Clinical trial NCT06072209: Long-term Effects ReSet Your Mind - Mechanisms
Official title: Long-term Effects of an Online Intervention Targeting Depression and Reward Sensitivity - Predictors and Mechanisms of Treatment Success
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression Mild
Depression Moderate
Keywords: reward sensitivity
reward processing
depression
randomized controlled trial
online intervention
behavioral activation
mindfulness
gratitude
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Depressive symptoms (Patient Health Questionnaire-9, PHQ-9)
timeFrame: baseline, post intervention (after 2 weeks), 4 months follow-up
measure: Reward sensitivity (Positive Valence System Scale-21, PVSS-21)
timeFrame: baseline, post intervention (after 2 weeks), 4 months follow-up
measure: Anhedonia (Snaith-Hamilton-Pleasure-Scale, SHAPS-D)
timeFrame: baseline, post intervention (after 2 weeks), 4 months follow-up
measure: Change in Stress level (Perceived-Stress-Scale 10, PSS-10)
timeFrame: baseline, post intervention (after 2 weeks), 4 months follow-up
measure: Change in Depressive Expectations (Depressive Expectations Scale, DES)
timeFrame: baseline, post intervention (after 2 weeks), 4 months follow-up
measure: Amount of physical activity reported during intervention exercises
timeFrame: during intervention
measure: Amount of social encounters reported during intervention exercises
timeFrame: during intervention
Secondary outcomes:
measure: Personality traits (Big Five Inventory 10, BFI-10)
timeFrame: Baseline, post intervention (after 2 weeks), four months follow-up]
measure: Adherence
timeFrame: post intervention (after 2 weeks), 4 months follow-up
measure: Treatment expectation (Generic Rating for Treatment Pre-Experiences, Treatment Expectations, and Treatment Effects, G-EEE)
timeFrame: Baseline, post intervention (after 2 weeks), 4 months follow-up
measure: Treatment credibility and expectancy (Credibility/Expectancy Questionnaire, CEQ)
timeFrame: Baseline
measure: Trait reward responsiveness (Reward Responsiveness Scale, RRS)
timeFrame: Baseline, post intervention (after 2 weeks), 4 months follow-up
Other outcomes:
measure: Sociodemographic variables
timeFrame: baseline
measure: Perceived system usability (System usability Scale, SUS), general feedback about the online intervention
timeFrame: post intervention (after 2 weeks)
measure: Problems and obstacles during the intervention
timeFrame: post intervention (after 2 weeks)
Locations:
city: Marburg
country: Germany
facility: Philipps University
Study officials:
affiliation: Dept. of Clinical Psychology and Psychotherapy, Philipps-University Marburg, Germany
name: Winfried Rief, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: