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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01003132
Recruitment Status : Completed
First Posted : October 28, 2009
Last Update Posted : November 9, 2010
NHS Greater Glasgow and Clyde
Information provided by:
University of Glasgow

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Psychosis Schizophrenia Bipolar Disorder Schizo-affective Disorder Other: Acceptance and Commitment Therapy Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Randomised Controlled Trial of Acceptance and Commitment Therapy for Distress Following Psychosis
Study Start Date : October 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Other: Acceptance and Commitment Therapy
Up to 10 sessions of a psychological therapy called Acceptance and Commitment Therapy
Other Name: ACT

Primary Outcome Measures :
  1. Measuring change in depression and anxiety [ Time Frame: Baseline and 3 month follow-up ]
    The Hospital Anxiety and Depression Scale

  2. Changes in believability, distress and frequency of positive symptoms [ Time Frame: Baseline and up to 9 months follow-up ]

Secondary Outcome Measures :
  1. Measuring change in mindfulness skills and psychological flexibility [ Time Frame: Baseline and up to 9 month follow-up ]
    The Kentucky Inventory of Mindfulness Skills, The Acceptance and Action Questionnaire

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01003132

United Kingdom
Greater Glasgow and Clyde NHS
Glasgow, Scotland, United Kingdom, G3 8YZ
Sponsors and Collaborators
University of Glasgow
NHS Greater Glasgow and Clyde
Principal Investigator: Ross G White, BSc, PhD, DClinPsy University of Glasgow

Responsible Party: Dr Ross White/Clinical Research Fellow, University of Glasgow Identifier: NCT01003132     History of Changes
Other Study ID Numbers: PN09CP213
Ethics Ref:09/S0701/74
First Posted: October 28, 2009    Key Record Dates
Last Update Posted: November 9, 2010
Last Verified: November 2010

Keywords provided by University of Glasgow:

Additional relevant MeSH terms:
Bipolar Disorder
Psychotic Disorders
Mental Disorders
Mood Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders