Health psychological approaches as treatments for depression: steps towards enjoyment in life
| ISRCTN | ISRCTN15458323 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15458323 |
- Submission date
- 26/05/2025
- Registration date
- 23/06/2025
- Last edited
- 13/06/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Depression is characterized by feeling hopeless and worthless. Affected persons perceive a barrier to feeling happiness and well-being, called anhedonia. Psychological aspects like rejection of oneself and others and physical aspects, like loss of energy and exhaustion, are intertwined.
The aim of this study is to test the efficacy of a meditation-based group therapy compared to an active control group, i.e. nondirective supportive therapy, for treating anhedonia in depressive patients.
Who can participate?
Patients aged between 18 and 65 years with depressive disorder and increased anhedonia, on/off medication stable for at least 4 weeks before inclusion
What does the study involve?
Both programs comprise 10 sessions of group therapy with an extensive initial and final diagnostic examination as well as an individual appointment before the group sessions begin. Group sessions can take place either online or in person. The decision for one of the settings has to be made in advance and cannot be changed once the programs begin.
Online questionnaires for self-assessment are sent to participants at T1 (baseline), T2 (after half of the group sessions), T3 (after treatment), T4 (follow-up, 6 months after treatment).
What are the possible benefits and risks of participating?
Possible benefits: extensive diagnostic examination and feedback, improvement of depressive symptoms, contribution to research about the treatment of anhedonia and depression
Possible risks: no change in depressive symptoms or deterioration of mental health
Where is the study run from?
Goethe University Frankfurt (Germany)
When is the study starting and how long is it expected to run for?
December 2021 to June 2026
Who is funding the study?
This study is funded by the LOEWE Top Professorship for Stefan G. Hofmann of the Hessian Ministry of Science and Arts (Germany)
Who is the main contact?
1. Dr. Elisabeth Arens, e.arens@psych.uni-frankfurt.de
2. Prof. Dr. Ulrich Stangier, stangier@psych.uni-frankfurt.de
Contact information
Principal Investigator
Department of Clinical Psychology and Psychotherapy, Goethe University Frankfurt, Varrentrappstr. 40-42
Frankfurt am Main
60486
Germany
 ORCID ID |
0000-0002-1945-1704 |
|---|---|
| Phone | +49 (0)69 798 23842 |
| nerad@psych.uni-frankfurt.de |
Scientific
Department of Clinical Psychology and Psychotherapy
Goethe University Frankfurt
Varrentrappstr. 40-42
Frankfurt am Main
60486
Germany
| ORCID ID |
0000-0002-9052-8006 |
|---|---|
| Phone | +49 (0)69 798 23250 |
| e.arens@psych.uni-frankfurt.de |
Public
Department of Clinical Psychology and Psychotherapy
Goethe University Frankfurt
Varrentrappstr. 40-42
Frankfurt am Main
60486
Germany
| Phone | +49 (0)69 798 25356 |
|---|---|
| kreis@psych.uni-frankfurt.de |
Study information
| Study design | Single-centre randomized controlled observer blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual, University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Metta-based cognitive behavioral therapy (MeCBT) as a transdiagnostic treatment for Anhedonia in patients with depression |
| Study acronym | STYLE |
| Study objectives | 1. We expect a significant decline of anhedonia symptoms and a significantly larger effect for Metta-based cognitive behavioral therapy (MeCBT) compared to nondirective supportive psychotherapy (nsPT). 2. We expect significant superiority by MeCBT at T1 and T2 in all these secondary variables. (Secondary outcome measures include self-rated social and physical anhedonia, quality of life, symptoms of depression, emotional and cognitive-behavioral avoidance, social functioning, prosocial interactions and benevolence.) |
| Ethics approval(s) |
Approved 24/05/2022, Local ethics committee of the Department of Psychology and Sports Sciences at Goethe University Frankfurt (Theodor-W.-Adorno-Platz 6, Frankfurt am Main, 60323, Germany; +49 (0)69 798 35253; klein@psych.uni-frankfurt.de), ref: 2022-06a-c |
| Health condition(s) or problem(s) studied | Anhedonia, depression |
| Intervention | Experimental intervention: MeCBT consisting of 10 sessions group treatment focusing on metta meditation and behavioral activation. Control intervention: nsPT consisting of group treatment of the same timeframe as the experimental intervention and including psychoeducation and supportive interventions. Both treatment arms receive treatment-as-usual (TAU) by their physician. Antidepressive medication will be controlled for its impact on outcome. Duration of intervention per patient: 10 weeks, 6-month follow-up. If eligibility for the study is confirmed, and informed consent to randomization is given, patients will be randomized. To allocate study participants to treatment conditions, a randomization list is created using the statistical software R. The group allocations are printed out and placed in sealed envelopes. For each newly included participant, a research assistant draws an envelope and reads off the group allocation. |
| Intervention type | Behavioural |
| Primary outcome measure | Anhedonia (clinician rating) assessed with the Clinical Assessment of Negative Symptoms (CAINS) at baseline (T1) and after treatment (T3) |
| Secondary outcome measures | 1. Self-rated hedonic capacity for social and interpersonal pleasure measured using the Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS) at T1 (baseline), T2 (after half of the group sessions), T3 (after treatment), T4 (follow-up, 6 months after treatment) 2. Symptoms of depression measured using Beck’s Depression Inventory-II (BDI-II) and Quick Inventory of Depressive Symptomatology (QIDS) at T1, T2, T3, T4, 3. Emotional and cognitive-behavioral avoidance, measured using the Behavioral Activation for Depression Scale (BADS) at T1, T2, T3, T4 4. Social functioning, measured using the Social Adaptation Self-evaluation Scale (SASS) at T1, T2, T3, T4 5. Benevolence, measured using Fragebogen zu Wohlwollen (FWW) at T1, T2, T3, T4 6. Mindfulness, measured using the Facet Mindfulness Questionnaire (FFMQ) at T1, T2, T3, T4 7. Cognitive and behavioral coping with depressive symptoms, measured using the Response Style Questionnaire – Deutsch (RSQ-D) at T1, T2, T3, T4 8. Positive and negative affect, measured using the Positive and Negative Affect Schedule (PANAS) at T1, T2, T3, T4 9. Acceptance of online group sessions, measured using Fragebogen zur Erfassung der Akzeptanz der Videotherapie (FAV) at T3 10. Behavioral Inhibition System and Behavioral Approach System, measured using Behavioral Activation and Behavioral Inhibition Scales (BIS/BAS) at T1 |
| Overall study start date | 01/12/2021 |
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Snaith-Hamilton Pleasure Scale (SHAPS-D) score >2 2. Depressive disorder 3. Aged 18-65 years |
| Key exclusion criteria | 1. Increased suicidality 2. Substance abuse or dependency 3. Diagnosis of borderline personality disorder 4. Untreated PTSD 5. Psychotic disorder 6. Bipolar disorder 7. Severe physical illness 8. Insufficient German language skills 9. Concurrent psychotherapeutic treatment |
| Date of first enrolment | 22/03/2024 |
| Date of final enrolment | 01/10/2025 |
Locations
Countries of recruitment
- Germany
Study participating centre
Klinische Psychologie und Psychotherapie
Varrentrappstr. 40-42
Frankfurt am Main
60486
Germany
Sponsor information
University/education
Institut für Psychologie
Schulstraße 12
Marburg
35037
Germany
| Phone | +49 (0)172 489 2245 |
|---|---|
| shofmann@bu.edu | |
| Website | https://www.uni-marburg.de/de/fb04/team-hofmann/team-1/prof-dr-stefan-hofmann |
"ROR" |
https://ror.org/01rdrb571 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Hessen State Ministry of Higher Education, Research and the Arts, Hessian Ministry for Science and the Arts, Hessian Ministry of Higher Education, Research and the Arts, Hessian Ministry for Science and Art
- Location
- Germany
Results and Publications
| Intention to publish date | 30/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Individual participant data that underlie the reported results will be shared on request after deidentification. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 13/06/2025 | No | No | ||
| Study website | 13/06/2025 | No | No |
Additional files
Editorial Notes
13/06/2025: Study's existence confirmed by the Local ethics committee of the Department of Psychology and Sports Sciences at Goethe University Frankfurt.
