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See: ClinicalTrials.gov ID: NCT05402150
Relevant for this Paper:
This investigation aims to evaluate the stability of the effectiveness of different two-week online interventions in a four months follow-up regarding reward sensitivity, anhedonia and depression.
The authors will further investigate factors influencing treatment success regarding reward sensitivity. The investigators assume that the more depressive expectations and stress improve during our online intervention, the more change in reward insensitivity is experienced at follow-up. In addition, it is hypothesized that the more people engaged in physical activities and social encounters during the two-week online intervention, the more change in reward insensitivity is experienced at follow-up.
See for main study: ClinicalTrials.gov ID: NCT05402150.
A possible maintaining role in depressive symptoms plays reward hyposensitivity. Therefore, treatments should include evidence-based psychological interventions that target and modify reward insensitivity. Prior research lacks studies investigating reward sensitivity as main outcome measure, especially in the web-based format. This is why this study investigated an online intervention with the following groups regarding effectively increasing reward sensitivity compared to a waitlist control condition:
a) mindfulness-based interventions, b) behavioral activation, c) a combination of both.
The daily exercises were supported via videos and worksheets. Here, the investigators explore the effects after a four-months follow-up. In addition, this paper will deal with the long-term prediction of reward sensitivity, a feature not considered in our main paper preregistered with the ID NCT05402150. Factors, which are considered to play a big role in reward sensitivity are perceived stress, depressive expectations, physical activity and the frequency of social encounters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Activation | Experimental | 14 days of daily excercises |
|
| Mindfulness and Gratitude | Experimental | 14 days of daily excercises |
|
| Combination: Behavioral Activation and Mindfulness and Gratitude | Experimental | 14 days of daily excercises |
|
| Waitlist control group | No Intervention | Will receive the intervention (combination) after two weeks of intervention time of the other groups. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Activation | Behavioral | - instruction to create a list of individual positive activities. - instruction to include daily positive activities and fill out a mood protocol, which covers the time period shortly before, during and after the activity. |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive symptoms (Patient Health Questionnaire-9, PHQ-9) |
| baseline, post intervention (after 2 weeks), 4 months follow-up |
| Reward sensitivity (Positive Valence System Scale-21, PVSS-21) |
| baseline, post intervention (after 2 weeks), 4 months follow-up |
| Anhedonia (Snaith-Hamilton-Pleasure-Scale, SHAPS-D) |
| baseline, post intervention (after 2 weeks), 4 months follow-up |
| Change in Stress level (Perceived-Stress-Scale 10, PSS-10) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Personality traits (Big Five Inventory 10, BFI-10) |
| Baseline, post intervention (after 2 weeks), four months follow-up] |
| Adherence |
| Measure | Description | Time Frame |
|---|---|---|
| Sociodemographic variables | - Gender, age, education, employment, medication, self report lifetime diagnosis of psychiatric conditions, previous experience with psychotherapy etc. | baseline |
| Perceived system usability (System usability Scale, SUS), general feedback about the online intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Winfried Rief, Prof. Dr. | Dept. of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philipps University | Marburg | 35037 | Germany |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Mindfulness and Gratitude | Behavioral | - instruction to fill out a mindfulness diary: reflection of daily pleasant situation, instructing the participants to revisit the impressions of their 5 senses during this situation, in addition they should specify how long they have actually dealt with |
|
| Combination of Behavioral Activation and Mindfulness and Gratitude | Behavioral | This group will do a combination of the two intervention types. |
|
| baseline, post intervention (after 2 weeks), 4 months follow-up |
| Change in Depressive Expectations (Depressive Expectations Scale, DES) |
| baseline, post intervention (after 2 weeks), 4 months follow-up |
| Amount of physical activity reported during intervention exercises | - Type of activities and reflected pleasant situations that have been selected in the daily online surveys | during intervention |
| Amount of social encounters reported during intervention exercises | - Type of activities and reflected pleasant situations that have been selected in the daily online surveys | during intervention |
|
| post intervention (after 2 weeks), 4 months follow-up |
| Treatment expectation (Generic Rating for Treatment Pre-Experiences, Treatment Expectations, and Treatment Effects, G-EEE) | - Items range from 0 to 10 (depending on the item from "no improvement" to "greatest improvement imaginable", from "no worsening" to "greatest worsening imaginable", from "no complaints" to "greatest complaints imaginable") and one item, where previous treatment experience is assessed via a choice of "I have never experienced this treatment." (continue with question 8), "I have experienced this treatment during the last 12 months (nearly) daily.", "I have experienced this treatment during the last 12 months on more than 10 days.", "I have experienced this treatment during the last 12 months on about 5 to 10 days.", I have experienced this treatment during the last 12 months on about 1 to 4 days." And "I have not experienced this treatment during the last 12 months, but I have experienced it before." | Baseline, post intervention (after 2 weeks), 4 months follow-up |
| Treatment credibility and expectancy (Credibility/Expectancy Questionnaire, CEQ) |
| Baseline |
| Trait reward responsiveness (Reward Responsiveness Scale, RRS) |
| Baseline, post intervention (after 2 weeks), 4 months follow-up |
|
| post intervention (after 2 weeks) |
| Problems and obstacles during the intervention | - Frequency of telephone contacts made with the principal contact person (Laura Potsch) and specified problems with the implementation of the daily excercises in the daily online survey | post intervention (after 2 weeks) |