Acceptance and commitment therapy for depression after psychosis: a pilot trial
| ISRCTN | ISRCTN33306437 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33306437 |
| Protocol serial number | Research Protocol Version Number: 1 (13/07/2012) |
| Sponsor | NHS Greater Glasgow & Clyde (UK) |
| Funder | Chief Scientist Office (CZH/4/743) |
- Submission date
- 01/03/2013
- Registration date
- 19/03/2013
- Last edited
- 30/11/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Depression is a common problem amongst people who experience psychosis. Depression is linked to greater feelings of stigma and shame, lower self esteem and increased risk of suicide. There is a need to develop specific treatments to assist individuals who have experienced psychosis who also develop depression.
Who can participate?
We are asking service users who are supported by community-based services run by NHS Greater Glasgow & Clyde (NHS GG&C), who have a diagnosis of schizophrenia and who also experience depression to participate in the study.
What does the study involve?
After a participant gives their informed consent to enter the study we will interview participants to determine how they have been feeling over the last two weeks. This will include a discussion about current symptoms including experiences of depression. Participants will also complete eight questionnaires. This meeting will last approximately 2 hours. This can take place over one or more sessions depending on preferences. Following this, participants will be seen again after 5 months and 10 months in order to find out how they are feeling. Each of these subsequent sessions will take about an hour. Taking part will not affect any current treatment that participants may be receiving or are about to receive. Everyone who takes part in the study will be offered treatment for the problems that they experience. One half or 50% of participants will also (in addition to their usual treatment) be offered a psychological therapy called Acceptance and Commitment Therapy (ACT). This will allow us to compare the outcomes for those who receive ACT as well as their usual care, with those who receive usual care. The results are compared to see if one is better than the other. To try to make sure the participants who receive ACT and those who receive usual care are the same to start with, each patient is allocated to treatment by chance (randomly). The treatment that participants receive will be selected at random by a computer. Those receiving ACT, will receive up to 20 individual sessions of ACT with a therapist over 5 months. Each session will last 50 minutes. Some participants who receive ACT will be asked if their sessions can be recorded on a digital audio recorder. This is to ensure that the therapist is doing the treatment correctly. These recordings are confidential and will be stored securely and will only be listened to by professional staff involved in the study, after which they will be destroyed. They can also be made available for participants to listen to if they wish (some people find this helpful).
Those who are not offered ACT will also continue to receive the treatment they would normally receive.
What are the possible benefits and risks of participating?
If you take part in the study, it is hoped that both the treatment and the monitoring will be of help to you. However, it is possible that talking about some of these issues may be upsetting.
Where is the study run from?
NHS Greater Glasgow and Clyde (UK)
When is the study starting and how long is it expected to run for?
The study will start on 1st April 2013 and will run for two years.
Who is funding the study?
The Chief Scientist Office, Scottish Government and NHS Greater Glasgow & Clyde (UK)
Who is the main contact?
Professor Andrew Gumley
andrew.gumley@glasgow.ac.uk
Contact information
Scientific
Institute Of Health and Wellbeing
Mental Health and Wellbeing
Gartnavel Royal Hospital
Glasgow
G12 0XH
United Kingdom
| andrew.gumley@glasgow.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | 24-month parallel-group randomised open blinded evaluation (PROBE) |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A parallel group randomised open blinded evaluation of acceptance and commitment therapy for depression after psychosis: a pilot trial (ADAPT) |
| Study acronym | ADAPT |
| Study objectives | The following research questions will be addressed: Population: 1. What are the potential numbers of participants who fulfil eligibility criteria? 2. What proportion of potential participants provide fully informed consent to participate in the trial? Based on our pilot work we expect to randomise at a rate of 5.5 participants per month. Intervention: 1. What proportion of participants engage with ACTdp as delivered by a trained, accredited therapist? 2. What is the fidelity and competence of therapists delivering ACTdp? 3. What is the association between therapist fidelity and competence and outcome in those participants randomised to ACTdp? Control: 1. What follow-up do participants in both groups receive from secondary mental health services? 2. What medications (antipsychotic, antidepressant, mood stabiliser and anxiolytic) are prescribed to participants in both groups? 3. What psychological therapies are offered to participants during the course of the trial? Outcomes: 1. What rates of improvement in quality of life, depression, hopelessness and negative symptoms are observed over at 5-month (end of treatment) follow-up and 10-month follow-up? 2. What are the rates of discontinuation from therapy? 3. What is the overall rate of follow-up in the first 5-months and at 10-months? 4. Are there identifiable characteristics of those that do not comply or are lost to follow-up? 5. What are the associations with ACT specific mechanisms (mindfulness skills, experiential avoidance and rumination) and outcome in terms of depression and negative symptoms? |
| Ethics approval(s) | West of Scotland REC 5, 19/12/2012, ref: 12/WS/0311 |
| Health condition(s) or problem(s) studied | Schizophrenia |
| Intervention | Participants will be consecutively recruited, assessed and randomised to ACTdp plus ST or ST alone. Acceptance and Commitment Therapy for depression after psychosis (ACTdp): Individuals will receive up to 5 months of individual ACTdp. ACTdp is based on the rationale that the experience of psychosis can threaten progress in valued life domains. The ACTdp protocol will identify problematic appraisals; highlight how attempts to avoid these appraisals can paradoxically increase their frequency; develop individuals ability to let go of appraisals rather than get caught up reacting to them; facilitate understanding about how distress can inform values; explore valued life domains; and help individuals to commit to behaviours consistent with these valued life domains. Standard Treatment (ST): We will examine treatment received by all participants in the trial in order to establish parameters of standard treatment according to relevant SIGN and NICE guidance. We will require that all participants are in receipt of antipsychotic medication, psychiatric follow-up and follow-up from a secondary specialist mental health service. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. The EQ-5D is a generic, preference-based quality of life instrument that has been successfully used in schizophrenia patients, and which facilitated the calculation of Quality Adjusted Life Years for health economic analyses. |
| Key secondary outcome measure(s) |
Therapy Mechanisms: |
| Completion date | 31/03/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Outpatients, aged 16 or over, receiving secondary mental health care from community based services in NHS Greater Glasgow and Clyde (NHSGG&C) 2. Meet DSM-IV-TR criteria for schizophrenia and criteria for major depression (confirmed by Structured Clinical Interview for DSM / SCID-I & Calgary Depression Scale / CDSS for Schizophrenia; score >721). Individuals with substance use problems will not be excluded. |
| Key exclusion criteria | 1. Those with significant learning disability 2. Who are unable to speak English |
| Date of first enrolment | 01/04/2013 |
| Date of final enrolment | 31/03/2015 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
G12 0XH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
30/11/2016: Publication reference added.