Assessing the Effectiveness of Acceptance and Commitment Therapy for Distress Following Psychosis (PACT)

This study has been completed.
Sponsor:
Collaborator:
Greater Glasgow and Clyde NHS
Information provided by:
University of Glasgow
ClinicalTrials.gov Identifier:
NCT01003132
First received: October 27, 2009
Last updated: November 8, 2010
Last verified: November 2010

October 27, 2009
November 8, 2010
October 2009
October 2010   (final data collection date for primary outcome measure)
  • Measuring change in depression and anxiety [ Time Frame: Baseline and 3 month follow-up ] [ Designated as safety issue: No ]
    The Hospital Anxiety and Depression Scale
  • Changes in believability, distress and frequency of positive symptoms [ Time Frame: Baseline and up to 9 months follow-up ] [ Designated as safety issue: No ]
Fear of Recurrence Scale [ Time Frame: Baseline and 3 month follow-up ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01003132 on ClinicalTrials.gov Archive Site
Measuring change in mindfulness skills and psychological flexibility [ Time Frame: Baseline and up to 9 month follow-up ] [ Designated as safety issue: No ]
The Kentucky Inventory of Mindfulness Skills, The Acceptance and Action Questionnaire
The Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983) [ Time Frame: Baseline and up to 9 month follow-up ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Assessing the Effectiveness of Acceptance and Commitment Therapy for Distress Following Psychosis
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:

  1. 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.
  2. 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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Psychosis
  • Schizophrenia
  • Bipolar Disorder
  • Schizo-affective Disorder
Other: Acceptance and Commitment Therapy
Up to 10 sessions of a psychological therapy called Acceptance and Commitment Therapy
Other Name: ACT
  • No Intervention: Treatment As Usual
    Treatment as usual as determined by the clinical team responsible for the individual's care
  • Active Comparator: Acceptance and Commitment Therapy
    Up to 10 sessions of Acceptance and Commitment Therapy plus treatment as usual
    Intervention: Other: Acceptance and Commitment Therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
October 2010
October 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01003132
PN09CP213, Ethics Ref:09/S0701/74
Yes
Dr Ross White/Clinical Research Fellow, University of Glasgow
University of Glasgow
Greater Glasgow and Clyde NHS
Principal Investigator: Ross G White, BSc, PhD, DClinPsy University of Glasgow
University of Glasgow
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP