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

• Register: ISRCTN
• Last refreshed on: 13 June 2023
• Main ID: ISRCTN11209732
• Date of registration: 22/08/2016
• Prospective Registration: No
• Primary sponsor: University of Basel (Switzerland)
• Public title: Effectiveness of Acceptance and Commitment Therapy (ACT)-based therapy
• Scientific title: Effectiveness of Acceptance and Commitment Therapy (ACT)-based therapy
• Date of first enrolment: 01/05/2016
• Target sample size: 170
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN11209732
• Study type: Interventional
• Study design: Effectiveness study with two non-randomized treatment arms (i.e., inpatient and outpatient) consisting of self-referring patients (Treatment)
• Phase: Not Applicable

Countries of recruitment

Switzerland

Contacts

• Name: Andrew Gloster

Key inclusion & exclusion criteria

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

Added 20/06/2019:
Some patients without previous therapy experience were included to enable full modelling of patients from those without treatment experience to those with treatment experience.
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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.

Primary Outcome(s)

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(s)

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.

Secondary ID(s)

EKNZ: 165/13

Source(s) of Monetary Support

Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 01/02/2021