Assessing the Effectiveness of Acceptance and Commitment Therapy for Distress Following Psychosis (PACT)
8 november 2010 uppdaterad av: University of Glasgow
A Pilot Randomised Controlled Trial of Acceptance and Commitment Therapy for Distress Following Psychosis
This research investigates a new talking therapy aimed at helping people to come to terms with the experience of psychosis. The new therapy is called Acceptance and Commitment Therapy for psychosis (PACT). PACT aims to help people:
- Develop a sense of "mindfulness." Mindfulness allows you to be fully aware of your here-and-now experience, with an attitude of openness and curiosity. It is hoped that this will help reduce the impact of painful thoughts and feelings.
- Take effective action that is conscious and deliberate, rather than impulsive. It is hoped that this will allow people to be motivated, guided, and inspired by the things that they value in life.
It is hoped that PACT will help to reduce the level of distress that individuals diagnosed with psychosis have been experiencing and help them to stay well in the future.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Emphasis has been placed on treating the 'positive symptoms' of psychosis (e.g.
hallucinations and delusions).
Concordance rates with anti-psychotic medication can be low.
Even when positive symptoms are successfully treated, emotional distress can remain e.g.
depression, anxiety and trauma.
Relapse occurs in up to two thirds of patients within two years of the first episode.
The treatment of subsequent episodes has been shown to be progressively less efficacious.
Research has shown that fear of recurrence patients can experience following psychosis is predictive of relapse.
Randomised clinical trials have found that Cognitive Behaviour Therapy (CBTp) is efficacious for treating residual distressing positive and negative symptoms.
However, the evidence for treating emotional dysfunction (e.g.
social anxiety, post-psychotic depression) is less clear.
Acceptance and Commitment Therapy (ACT) incorporates acceptance and mindfulness elements into a CBT framework.
Rather than altering the content or frequency of cognitions, ACT seeks to alter the individual's psychological relationship with thoughts, feelings and sensations to promote psychological flexibility.
This research will be a pilot randomised control trial of ACT for treating distress following psychosis.
This pilot study will establish (a) whether a larger scale multi-centre randomised controlled trial is warranted, (b) the acceptability of Acceptance and Commitment Therapy (c) the expected primary and secondary outcomes for such a trial and (d) the sample size required to detect such outcomes.
It is hypothesised that ACT plus treatment as usual will be associated with a greater reduction in levels of distress than treatment as usual only.
Studietyp
Interventionell
Inskrivning (Faktisk)
27
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Scotland
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Glasgow, Scotland, Storbritannien, G3 8YZ
- Greater Glasgow and Clyde NHS
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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:
- Participants will meet DSM-IV-TR (APA, 2000) criteria for a psychotic disorder determined by a diagnosis of a psychotic disorder (i.e., Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder, Brief Psychotic Disorder, Psychotic Disorder NOS) or Bipolar Disorder (with psychotic features).
- Participants will also be aged 18-65
Exclusion Criteria:
Participants will be excluded if there is a
- diagnosis of learning disability
- inability to participate in psychotherapy/research due to acute medical condition or florid psychosis (as defined by a score of 5 or over on the Positive Syndrome scale of the PANSS)
- psychotic symptoms due to a general medical condition
- they are receiving a systematic psychological therapy at the point of recruitment/randomization.
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 |
|---|---|
|
Inget ingripande: Treatment As Usual
Treatment as usual as determined by the clinical team responsible for the individual's care
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Aktiv komparator: Acceptance and Commitment Therapy
Up to 10 sessions of Acceptance and Commitment Therapy plus treatment as usual
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Up to 10 sessions of a psychological therapy called Acceptance and Commitment Therapy
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Measuring change in depression and anxiety
Tidsram: Baseline and 3 month follow-up
|
The Hospital Anxiety and Depression Scale
|
Baseline and 3 month follow-up
|
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Changes in believability, distress and frequency of positive symptoms
Tidsram: Baseline and up to 9 months follow-up
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Baseline and up to 9 months follow-up
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Measuring change in mindfulness skills and psychological flexibility
Tidsram: Baseline and up to 9 month follow-up
|
The Kentucky Inventory of Mindfulness Skills, The Acceptance and Action Questionnaire
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Baseline and up to 9 month follow-up
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Ross G White, BSc, PhD, DClinPsy, University of Glasgow
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.
Allmänna publikationer
- Bach P, Hayes SC. The use of acceptance and commitment therapy to prevent the rehospitalization of psychotic patients: a randomized controlled trial. J Consult Clin Psychol. 2002 Oct;70(5):1129-39. doi: 10.1037//0022-006x.70.5.1129.
- Gaudiano BA, Herbert JD. Acute treatment of inpatients with psychotic symptoms using Acceptance and Commitment Therapy: pilot results. Behav Res Ther. 2006 Mar;44(3):415-37. doi: 10.1016/j.brat.2005.02.007. Erratum In: Behav Res Ther. 2020 Jan;124:103534.
- Hayes, S.C., Strosahl, K. and Wilson, K.G. (1999). Acceptance and Commitment Therapy: An experiential approach to behavior change, The Guilford Press, New York
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 oktober 2009
Primärt slutförande (Faktisk)
1 oktober 2010
Avslutad studie (Faktisk)
1 oktober 2010
Studieregistreringsdatum
Först inskickad
27 oktober 2009
Först inskickad som uppfyllde QC-kriterierna
27 oktober 2009
Första postat (Uppskatta)
28 oktober 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
9 november 2010
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 november 2010
Senast verifierad
1 november 2010
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PN09CP213
- Ethics Ref:09/S0701/74
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 .