NCT01003132

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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

November 9, 2010

Status Verified

November 1, 2010

Enrollment Period

1 year

First QC Date

October 27, 2009

Last Update Submit

November 8, 2010

Conditions

Keywords

PsychosisDistressMindfulnessAcceptanceValues

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Measuring change in mindfulness skills and psychological flexibility

    Baseline and up to 9 month follow-up

Study Arms (2)

Treatment As Usual

NO INTERVENTION

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

Acceptance and Commitment Therapy

ACTIVE COMPARATOR

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

Other: Acceptance and Commitment Therapy

Interventions

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

Also known as: ACT
Acceptance and Commitment Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Greater Glasgow and Clyde NHS

Glasgow, Scotland, G3 8YZ, United Kingdom

Location

Related 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. doi: 10.1037//0022-006x.70.5.1129.

    PMID: 12362963BACKGROUND
  • 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.

    PMID: 15893293BACKGROUND
  • 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

    BACKGROUND

MeSH Terms

Conditions

Psychotic DisordersSchizophreniaBipolar Disorder

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Ross G White, BSc, PhD, DClinPsy

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 27, 2009

First Posted

October 28, 2009

Study Start

October 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

November 9, 2010

Record last verified: 2010-11

Locations