidance/psychological inflexibility
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Baseline and 6 weeks
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Shane A Ford, National Health Service, United Kingdom
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
Collegamenti utili
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Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 166325
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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