Condition category
Mental and Behavioural Disorders
Date applied
20/05/2016
Date assigned
22/08/2016
Last edited
22/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Mental disorders are impairing for the individual and are associated with low quality of life and reduced well-being. Treatment resistance (inadequate response to treatment) occurs in 25%-50% of patients. Acceptance and Commitment Therapy (ACT), a further development of traditional behavioral therapy, may offer a starting point for treatment-resistant patients precisely because the therapy does not attempt to eliminate symptoms. Instead, the therapy helps the patient to stop the unsuccessful struggle by fostering the willingness to openly experience emotions and thoughts as such. ACT has shown promising results even with highly impacted patients suffering from diverse psychological disorders. What remains unknown is whether and to what extent ACT transfers to treatment-resistant, chronic (long-term) patients treated in routine in- and out-patients treatment settings. Furthermore, the mechanisms underlying treatment success or failure remain largely unknown. This study will therefore examine the effectiveness of ACT treatment for patients with treatment-resistant disorders.

Who can participate?
Inpatients and outpatients aged 18 – 65 presenting for specialized treatment in a psychiatric university clinic

What does the study involve?
Both the inpatient unit and outpatient units of the Universitären Psychiatrischen Kliniken in Basel both apply Acceptance and Commitment Therapy. The treatment program in the inpatient unit involves intensive psychotherapy, individually and in groups. Treatment in the outpatient unit consists of individual intensive psychotherapy. The goal is to limit treatment to 3 months on average, however the length differs by individual, and is determined by clinical necessity. In addition, the patients are followed-up once they leave the clinic after 1, 4, 9 and 12 months.

What are the possible benefits and risks of participating?
Participants can obtain a summary of their responses that will be shared with their treatment provider. The results will inform us about the processes involved in successful and unsuccessful treatment. Participation in the assessment procedures of this study is not known to be associated with any risks.

Where is the study run from?
Universitäre Psychiatrische Kliniken Basel (Switzerland)

When is the study starting and how long is it expected to run for?
May 2016 to June 2018

Who is funding the study?
Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (Switzerland)

Who is the main contact?
Prof. Andrew Gloster

Trial website

Contact information

Type

Scientific

Primary contact

Prof Andrew Gloster

ORCID ID

Contact details

Missionsstrasse 62a
University of Basel
Department of Psychology
Basel
4055
Switzerland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EKNZ: 165/13

Study information

Scientific title

Effectiveness of Acceptance and Commitment Therapy (ACT)-based therapy

Acronym

Study hypothesis

Effectiveness:
1. The Acceptance and Commitment Therapy (ACT)-specific intervention will lead to significant positive changes in two treatment settings (i.e., inpatient and outpatient).

Moderator variables:
2. Psychological flexibility will moderate the negative impact of stressors such that it will be buffered in patients who show high levels in psychological flexibility.

Long-Term Course and Outcome:
3. Positive changes observed between pretest and post-test will remain stable for 12 months following treatment in the ACT-condition.
4. The percentage of patients who successfully apply treatment processes following treatment will differ between the in- and out-patient settings. However, irrespective of setting, those patients who apply the processes will have less relapse.

Ethics approval

Ethikkommission Nordwest- und Zentralschweiz, May 2016; Ref: EKNZ: 165/13

Study design

Effectiveness study with two non-randomized treatment arms (i.e., inpatient and outpatient) consisting of self-referring patients

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Transdiagnostic, treatment-resistant patients, presenting for specialized in- and out-patient treatment

Intervention

Both the inpatient unit and outpatient units of the Universitären Psychiatrischen Kliniken in Basel will both apply Acceptance and Commitment Therapy. The treatment program in the inpatient unit involves intensive psychotherapy, individually and in groups. Treatment in the outpatient unit consists of individual intensive psychotherapy. Patients self-present for treatment and there is no randomisation. The goal is to limit treatment to 3 months on average, however the length differs by individual, and will be determined by clinical necessity, and cannot be guaranteed a priori.

The study includes a pre-, post- and follow-up measurement. The follow up (FU) assessments will take place after 1, 4, 9 and 12 months.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Symptoms: Brief Symptom Checklist (BSCL)
2. General Functioning: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0; 12-item version)
3. Well-Being: Mental Health Continuum (MHC-SF)

Primary outcomes are measured at baseline, post, and 12 months follow up.

Secondary outcome measures

Measures of:
1. Psychological flexibility/emotional avoidance
2. Depression
3. Worry
4. Anxiety/fear
5. Obsessions and compulsions
6. Social Interaction
7. Social fear
8. Process of psychological flexibility
9. Committed action
10. Cognitive fusion
11. Mindfulness
12. Values
13. Meaning of life
14. (Problematic) emotion regulation
15. Overall social support
16. Relationship satisfaction
17. Social network quality
18. Values
19. Perceived stress
20. Daily stress
21. Prosocial behaviors
22. Cooperation
23. Expectancy

Secondary outcomes are measured at baseline, post and 12 months follow up. Process measures of psychological flexibility, social interactions, social network quality, and daily stress are additionally measured at 1, 4 and 9 month follow-up.

Overall trial start date

01/05/2016

Overall trial end date

01/06/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Individuals 18 – 65 years of age
2. Inpatients and outpatients presenting for specialized treatment in a psychiatric university clinic
3. A history of at least one course of previous therapy
4. Signed letter of consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

170

Participant exclusion criteria

1. Less than 18, greater than 65 years of age
2. Inability to understand the local language (German) in written form
3. Inability to complete the study design

Recruitment start date

01/05/2016

Recruitment end date

01/06/2018

Locations

Countries of recruitment

Switzerland

Trial participating centre

Universitäre Psychiatrische Kliniken Basel
4012
Switzerland

Sponsor information

Organisation

University of Basel (Switzerland)

Sponsor details

c/o Prof. Dr Andrew Gloster
Missionsstrasse 62a
University of Basel
Department of Psychology
Basel
4055
Switzerland

Sponsor type

University/education

Website

https://psycho.unibas.ch/fakultaet/personen/profil/person/andrew-gloster/

Funders

Funder type

Research organisation

Funder name

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung

Alternative name(s)

Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Switzerland

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes