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Completed

NCT Number: NCT06072209

Long-term Effects ReSet Your Mind - Mechanisms

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.

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Key information

Conditions

Depression Mild Behavior Behavioral Symptoms Depression Depression Moderate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Philipps University

Marburg, 35037, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 or above
  • Fluent in German
  • Informed consent
  • Depressive symptoms (PHQ-9 > 5)

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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

Secondary outcomes

  1. Personality traits (Big Five Inventory 10, BFI-10)

    Time frame: Baseline, post intervention (after 2 weeks), four months follow-up]

    • Items range from 1 (disagree strongly) to 5 (agree strongly).
    • Scales: openness to experience, conscientiousness, extraversion, agreeableness and neuroticism

  2. Adherence

    Time frame: post intervention (after 2 weeks), 4 months follow-up

    • 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.

  3. 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

    • 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."

  4. Treatment credibility and expectancy (Credibility/Expectancy Questionnaire, CEQ)

    Time frame: Baseline

    • 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)

  5. Trait reward responsiveness (Reward Responsiveness Scale, RRS)

    Time frame: Baseline, post intervention (after 2 weeks), 4 months follow-up

    • 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.

Other outcomes

  1. Sociodemographic variables

    Time frame: baseline

    • Gender, age, education, employment, medication, self report lifetime diagnosis of psychiatric conditions, previous experience with psychotherapy etc.

  2. Perceived system usability (System usability Scale, SUS), general feedback about the online intervention

    Time frame: post intervention (after 2 weeks)

    • 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

  3. Problems and obstacles during the intervention

    Time frame: post intervention (after 2 weeks)

    • 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

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Registry information

Official study title

Long-term Effects of an Online Intervention Targeting Depression and Reward Sensitivity - Predictors and Mechanisms of Treatment Success

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 10, 2023
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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