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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Bipolar Disorder; Schizo-affective Disorder; Psychosis
• Intervention / Treatment: Other: Acceptance and Commitment Therapy

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
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Scotland
    • Glasgow, Scotland, United Kingdom, G3 8YZ
      • Greater Glasgow and Clyde NHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: ACT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring change in depression and anxiety	The Hospital Anxiety and Depression Scale	Baseline and 3 month follow-up
Changes in believability, distress and frequency of positive symptoms		Baseline and up to 9 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring change in mindfulness skills and psychological flexibility	The Kentucky Inventory of Mindfulness Skills, The Acceptance and Action Questionnaire	Baseline and up to 9 month follow-up

Collaborators and Investigators

• Sponsor: University of Glasgow
• Collaborators: NHS Greater Glasgow and Clyde
• Investigators: Principal Investigator: Ross G White, BSc, PhD, DClinPsy, University of Glasgow

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: October 27, 2009
• First Submitted That Met QC Criteria: October 27, 2009
• First Posted (Estimate): October 28, 2009

Study Record Updates

• Last Update Posted (Estimate): November 9, 2010
• Last Update Submitted That Met QC Criteria: November 8, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Psychosis; Mindfulness; Distress; Acceptance; Values
• Additional Relevant MeSH Terms: Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Schizophrenia; Disease; Psychotic Disorders; Mental Disorders; Bipolar Disorder; Mood Disorders
• Other Study ID Numbers: PN09CP213; Ethics Ref:09/S0701/74