Digital ACT Psychological Support for Primary Caregivers of Older Adults With Severe Mental Illness (DACT-Care)

November 6, 2026 updated by: Hao Zhang, Harbin Medical University

Development and Effectiveness Evaluation of a Digital ACT-Based Psychological Support Program for Primary Caregivers of Older Adults With Severe Mental Illness in Less Developed Regions

The goal of this clinical trial is to evaluate the effect of a digital Acceptance and Commitment Therapy (ACT)-based psychological support program for primary caregivers of older adults with severe mental disorders (SMD) in underdeveloped regions. It will also assess the feasibility and acceptability of this WeChat-mini-program-based intervention. The main questions it aims to answer are:

Does the digital ACT-based psychological support program improve psychological flexibility and family functioning among primary caregivers of older adults with SMD? Can this digital intervention improve psychological distress, perceived social support, caregiver needs-resources and disease-care-related knowledge for participating caregivers?

Researchers will compare digital ACT-based psychological support plus identical routine psychological support versus the same routine psychological support plus daily general mental-health and care-related popular-science reading materials to see whether the digital ACT program produces better outcomes.

Participants will:

Receive assigned 8-week study-related daily content on the basis of identical routine psychological support Complete online-or-paper-based questionnaires at baseline, immediately after intervention, and 1-month follow-up Take part in brief follow-up reminders via phone or WeChat during the study

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a single-center, parallel-group randomized controlled trial conducted in Tieli City, Yichun, Heilongjiang Province, China. A total of 64 eligible primary caregivers of older adults (≥60 years old) with severe mental disorders (SMD) will be enrolled and randomly assigned at a 1:1 ratio, with 32 participants in the intervention group and 32 participants in the control group. The sample-size calculation was performed using G*Power 3.1.9.7 for repeated-measures ANOVA (group-by-time interaction): effect size f = 0.25, α = 0.05, power (1-β) = 0.95, 2 groups, 3 measurement time-points. The calculated minimum analyzable sample size is 44 participants. A 30 % anticipated attrition rate was added, leading to the final recruitment target of 64 participants.

All participants in both groups will receive identical routine psychological support, including regular disease-related and care-related knowledge education and basic empathetic listening provided via telephone and WeChat three times per week.

Participants allocated to the intervention group will additionally receive an 8-week digital psychological support program based on Acceptance and Commitment Therapy (ACT), delivered through a lightweight WeChat mini-program. The ACT training module is the core component and consists of eight sequentially unlocked weekly sessions: an ACT introduction session using a choice-point tool to identify experiential avoidance, followed by acceptance, cognitive defusion, contacting the present moment, observing self, values clarification, and committed action, and a final session of review and consolidation. Each session combines short video or illustrated texts, scenario-based comprehension items and a guided self-reflection exercise. Scenario items are built on real caregiving situations and use neutral response options without negative feedback, in line with the accepting stance of ACT. The program delivers a pre-planned daily schedule consisting of six learning days and one weekly review day: each learning day requires approximately 7-8 minutes (a 2-minute optional daily emotion check-in plus 5-6 minutes of core learning content), and the weekly review day requires approximately 10 minutes of emotion-data review, knowledge consolidation and practice. Three supplementary modules can be used on demand without a fixed sequence: an emotion check-in module (daily emotion record, personal emotion calendar and structured emotional review), a caregiving skill workshop (management of acute relapse, medication refusal and hoarding, self-harm and suicide risk, aggressive behavior and emergency referral, routine home care skills, SMD knowledge education and scenario-based practice), and a resource navigation module (national, provincial, municipal and county-level mental health policies, local designated psychiatric facilities, welfare subsidies and medical insurance reimbursement procedures). Local grassroots staff will provide simple operational guidance and adherence reminders by phone or WeChat, without interpreting ACT professional content.

Participants in the control group will maintain the same daily contact frequency and overall time burden as the intervention group. General mental-health and care-related popular-science reading materials without any ACT-related or other psychological-regulation training content will be delivered via WeChat every day over the 8-week period, with reading duration (approximately 7-8 minutes per day) and total reading load matched to the daily learning volume of the intervention group. Participants only need to read the materials, with no homework, reflection tasks or interactive psychological exercises. Both groups receive no additional psychological treatment during the study period.

Outcome assessments will be performed at three time-points: baseline (T0, before randomization), immediately after completion of the 8-week intervention (T1), and one-month follow-up after intervention termination (T2). Questionnaires can be completed online via QR-code or using identical paper versions for participants with limited digital operation ability. The primary outcome is psychological flexibility measured by the Chinese version of the Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT), a 23-item instrument covering the dimensions of openness to experience, awareness and engaged action, scored on a 7-point Likert scale from 0 (never) to 6 (always), with higher total scores indicating greater psychological flexibility. Secondary outcomes include: family functioning measured by the Chinese revised Family Assessment Device (FAD), a 30-item scale covering affective involvement, positive communication, self-absorption, problem solving and family rules, scored on a 4-point Likert scale (total range 30-120, higher scores indicating better family functioning); psychological distress measured by the 12-item General Health Questionnaire (GHQ-12, Zhang Mingyuan Chinese version), a 12-item self-report screening instrument scored continuously; caregiver needs and resources measured by the Chinese version of the Caregiver Needs and Resources Assessment (CNRA), a 36-item instrument with two dimensions (needs and resources) across 12 domains, two reverse-scored items, scored on a 5-point Likert scale; disease- and care-related knowledge measured by an instrument adapted from the schizophrenia knowledge-attitude-practice awareness questionnaire, covering disease attribution, risk factors, treatment and social rehabilitation across 30 items and reworded for caregivers of older adults with SMD; and perceived social support measured by the Chinese version of the Perceived Social Support Scale (PSSS), a 12-item instrument covering family, friend and other support scored on a 7-point Likert scale. Objective system-usage logs (login frequency, module completion, learning-day adherence) and a self-reported satisfaction questionnaire will be collected to evaluate intervention feasibility and acceptability.

All adverse events and unanticipated problems reported by participants or identified through routine contact will be recorded and reported to the ethics committee. Participants are free to withdraw at any time without affecting their routine care.

After finishing all research assessments, participants in the control group will be granted full access to the digital ACT psychological support mini-program as a benefit for study participation.

Statistical analysis will follow modified intention-to-treat (mITT) and per-protocol (PP) principles. Generalized linear mixed models will be applied to examine group-by-time interaction effects for outcome indicators, with baseline values and covariates adjusted as appropriate. Missing data will be handled by multiple imputation, with sensitivity analysis conducted.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Primary family caregiver of an older adult (≥60 years) with severe mental disorder, aged 18 years or older.

Having basic cognitive ability (Mini-Cog score of 3, or 1-2 with normal Clock Drawing Test) and basic reading ability.

Willing to participate and providing signed informed consent.

Exclusion Criteria:

Currently participating in another psychological intervention study, or having received structured psychological support within the past 3 months.

Family experienced a major adverse event within the past 6 months (such as bereavement, major financial crisis, or natural disaster).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ACT digital intervention group

Participants receive a 4-week digital Acceptance and Commitment Therapy intervention. Daily 7-8 minutes fragmented ACT training for family caregivers of people with severe mental disorders.
Behavioral: Acceptance and Commitment Therapy (ACT) digital intervention

An 8-week digital Acceptance and Commitment Therapy (ACT) intervention delivered via WeChat for family caregivers of people with severe mental disorders. It includes daily 7-8 minute fragmented ACT training modules covering acceptance, cognitive defusion, self-as-context, values, and committed action practice.
Active Comparator: Routine care control group

Participants receive routine care and general caregiver health education, without access to the ACT digital intervention.
Behavioral: Routine care and general health education

Routine supportive care and general health education delivered through WeChat educational posts for family caregivers of people with severe mental disorders. Participants will not receive the 8-week digital ACT intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Psychological flexibility
Time Frame: 12 weeks

Psychological flexibility was assessed using the Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT) questionnaire developed by Francis et al. This study employed the Chinese version translated by Fang et al. The scale consists of 23 items across three dimensions: Openness, Awareness, and Action. It uses a 7-point Likert scale ranging from "Never" to "Always," scored from 0 to 6, with higher total scores indicating a greater level of psychological flexibility
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Family function
Time Frame: 12 weeks

Family function assessed by the Family Assessment Device (FAD), comprising 30 items across five dimensions, scored on a 4-point Likert scale (30-120). Higher scores indicate better family function.
12 weeks
Caregiver Needs and Resources
Time Frame: 12 weeks

Caregiver needs and resources were assessed using the Caregiver Needs and Resources Assessment (CNRA) scale developed by Li et al. The scale consists of 36 items across two dimensions (Needs and Resources) and 12 domains, with 2 of the items being reverse-scored. It employs a 5- point Likert scale ranging from "Never" to "Extremely Much," scored from 1 to 5. Higher scores indicate more pronounced levels of the corresponding needs or resources.
12 weeks
Psychological distress
Time Frame: 12 weeks

Psychological distress measured by the 12-item General Health Questionnaire (GHQ-12), a self-report screening tool covering anxiety, depression, and impaired social functioning.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harbin Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Quanzhi Zhang, PhD, Harbin Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HMUDQ20251221001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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