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

Schizophrenia Clinical Trial

— PACT  

Official title:

A Pilot Randomised Controlled Trial of Acceptance and Commitment Therapy for Distress Following Psychosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003132
• Other study ID #: PN09CP213
• Secondary ID: Ethics Ref:09/S0
• Status: Completed
• Phase: N/A
• First received: October 27, 2009
• Last updated: November 8, 2010
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: November 2010
• Source: University of Glasgow
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Disease
• Mental Disorders
• Mood Disorders
• Psychosis
• Psychotic Disorders
• Schizo-affective Disorder
• Schizophrenia

Intervention

Other:
• Acceptance and Commitment Therapy
Up to 10 sessions of a psychological therapy called Acceptance and Commitment Therapy

Locations

Country	Name	City	State
United Kingdom	Greater Glasgow and Clyde NHS	Glasgow	Scotland

Sponsors (2)

Lead Sponsor	Collaborator
University of Glasgow	NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring change in depression and anxiety	The Hospital Anxiety and Depression Scale	Baseline and 3 month follow-up	No
Primary	Changes in believability, distress and frequency of positive symptoms		Baseline and up to 9 months follow-up	No
Secondary	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	No