Does paying attention to religious themes in therapy influence treatment outcomes?
| ISRCTN | ISRCTN22444109 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22444109 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | NL19473.058.08 |
| Sponsor | Vrije Universiteit Amsterdam |
| Funder | Eleos |
- Submission date
- 08/02/2024
- Registration date
- 27/02/2024
- Last edited
- 26/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Cross-sectional studies show positive correlations between psychological wellbeing and religiosity. Most religious patients prefer to discuss religious topics during their therapy. However, it is virtually unknown whether addressing religious issues in psychotherapy increases the effectiveness of psychotherapy of religious patients, as are potential moderating and mediating mechanisms. The main aim of the study is to investigate the influence of discussing religious issues during therapy on treatment outcome, both 6 months after the start of treatment and 1.5 years after the start of treatment. In addition, the study will take possible mediating variables into account, such as cognitive schemas, image of God, and therapeutic alliance. Structural features of personality pathology will be investigated as moderator variables.
Who can participate?
Patients aged from 18 to 65 years who apply for psychotherapy at a mental health institute that is involved in this study and who have been assigned to psychotherapy of 1 to 12 months duration with about 5 to 40 sessions
What does the study involve?
Patients are randomly allocated to:
1. Regular therapy including approximately 15 minutes of talking about religious or spiritual themes each session
2. Regular therapy without talking about religious or spiritual subjects
All patients fill in questionnaires before treatment, 6 months after the start of treatment, and at follow-up 1.5 years after the start of treatment.
What are the possible benefits and risks of participating?
Participants will contribute to expanding and deepening scientific knowledge about the effectiveness of psychological treatments for religious patients. Filling in the questionnaires can make some patients emotionally upset. Clinical experience however shows that these emotional reactions do not frequently occur or are of short duration. Furthermore, there is a risk of disappointment for patients depending on the group they are assigned to.
Where is the study run from?
Vrije Universiteit Amsterdam (Netherlands)
When is the study starting and how long is it expected to run for?
January 2008 to July 2024
Who is funding the study?
Eleos (Netherlands)
Who is the main contact?
Annette Bouwhuis, annettebouwhuis@hotmail.com
Contact information
Public, Scientific
Erve Wolters 20
Rijssen
7463CN
Netherlands
| Phone | +31 (0)612125528 |
|---|---|
| annettebouwhuis@hotmail.com |
Principal investigator
De Boelelaan1105
Amsterdam
1081HV
Netherlands
| Phone | +31 (0)610914513 |
|---|---|
| g.glas@vu.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentred longitudinal two-arm interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The influence of attention to religion in psychological therapy in the short- and long-term on the change in psychological functioning, and the contribution of the possible mediating variables: cognitive schemes, the image of God, and therapeutic alliance and the possible moderating variable: structural personality traits |
| Study acronym | R/S therapy |
| Study objectives | The main aim of the study is to investigate the influence of discussing religious issues during therapy on treatment outcomes, both 0.5 and 1.5 years after starting treatment. In addition, the study will take possible mediating variables into account, such as cognitive schemas, image of God, and therapeutic alliance. Structural features of personality pathology will be investigated as a moderator variable. Hypothesis: Treatment where religion/spirituality is part of the therapy is slightly more effective than treatment as usual, especially for depressed patients. |
| Ethics approval(s) |
Approved 18/03/2009, Leiden University Medical Center, METC (Albinusdreef 2, Leiden, 2333 ZA, Netherlands; +31 (0)71 - 5265106; metc-ldd@lumc.nl), ref: P08.107/DT/ib |
| Health condition(s) or problem(s) studied | Mental disorders |
| Intervention | The method of randomisation was per participating institution by order of enrollment. The first subject was assigned to the 'yes group' and the second to the 'no group', and so on. Patients are randomized into: 1. R/S based therapy. An R/S-based therapy is a regular therapy including approximately 15 minutes of talking about religious or spiritual themes each session. 2. Non-R/S based therapy. A non-R/S-based therapy is a regular therapy without talking about religious or spiritual subjects. After each session, the therapist records the number of minutes spent on R/S subjects and the type of intervention. (http://geloofintherapie.nl/index.php?option=com_bfsurvey_basictrial&view=onepage&catid=1&Itemid=5) To measure the influence of desirability, before the start of treatment each patient is asked the question: 'It is possible that religious themes are discussed in your treatment. How desirable do you think that is on a scale of 1 (absolutely not) - 8 (absolutely yes).' At three times, all patients fill in questionnaires: (T0) before treatment; (T1) 6 months after the start of treatment; and (T3) at follow-up 1.5 years after the start of treatment. Patients complete the following questionnaires: 1. Brief Symptom Inventory 2. Rand-36 3. Spiritual Well-Being Scale 4. Dutch Abbreviated MMPI (NVM) 5. Young Schema Questionnaire (YSQ) 6. God Image Questionnaire (VGB) 7. Working Alliance Inventory (WAI) The total duration of interventions depends on the overall duration of treatment. It is tailored to the individual patient and can vary. In the intervention group, the 'intervention' (talking about religion/spirituality) is applied for between 10 and 15 minutes per session and this time is recorded by the psychologist. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Change in psychological functioning: |
| Key secondary outcome measure(s) |
Changes in variables that could mediate or moderate changes in psychological functioning after psychotherapy: |
| Completion date | 01/07/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 74 |
| Total final enrolment | 95 |
| Key inclusion criteria | 1. Males and females ranging in age from 18 to 75 years 2. Apply for psychotherapy at the mental health institute that is involved in this study 3. Have been assigned to psychotherapy of 1 month to 12 months duration with approximately 5 to 40 sessions |
| Key exclusion criteria | Patients who consider themselves as non-religious, and patients with (a history of) psychosis |
| Date of first enrolment | 01/09/2010 |
| Date of final enrolment | 31/12/2022 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
Hoevelaken
3871 MR
Netherlands
Amsterdam
1063 LW
Netherlands
Drachten
9202 PE
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
08/02/2024: Study's existence confirmed by Vrije Universiteit Amsterdam.
