Depression MildNCT06072209
Long-term Effects ReSet Your Mind - Mechanisms
A study testing Behavioral Activation, Mindfulness and Gratitude and Combination of Behavioral Activation and Mindfulness and Gratitude in people with Depression Mild and Depression Moderate, run by Philipps University Marburg at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression Mild, Depression Moderate
- What is being tested?
- Behavioral Activation, Mindfulness and Gratitude and Combination of Behavioral Activation and Mindfulness and Gratitude
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteGermany
- Study dates
- 30 May 2022to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or above
- Fluent in German
- Informed consent
- Depressive symptoms (PHQ-9 > 5)
Who cannot join
- suicidality, severe depression
- current or lifetime: substance use disorder, psychotic disorders, bipolar I or II
- current psychotherapy
- if antidepressant medication: has not been stable over the last 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Effects of an Online Intervention Targeting Depression and Reward Sensitivity - Predictors and Mechanisms of Treatment Success
See: ClinicalTrials.gov ID: NCT05402150
Relevant for this Paper:
Read more
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.
Read the detailed description
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:
- 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.
- Conditions
- Depression Mild, Depression Moderate
- Being tested
- Behavioral Activation, Mindfulness and Gratitude, Combination of Behavioral Activation and Mindfulness and Gratitude
- Keywords
- reward sensitivity, reward processing, depression, randomized controlled trial, online intervention, behavioral activation, mindfulness, gratitude
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ActivationBehavioural
- 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.
Mindfulness and GratitudeBehavioural
- 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 GratitudeBehavioural
This group will do a combination of the two intervention types.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation | Experimental | 14 days of daily excercises Receives: Behavioral: Behavioral Activation |
| Mindfulness and Gratitude | Experimental | 14 days of daily excercises Receives: Behavioral: Mindfulness and Gratitude |
| Combination: Behavioral Activation and Mindfulness and Gratitude | Experimental | 14 days of daily excercises Receives: Behavioral: Combination of Behavioral Activation and Mindfulness and Gratitude |
| Waitlist control group | No intervention | Will receive the intervention (combination) after two weeks of intervention time of the other groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: during intervention
Secondary outcomes (5)
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
Measured: 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.
Measured: 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."
Measured: 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)
Measured: 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.
Measured: Baseline, post intervention (after 2 weeks), 4 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start30 May 2022
- Primary completion15 May 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression MildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Winfried Rief, Prof. Dr., Principal investigator, Dept. of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06072209
- Sponsor's protocol ID
- ReSet your Mind - Mechanisms
- Status last verified
- Oct 2023
- First submitted
- 2 Oct 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of an Online Intervention Targeting Depression and Reward Sensitivity - Predictors and Mechanisms of Treatment Success
- ClinicalTrials.gov ID
- NCT06072209
- Acronym / sponsor ID
- ReSet your Mind - Mechanisms
- Conditions
- Depression Mild, Depression Moderate
- Keywords
- reward sensitivity, reward processing, depression, randomized controlled trial, online intervention, behavioral activation, mindfulness, gratitude
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation | Experimental | Behavioral: Behavioral Activation14 days of daily excercises |
| Mindfulness and Gratitude | Experimental | Behavioral: Mindfulness and Gratitude14 days of daily excercises |
| Combination: Behavioral Activation and Mindfulness and Gratitude | Experimental | Behavioral: Combination of Behavioral Activation and Mindfulness and Gratitude14 days of daily excercises |
| Waitlist control group | No intervention | –Will receive the intervention (combination) after two weeks of intervention time of the other groups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or above
- Fluent in German
- Informed consent
- Depressive symptoms (PHQ-9 > 5)
Key exclusion criteria (4 listed)
- suicidality, severe depression
- current or lifetime: substance use disorder, psychotic disorders, bipolar I or II
- current psychotherapy
- if antidepressant medication: has not been stable over the last 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Activation- 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. | Behavioural | Behavioral Activation |
| Mindfulness and Gratitude- 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 | Behavioural | Mindfulness and Gratitude |
| Combination of Behavioral Activation and Mindfulness and GratitudeThis group will do a combination of the two intervention types. | Behavioural | Combination: Behavioral Activation and Mindfulness and Gratitude |
Primary outcome
Depressive symptoms (Patient Health Questionnaire-9, PHQ-9)
Time frame: baseline, post intervention (after 2 weeks), 4 months follow-up
* 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.
Reward sensitivity (Positive Valence System Scale-21, PVSS-21)
Time frame: baseline, post intervention (after 2 weeks), 4 months follow-up
* 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.
Anhedonia (Snaith-Hamilton-Pleasure-Scale, SHAPS-D)
Time frame: baseline, post intervention (after 2 weeks), 4 months follow-up
* 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.
Change in Stress level (Perceived-Stress-Scale 10, PSS-10)
Time frame: baseline, post intervention (after 2 weeks), 4 months follow-up
* 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.
Change in Depressive Expectations (Depressive Expectations Scale, DES)
Time frame: baseline, post intervention (after 2 weeks), 4 months follow-up
* 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.
Amount of physical activity reported during intervention exercises
Time frame: during intervention
- Type of activities and reflected pleasant situations that have been selected in the daily online surveys
Amount of social encounters reported during intervention exercises
Time frame: during intervention
- Type of activities and reflected pleasant situations that have been selected in the daily online surveys
5 secondary outcomes
Personality traits (Big Five Inventory 10, BFI-10)
Time frame: Baseline, post intervention (after 2 weeks), four months follow-up]
Adherence
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)
Time frame: Baseline, post intervention (after 2 weeks), 4 months follow-up
Treatment credibility and expectancy (Credibility/Expectancy Questionnaire, CEQ)
Time frame: Baseline
Trait reward responsiveness (Reward Responsiveness Scale, RRS)
Time frame: Baseline, post intervention (after 2 weeks), 4 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winfried Rief, Prof. Dr. principal investigator
Dept. of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation, Mindfulness and Gratitude and Combination of Behavioral Activation and Mindfulness and Gratitude in people with Depression Mild and Depression Moderate, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (Patient Health Questionnaire-9, PHQ-9) (time frame: baseline, post intervention (after 2 weeks), 4 months follow-up). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.