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

Primary Purpose

Psychosis, Schizophrenia, Bipolar Disorder

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy
Sponsored by
University of Glasgow
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis focused on measuring Psychosis, Distress, Mindfulness, Acceptance, Values

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Greater Glasgow and Clyde NHS

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Treatment As Usual

Acceptance and Commitment Therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Measuring change in depression and anxiety
The Hospital Anxiety and Depression Scale
Changes in believability, distress and frequency of positive symptoms

Secondary Outcome Measures

Measuring change in mindfulness skills and psychological flexibility
The Kentucky Inventory of Mindfulness Skills, The Acceptance and Action Questionnaire

Full Information

First Posted
October 27, 2009
Last Updated
November 8, 2010
Sponsor
University of Glasgow
Collaborators
NHS Greater Glasgow and Clyde
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1. Study Identification

Unique Protocol Identification Number
NCT01003132
Brief Title
Assessing the Effectiveness of Acceptance and Commitment Therapy for Distress Following Psychosis
Acronym
PACT
Official Title
A Pilot Randomised Controlled Trial of Acceptance and Commitment Therapy for Distress Following Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Glasgow
Collaborators
NHS Greater Glasgow and Clyde

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, Schizophrenia, Bipolar Disorder, Schizo-affective Disorder
Keywords
Psychosis, Distress, Mindfulness, Acceptance, Values

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment As Usual
Arm Type
No Intervention
Arm Description
Treatment as usual as determined by the clinical team responsible for the individual's care
Arm Title
Acceptance and Commitment Therapy
Arm Type
Active Comparator
Arm Description
Up to 10 sessions of Acceptance and Commitment Therapy plus treatment as usual
Intervention Type
Other
Intervention Name(s)
Acceptance and Commitment Therapy
Other Intervention Name(s)
ACT
Intervention Description
Up to 10 sessions of a psychological therapy called Acceptance and Commitment Therapy
Primary Outcome Measure Information:
Title
Measuring change in depression and anxiety
Description
The Hospital Anxiety and Depression Scale
Time Frame
Baseline and 3 month follow-up
Title
Changes in believability, distress and frequency of positive symptoms
Time Frame
Baseline and up to 9 months follow-up
Secondary Outcome Measure Information:
Title
Measuring change in mindfulness skills and psychological flexibility
Description
The Kentucky Inventory of Mindfulness Skills, The Acceptance and Action Questionnaire
Time Frame
Baseline and up to 9 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ross G White, BSc, PhD, DClinPsy
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Greater Glasgow and Clyde NHS
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G3 8YZ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
12362963
Citation
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.
Results Reference
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PubMed Identifier
15893293
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. doi: 10.1016/j.brat.2005.02.007. Erratum In: Behav Res Ther. 2020 Jan;124:103534.
Results Reference
background
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
Results Reference
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Assessing the Effectiveness of Acceptance and Commitment Therapy for Distress Following Psychosis

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