PsychosisPACTNCT01003132
Assessing the Effectiveness of Acceptance and Commitment Therapy for Distress Following Psychosis
A study testing Acceptance and Commitment Therapy in people with Psychosis and Schizophrenia, run by University of Glasgow at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychosis, Schizophrenia, Bipolar Disorder
- What is being tested?
- Acceptance and Commitment Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2009to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Greater Glasgow and Clyde NHS
Glasgow, Scotland, G3 8YZ
About this study
Official title: 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:
- 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.
Read the 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
- Being tested
- Acceptance and Commitment Therapy
- Keywords
- Psychosis, Distress, Mindfulness, Acceptance, Values
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyOther
Also called ACT
Up to 10 sessions of a psychological therapy called Acceptance and Commitment Therapy
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring change in depression and anxiety
The Hospital Anxiety and Depression Scale
Measured: Baseline and 3 month follow-up
Changes in believability, distress and frequency of positive symptoms
Measured: Baseline and up to 9 months follow-up
Secondary outcomes (1)
Measuring change in mindfulness skills and psychological flexibility
The Kentucky Inventory of Mindfulness Skills, The Acceptance and Action Questionnaire
Measured: Baseline and up to 9 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
- Investigators
- Ross G White, BSc, PhD, DClinPsy, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003132
- Sponsor's protocol ID
- PN09CP213
- Other IDs
- Ethics Ref:09/S0701/74
- Acronym
- PACT
- Status last verified
- Nov 2010
- First submitted
- 27 Oct 2009
- Last updated
- 9 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 12362963Gaudiano 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.
PubMed 15893293Hayes, 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 at a glance
From the registry record, last updated by the sponsor on 9 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomised Controlled Trial of Acceptance and Commitment Therapy for Distress Following Psychosis
- ClinicalTrials.gov ID
- NCT01003132
- Acronym / sponsor ID
- PACT / PN09CP213
- Conditions
- Psychosis, Schizophrenia, Bipolar Disorder, Schizo-affective Disorder
- Keywords
- Psychosis, Distress, Mindfulness, Acceptance, Values
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- NHS Greater Glasgow and Clyde
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 28 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Acceptance and Commitment TherapyUp to 10 sessions of Acceptance and Commitment Therapy plus treatment as usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- Participants will be excluded if there is a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment TherapyAlso: ACTUp to 10 sessions of a psychological therapy called Acceptance and Commitment Therapy | Other | Acceptance and Commitment Therapy |
Primary outcome
Measuring change in depression and anxiety
Time frame: Baseline and 3 month follow-up
The Hospital Anxiety and Depression Scale
Changes in believability, distress and frequency of positive symptoms
Time frame: Baseline and up to 9 months follow-up
1 secondary outcome
Measuring change in mindfulness skills and psychological flexibility
Time frame: Baseline and up to 9 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2010.
- Background: PubMed 12362963Bach 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.
- Background: PubMed 15893293Gaudiano 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.
- BackgroundHayes, S.C., Strosahl, K. and Wilson, K.G. (1999). Acceptance and Commitment Therapy: An experiential approach to behavior change, The Guilford Press, New York
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ross G White, BSc, PhD, DClinPsy principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Psychosis and Schizophrenia, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring change in depression and anxiety (time frame: Baseline and 3 month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01003132, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2010.