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
  Purpose

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 Intervention
Psychosis
Schizophrenia
Bipolar Disorder
Schizo-affective Disorder
Other: Acceptance and Commitment Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Randomised Controlled Trial of Acceptance and Commitment Therapy for Distress Following Psychosis

Resource links provided by NLM:


Further study details as provided by University of Glasgow:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Enrollment: 27
Study Start Date: October 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01003132

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

Publications:
Responsible Party: Dr Ross White/Clinical Research Fellow, University of Glasgow
ClinicalTrials.gov Identifier: NCT01003132     History of Changes
Other Study ID Numbers: PN09CP213, Ethics Ref:09/S0701/74
Study First Received: October 27, 2009
Last Updated: November 8, 2010
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Glasgow:
Psychosis
Distress
Mindfulness
Acceptance
Values

Additional relevant MeSH terms:
Bipolar Disorder
Mental Disorders
Psychotic Disorders
Schizophrenia
Mood Disorders
Affective Disorders, Psychotic
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 27, 2014