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

NCT ID: NCT01003132

Last Updated: 2010-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-10-31

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.

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.

Conditions

Psychosis; Schizophrenia; Bipolar Disorder; Schizo-affective Disorder

Keywords

Psychosis; Distress; Mindfulness; Acceptance; Values

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Treatment As Usual

Treatment as usual as determined by the clinical team responsible for the individual's care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Acceptance and Commitment Therapy

Up to 10 sessions of Acceptance and Commitment Therapy plus treatment as usual

Group Type: ACTIVE_COMPARATOR

Acceptance and Commitment Therapy

Intervention Type: OTHER

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

Interventions

Acceptance and Commitment Therapy

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

Intervention Type: OTHER

Other Intervention Names

ACT

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role: collaborator

University of Glasgow

OTHER

Sponsor Role: lead

Responsible Party

University of Glasgow

Principal Investigators

Ross G White, BSc, PhD, DClinPsy

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Locations

Greater Glasgow and Clyde NHS

Glasgow, Scotland, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 12362963 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15893293 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

Ethics Ref:09/S0701/74

Identifier Type: -

Identifier Source: secondary_id

PN09CP213

Identifier Type: -

Identifier Source: org_study_id