An interventional study of Behavioral Activation and Mindfulness and Gratitude in Depression Mild and Depression Moderate, sponsored by Philipps University Marburg. Completed at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-12.
Sponsored by Philipps University Marburg · Not applicable, Interventional, and Treatment
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.
8,240 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 224 is above the median of 84 across 6,869 interventional studies indexed under Depression.
Browse Depression studies →Philipps University Marburg is the lead sponsor of 116 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
14 days of daily excercises
Behavioral: Behavioral Activation
14 days of daily excercises
Behavioral: Mindfulness and Gratitude
14 days of daily excercises
Behavioral: Combination of Behavioral Activation and Mindfulness and Gratitude
Will receive the intervention (combination) after two weeks of intervention time of the other groups.
\- 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.
\- 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
This group will do a combination of the two intervention types.
Depressive symptoms (Patient Health Questionnaire-9, PHQ-9)
* Items range from 0 to 3 (0 = not at all; 1 = several days; 2 = more than a week; 3 = nearly every day). * PHQ-9 total score ranges from 0 to 27 (classification of scores: 5-9 mild depression; 10-14 as moderate depression; 15-19: moderately severe depression; 20 - 27 severe depression). * Consequently, a higher score means worse depressive symptoms.
Time frame: baseline, post intervention (after 2 weeks), 4 months follow-up
Reward sensitivity (Positive Valence System Scale-21, PVSS-21)
* Items range from 1 to 9 (1 = extremely untrue of me, 2 = very untrue of me, 3 = moderately untrue of me, 4 = slightly untrue of me, 5 = neutral, 6 = slightly true of me, 7 = moderately true of me, 8 = very true of me, 9 = extremely true of me). * PVSS-21 total score ranges from 21 to 189. * Consequently, a higher score means a higher reward responding.
Time frame: baseline, post intervention (after 2 weeks), 4 months follow-up
Anhedonia (Snaith-Hamilton-Pleasure-Scale, SHAPS-D)
* Items range from "Definitely Agree", "Agree", "Disagree", and "Strongly Disagree". Either of the "Disagree responses" receive a score of 1 and either of the "Agree responses" receive a score of 0. * SHAPS-D total score ranges from 0 to 14. * Consequently, a higher score means a greater state anhedonia.
Time frame: baseline, post intervention (after 2 weeks), 4 months follow-up
Change in Stress level (Perceived-Stress-Scale 10, PSS-10)
* Items range from 1 to 5 (1= never, 2 = almost never, 3 = sometimes, 4 = fairly often, 5 = very often) Items 4, 5, 7 and 8 are reverse scored for the total score. * PH=perceived helplessness subscale; PSE=perceived self-efficacy subscale * PH subscale is computed by summing up Items 1, 2, 3, 6, 9 and 10; the PSE subscale is computed by summing up items 4, 5, 7 and 8 * PSS-10 total score is the sum of all PH and reversed PSE items * Consequently, a higher score means a greater level of stress.
Time frame: baseline, post intervention (after 2 weeks), 4 months follow-up
Change in Depressive Expectations (Depressive Expectations Scale, DES)
* Items range from 1 to 5 (1 = I disagree , 2 = I partially disagree, 3 = neutral, 4 = I partially agree, 5 = I agree). * DES total score ranges from 25 to 125 * Consequently, a higher score means more dysfunctional depressive expectations.
Time frame: 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
Time frame: 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
Time frame: during intervention
Personality traits (Big Five Inventory 10, BFI-10)
* Items range from 1 (disagree strongly) to 5 (agree strongly). * Scales: openness to experience, conscientiousness, extraversion, agreeableness and neuroticism
Time frame: Baseline, post intervention (after 2 weeks), four months follow-up]
Adherence
* Number of completed online surveys regarding the intervention exercises (T1 to T14: daily online surveys over the course of two weeks) * Self report of implementation of daily exercises in post intervention survey and follow up survey.
Time frame: 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."
Time frame: Baseline, post intervention (after 2 weeks), 4 months follow-up
Treatment credibility and expectancy (Credibility/Expectancy Questionnaire, CEQ)
* Items range from 1 to 9 (Item 1 of Set 1: 1= not at all logical, 5 = somewhat logical, 9 = very logical, Item 2 of Set 1: 1= not at all useful, 5 = somewhat useful, 9 = very useful, Item 3 of Set 1: 1 = not at all confident, 5 = somewhat confident, 9 = very confident, Item 1 of Set 2: 1 = not at all, 5 = somewhat, 9 = very much), Item 4 of Set 1 and Item 2 of Set 2 give a choice of 0% to 100% in steps of 10 %. * CEQ composite score can be derived for each factor (expectancy and credibility)
Time frame: Baseline
Trait reward responsiveness (Reward Responsiveness Scale, RRS)
* Items range from 1 to 4 (1= strong disagreement, 2 = mild disagreement, 3 = mild agreement, 4 = strong agreement) * RRS total score ranges from 8 to 32. * Consequently, a higher score means a higher reward responsiveness.
Time frame: Baseline, post intervention (after 2 weeks), 4 months follow-up
Sociodemographic variables
\- Gender, age, education, employment, medication, self report lifetime diagnosis of psychiatric conditions, previous experience with psychotherapy etc.
Time frame: baseline
Perceived system usability (System usability Scale, SUS), general feedback about the online intervention
* Items of the SUS range from 1 to 5 (1= strongly disagree to 5 = strongly agree). * After a computation, the SUS score can range from 0 to 100. A SUS score above a 68 is considered above average. * general feedback about the online intervention: free text entries about the online intervention: criticism, change requests, praise, one closed question: "Would you recommend the online intervention to someone else?" Yes/No
Time frame: 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
Time frame: post intervention (after 2 weeks)
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2022 to primary completion in May 2023, 11 months.
Of 3,016 non-industry interventional studies with no phase under Depression, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's 11 months is below that.
Counting every sponsor, half of 3,112 studies reached it within 22 months; a quarter within 10 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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